Long-Term Efficacy and Safety of Risankizumab in Patients with Active Psoriatic Arthritis: Results from a 76-Week Phase 2 Randomized Trial.

Content Provider	Europe PMC
Author	Mease, Philip J. Kellner, Herbert Morita, Akimichi Kivitz, Alan J. Aslanyan, Stella Padula, Steven J. Topp, Andrew S. Eldred, Ann Behrens, Frank Papp, Kim A.
Abstract	IntroductionThe objective of this work was to assess the efficacy and safety of risankizumab in psoriatic arthritis (PsA) over 76 weeks.MethodsIn this double-blind, dose-ranging phase 2 study, adults with active PsA were randomized 2:2:2:1:2 to risankizumab 150 mg at weeks 0, 4, 8, 12, and 16 (arm 1), 150 mg at weeks 0, 4, and 16 (arm 2), 150 mg at weeks 0 and 12 (arm 3), 75 mg at week 0 (arm 4), or placebo (arm 5). Patients completing week 24 could receive risankizumab 150 mg in a 52-week open-label extension study. Efficacy assessments included American College of Rheumatology (ACR) responses, Psoriasis Area Severity Index (PASI) responses, minimal disease activity (MDA), and 28-joint Disease Activity Score based on C-reactive protein (DAS28[CRP]).ResultsOf 185 randomized patients, 173 (93.5%) completed week 16 and 145 (78.4%) entered the open-label extension. Significantly more patients in each risankizumab arm achieved ACR20 at week 16 versus placebo (primary endpoint: pooled arms 1 + 2 [59.5%] versus placebo [35.7%]; treatment difference [90% CI] 24.0 [9.3, 38.7]; P = 0.007). Similarly, significantly more patients in most risankizumab arms achieved ACR20/50/70, PASI75/90/100, MDA, and greater improvements in DAS28(CRP) versus placebo at week 16. These benefits of risankizumab were maintained long term. Treatment-emergent adverse events were comparable across treatment arms. Risankizumab 150 mg was well tolerated over 76 weeks.ConclusionsRisankizumab improved joint and skin symptoms versus placebo in patients with active PsA over 16 weeks; improvements were sustained long term. Risankizumab was well tolerated over the long term with no new safety findings.Trial Registration NumbersNCT02719171 and NCT02986373.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40744-022-00474-5.
Related Links	https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC9510089&blobtype=pdf
ISSN	21986576
Journal	Rheumatology and Therapy [Rheumatol Ther]
Volume Number	9
DOI	10.1007/s40744-022-00474-5
PubMed Central reference number	PMC9510089
Issue Number	5
PubMed reference number	35931879
e-ISSN	21986584
Language	English
Publisher	Springer Healthcare
Publisher Date	2022-08-05
Publisher Place	Cheshire
Access Restriction	Open
Rights License	Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/. © The Author(s) 2022
Subject Keyword	Interleukins Psoriatic arthritis Randomized trial Risankizumab
Content Type	Text
Resource Type	Article
Subject	Immunology and Allergy Rheumatology