@article{10902/27887,
year = {2022},
month = {10},
url = {https://hdl.handle.net/10902/27887},
abstract = {Objective: Psoriatic arthritis (PsA) is a chronic inflammatory disease in which the skin and joints are affected. 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 two biologic therapies (Bio-IR) or one or more conventional synthetic disease-modifying antirheumatic drug (csDMARD-IR) were evaluated.

Methods: In the ongoing, phase 3, KEEPsAKE 2 trial, patients with active PsA were randomized 1:1 to receive subcutaneous risankizumab 150 mg or placebo at weeks 0, 4 and 16 (period 1). At week 24 (period 2), patients who received placebo were switched to risankizumab, and all patients received risankizumab 150 mg every 12 weeks from weeks 28-208.

Results: At week 24, 51.3% of risankizumab-treated patients (N = 224) achieved ?20% improvement in American College of Rheumatology criteria (ACR20) vs 26.5% of placebo-treated patients (N = 220; P < 0.001). At week 52, 58.5% of patients randomized to receive continuous risankizumab achieved ACR20, and 55.7% of patients who switched from placebo to risankizumab at week 24 achieved ACR20. Similar trends were observed for other efficacy measures. Rates of serious treatment-emergent adverse events (TEAEs) and TEAEs leading to discontinuation remained stable through week 52, and no deaths were reported.

Conclusion: Risankizumab was well tolerated and improved symptoms of PsA in Bio-IR/csDMARD-IR patients, with a consistent long-term safety profile from weeks 24-52.},
organization = {Funding: This work was supported by AbbVie, Inc. (North Chicago, IL, USA)
Acknowledgements: 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. Medical writing support, funded by AbbVie, was provided by Spencer Hughes, PhD, Jay Parekh, PharmD, and Melissa Julyanti, PharmD, of JB Ashtin, who developed the manuscript based on an author-approved outline and assisted in implementing author revisions throughout the editorial process. JB Ashtin adheres to Good Publication Practice (GPP3) guidelines and International Committee of Medical Journal Editors (ICMJE) recommendations. Disclosure statement: A.Ö. has received speaker or consulting fees and/or research grants from AbbVie, Bristol Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi and UCB. F.V.dB. has received speaker and/or consulting fees from AbbVie, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer 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, Lilly, LEO Pharma, MedImmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Stiefel, Sun Pharma, Takeda and UCB. C.A. has received honoraria or fees for serving on advisory boards or as a speaker, as well as research support from AbbVie, Amgen, Genentech, Janssen, Lilly, Pfizer, Roche and R-Pharm. R.B. has received grants or research support from AbbVie, Merck and Roche. He has received consultation fees or honoraria for serving as a speaker for AbbVie, Bristol Myers Squibb, Janssen, Lilly, Merck, Pfizer and Roche. J.A. has received grants or research support from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Galapagos/Gilead, Genentech, GlaxoSmithKline, Lilly, Mallinckrodt, Nektar Therapeutics, Nichi-Iko, Novartis, Pfizer, Regeneron, Roche, Sanofi, Selecta Biosciences and UCB. W.L., A.E., and B.P. are fulltime employees of AbbVie, and may hold AbbVie stock or stock options. A.M.S. is a full-time employee of AbbVie, may hold AbbVie stock or stock options and is a co-inventor on AbbVie patents. Z.W. is a former employee of AbbVie and may hold AbbVie stock. A.K. is a shareholder of or has received honoraria or fees as a consultant, speaker, or expert witness for AbbVie, Boehringer Ingelheim, Celgene, Flexion, Gilead, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma and UCB.},
publisher = {Oxford University Press},
publisher = {Rheumatology, keac605},
title = {Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 2 study},
author = {Östör, Andrew and Van den Bosch, Filip and Papp, Kim and Asnal, Cecilia and Blanco Alonso, Ricardo and Aelion, Jacob and Lu, Wenjing and Wang, Zailong and Soliman, Ahmed M. and Eldred, Ann and Padilla, Byron and Kivitz, Alan},
}