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Presentation
Efficacy and Safety Results from a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor, in Patients with Active Psoriatic Arthritis. American College of Rheumatology (ACR) Annual Meeting, San Diego CA, Nov. 2017. Arthritis Rheumatol 2017.
American College of Rheumatology (ACR) Annual Meeting (2017)
  • Philip Mease, Providence St. Joseph Health
  • H Kellner
  • A Morita
  • Alan J. Kivitz, Cedars-Sinai Medical Center
  • K Papp
  • S Aslanyan
  • Beate Berner
  • Kun Chen, Zhejiang University
  • A Eldred
  • F Behrens
Abstract
Background/Purpose: Interleukin-23 (IL-23), a key regulator of multiple effector cytokines (including IL-17, IL-22, and TNF), has been implicated in psoriatic lesions, synovitis, enthesitis, and bone erosion. Risankizumab (RZB) is a potent humanized IgG1 mAb that inhibits IL-23 by specifically binding its p19 subunit. The purpose of this Phase 2 study was to investigate the safety and efficacy of RZB in patients (pts) with active psoriatic arthritis (PsA).
Methods: Pts with active PsA were randomized in a 2:2:2:1:2 ratio to receive RZB (150 mg at weeks [Wks] 0, 4, 8, 12, and 16 [Arm 1], 150 mg at Wks 0, 4, and 16 [Arm 2], 150 mg at Wks 0 and 12 [Arm 3], 75 mg single dose at Wk 0 [Arm 4]) or matching placebo (PBO, Arm 5) in this ongoing double-blind, parallel-design, dose-ranging Phase 2 study. Pts were stratified at randomization by prior TNFi use and concurrent MTX use. The primary efficacy endpoint was ACR20 response at Wk 16. Additional efficacy endpoints included ACR50/70, minimal disease activity (MDA), DAS28(CRP), dactylitis count, SPARCC enthesitis index, pain on visual analog scale (VAS), and HAQ-DI; PASI responses were assessed only in pts with psoriasis (PsO) affecting ≥3% body surface area (BSA) at baseline (BL).
Results: Among the 185 pts who were randomized and received the study drug, 172 (93.0%) completed 16 wks of treatment. BL demographics and disease characteristics were similar across treatment arms. The median age was 51 years; 80 (43.2%) pts were female and 89 (49.4%) pts had PsO ≥3% BSA. At BL, dactylitis or enthesitis was present in 56 (30.4%) and 119 (64.7%) pts, respectively; 45 (24.3%) pts had prior TNFi exposure and 106 (57.3%) pts were receiving concomitant MTX. At Wk 16, ACR20 responses were significantly greater in pts receiving RZB (across all arms, 57.1–65.0%) compared with PBO (37.5%, Table 1). PASI75/90/100 responses at Wk 16 were significantly higher in RZB-treated pts compared with PBO. ACR50 responses were numerically higher and improvements in HAQ-DI and enthesitis from BL were numerically greater in RZB arms. At Wk 16, RZB-treated pts achieved significantly higher ACR70 and MDA responses as well as greater improvements in DAS28(CRP) and Pain–VAS. Treatment-emergent adverse events (TEAEs) were comparable across treatment arms (Table 2); the most common TEAE was infection. There were no deaths or cases of tuberculosis in RZB-treated pts; 1 adjudicated major adverse cardiovascular event was reported in RZB arm.
Conclusion: In this Phase 2 study, RZB significantly improved joint and skin symptoms in pts with active PsA. RZB was well-tolerated with no new or unexpected safety findings.

Disclosure: P. J. Mease, AbbVie, Amgen, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Sun Pharma, and UCB, 2,AbbVie, Amgen, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Sun Pharma, and UCB, 5,AbbVie, Amgen, Bristol Myers, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Sun Pharma, and UCB, 8; H. Kellner, AbbVie, BMS, MSD, Novartis, Pfizer, Roche and UCB, 2,AbbVie, BMS, MSD, Novartis, Pfizer, Roche and UCB, 5,AbbVie, BMS, MSD, Novartis, Pfizer, Roche and UCB, 8; A. Morita, AbbVie, Eli Lilly Japan K.K., Janssen Pharmaceutical K. K., Kyowa Hakko Kirin Co., Ltd, Leo Pharma, Maruho Co, Ltd, Mitsubishi-Tanabe Pharma, and Novartis, 2,AbbVie, Eli Lilly Japan K.K., Janssen Pharmaceutical K. K., Kyowa Hakko Kirin Co., Ltd, Leo Pharma, Maruho Co, Ltd, Mitsubishi-Tanabe Pharma, and Novartis, 5,AbbVie, Eli Lilly Japan K.K., Janssen Pharmaceutical K. K., Kyowa Hakko Kirin Co., Ltd, Leo Pharma, Maruho Co, Ltd, Mitsubishi-Tanabe Pharma, and Novartis, 8; A. J. Kivitz, AbbVie, Amgen, Boehringer Ingelheim, Celgene, Genentech, Genzyme, Horizon, Janssen, Merck, Novartis, Pfizer, Sanofi, Sun Pharma Advanced Research, Regeneron, UCB, and Vertex, 5,AbbVie, Amgen, Boehringer Ingelheim, Celgene, Genentech, Genzyme, Horizon, Janssen, Merck, Novartis, Pfizer, Sanofi, Regeneron, UCB, and Vertex, 8; K. A. Papp, AbbVie, Amgen, Astellas, Baxalta, Baxter, BI, BMS, Celgene, Dermira, Lilly, Forward, Galderma, Genentech, GSK, Janssen, Kyowa-Hakko Kirin, Leo, MedImmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi-Genzyme, Stiefel, Sun, Takeda, UCB, and Valeant, 2,AbbVie, Amgen, Astellas, Baxalta, Baxter, BI, BMS, Celgene, Dermira, Lilly, Forward, Galderma, Genentech, GSK, Janssen, Kyowa-Hakko Kirin, Leo, MedImmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi-Genzyme, Stiefel, Sun, Takeda, UCB, and Valeant, 5,AbbVie, Amgen, Astellas, Baxalta, Baxter, BI, BMS, Celgene, Dermira, Lilly, Forward, Galderma, Genentech, GSK, Janssen, Kyowa-Hakko Kirin, Leo, MedImmune, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi-Genzyme, Stiefel, Sun, Takeda, UCB, and Valeant, 8; S. Aslanyan, Boehringer Ingelheim, 3; B. Berner, Boehringer Ingelheim, 3; K. Chen, AbbVie Inc, 1,AbbVie Inc, 3; A. Eldred, AbbVie, 1,AbbVie, 3; F. Behrens, AbbVie, Amgen, Celgene, Chugai, Eli Lilly, Genzyme Janssen, Novartis, Pfizer, Roche, Sandoz, and Sanofi, 2,AbbVie, Amgen, Celgene, Chugai, Eli Lilly, Genzyme Janssen, Novartis, Pfizer, Roche, Sandoz, and Sanofi, 5,AbbVie, Amgen, Celgene, Chugai, Eli Lilly, Genzyme Janssen, Novartis, Pfizer, Roche, Sandoz, and Sanofi, 8.
Disciplines
Publication Date
October, 2017
Citation Information
Philip Mease, H Kellner, A Morita, Alan J. Kivitz, et al.. "Efficacy and Safety Results from a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor, in Patients with Active Psoriatic Arthritis. American College of Rheumatology (ACR) Annual Meeting, San Diego CA, Nov. 2017. Arthritis Rheumatol 2017." American College of Rheumatology (ACR) Annual Meeting (2017)
Available at: http://works.bepress.com/philip-mease/151/