دورية أكاديمية
Efficacy and safety of risankizumab for active psoriatic arthritis: 100-Week results from the KEEPsAKE 2 randomized clinical trial
| العنوان: | Efficacy and safety of risankizumab for active psoriatic arthritis: 100-Week results from the KEEPsAKE 2 randomized clinical trial |
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| المؤلفون: | Östör, Andrew, Van den Bosch, Filip, Papp, Kim, Asnal, Cecilia, Blanco Alonso, Ricardo, Aelion, Jacob, Carter, Kyle, Stakias, Vassilis, Lippe, Ralph, Drogaris, Leonidas, Soliman, Ahmed M., Chen, Michael M., Padilla, Byron, Kivitz, Alan |
| المساهمون: | Universidad de Cantabria |
| المصدر: | Rheumatology and Therapy, 2024 |
| بيانات النشر: | Springer Nature |
| سنة النشر: | 2024 |
| المجموعة: | Universidad de Cantabria: UCrea |
| مصطلحات موضوعية: | bDMARD-IR, csDMARD-IR, IL-23, KEEPsAKE 2, Long-term treatment, Psoriatic arthritis, Risankizumab |
| الوصف: | Introduction: Long-term therapeutic options providing durable response and tolerability are needed for psoriatic arthritis (PsA). The ongoing KEEPsAKE 2 trial is evaluating risankizumab treatment in patients with active PsA who previously had inadequate response/intolerance to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) and/or 1-2 biologic DMARDs (bDMARD-IR). Herein, we report results through 100 weeks of treatment. Methods: KEEPsAKE 2 is a global phase 3 trial. Patients with active PsA were randomized 1:1 to double-blind subcutaneous risankizumab 150 mg or placebo (weeks 0, 4, and 16). At week 24, all patients received open-label risankizumab every 12 weeks until end of study. Efficacy endpoints included achieving ≥20% improvement in PsA symptoms using American College of Rheumatology criteria (ACR20), attaining minimal disease activity (MDA; meeting ≥5/7 criteria of low disease activity and extent), and improving in other measures. Results: At the cutoff date, 345/443 (77.9%) patients were ongoing in the study. ACR20 was achieved in 57.1% and 52.5% of the continuous risankizumab and placebo/risankizumab cohorts, respectively, at week 100 and in 60.0% and 55.8%, respectively, at week 52. In week 52 responders, maintenance of ACR20 at week 100 was achieved in 74.8% (continuous risankizumab) and 78.7% (placebo/risankizumab) of patients. In the continuous risankizumab and placebo/risankizumab cohorts, respectively, MDA was achieved by 33.0% and 33.3% of patients at week 100 and by 27.2% and 33.8% at week 52. Among MDA responders at week 52, maintenance of MDA response was achieved by 83.6% and 73.0% of the continuous risankizumab and placebo/risankizumab cohorts, respectively. Risankizumab was well tolerated through week 100. Conclusions: Risankizumab demonstrated durable efficacy and tolerability through 100 weeks; most patients who achieved ACR20 and MDA responses at week 52 maintained this achievement through week 100. There were no new safety signals in patients who had ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 2198-6576 2198-6584 |
| العلاقة: | https://hdl.handle.net/10902/32934Test |
| DOI: | 10.1007/s40744-024-00657-2 |
| الإتاحة: | https://doi.org/10.1007/s40744-024-00657-2Test https://hdl.handle.net/10902/32934Test |
| حقوق: | © The Author(s) 2024. This 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. ; http://creativecommons.org/licenses/by-nc/4.0Test/ ; openAccess |
| رقم الانضمام: | edsbas.D804CA6F |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 21986576 21986584 |
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| DOI: | 10.1007/s40744-024-00657-2 |