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Abstract Number: 2L

Efficacy and Safety Results from a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor, in Patients with Active Psoriatic Arthritis

Philip J Mease1, Herbert Kellner2, Akimichi Morita3, Alan J. Kivitz4, Kim A. Papp5, Stella Aslanyan6, Beate Berner7, Kun Chen8, Ann Eldred8 and Frank Behrens9, 1Swedish Medical Center and University of Washington School of Medicine, Seattle, WA, 2Private Practice and Division of Rheumatology KHI Neuwittelsbach, München, Germany, 3Dept of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan, 4Altoona Center for Clinical Research, Duncansville, PA, 5K Papp Clinical Research and Probity Medical Research Inc, Waterloo, ON, Canada, 6Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, 7Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany, 8AbbVie Inc., North Chicago, IL, 9CIRI/Rheumatology and Fraunhofer Institute IME, Translational Medicine and Pharmacology, Goethe University, Frankfurt, Germany

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: October 19, 2017

Keywords: IL-23, Interleukins (IL) and psoriatic arthritis, Late-Breaking 2017

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Session Information

Date: Tuesday, November 7, 2017

Session Title: ACR Late-Breaking Abstract Session

Session Type: ACR Late-breaking Abstract Session

Session Time: 4:30PM-6:00PM

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.

To cite this abstract in AMA style:

Mease PJ, Kellner H, Morita A, Kivitz AJ, Papp KA, Aslanyan S, Berner B, Chen K, Eldred A, Behrens F. Efficacy and Safety Results from a Phase 2 Trial of Risankizumab, a Selective IL-23p19 Inhibitor, in Patients with Active Psoriatic Arthritis [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-results-from-a-phase-2-trial-of-risankizumab-a-selective-il-23p19-inhibitor-in-patients-with-active-psoriatic-arthritis/. Accessed January 16, 2021.
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