OP0228 EFFICACY AND SAFETY OF RISANKIZUMAB FOR ACTIVE PSORIATIC ARTHRITIS, INCLUDING PATIENTS WITH INADEQUATE RESPONSE OR INTOLERANCE TO BIOLOGIC THERAPIES: 24-WEEK RESULTS FROM THE PHASE 3, RANDOMIZED, DOUBLE-BLIND, KEEPSAKE 2 TRIAL
Authors: A. Ostor, F. Van den Bosch, K. Papp, C. Asnal, R. Blanco, J. Aelion, G. Alperovich, Y. Zhang, Z. Wang, A. M. Soliman, A. Eldred, A. Kivitz
Journal: Annals of the Rheumatic Diseases (2021)

Background: Risankizumab (RZB) is a humanized immunoglobin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding its p19 subunit. RZB is being investigated as a treatment for adults with psoriatic arthritis (PsA). Objectives: To compare the efficacy and safety of RZB vs placebo (PBO) for the treatment of active PsA in patients who have had inadequate response or intolerance to 1 or 2 biologic therapies (Bio-IR) or to ≥ 1 conventional synthetic disease modifying antirheumatic drug (csDMARD-IR). Methods: KEEPsAKE 2 ( NCT03671148 ) enrolled adults with active PsA (≥ 5 swollen joints [SJC] and ≥ 5 tender joints [TJC]) who were Bio-IR or csDMARD-IR. Patients were randomized to receive blinded subcutaneous RZB 150 mg or PBO at weeks 0, 4, and 16. The primary endpoint was the proportion of patients achieving ≥ 20% improvement in American College of Rheumatology score (ACR20) at week 24. Ranked secondary endpoints and other secondary endpoints are shown in the Table. Safety was assessed throughout the study. Results reported here are from the 24-week double-blind period; the open-label period with all patients receiving RZB is ongoing. Results: A total of 443 patients (RZB, N = 224; PBO, N = 219) were included in the analysis. Demographics and baseline disease characteristics were similar across treatment arms (mean SJC: 13.3; mean TJC: 22.6; mean duration of PsA: 8.2 years; mean body surface area involved with psoriasis [BSA] in patients with BSA ≥ 3%: 12.1%); 206 patients (46.5%) were Bio-IR. Significantly greater proportions of RZB-treated patients vs PBO-treated patients achieved the primary endpoint (51.3% vs 26.5%, respectively; P &lt; .001) and all ranked secondary endpoints ( P &lt; .001 for all except for Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue; P &lt; .009]; Table). Other secondary outcomes also showed improvement for RZB- vs PBO-treated patients (Table). Serious adverse events were reported for 4.0% and 5.5% of RZB- and PBO-treated patients, respectively; serious infections were reported for 0.9% and 2.3%. Conclusion: RZB resulted in significantly greater improvements in signs and symptoms of PsA compared with PBO and was well tolerated in patients who were Bio-IR or csDMARD-IR. Disclosure of Interests: Andrew Ostor Speakers bureau: AÖ 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., Consultant of: AÖ 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., Grant/research support from: AÖ 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., Filip van den Bosch Speakers bureau: FVdB has received speaker and/or consulting fees from Abbvie, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB., Consultant of: FVdB has received speaker and/or consulting fees from Abbvie, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB., Kim Papp Speakers bureau: KP 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., Consultant of: KP 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., Grant/research support from: KP 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., CECILIA ASNAL Speakers bureau: CA has received honoraria or fees for serving on advisory boards or as a speaker, as well as research support from AbbVie, Genentech, Janssen, Lilly, Pfizer, and Roche., Grant/research support from: CA has received honoraria or fees for serving on advisory boards or as a speaker, as well as research support from AbbVie, Genentech, Janssen, Lilly, Pfizer, and Roche., Ricardo Blanco Speakers bureau: RB has received grants or research support from AbbVie, Merck, and Roche; and has received consultation fees or honoraria for serving as a speaker for AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Merck, Pfizer, and Roche., Consultant of: RB has received grants or research support from AbbVie, Merck, and Roche; and has received consultation fees or honoraria for serving as a speaker for AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Merck, Pfizer, and Roche., Grant/research support from: RB has received grants or research support from AbbVie, Merck, and Roche; and has received consultation fees or honoraria for serving as a speaker for AbbVie, Bristol-Myers Squibb, Janssen, Lilly, Merck, Pfizer, and Roche., Jacob Aelion Grant/research support from: JA 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., Gabriela Alperovich Shareholder of: GA is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Employee of: GA is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Ying Zhang Shareholder of: YZ is a former AbbVie employee, and may hold AbbVie stock or stock options., Employee of: YZ is a former AbbVie employee, and may hold AbbVie stock or stock options., Zailong Wang Shareholder of: ZW is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Employee of: ZW is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Ahmed M. Soliman Shareholder of: AS is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Employee of: AS is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Ann Eldred Shareholder of: AE is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Employee of: AE is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Alan Kivitz Shareholder of: AK 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., Speakers bureau: AK 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., Consultant of: AK 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.