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.
Psoriasis is a chronic inflammatory skin disease requiring prolonged treatment. New biologic therapies require long-term evaluation to assess durability of their efficacy and safety profile over time.To evaluate long-term efficacy and safety of risankizumab (RZB) for the treatment of psoriasis.LIMMitless is an ongoing, phase 3, open-label extension study evaluating long-term efficacy and safety of RZB in adults with moderate-to-severe plaque psoriasis following multiple phase 2/3 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.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 non-responder imputation. Rates of AEs leading to discontinuation and AEs of safety interest were low with long-term treatment and comparable to those identified in the base studies.Overall, long-term continuous RZB was well tolerated and showed high and durable efficacy over 172 weeks.
Authors: K A Papp, M G Lebwohl, L Puig, M Ohtsuki, S Beissert, J Zeng, S Rubant, R Sinvhal, Y Zhao, A M Soliman, G Alperovich, C Leonardi