IN AN OPEN-LABEL ASSESSOR BLINDED STUDY, SKYRIZI
DEMONSTRATED SUPERIOR RATES OF PASI 90 AT WEEK 522
SKYRIZI 5 doses a year and COSENTYX 16 doses a year
SECONDARY ENDPOINT DATA2
IN AN OPEN-LABEL, ASSESSOR-BLINDED STUDY, SKYRIZI
DEMONSTRATED SUPERIOR RATES OF PASI 100 AND sPGA 0/1 AT WEEK 52
In this study, 46 patients outside of the US received non–US-licensed secukinumab. Data regarding comparability between US and non-US secukinumab is not publicly available.3
The head-to-head study was an open-label assessor-blinded, 52 week study where patients were randomized 1:1 to receive either SKYRIZI 150 mg (two 75 mg injections) at Weeks 0, 4, and every 12 weeks until the last dose at Week 40, or COSENTYX* 300 mg (two 150 injections); at Weeks 0, 1, 2, 3, 4, and every 4 weeks until the last dose at Week 48.2
The adverse events observed in this study were consistent with those observed in previously reported studies and as described in the full Prescribing Information for SKYRIZI and COSENTYX.* No new safety signals were observed through Week 52.1,2
NRI= Non-responder imputation
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*COSENTYX is a registered trademark of Novartis AG. See US Prescribing Information for further Information.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR SKYRIZI® (risankizumab-rzaa)1
SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Important Safety Information
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.
Pre-Treatment Evaluation for 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.
Prior to initiating SKYRIZI, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with SKYRIZI.
Most common (≥1 %) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
Please see Full Prescribing Information.
- SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc.
- Warren RB, Blauvelt A, Poulin Y, et al. Risankizumab vs secukinumab in patients with moderate-to-severe plaque psoriasis: a phase 3 trial. Presented at the Virtual Annual Meeting of the American Academy of Dermatology; June 12-14, 2020.
- Data on file, ABVRRTI70649.
- Risankizumab versus secukinumab for subjects with moderate to severe plaque psoriasis. ClinicalTrials.gov identifier: NCT03478787. https://clinicaltrials.gov/ct2/show/NCT03478787. Updated September 20, 2019. Accessed March 15, 2020.
- 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.