Long‐term efficacy and safety of risankizumab for the treatment of moderate‐to‐severe plaque psoriasis: interim analysis of the LIMMitless open‐label extension trial beyond 3 years of follow‐up. (1st December 2021)

• Record Type: Journal Article
• Authors: Papp, K.A.; Lebwohl, M.G.; Puig, L.; Ohtsuki, M.; Beissert, S.; Zeng, J.; Rubant, S.; Sinvhal, R.; Zhao, Y.; Soliman, A.M.; Alperovich, G.; Leonardi, C.
• Is Part Of: British journal of dermatology. Volume 185:Number 6(2021)
• Page Start: 1135
• Page End: 1145
• Publication Date: 2021-12-01
• Subjects: Dermatology -- Periodicals; Skin -- Diseases -- Periodicals; 616.5
• DOI: 10.1111/bjd.20595
• Languages: English
• ISSNs: 0007-0963

Abstract

Summary: Background: Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long‐term evaluation to assess the durability of their efficacy and safety profiles over time. Objectives: To evaluate the long‐term efficacy and safety of risankizumab (RZB) for the treatment of psoriasis. Methods: LIMMitless is an ongoing, phase III, open‐label extension study evaluating the long‐term efficacy and safety of RZB in adults with moderate‐to‐severe plaque psoriasis following multiple phase II/III studies. This analysis assessed efficacy through 172 weeks of continuous RZB treatment by examining the proportion of patients achieving ≥ 90% or 100% improvement in Psoriasis Area and Severity Index (PASI 90 and PASI 100), static Physician's Global Assessment of clear or almost clear (sPGA 0/1) and Dermatology Life Quality Index of no effect on quality of life (DLQI 0/1). Safety was assessed by recording adverse events (AEs) through the data cutoff date. The study is registered at ClinicalTrials.gov (identifier: NCT03047395). Results: Of 955 patients randomized to RZB 150 mg in the base studies, 897 patients continued into LIMMitless; 799 patients were still receiving treatment in LIMMitless at the time of data cutoff for this analysis. After 172 weeks of continuous RZB treatment, 85·5% of patients achieved PASI 90, 54·4% achieved PASI 100, 85·2% achieved sPGA 0/1, and 78·4% achieved DLQI 0/1 using modified nonresponder imputation. Rates of AEs leading to discontinuation and AEs of safety interest were low with long‐term treatment and comparable with those identified in the base studies. Conclusions: Overall, long‐term continuous RZB was well tolerated and showed high and durable efficacy over 172 weeks.