Abstract

Objectives

Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. BKZ treatment has demonstrated superior efficacy versus placebo (PBO) at Week 16 in biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with active psoriatic arthritis (PsA). Here, we report long-term efficacy and safety to Week 52.

Methods

BE OPTIMAL comprised a 16-week, double-blind, PBO-controlled period, then 36 weeks treatment-blind. Patients were randomised 3:2:1 to subcutaneous BKZ 160 mg every 4 weeks, PBO with switch to BKZ at Week 16, or reference arm (adalimumab (ADA) 40 mg every 2 weeks). Efficacy outcomes included the American College of Rheumatology (ACR) response criteria 20/50/70, Psoriasis Area and Severity Index (PASI) 75/90/100 in patients with baseline psoriasis affecting ≥3% body surface area and minimal disease activity (MDA); non-responder imputation.

Results

ACR20/50/70, PASI75/90/100 and MDA responses were sustained with BKZ to Week 52, consistent with results observed at Week 16. Patients who switched to BKZ at Week 16 demonstrated improvements in efficacy with similar results to BKZ-randomised patients by Week 52.

To Week 52, 555/702 (79.1%) patients had ≥1 treatment-emergent adverse event (TEAE) during BKZ treatment; 113/140 (80.7%) on ADA. On BKZ, 46 (6.6%) patients had serious TEAEs. 54 (7.7%) Candida infections occurred during BKZ treatment and 1 (0.7%) during ADA; all cases were localised and non-serious. One death occurred in a BKZ-treated patient, unrelated to treatment.

Conclusions

The efficacy of BKZ in bDMARD-naïve patients with PsA was sustained from Week 16 to Week 52. BKZ was well tolerated with no new safety signals observed.

Trial registration number

NCT03895203.

Details

Title
Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study
Author
Ritchlin, Christopher T 1   VIAFID ORCID Logo  ; Coates, Laura C 2   VIAFID ORCID Logo  ; McInnes, Iain B 3 ; Mease, Philip J 4   VIAFID ORCID Logo  ; Merola, Joseph F 5 ; Tanaka, Yoshiya 6   VIAFID ORCID Logo  ; Asahina, Akihiko 7 ; Gossec, Laure 8   VIAFID ORCID Logo  ; Gottlieb, Alice B 9 ; Warren, Richard B 10 ; Ink, Barbara 11 ; Bajracharya, Rajan 11 ; Shende, Vishvesh 11 ; Coarse, Jason 12 ; Landewé, Robert BM 13   VIAFID ORCID Logo 

1  Allergy, Immunology & Rheumatology Division, University of Rochester Medical School, University of Rochester, Rochester, New York, USA 
2  Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK 
3  College of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK 
4  Swedish Medical Center and Providence St. Joseph Health, University of Washington, Seattle, Washington, USA 
5  Brigham and Women's Hospital, Department of Dermatology, Harvard Medical School, Boston, Massachusetts, USA; Division of Rheumatology, Department of Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts, USA 
6  First Department of Internal Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Fukoka, Japan 
7  Department of Dermatology, Jikei University School of Medicine, Tokyo, Japan 
8  INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France; AP-HP, Rheumatology Department, Pitié-Salpêtrière Hospital, Paris, France 
9  Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA 
10  Dermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, UK; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK 
11  UCB Pharma, Slough, UK 
12  UCB Pharma, Morrisville, North Carolina, USA 
13  Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam, The Netherlands; Zuyderland Medical Centre, Heerlen, The Netherlands 
Pages
1404-1414
Section
Psoriatic arthritis
Publication year
2023
Publication date
Nov 2023
Publisher
Elsevier Limited
ISSN
00034967
e-ISSN
14682060
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1136/ard-2023-224431
ProQuest document ID
2875976322
Copyright
© 2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.