Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study
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PsA is a chronic disease with heterogeneous clinical manifestations requiring treatment options with long-term efficacy and safety. In this follow-up analysis, the 52-week efficacy and safety of risankizumab 150 mg in patients with active PsA who had previous inadequate response/intolerance to one or more conventional synthetic DMARDs (csDMARD-IR) were evaluated.
Methods
KEEPsAKE 1 is an ongoing, global, phase 3 study with a 24-week, double-blind, placebo-controlled period (period 1) and an open-label extension period (period 2). In period 1, eligible patients were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16. At week 24 (period 2), all continuing patients received open-label risankizumab 150 mg every 12 weeks through week 208.
Results
At week 24, 57.3% of risankizumab-treated patients (n = 483) achieved ≥20% improvement in ACR criteria (ACR20) vs 33.5% of placebo-treated patients (n = 481; P < 0.001). At week 52, 70.0% of patients who were randomized to receive continuous risankizumab therapy and 63.0% of patients who were randomized to receive placebo in period 1 and then receive risankizumab at week 24 achieved ACR20. Similar result trends were observed for other efficacy measures. Risankizumab was well tolerated through 52 weeks of treatment with a consistent safety profile from week 24 through week 52.
Conclusion
In patients with active PsA who were csDMARD-IR, continuous risankizumab treatment demonstrated robust long-term efficacy and was well tolerated through 52 weeks of treatment.
Trial registration
ClinicalTrials.gov, http://clinicaltrials.gov, KEEPsAKE1, NCT03675308.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Rheumatology (United Kingdom) |
| Vol/bind | 62 |
| Udgave nummer | 6 |
| Sider (fra-til) | 2113-2121 |
| Antal sider | 9 |
| ISSN | 1462-0324 |
| DOI | |
| Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:
AbbVie Inc. participated in the study design; study research; collection, analysis and interpretation of data; and writing, reviewing and approving this manuscript. All authors had access to the data and participated in the development, review, approval and decision to submit this manuscript for publication. AbbVie and the authors thank all study investigators for their contributions and the patients who participated in this study. AbbVie funded the research for this study and provided writing support for this manuscript. No honoraria or payments were made for authorship. Medical writing assistance, funded by AbbVie, was provided by Jay H. Parekh, PharmD, and Melissa Julyanti, PharmD, of JB Ashtin.
Funding Information:
Disclosure statement: L.E.K. has received honoraria or fees for serving as a speaker or consultant from AbbVie, Amgen, Biogen, Bristol Myers Squibb, Gilead, Janssen, Lilly, Merck, Novartis, Pfizer and UCB. He has received investigator-initiated study grants from AbbVie, Biogen, Janssen, Lilly, Novartis, Pfizer and UCB. M.K. has received honoraria or fees for serving on advisory boards, as a speaker or as a consultant, and has received grants as a principal investigator from AbbVie, Amgen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, Roche and UCB. K.P. has received honoraria or fees for serving on advisory boards, as a speaker and as a consultant as well as grants as principal investigator from AbbVie, Amgen, Astellas, Bausch Health (Valeant), Baxalta, Baxter, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus, Dermira, EMD Serono, Forward Pharma, Galderma, Genentech, GlaxoSmithKline, Janssen, Kyowa Kirin, LEO Pharma, Lilly, MedImmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Stiefel, Sun Pharma, Takeda and UCB. L.M. has received fees for serving on an advisory board from Lilly. D.W. has received honoraria or fees for serving on advisory boards, as a speaker and as a consultant from AbbVie and Novartis. W.L., A.M.S., A.E. and L.B. are full-time employees of AbbVie, and may hold AbbVie stock or stock options. A.M.S. is listed as an inventor on some AbbVie patents. F.B. has received research grants, honoraria or fees for serving as a consultant or speaker from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Chugai, Galapagos, Genzyme, Gilead, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sandoz and Sanofi. Acknowledgements
Publisher Copyright:
© 2022 The Author(s). Published by Oxford University Press on behalf of the British Society for Rheumatology.
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