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AB0559 EFFICACY AND SAFETY OF RISANKIZUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS AFTER INADEQUATE RESPONSE OR INTOLERANCE TO DMARDs: 24-WEEK RESULTS FROM THE PHASE 3, RANDOMIZED, DOUBLE-BLIND KEEPsAKE 1 TRIAL
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  1. L. E. Kristensen1,
  2. M. Keiserman2,
  3. K. Papp3,
  4. L. Mccasland4,
  5. D. White5,
  6. L. Barcomb6,
  7. W. Lu6,
  8. Z. Wang6,
  9. A. M. Soliman6,
  10. A. Eldred6,
  11. F. Behrens7
  1. 1Copenhagen University, The Parker Institute, Copenhagen, Denmark
  2. 2Pontifical Catholic University, Rheumatology Section, Porto Alegre, Peru
  3. 3Probity Medical Research, K Papp Clinical Research, Waterloo, Canada
  4. 4Loyola University Medical Center, Department of Rheumatology, Maywood, United States of America
  5. 5Waikato Hospital, Rheumatology Department, Hamilton, New Zealand
  6. 6AbbVie, Inc, Not Applicable, North Chicago, United States of America
  7. 7Goethe University Frankfurt, CIRI/Rheumatology & Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt, Germany

Abstract

Background: Risankizumab (RZB) is a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin 23 by binding to 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 conventional synthetic disease modifying antirheumatic drug (csDMARD-IR).

Methods: In KEEPsAKE 1 (NCT03675308), eligible adults (csDMARD-IR with ≥ 5 swollen joints [SJC] and ≥ 5 tender joints [TJC]) were randomized (1:1) 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 and other secondary endpoints are shown in the Table 1. 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: 964 patients (RZB, N = 483; PBO, N = 481) were evaluated at week 24. Demographics and baseline characteristics were generally balanced between treatment groups (mean duration of PsA: 7.12 years; mean SJC: 12.2; mean TJC: 20.6; mean body surface area involved with psoriasis [BSA] in patients with BSA ≥ 3%: 16.7%). A significantly greater proportion of RZB- vs PBO-treated patients (57.3% and 33.5%, respectively) achieved the primary endpoint of ACR20 at week 24 (P < .001; Table 1). Significant differences were also observed for RZB vs PBO for the first 8 ranked secondary endpoints (P < .001 for all; Table 1). Serious adverse events were reported for 2.5% and 3.7% of RZB- and PBO-treated patients, respectively; serious infections were reported for 1.0% and 1.2%. There was 1 death in the RZB group.

Conclusion: RZB resulted in significantly greater improvements in signs and symptoms of PsA compared with PBO and was well tolerated in patients who were csDMARD-IR.

Disclosure of Interests: Lars Erik Kristensen Speakers bureau: LK 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., Consultant of: LK 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., MAURO KEISERMAN Speakers bureau: MK has received honoraria or fees for serving on advisory boards, as a speaker or as a consultant, and grants as a principal investigator from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, Roche, and UCB., Consultant of: MK has received honoraria or fees for serving on advisory boards, as a speaker or as a consultant, and grants as a principal investigator from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, Roche, and UCB., Grant/research support from: MK has received honoraria or fees for serving on advisory boards, as a speaker or as a consultant, and grants as a principal investigator from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Novartis, Pfizer, Roche, 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., Leslie McCasland Speakers bureau: LM has received fees for serving on an advisory board from Lilly., Douglas White Speakers bureau: DW has received honoraria or fees for serving on advisory boards, as a speaker, and as a consultant from AbbVie, Merck, Novartis, and Roche., Consultant of: DW has received honoraria or fees for serving on advisory boards, as a speaker, and as a consultant from AbbVie, Merck, Novartis, and Roche., Lisa Barcomb Shareholder of: LB is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Employee of: LB is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Wenjing Lu Shareholder of: WL is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Employee of: WL is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Zailong Wang Shareholder of: ZE is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Employee of: ZE is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Ahmed M. Soliman Shareholder of: AMS is a full-time employee of AbbVie, and may hold AbbVie stock or stock options., Employee of: AMS 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., Frank Behrens Speakers bureau: FB has received research grants, honoraria, or fees for serving as a consultant or speaker from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Chugai, Galapagos, Genzyme, Gilead, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, and Sanofi., Consultant of: FB has received research grants, honoraria, or fees for serving as a consultant or speaker from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Chugai, Galapagos, Genzyme, Gilead, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, and Sanofi., Grant/research support from: FB has received research grants, honoraria, or fees for serving as a consultant or speaker from AbbVie, Amgen, Boehringer Ingelheim, Celgene, Chugai, Galapagos, Genzyme, Gilead, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, and Sanofi.

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