@article{10902/32934,
year = {2024},
url = {https://hdl.handle.net/10902/32934},
abstract = {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 csDMARD-IR and bDMARD-IR.},
organization = {Funding: AbbVie funded this study and participated in the study design, study research, data collection, analysis, and interpretation of data, reviewing, and approval of this manuscript. The Rapid Service Fee of this manuscript was funded by AbbVie.
Acknowledgements: AbbVie and the authors thank all study investigators for their contributions and the patients who participated in this study.},
publisher = {Springer Nature},
publisher = {Rheumatology and Therapy, 2024},
title = {Efficacy and safety of risankizumab for active psoriatic arthritis: 100-Week results from the KEEPsAKE 2 randomized clinical trial},
author = {Östör, Andrew and Van den Bosch, Filip and Papp, Kim and Asnal, Cecilia and Blanco Alonso, Ricardo and Aelion, Jacob and Carter, Kyle and Stakias, Vassilis and Lippe, Ralph and Drogaris, Leonidas and Soliman, Ahmed M. and Chen, Michael M. and Padilla, Byron and Kivitz, Alan},
}