CO-PRIMARY ENDPOINTS IN ULTIMMA-1 AND ULTIMMA-2 (NRI)1,2

PASI 90 at Week 16
UltIMMa-1: SKYRIZI 75% (229/304),
placebo 5% (5/102) p<0.0001
UltIMMa-2: SKYRIZI 75% (220/294),
placebo 2% (2/98) p<0.0001
sPGA 0/1 at Week 16
UltIMMa-1: SKYRIZI 88% (267/304),
placebo 8% (8/102) p<0.0001
UltIMMa-2: SKYRIZI 84% (246/294),
placebo 5% (5/98) p<0.0001
Study Design: UltIMMa-1 (N=506) and UltIMMa-2 (N=491) were replicate phase 3, randomized, double-blind, placebo- and active-controlled studies to evaluate the efficacy and safety of SKYRIZI (150 mg) vs placebo over 16 weeks and biologic active control (45 mg or 90 mg, based on screening weight) over 52 weeks in adult patients with moderate to severe plaque psoriasis. Patients received SKYRIZI 150 mg at Week 0, Week 4, and every 12 weeks thereafter.1,2
NRI=nonresponder imputation.

Superior Skin Clearance Data vs 2 Orals

SKYRIZI WAS STUDIED AGAINST OTEZLA® (apremilast) AND SOTYKTU® (deucravacitinib) IN 2 SEPARATE CLINICAL TRIALS.3,4
IN 2 SEPARATE STUDIES OF PATIENTS WITH MODERATE PLAQUE PSORIASIS
SKYRIZI ACHIEVED HIGHER PASI 90 RATES AT WEEK 163,4
PERIOD A

Co-primary endpoints: PASI 90 and sPGA 0/1 at Week 16
sPGA 0/1 at Week 16: SKYRIZI: 75% (n=89/118),
OTEZLA: 18% (n=43/234)

Secondary endpoint:
PASI 75 at Week 16: SKYRIZI: 85% (n=100/118),
OTEZLA: 19% (n=44/234)

Study Design: IMMpulse was a 2-part, 52-week, phase 4, multicenter, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared with OTEZLA for the treatment of adult subjects with moderate Ps who were candidates for systemic therapy. Patients were eligible for inclusion in the study if they had a baseline PASI ≥12, BSA 10%-15%, and sPGA=3. Patients were randomly assigned (1:2) to either SKYRIZI 150 mg as a single subcutaneous injection at Weeks 0, 4, and 16 and every 12 weeks thereafter or OTEZLA 30 mg orally twice daily, post-titration per label.
*IMMpulse NRI-MI=nonresponder imputation incorporating multiple imputations to handle missing data due to COVID-19.
Co-primary endpoints: PASI 90 and sPGA 0/1 at Week 16
sPGA 0/1 at Week 16: SKYRIZI: 80% (n=105/131),
SOTYKTU: 40% (n=104/262)

Secondary endpoint:
PASI 75 at Week 16: SKYRIZI: 85% (n=100/118),
OTEZLA: 19% (n=44/234)

Study Design: IMMpactful is a 2-part, 52-week, phase 4, multicenter, randomized, open-label, efficacy assessor-blinded study of SKYRIZI compared to SOTYKTU for the treatment of adults with moderate plaque psoriasis who are bio-naive and candidates for systemic therapy. Patients were eligible for inclusion in the study if they had a baseline PASI ≥12, BSA 10%-15%, and sPGA=3. Patients were randomly assigned (1:2) to either SKYRIZI 150 mg as a single subcutaneous injection at Weeks 0 and 4 and every 12 weeks thereafter or SOTYKTU 6 mg daily per label.
†IMMpactful NRI-MI=nonresponder imputation incorporating multiple imputations for missing data that can be reasonably assumed to be missing at random.
Skyrizi brochure

Learn More About How Skyrizi Performed vs 2 Orals

Download the H2H brochure
Visit the SKYRIZI website for more information

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR SKYRIZI® (risankizumab-rzaa)1

Indications

Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.

Important Safety Information

Hypersensitivity Reactions

SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.

Infection

SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.

Tuberculosis (TB)

Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.

Administration of Vaccines

Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age appropriate vaccinations according to current immunization guidelines.

Adverse Reactions

Most common (≥1%) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.



SKYRIZI is available in a 150 mg/mL prefilled syringe and pen.

Please see Full Prescribing Information.

References:
1. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc. 2. Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-661. doi:10.1016/S0140-6736(18)31713-6 3. Stein Gold LF, Bagel J, Tyring SK, et al. Comparison of risankizumab and apremilast for the treatment of adults with moderate plaque psoriasis eligible for systemic therapy: results from a randomized, open-label, assessor-blinded phase IV study (IMMpulse). Br J Dermatol. 2023;189(5):540-552. doi:10.1093/bjd/ljad252 4. Data on file, AbbVie Inc. ABVRRTI81462.

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