ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2881

Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with Active Psoriatic Arthritis: Disease Activity and Remission in a 48-Week Phase 2b, Randomized, Double‑Blind, Placebo-Controlled, Dose-Ranging Study

Philip Mease1, Laure Gossec 2, Laura Coates 3, Alice B. Gottlieb 4, Deepak Assudani 5, Barbara Ink 5, Jason Coarse 6, Oscar Irvin-Sellers 5 and Dafna Gladman 7, 1Swedish Medical Center/Providence St Joseph Health, and University of Washington, Seattle, WA, 2Sorbonne Université and Hôpital Pitié-Salpêtrière, Paris, France, 3University of Oxford, Oxford, United Kingdom, 4Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA, Philadelphia, PA, 5UCB Pharma, Slough, UK, Slough, United Kingdom, 6UCB Pharma, Raleigh, NC, USA, Raleigh, NC, 7Toronto Western Hospital, Toronto, Canada, Toronto, ON, Canada

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: , , ,

Session Information

Date: Wednesday, November 13, 2019

Title: 6W014: Spondyloarthritis Including Psoriatic Arthritis – Clinical VII: Psoriatic Arthritis Treatment (2876–2881)

Session Type: ACR Abstract Session

Session Time: 9:00AM-10:30AM

Background/Purpose: The ultimate goal of therapy in patients with psoriatic arthritis (PsA) is clinical remission, defined as ‘the absence of clinical and laboratory evidence of significant inflammatory disease activity’.1,2 Since many patients with PsA may not achieve clinical remission, treatment recommendations recognise minimal or low disease activity as an important alternative treatment target.1,2 Bimekizumab is in development for the treatment of psoriasis, PsA, and axial spondyloarthritis; it potently and selectively neutralizes both IL-17A and IL-17F.3 The efficacy and safety of bimekizumab in patients with active PsA was assessed in a Phase 2b study over 48 weeks (NCT02969525);4 disease activity outcomes are reported here.

Methods: Patients with active PsA, ≥3/76 swollen joint count and ≥3/78 tender joint count and fulfilling the Classification Criteria for PsA (CASPAR, score ≥3), were randomized (1:1:1:1:1) to receive subcutaneous bimekizumab 16 mg, 160 mg, 160 mg with 320 mg loading dose (160 mg [LD]), 320 mg, or placebo every 4 weeks (Q4W) for 12 weeks (double-blind period). After Week 12, patients receiving placebo or bimekizumab 16 mg were re-randomized (1:1) to receive bimekizumab 160 mg or 320 mg; all other patients continued on their previous dose (dose-blind period). The primary endpoint was a ≥50% improvement in American College of Rheumatology response criteria (ACR50) at Week 12; key results up to Week 48 have been reported previously.4 Other and post-hoc efficacy variables included: minimal disease activity (MDA), very low disease activity (VLDA), disease activity index for psoriatic arthritis (DAPSA) remission, and DAPSA low disease activity (LDA).

Results: Of 206 patients randomized, 203 and 190 completed the double- and dose-blind periods, respectively. In patients receiving bimekizumab 160 mg, 160 mg (LD) or 320 mg throughout the study, 46.3–58.5% achieved MDA, 22.0–36.6% achieved VLDA, 34.1–43.9% achieved DAPSA remission and 22.0–43.9% achieved DAPSA LDA at Week 48 (Table 1). In general, disease activity improved across these measures from Week 12 to Week 24, with improvements typically maintained or further increased to Week 48.

Serious adverse events were reported by 9/204 (4.4%) patients up to Week 48 (8/204 [3.9%] receiving bimekizumab). The most common treatment-emergent adverse event up to Week 48 was nasopharyngitis (25/204 [12.1%]). Up to Week 48, oral candidiasis occurred in 10/204 (4.9%) patients (all on bimekizumab treatment). No deaths, cases of inflammatory bowel disease, uveitis, or major cardiovascular adverse events were reported.

Conclusion: Treatment with bimekizumab 160 mg, 160 mg (LD) or 320 mg throughout the study was associated with achievement of low and/or minimal disease activity. Disease activity measures generally improved to Week 24 and were maintained to Week 48. These data provide further support that neutralizing both IL‑17F and IL-17A with bimekizumab is a promising therapeutic approach in patients with active PsA.

References: 1Smolen Ann Rheum Dis 2018;77:3–17; 2Gossec Ann Rheum Dis 2016;75:499–510; 3Papp JAAD 2018;79:277–86; 4Ritchlin Arthritis Rheumatol 2018;70(suppl 10):L17.


Mease_PA0008 ACR abstract_Final_03Jun19_Table

Table 1. Proportion of patients achieving MDA, VLDA, DAPSA remission and DAPSA LDA -full analysis set-

Disclosure: P. Mease, Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Genentech, Janssen, Novartis, Pfizer, Roche, UCB, 2, 5, Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB, 8, AbbVie, 2, 5, 8, Abbvie, 2, 5, 8, Abbvie, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 5, Abbvie, Amgen, Bristol Myers Squibb, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, 8, Abbvie, Amgen, Bristol Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Leo, Merck, Novartis, Pfizer and UCB., 5, 8, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, Inc., and UCB, 2, Abbvie, Amgen, Brsitol Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 5, Abbvie, Amgen, Brsitol Myers Squibb, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer, UCB, 8, Abbvie, Amgen, Brsitol Myers Squibb,Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, 2, Amgen, 2, 5, 6, 8, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Gilead, GSK, Janssen, Leo, Eli Lilly, Merck, Novartis, Pfizer, Sun Pharmaceutical Industries, and UCB, 5, BMS, 2, 5, 8, Boehringer Ingelheim, 2, 5, Boerhinger Ingelheim, 5, Bristol Myers Squibb, 2, 5, 8, Bristol Myers Squibb Co., 2, 5, 8, Bristol-Myers Squibb, 2, 5, 6, 8, Celgene, 2, 5, 6, 8, Celgene Corp., 2, 5, 8, CORRONA, 5, Eli Lilly, 2, 5, 8, Galapagos, 2, 5, 8, Genentech, 2, 5, 6, 8, Gilead, 2, 5, 8, Janssen, 2, 5, 6, 8, Janssen Inc, 2, 5, 8, Leo, 2, 5, 8, Lilly, 2, 5, 6, 8, Merck, 2, 5, 8, Novartis, 2, 5, 6, 8, Pfizer, 2, 5, 8, Pfizer Inc, 2, 5, 6, Sun, 2, 5, SUN, 2, 5, Sun Pharma, 2, 5, Sun Pharmaceutical Industries, 2, 5, Sun Pharmaceutical Industries, Inc., 2, 5, 8, UCB, 2, 5, 6, 8, UCB Pharma, 2, 5, 8; L. Gossec, Abbvie, 5, AbbVie, 5, Abbvie, Biogen, BMS, Celgene, Lilly, Novartis, Pfizer, SAnofi-Aventis, UCB, 5, Amgen, 5, Biogen, 5, BMS, 2, 5, Celgene, 5, Celgene Corporation, 2, Janssen, 5, Lilly, 2, 5, MSD, 5, Nordic Pharma, 5, Novartis, 5, Pfizer, 2, 5, Sanofi, 5, Sanofi-Aventis, 5, UCB, 5; L. Coates, Abbvie, 2, 5, 8, AbbVie, 2, 5, 8, AbbVie, Amgen, BMS, Celgene Corporation, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Prothena, Sun Pharma, UCB, 5, Abbvie, Amgen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB, 5, Abbvie, Amgen, Lilly, Novartis, Pfizer, UCB, 8, AbbVie, Celgene Corporation, Eli Lilly, Janssen, Novartis, UCB, 8, AbbVie, Celgene Corporation, Eli Lilly, Novartis, Pfizer, 2, AbbVie, Celgene Corporation, Novartis, Pfizer, 2, Abbvie, Celgene, Novartis, Pfizer, Lilly, 2, Amgen, 5, 8, Biogen, 8, Bristol-Myers Squibb, 5, Celgene, 2, 5, 8, Eli Lilly, 2, 5, 8, Galapagos, 5, Gilead, 5, Janssen, 2, 5, 8, Janssen Research & Development, LLC, Lilly, 2, 5, 8, MSD, 5, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Pfizer Inc, 2, 5, 8, Prothena, 5, Sun Pharma, 5, UCB, 5, 8, UCB Pharma, 5; A. Gottlieb, Janssen, 2, 5, Celgene, 5, Beiersdorf, 5, Bristol-Myers Squibb, 5, AbbVie, 5, UCB, 2, 5, Novartis, 2, 5, Incyte, 2, 5, Lilly, 5, Reddy Labs, 5, Valeant, 5, Dermira, 5, Allergan, 5, Sun Pharmaceutical Industries, 5, XBiotech, 2, 5, Leo, 5, Avotres Therapeutics, 5, Boehringer Ingelheim, 2, 5; D. Assudani, UCB, 1, 3, 4; B. Ink, UCB, 3, GSK, 4; J. Coarse, UCB, 3, UCB Pharma, 3, 4; O. Irvin-Sellers, UCB Pharma, 3; D. Gladman, AbbVie, 2, 5, Amgen, 2, 5, BMS, 5, Celgene, 2, 5, Eli Lilly, 2, 5, Galapagos, 5, Galapagos NV, 5, Gilead, 5, GSI, 5, Janssen, 5, Janssen Research & Development, LLC, 2, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2, 5.

To cite this abstract in AMA style:

Mease P, Gossec L, Coates L, Gottlieb A, Assudani D, Ink B, Coarse J, Irvin-Sellers O, Gladman D. Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with Active Psoriatic Arthritis: Disease Activity and Remission in a 48-Week Phase 2b, Randomized, Double‑Blind, Placebo-Controlled, Dose-Ranging Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/dual-neutralization-of-il-17a-and-il-17f-with-bimekizumab-in-patients-with-active-psoriatic-arthritis-disease-activity-and-remission-in-a-48-week-phase-2b-randomized-double%e2%80%91blind-placebo-c/. Accessed .

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