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Indication
SOTYKTU™ (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Learn more about SOTYKTU, the first and only pill of its kind1,2*
Are you ready to learn about SOTYKTU?
*STUDY DESIGN1
POETYK PSO-1 (N=664) and POETYK PSO-2 (N=1020) were two, 52-week, multicenter, randomized, double-blind, placebo- and active (apremilast 30 mg twice daily)-controlled, Phase 3 studies to evaluate the safety and efficacy of SOTYKTU (6 mg once daily) in adult patients with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy. Patients had a body surface area (BSA) involvement of ≥10%, a Psoriasis Area and Severity Index (PASI) score ≥12, and a static Physician's Global Assessment (sPGA) ≥3 (moderate or severe).
Both studies assessed the responses at Week 16 compared with placebo for the two co-primary endpoints:
- The proportion of patients who achieved at least a 75% improvement in PASI scores from baseline (PASI 75)
- The proportion of patients who achieved an sPGA score of 0 (clear) or 1 (almost clear)
There were multiple ranked secondary endpoints, including:
- The proportion of patients who achieved PASI 75 at Week 16 and Week 24 vs apremilast
- The proportion of patients who achieved at least a 90% improvement in PASI scores from baseline (PASI 90) at Week 16 and Week 24 vs apremilast
- The proportion of patients who achieved a scalp-specific PGA (ss-PGA) score of 0 (clear) or 1 (almost clear) at Week 16 vs placebo and vs apremilast
†STUDY RESULTS1,3-6
Comparison between SOTYKTU and apremilast was a secondary endpoint
Co-primary endpoints:
- PASI 75 at Week 16 for SOTYKTU vs placebo: PSO-1: 58% (n=193/330) vs 13% (n=21/166), P<0.0001; PSO-2: 53% (n=271/511) vs 9% (n=24/255), P<0.0001
- sPGA 0/1 at Week 16 for SOTYKTU vs placebo: PSO-1: 54% (n=178/330) vs 7% (n=12/166), P<0.0001; PSO-2: 50% (n=253/511) vs 9% (n=22/255), P<0.0001
Select secondary endpoints:
- PASI 75 at Week 16 for SOTYKTU vs apremilast: PSO-1: 58% (n=193/330) vs 35% (n=59/168), P<0.0001; PSO-2: 53% (n=271/511) vs 40% (n=101/254), P=0.0004
- PASI 90 at Week 24 for SOTYKTU vs apremilast: PSO-1: 42% (n=140/330) vs 22% (n=37/168), P<0.0001; PSO-2: 32% (n=164/511) vs 20% (n=50/254), P=0.0002
- ss-PGA 0/1 at Week 16 for SOTYKTU vs apremilast in patients with baseline ss-PGA score of ≥3: PSO-1: 70% (n=147/209) vs 39% (n=43/110) P<0.0001; PSO-2: 60% (n=182/305) vs 37% (n=61/166), P<0.0001
LONG-TERM STUDY DESIGN7,8
- Enrollment into POETYK PSO-LTE; patients who completed treatment through Week 52 in either PSO-1 or PSO-2 were eligible to enroll in an optional LTE and be switched to open-label SOTYKTU 6mg once daily
BL=baseline; BSA=body surface area; PASI=psoriasis area and severity index;PASI 90≥90% improvement from baseline PASI score; PGA-F=Physician's Global Assessment of Fingernail; PSSD=Psoriasis Symptoms and Signs Diary; sPGA 0/1=static Physician's Global Assessment, patients achieving clear (0) or almost clear (1) skin; ss-PGA=Scalp-Specific Physician's Global Assessment; TYK2=tyrosine kinase 2.
SUMMARY OF WARNINGS AND PRECAUTIONS
SOTYKTU is associated with the following Warnings and Precautions: Hypersensitivity, Infections, Tuberculosis, Malignancy including Lymphomas, Rhabdomyolysis and Elevated CPK, Laboratory Abnormalities, Immunizations, and Potential Risks Related to JAK Inhibition.
Please see additional Important Safety Information below.
PEER PERSPECTIVES
Hear why SOTYKTU may be the right choice for your adult moderate-to-severe plaque psoriasis patients from others in the dermatology field.
NARRATOR: SOTYKTU, also known as deucravacitinib, is a novel, oral, selective, allosteric TYK2 inhibitor.
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
SOTYKTU is associated with the following warnings and precautions: Hypersensitivity, Infections, Tuberculosis, Malignancy including Lymphomas, Rhabdomyolysis and Elevated CPK, Laboratory Abnormalities, Immunizations, and Potential Risks Related to JAK Inhibition
LAKSHI ALDREDGE: Hi. I’m Lakshi Aldredge, and I'm excited to share my perspective on Sotyktu, a once-daily oral treatment option for adult patients with moderate-to-severe plaque psoriasis. Right now, I'd like to focus on clinical settings where I would consider Sotyktu. 00:00:43 I would consider Sotyktu when looking for a first-line oral systemic option. This is due to its superior skin clearance versus apremilast in the pivotal trials’ safety and efficacy data through two years in clinical trials and once-daily dosing. The once-daily aspect may really appeal to some patients. 00:01:08 In Phase 3 clinical trials POETYK PSO-1 and POETYK PSO-2, Sotyktu not only met co-primary endpoints versus placebo, but also achieved superior skin clearance versus apremilast in several secondary endpoints. As you can see, at week 24 in POETYK PSO-1, Sotyktu achieved a 69% PASI 75 response rate compared with 38% for apremilast. In PSO-2, the rates were 58% versus 38%, respectively. 00:01:49 Sotyktu is associated with the following warnings and precautions: Hypersensitivity; infections; tuberculosis; malignancy, including lymphomas; rhabdomyolysis and elevated CPK; laboratory abnormalities; immunizations; and potential risks related to JAK inhibition. 00:02:22 Sotyktu really demonstrated its efficacy potential with its PASI 90 data where it once again showed superiority to apremilast. At week 24 in POETYK PSO-1, Sotyktu achieved a 42% PASI 90 response rate compared with 22% for apremilast. In PSO-2, the rates were 32% versus 20%, respectively. 00:02:52 Of note, Sotyktu also showed efficacy in a hard-to-treat area, the scalp. At week 16 in POETYK PSO-1, Sotyktu achieved a 70% scalp severity PGA 0 or 1 response compared with 39% for apremilast. In PSO-2, the rates were 60% versus 37%, respectively. 00:03:20 Coupled with this efficacy data, I would also consider Sotyktu’s safety and tolerability profile. Seen here are the rates of the most common adverse reactions reported through week 16 in at least 1% of patients on Sotyktu and more frequently than placebo, which included upper respiratory infections, blood creatinine phosphokinase increase, herpes simplex, mouth ulcers, folliculitis, and acne. 00:03:54 Another measure I would look at is the discontinuation rate within the clinical trial. As you can see on screen, at week 16 the discontinuation rate was 2.4% for Sotyktu, 3.8% for placebo, and 5.2% for apremilast. Please note these studies were not designed to compare the safety of apremilast to Sotyktu. 00:04:25 Some of the observed safety rates for apremilast may differ from those previously reported. Please refer to the apremilast full prescribing information. 00:04:46 As I said, I'm excited about Sotyktu as a once-daily treatment option for adult patients with moderate-to-severe plaque psoriasis. 00:04:57
NARRATOR: IMPORTANT SAFETY INFORMATION INDICATION SOTYKTU (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:
with chronic or recurrent infection
who have been exposed to tuberculosis
with a history of a serious or an opportunistic infection
with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (for example, herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multi dermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, post marketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breast feeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.”
NARRATOR: SOTYKTU, also known as deucravacitinib, is a novel, oral, selective, allosteric TYK2 inhibitor.
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
SOTYKTU is associated with the following warnings and precautions: Hypersensitivity, Infections, Tuberculosis, Malignancy including Lymphomas, Rhabdomyolysis and Elevated CPK, Laboratory Abnormalities, Immunizations, and Potential Risks Related to JAK Inhibition
JAYME HEIM: Hi. I'm Jayme Heim and I'm excited to share with you my perspective on Sotyktu, a once-daily oral treatment option that I have prescribed for a number of my adult patients with moderate-to-severe plaque psoriasis.
00:00:38
Right now, I'd like to take another look at some select Sotyktu data that I find impactful. Before diving into the data, I'd like to remind you that Sotyktu is a first in class TYK2 inhibitor. TYK2 mediates multiple cytokine pathways, such as IL-23. By doing so, TYK2 impacts the production of IL-17. TYK2 is an important link between IL-23 and IL-17, key inflammatory cytokines in moderate-to-severe plaque psoriasis.
00:01:18
For those of us prescribing biologic agents, we are used to talking about the IL-23/IL-17 pathway. It’s exciting to expand that conversation to include Sotyktu, an oral agent with TYK2 inhibition. Now, let’s take another look at some of the clinical trial data for Sotyktu.
00:01:41
In its Phase 3 clinical trials, POETYK PSO-1 and POETYK PSO-2, Sotyktu not only met co-primary endpoints versus placebo, but also achieved a superior skin clearance versus apremilast in several secondary endpoints, which I will now review.
00:02:04
Sotyktu really demonstrates its efficacy potential when we look at its PASI 90 data. At week 24 in POETYK PSO-1, Sotyktu achieved a 42% PASI 90 response rate compared with 22% for apremilast. In PSO-2, the rates were 32% versus 20%, respectively.
00:02:31
Sotyktu is associated with the following warnings and precautions: Hypersensitivity; infections; tuberculosis; malignancy, including lymphomas; rhabdomyolysis and elevated CPK; laboratory abnormalities; immunizations; and potential risks related to JAK inhibition.
00:03:00
Of note, Sotyktu also showed efficacy in a hard-to-treat area, scalp. At week 16 in POETYK PSO-1, Sotyktu achieved a 70% ss-PGA 0/1 response compared with 39% for apremilast. In PSO-2, the rates were 60% versus 37%, respectively.
00:03:26
Another key insight from the clinical trials is the fact that Sotyktu may be appropriate for both systemic naïve and systemic experienced patients. In the POETYK trials, 41% had received prior non-biologic systemic treatment, 35% had received prior biologic treatment, and 42% were naïve to any systemic treatment. At week 16, no differences in response to Sotyktu were identified among systemic naïve and systemic experienced patients, including among biologic experienced.
00:04:06
As you could see on the slide, there was a 40% treatment difference between the PASI 75 response rates for Sotyktu and placebo for patients who were systemic naïve and a 48% treatment difference between the PASI 75 response rates for Sotyktu and placebo for patients who were systemic experienced. Please note that these analysis of predefined subgroups were not ranked primary or secondary endpoints and were analyzed descriptively. They are also associated with limitations that you can see on the slide.
00:04:44
As I said, I’ve prescribed Sotyktu for a lot of my adult patients with moderate-to-severe plaque psoriasis and will continue to consider it as a treatment option for appropriate patients.
00:04:58
NARRATOR: IMPORTANT SAFETY INFORMATION INDICATION SOTYKTU (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:
with chronic or recurrent infection
who have been exposed to tuberculosis
with a history of a serious or an opportunistic infection
with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (for example, herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multi dermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, post marketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breast feeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.”
NARRATOR: SOTYKTU, also known as deucravacitinib, is a novel, oral, selective, allosteric TYK2 inhibitor.
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
SOTYKTU is associated with the following warnings and precautions: Hypersensitivity, Infections, Tuberculosis, Malignancy including Lymphomas, Rhabdomyolysis and Elevated CPK, Laboratory Abnormalities, Immunizations, and Potential Risks Related to JAK Inhibition
MATTHEW BRUNNER: Hi. I'm Matthew Brunner and I'm excited to share my perspective on Sotyktu, a once-daily oral treatment option that I’ve prescribed for a number of my adult patients with moderate-to-severe plaque psoriasis. Right now, I'd like to focus on dosing and evaluations for Sotyktu.
Sotyktu has simple once-daily dosing with one 6 mg tablet right from the start with no loading dose, titrations, or adjustments. There are no known drug interactions, and the tablet can be taken with or without food.
Only an evaluation for tuberculosis is required for treatment initiation, unless patients have known or suspected liver disease. In patients with known or suspected liver disease, evaluate liver enzymes at baseline and thereafter according to routine management. Sotyktu is not recommended for use in patients with severe hepatic impairment. Prior to starting Sotyktu, it is also recommended that immunizations be updated according to current immunization guidelines. Use of live vaccines while on Sotyktu treatment should be avoided.
After starting Sotyktu, all patients should have their serum triglyceride levels evaluated periodically according to clinical guidelines for hyperlipidemia. In my practice, this is something I'm used to doing for my moderate-to-severe plaque psoriasis patients. For context, according to the Sotyktu prescribing information, mean triglycerides increased by 10.3 mg/dl during the 16-week treatment period and by 9.1 mg/dl during the 52-week treatment period in patients treated with Sotyktu.
Sotyktu is associated with the following warnings and precautions: Hypersensitivity; infections; tuberculosis; malignancy, including lymphomas; rhabdomyolysis and elevated CPK; laboratory abnormalities; immunizations; and potential risks related to JAK inhibition.
As someone who has treated moderate-to-severe plaque psoriasis for many years, these types of evaluations are not new to me. Of course, patients may not be as familiar with monitoring as we are. So, when I offer my patients Sotyktu, I explain its dosing, specifically that it’s a 6 mg once-daily tablet. Then I address the requirement for an initial TB evaluation and routine triglyceride monitoring throughout treatment.
If the patient has known or suspected liver disease, I also share the need to evaluate and monitor their liver enzymes. I discuss potential adverse events with every patient and counsel them to let me know if they experience any of those side effects. If they’re comfortable, we initiate treatment with Sotyktu.
NARRATOR: IMPORTANT SAFETY INFORMATION INDICATION SOTYKTU (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:
with chronic or recurrent infection
who have been exposed to tuberculosis
with a history of a serious or an opportunistic infection
with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (for example, herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multi dermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, post marketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breast feeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.”
NARRATOR: SOTYKTU, also known as deucravacitinib, is a n\.\novel, oral, selective, allosteric TYK2 inhibitor.
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
SOTYKTU is associated with the following warnings and precautions: Hypersensitivity, Infections, Tuberculosis, Malignancy including Lymphomas, Rhabdomyolysis and Elevated CPK, Laboratory Abnormalities, Immunizations, and Potential Risks Related to JAK Inhibition
DOUGLAS DIRUGGERIO: Hi. I'm Douglas DiRuggerio and I'm excited to share my perspective on Sotyktu, a once-daily oral treatment that I prescribe for a number of my adult patients with moderate-to-severe plaque psoriasis.
Let’s talk about the mechanism of action of Sotyktu. But before we get into that, it’s very important we understand how TYK2 works. TYK2 is an intracellular enzyme, one of many enzymes that’s implicated in the pathogenesis of psoriasis. TYK2 pairs with JAK1 or JAK2 to mediate multiple cytokine pathways and transmit signals. Specifically for IL-23, an inflammatory cytokine involved in moderate-to-severe plaque psoriasis, TYK2, in combination with JAK2, transmits the signal intracellularly such that IL-17 can be produced downstream.
Sotyktu inhibits TYK2 allosterically by binding to the regulatory domain of TYK2, which is unique across the JAK family. By binding to the regulatory domain of TYK2, Sotyktu inhibits the interaction between the regulatory and catalytic domains of the enzyme. This locks the TYK2 enzyme in a conformation such that ATP is unable to bind. As a result, TYK2 cannot perform its normal function and the downstream activation of STATs is inhibited. This unique allosteric inhibition of TYK2 is something we haven’t seen before. It’s also important to note that the precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness in the treatment of adults with moderate-to-severe plaque psoriasis is currently not known.
Please note the important safety information regarding potential risks related to JAK inhibition on screen. It is not known whether TYK2 inhibition may be associated with the observed or potential adverse reactions of JAK inhibition.
Sotyktu represents a first in new class of medicines with its unique MOA of allosteric inhibition of TYK2. As I’ve said, I prescribe Sotyktu for a lot of my adult patients with moderate-to-severe plaque psoriasis and will continue to consider it as a treatment option for appropriate patients.
NARRATOR: IMPORTANT SAFETY INFORMATION INDICATION SOTYKTU (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:
with chronic or recurrent infection
who have been exposed to tuberculosis
with a history of a serious or an opportunistic infection
with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (for example, herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multi dermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, post marketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breast feeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.”
NARRATOR: SOTYKTU, also known as deucravacitinib, is a novel, oral, selective, allosteric TYK2 inhibitor.
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
SOTYKTU is associated with the following warnings and precautions: Hypersensitivity, Infections, Tuberculosis, Malignancy including Lymphomas, Rhabdomyolysis and Elevated CPK, Laboratory Abnormalities, Immunizations, and Potential Risks Related to JAK Inhibition
LAKSHI ALDREDGE: Hi. I’m Lakshi Aldredge, and I'm excited to share my perspective on Sotyktu, a once-daily oral treatment option for adult patients with moderate-to-severe plaque psoriasis. Right now, I'd like to focus on clinical settings where I would consider Sotyktu. 00:00:43 I would consider Sotyktu when looking for a first-line oral systemic option. This is due to its superior skin clearance versus apremilast in the pivotal trials’ safety and efficacy data through two years in clinical trials and once-daily dosing. The once-daily aspect may really appeal to some patients. 00:01:08 In Phase 3 clinical trials POETYK PSO-1 and POETYK PSO-2, Sotyktu not only met co-primary endpoints versus placebo, but also achieved superior skin clearance versus apremilast in several secondary endpoints. As you can see, at week 24 in POETYK PSO-1, Sotyktu achieved a 69% PASI 75 response rate compared with 38% for apremilast. In PSO-2, the rates were 58% versus 38%, respectively. 00:01:49 Sotyktu is associated with the following warnings and precautions: Hypersensitivity; infections; tuberculosis; malignancy, including lymphomas; rhabdomyolysis and elevated CPK; laboratory abnormalities; immunizations; and potential risks related to JAK inhibition. 00:02:22 Sotyktu really demonstrated its efficacy potential with its PASI 90 data where it once again showed superiority to apremilast. At week 24 in POETYK PSO-1, Sotyktu achieved a 42% PASI 90 response rate compared with 22% for apremilast. In PSO-2, the rates were 32% versus 20%, respectively. 00:02:52 Of note, Sotyktu also showed efficacy in a hard-to-treat area, the scalp. At week 16 in POETYK PSO-1, Sotyktu achieved a 70% scalp severity PGA 0 or 1 response compared with 39% for apremilast. In PSO-2, the rates were 60% versus 37%, respectively. 00:03:20 Coupled with this efficacy data, I would also consider Sotyktu’s safety and tolerability profile. Seen here are the rates of the most common adverse reactions reported through week 16 in at least 1% of patients on Sotyktu and more frequently than placebo, which included upper respiratory infections, blood creatinine phosphokinase increase, herpes simplex, mouth ulcers, folliculitis, and acne. 00:03:54 Another measure I would look at is the discontinuation rate within the clinical trial. As you can see on screen, at week 16 the discontinuation rate was 2.4% for Sotyktu, 3.8% for placebo, and 5.2% for apremilast. Please note these studies were not designed to compare the safety of apremilast to Sotyktu. 00:04:25 Some of the observed safety rates for apremilast may differ from those previously reported. Please refer to the apremilast full prescribing information. 00:04:46 As I said, I'm excited about Sotyktu as a once-daily treatment option for adult patients with moderate-to-severe plaque psoriasis. 00:04:57
NARRATOR: IMPORTANT SAFETY INFORMATION INDICATION SOTYKTU (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:
with chronic or recurrent infection
who have been exposed to tuberculosis
with a history of a serious or an opportunistic infection
with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (for example, herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multi dermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, post marketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breast feeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.”
NARRATOR: SOTYKTU, also known as deucravacitinib, is a novel, oral, selective, allosteric TYK2 inhibitor.
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
SOTYKTU is associated with the following warnings and precautions: Hypersensitivity, Infections, Tuberculosis, Malignancy including Lymphomas, Rhabdomyolysis and Elevated CPK, Laboratory Abnormalities, Immunizations, and Potential Risks Related to JAK Inhibition
JAYME HEIM: Hi. I'm Jayme Heim and I'm excited to share with you my perspective on Sotyktu, a once-daily oral treatment option that I have prescribed for a number of my adult patients with moderate-to-severe plaque psoriasis.
00:00:38
Right now, I'd like to take another look at some select Sotyktu data that I find impactful. Before diving into the data, I'd like to remind you that Sotyktu is a first in class TYK2 inhibitor. TYK2 mediates multiple cytokine pathways, such as IL-23. By doing so, TYK2 impacts the production of IL-17. TYK2 is an important link between IL-23 and IL-17, key inflammatory cytokines in moderate-to-severe plaque psoriasis.
00:01:18
For those of us prescribing biologic agents, we are used to talking about the IL-23/IL-17 pathway. It’s exciting to expand that conversation to include Sotyktu, an oral agent with TYK2 inhibition. Now, let’s take another look at some of the clinical trial data for Sotyktu.
00:01:41
In its Phase 3 clinical trials, POETYK PSO-1 and POETYK PSO-2, Sotyktu not only met co-primary endpoints versus placebo, but also achieved a superior skin clearance versus apremilast in several secondary endpoints, which I will now review.
00:02:04
Sotyktu really demonstrates its efficacy potential when we look at its PASI 90 data. At week 24 in POETYK PSO-1, Sotyktu achieved a 42% PASI 90 response rate compared with 22% for apremilast. In PSO-2, the rates were 32% versus 20%, respectively.
00:02:31
Sotyktu is associated with the following warnings and precautions: Hypersensitivity; infections; tuberculosis; malignancy, including lymphomas; rhabdomyolysis and elevated CPK; laboratory abnormalities; immunizations; and potential risks related to JAK inhibition.
00:03:00
Of note, Sotyktu also showed efficacy in a hard-to-treat area, scalp. At week 16 in POETYK PSO-1, Sotyktu achieved a 70% ss-PGA 0/1 response compared with 39% for apremilast. In PSO-2, the rates were 60% versus 37%, respectively.
00:03:26
Another key insight from the clinical trials is the fact that Sotyktu may be appropriate for both systemic naïve and systemic experienced patients. In the POETYK trials, 41% had received prior non-biologic systemic treatment, 35% had received prior biologic treatment, and 42% were naïve to any systemic treatment. At week 16, no differences in response to Sotyktu were identified among systemic naïve and systemic experienced patients, including among biologic experienced.
00:04:06
As you could see on the slide, there was a 40% treatment difference between the PASI 75 response rates for Sotyktu and placebo for patients who were systemic naïve and a 48% treatment difference between the PASI 75 response rates for Sotyktu and placebo for patients who were systemic experienced. Please note that these analysis of predefined subgroups were not ranked primary or secondary endpoints and were analyzed descriptively. They are also associated with limitations that you can see on the slide.
00:04:44
As I said, I’ve prescribed Sotyktu for a lot of my adult patients with moderate-to-severe plaque psoriasis and will continue to consider it as a treatment option for appropriate patients.
00:04:58
NARRATOR: IMPORTANT SAFETY INFORMATION INDICATION SOTYKTU (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:
with chronic or recurrent infection
who have been exposed to tuberculosis
with a history of a serious or an opportunistic infection
with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (for example, herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multi dermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, post marketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breast feeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.”
NARRATOR: SOTYKTU, also known as deucravacitinib, is a novel, oral, selective, allosteric TYK2 inhibitor.
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
SOTYKTU is associated with the following warnings and precautions: Hypersensitivity, Infections, Tuberculosis, Malignancy including Lymphomas, Rhabdomyolysis and Elevated CPK, Laboratory Abnormalities, Immunizations, and Potential Risks Related to JAK Inhibition
MATTHEW BRUNNER: Hi. I'm Matthew Brunner and I'm excited to share my perspective on Sotyktu, a once-daily oral treatment option that I’ve prescribed for a number of my adult patients with moderate-to-severe plaque psoriasis. Right now, I'd like to focus on dosing and evaluations for Sotyktu.
Sotyktu has simple once-daily dosing with one 6 mg tablet right from the start with no loading dose, titrations, or adjustments. There are no known drug interactions, and the tablet can be taken with or without food.
Only an evaluation for tuberculosis is required for treatment initiation, unless patients have known or suspected liver disease. In patients with known or suspected liver disease, evaluate liver enzymes at baseline and thereafter according to routine management. Sotyktu is not recommended for use in patients with severe hepatic impairment. Prior to starting Sotyktu, it is also recommended that immunizations be updated according to current immunization guidelines. Use of live vaccines while on Sotyktu treatment should be avoided.
After starting Sotyktu, all patients should have their serum triglyceride levels evaluated periodically according to clinical guidelines for hyperlipidemia. In my practice, this is something I'm used to doing for my moderate-to-severe plaque psoriasis patients. For context, according to the Sotyktu prescribing information, mean triglycerides increased by 10.3 mg/dl during the 16-week treatment period and by 9.1 mg/dl during the 52-week treatment period in patients treated with Sotyktu.
Sotyktu is associated with the following warnings and precautions: Hypersensitivity; infections; tuberculosis; malignancy, including lymphomas; rhabdomyolysis and elevated CPK; laboratory abnormalities; immunizations; and potential risks related to JAK inhibition.
As someone who has treated moderate-to-severe plaque psoriasis for many years, these types of evaluations are not new to me. Of course, patients may not be as familiar with monitoring as we are. So, when I offer my patients Sotyktu, I explain its dosing, specifically that it’s a 6 mg once-daily tablet. Then I address the requirement for an initial TB evaluation and routine triglyceride monitoring throughout treatment.
If the patient has known or suspected liver disease, I also share the need to evaluate and monitor their liver enzymes. I discuss potential adverse events with every patient and counsel them to let me know if they experience any of those side effects. If they’re comfortable, we initiate treatment with Sotyktu.
NARRATOR: IMPORTANT SAFETY INFORMATION INDICATION SOTYKTU (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:
with chronic or recurrent infection
who have been exposed to tuberculosis
with a history of a serious or an opportunistic infection
with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (for example, herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multi dermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, post marketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breast feeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.”
NARRATOR: SOTYKTU, also known as deucravacitinib, is a n\.\novel, oral, selective, allosteric TYK2 inhibitor.
SOTYKTU is a tyrosine kinase 2 (TYK2) inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
SOTYKTU is associated with the following warnings and precautions: Hypersensitivity, Infections, Tuberculosis, Malignancy including Lymphomas, Rhabdomyolysis and Elevated CPK, Laboratory Abnormalities, Immunizations, and Potential Risks Related to JAK Inhibition
DOUGLAS DIRUGGERIO: Hi. I'm Douglas DiRuggerio and I'm excited to share my perspective on Sotyktu, a once-daily oral treatment that I prescribe for a number of my adult patients with moderate-to-severe plaque psoriasis.
Let’s talk about the mechanism of action of Sotyktu. But before we get into that, it’s very important we understand how TYK2 works. TYK2 is an intracellular enzyme, one of many enzymes that’s implicated in the pathogenesis of psoriasis. TYK2 pairs with JAK1 or JAK2 to mediate multiple cytokine pathways and transmit signals. Specifically for IL-23, an inflammatory cytokine involved in moderate-to-severe plaque psoriasis, TYK2, in combination with JAK2, transmits the signal intracellularly such that IL-17 can be produced downstream.
Sotyktu inhibits TYK2 allosterically by binding to the regulatory domain of TYK2, which is unique across the JAK family. By binding to the regulatory domain of TYK2, Sotyktu inhibits the interaction between the regulatory and catalytic domains of the enzyme. This locks the TYK2 enzyme in a conformation such that ATP is unable to bind. As a result, TYK2 cannot perform its normal function and the downstream activation of STATs is inhibited. This unique allosteric inhibition of TYK2 is something we haven’t seen before. It’s also important to note that the precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness in the treatment of adults with moderate-to-severe plaque psoriasis is currently not known.
Please note the important safety information regarding potential risks related to JAK inhibition on screen. It is not known whether TYK2 inhibition may be associated with the observed or potential adverse reactions of JAK inhibition.
Sotyktu represents a first in new class of medicines with its unique MOA of allosteric inhibition of TYK2. As I’ve said, I prescribe Sotyktu for a lot of my adult patients with moderate-to-severe plaque psoriasis and will continue to consider it as a treatment option for appropriate patients.
NARRATOR: IMPORTANT SAFETY INFORMATION INDICATION SOTYKTU (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
CONTRAINDICATIONS SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:
with chronic or recurrent infection
who have been exposed to tuberculosis
with a history of a serious or an opportunistic infection
with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (for example, herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multi dermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, post marketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
ADVERSE REACTIONS Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.
SPECIFIC POPULATIONS
Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company’s Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breast feeding should be considered along with the mother’s clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.”
Safety Profile1
Week 16 Safety Profile1
Adverse Reactions That Occurred In ≥1% Of Patients Treated With SOTYKTU and More Frequently Than Placebo Through Week 16 From PSO-1 AND PSO-21
AR=adverse reaction; CPK=creatine phosphokinase.
*Includes upper respiratory tract infection (viral, bacterial, and unspecified), nasopharyngitis, pharyngitis (including viral, streptococcal, and unspecified), sinusitis (includes acute, viral, bacterial), rhinitis, rhinotracheitis, tracheitis, laryngitis, and tonsillitis (including bacterial, streptococcal).1
†Includes oral herpes, genital herpes, herpes simplex, and herpes virus infection.1
‡Includes mouth ulceration, aphthous ulcer, tongue ulceration, and stomatitis.1
§Includes acne, acne cystic, and dermatitis acneiform.1
- Adverse reactions that occurred in <1% of patients in the SOTYKTU group were herpes zoster1
- Infections: In the first 16 weeks, infections occurred in 29% of the SOTYKTU group (116/100 PY) compared to 22% of the placebo group (83.7/100 PY). The majority of infections were non-serious and mild to moderate in severity and did not lead to discontinuation of SOTYKTU. The incidence of serious infections were reported in 5 patients (2.0/100 PY) treated with SOTYKTU, and 2 patients (1.6/100 PY) treated with placebo1
- Malignancies (excluding non-melanoma skin cancer) through Week 52 (total exposure of 986 PY with SOTYKTU) were reported in 3 patients treated with SOTYKTU (0.3/100 PY)1
- During clinical trials, including an open-label extension trial, 3 SOTYKTU patients (0.1/100 PY) developed lymphoma1
PY=patient year.
SELECT IMPORTANT SAFETY INFORMATION:
CONTRAINDICATIONS
SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
WARNINGS AND PRECAUTIONS
Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Why SOTYKTU?
SOTYKTU Demonstrated Superior Clearance vs Apremilast1,3-6*†
SOTYKTU Has Safety Data Available Through 3 Years1,7,8
Once-Daily Dosing1
 |
No dose titration or dose adjustment |
 |
No known drug-to-drug interactions Avoid use with live vaccines |
 |
Can be taken with or without food |
Patient support for your practice
StartHelp to get your patients started on SOTYKTU
StayHelp patients stay on treatment
SaveAssistance to save on treatment
Important Safety Information
Contraindications
SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.
Warnings and Precautions
Hypersensitivity: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.
Infections: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients with psoriasis who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of treatment prior to initiating SOTYKTU in patients:
- with chronic or recurrent infection
- who have been exposed to tuberculosis
- with a history of a serious or an opportunistic infection
- with underlying conditions that may predispose them to infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing, have appropriate antimicrobial therapy initiated and be closely monitored. Interrupt SOTYKTU if a patient develops a serious infection. Do not resume SOTYKTU until the infection resolves or is adequately treated.
Viral Reactivation
Herpes virus reactivation (e.g., herpes zoster, herpes simplex) was reported in clinical trials with SOTYKTU. Through Week 16, herpes simplex infections were reported in 17 patients (6.8 per 100 patient-years) treated with SOTYKTU, and 1 patient (0.8 per 100 patient-years) treated with placebo. Multidermatomal herpes zoster was reported in an immunocompetent patient. During PSO-1, PSO-2, and the open-label extension trial, the majority of patients who reported events of herpes zoster while receiving SOTYKTU were under 50 years of age. The impact of SOTYKTU on chronic viral hepatitis reactivation is unknown. Consider viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting and during therapy with SOTYKTU. If signs of reactivation occur, consult a hepatitis specialist. SOTYKTU is not recommended for use in patients with active hepatitis B or hepatitis C.
Tuberculosis (TB): In clinical trials, of 4 patients with latent TB who were treated with SOTYKTU and received appropriate TB prophylaxis, no patients developed active TB (during the mean follow-up of 34 weeks). One patient, who did not have latent TB, developed active TB after receiving 54 weeks of SOTYKTU. Evaluate patients for latent and active TB infection prior to initiating treatment with SOTYKTU. Do not administer SOTYKTU to patients with active TB. Initiate treatment of latent TB prior to administering SOTYKTU. Consider anti-TB therapy prior to initiation of SOTYKTU in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during treatment.
Malignancy including Lymphomas: Malignancies, including lymphomas, were observed in clinical trials with SOTYKTU. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with SOTYKTU, particularly in patients with a known malignancy (other than a successfully treated non-melanoma skin cancer) and patients who develop a malignancy when on treatment with SOTYKTU.
Rhabdomyolysis and Elevated CPK: Treatment with SOTYKTU was associated with an increased incidence of asymptomatic creatine phosphokinase (CPK) elevation and rhabdomyolysis compared to placebo. Discontinue SOTYKTU if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Laboratory Abnormalities: Treatment with SOTYKTU was associated with increases in triglyceride levels. Periodically evaluate serum triglycerides according to clinical guidelines during treatment. SOTYKTU treatment was associated with an increase in the incidence of liver enzyme elevation compared to placebo. Evaluate liver enzymes at baseline and thereafter in patients with known or suspected liver disease according to routine management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt SOTYKTU until a diagnosis of liver injury is excluded.
Immunizations: Prior to initiating therapy with SOTYKTU, consider completion of all age-appropriate immunizations according to current immunization guidelines including prophylactic herpes zoster vaccination. Avoid use of live vaccines in patients treated with SOTYKTU. The response to live or non-live vaccines has not been evaluated.
Potential Risks Related to JAK Inhibition: It is not known whether tyrosine kinase 2 (TYK2) inhibition may be associated with the observed or potential adverse reactions of Janus Kinase (JAK) inhibition. In a large, randomized, postmarketing safety trial of a JAK inhibitor in rheumatoid arthritis (RA), patients 50 years of age and older with at least one cardiovascular risk factor, higher rates of all-cause mortality, including sudden cardiovascular death, major adverse cardiovascular events, overall thrombosis, deep venous thrombosis, pulmonary embolism, and malignancies (excluding non-melanoma skin cancer) were observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. SOTYKTU is not approved for use in RA.
Adverse Reactions
Most common adverse reactions (≥1% of patients on SOTYKTU and more frequently than with placebo) include upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis and acne.
Specific Populations
Pregnancy: Available data from case reports on SOTYKTU use during pregnancy are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Report pregnancies to the Bristol-Myers Squibb Company's Adverse Event reporting line at 1-800-721-5072.
Lactation: There are no data on the presence of SOTYKTU in human milk, the effects on the breastfed infant, or the effects on milk production. SOTYKTU is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SOTYKTU and any potential adverse effects on the breastfed infant from SOTYKTU or from the underlying maternal condition.
Hepatic Impairment: SOTYKTU is not recommended for use in patients with severe hepatic impairment.
SOTYKTU is available in 6 mg tablets.
INDICATION
SOTYKTU™ (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Limitations of Use:
SOTYKTU is not recommended for use in combination with other potent immunosuppressants.
Please see U.S. Full Prescribing Information, including Medication Guide, for SOTYKTU.
References:
- SOTYKTU [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
- Chimalakonda A, Burke J, Cheng L, et al. Selectivity profile of the tyrosine kinase 2 inhibitor deucravacitinib compared with Janus kinase 1/2/3 inhibitors. Dermatol Ther (Heidelb). 2021;11(5):1763-1776.
- Armstrong AW, Gooderham M, Warren RB, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2023;88(1):29-39.
- Strober B, Thaçi D, Sofen H, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 POETYK PSO-2 trial. J Am Acad Dermatol. 2023;88(1):40-51.
- Data on file. BMS-REF-DEU-0020. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
- Data on file. BMS-REF-DEU-0021. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
- Warren RB, Sofen H, Imafuku S, et al. Deucravacitinib long-term efficacy and safety in plaque psoriasis: 2-year results from the phase 3 POETYK PSO program. Poster presented at: European Academy of Dermatology and Venereology Spring Symposium; May 12-14, 2022; Ljubljana, Slovenia. Poster P465.
- Armstrong AW, Lebwohl M, Warren RB, et al. Deucravacitinib in plaque psoriasis: 3-year safety and efficacy results from the phase 3 POETYK PSO-1 and PSO-2 trials. Oral presentation at: European Academy of Dermatology & Venereology (EADV) Congress; October 11-14, 2023; Berlin, Germany.
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