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Randomized Controlled Trial
. 2024 Jan 11;83(2):199-213.
doi: 10.1136/ard-2023-224803.

Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies

Xenofon Baraliakos  1 , Atul Deodhar  2 , Désirée van der Heijde  3 , Marina Magrey  4 , Walter P Maksymowych  5 , Tetsuya Tomita  6 , Huji Xu  7 , Ute Massow  8 , Carmen Fleurinck  9 , Alicia M Ellis  10 , Thomas Vaux  11 , Julie Shepherd-Smith  11 , Alexander Marten  8 , Lianne S Gensler  12
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Free article
Randomized Controlled Trial

Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies

Xenofon Baraliakos et al. Ann Rheum Dis. .
Free article

Abstract

Objectives: Bimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated superior efficacy versus placebo in patients with non-radiographic (nr-) and radiographic (r-) axial spondyloarthritis (axSpA) at Week 16. Here, the objective is to report the efficacy and safety of BKZ at Week 52.

Methods: BE MOBILE 1 (nr-axSpA; NCT03928704) and BE MOBILE 2 (r-axSpA; NCT03928743) comprised a 16-week, double-blind, placebo-controlled period, then a 36-week maintenance period. From Week 16, all patients received subcutaneous BKZ 160 mg every 4 weeks.

Results: Improvements versus placebo in Assessment of SpondyloArthritis International Society ≥40% response (primary endpoint), Ankylosing Spondylitis Disease Activity Score, high-sensitivity C-reactive protein levels and MRI inflammation of the sacroiliac joints/spine at Week 16 were sustained to Week 52 in BKZ-randomised patients. At Week 52, responses of patients switching from placebo to BKZ at Week 16 were comparable to BKZ-randomised patients. At Week 52, ≥1 treatment-emergent adverse events (TEAEs) were reported in 183 (75.0%) and 249 (75.5%) patients with nr-axSpA and r-axSpA, respectively. Serious TEAEs occurred in 9 (3.7%) patients with nr-axSpA and 20 (6.1%) patients with r-axSpA. Oral candidiasis was the most frequent fungal infection (nr-axSpA: 18 (7.4%); r-axSpA: 20 (6.1%)). Uveitis occurred in three (1.2%) and seven (2.1%) patients with nr-axSpA and r-axSpA, and inflammatory bowel disease in two (0.8%) and three (0.9%).

Conclusions: At Week 52, dual inhibition of IL-17A and IL-17F with BKZ resulted in sustained efficacy across the axSpA spectrum; the safety profile was consistent with the known safety of BKZ.

Trial registration number: NCT03928704; NCT03928743.

Keywords: autoimmune diseases; biological therapy; cytokines; inflammation; spondylitis, ankylosing.

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Conflict of interest statement

Competing interests: XB: Speakers bureau for AbbVie, BMS, Chugai, Eli Lilly, Galapagos, MSD, Novartis, Pfizer and UCB Pharma; paid instructor for AbbVie, BMS, Chugai, Eli Lilly, Galapagos, MSD, Novartis, Pfizer and UCB Pharma; consultant of AbbVie, BMS, Chugai, Eli Lilly, Galapagos, Gilead, MSD, Novartis, Pfizer and UCB Pharma; grant/research support from Novartis and UCB Pharma. AAD: Speakers bureau for Janssen, Novartis and Pfizer; consultant for AbbVie, Amgen, Aurinia, BMS, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB Pharma; grant/research support from AbbVie, BMS, Celgene, Eli Lilly, MoonLake, Novartis, Pfizer and UCB Pharma. DvdH: Consulting fees from AbbVie, Bayer, BMS, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, Takeda and UCB Pharma; director of Imaging Rheumatology BV. MM: Consultancy fees from AbbVie, BMS, Eli Lilly, Novartis, Pfizer and UCB Pharma; research grants from AbbVie, BMS and UCB Pharma. WPM: Honoraria/consulting fees from AbbVie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma; research grants from AbbVie, Pfizer and UCB Pharma; educational grants from AbbVie, Janssen, Novartis, and Pfizer; Chief Medical Officer for CARE ARTHRITIS. TT: Consultancy fees from AbbVie, Eli Lilly, Gilead, Novartis and Pfizer; speaker fees from AbbVie, Astellas, Bristol-Myers Squibb, Eisai, Eli Lilly, Janssen, Kyowa Kirin, Mitsubishi-Tanabe, Novartis and Pfizer. HX: Speaker for AbbVie, Janssen, Novartis, Pfizer, and UCB Pharma; consultant for AbbVie, Beigene, BioMap, IASO, Pfizer and UCB Pharma; clinical investigator for Peking-Tsinghua Center for Life Sciences. UM, CF, AME, TV, JS-S, AM: Employees of UCB Pharma. LSG: Grants from Novartis and UCB Pharma paid to institution; consulting fees from AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer and UCB Pharma.

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