Title:
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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
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Author:
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Papp, Kim A; Lebwohl, M. G.; Puig Sanz, Lluís; Ohtsuki, M.; Beissert, Stefan; Zeng, J.; Rubant, S.; Sinvhal, R.; Zhao, Y.; Soliman, A.M.; Alperovich, G.; Leonardi, C.
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Abstract:
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AbbVie Inc. |
Abstract:
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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. |
Subject(s):
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-Adult -Antibodies, Monoclonal -Double-Blind Method -Follow-Up Studies -Humans -Psoriasis -Quality of Life -Severity of Illness Index -Treatment Outcome |
Rights:
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open access
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https://creativecommons.org/licenses/by-nc/4.0/ |
Document type:
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Article |
Published by:
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Uri:
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https://ddd.uab.cat/record/270201
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