Low Uveitis Rates in Patients with Axial Spondyloarthritis Treated with Bimekizumab: Pooled Results from Phase 2b/3 Trials

Martin Rudwaleit¹, Matthew A. Brown², Floris Van Gaalen³, Nigil Haroon⁴, Lianne Gensler⁵, Carmen Fleurinck⁶, Alexander Marten⁷, Ute Massow⁸, Natasha De Peyrecave⁹, Thomas Vaux¹⁰, Katy White¹⁰, Atul Deodhar¹¹ and Irene van der Horst-Bruinsma¹², ¹University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany, ²Genomics England, London, United Kingdom, ³Leiden University Medical Center, Department of Rheumatology, Leiden, Netherlands, ⁴University of Toronto, University Health Network, Schroeder Arthritis Institute, Department of Medicine/Rheumatology, Toronto, ON, Canada, ⁵University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA, ⁶UCB Pharma, Oosterzele, Belgium, ⁷UCB Pharma, Monheim, Germany, ⁸UCB Pharma, Monheim am Rhein, Germany, ⁹UCB Pharma, Brussels, Belgium, ¹⁰UCB Pharma, Slough, United Kingdom, ¹¹Division of Arthritis and Rheumatic Disease, Oregon Health & Science University, Portland, OR, ¹²Radboud University Medical Centre, Department of Rheumatology, Nijmegen, Netherlands

Meeting: ACR Convergence 2023

Keywords: clinical trial, Eye Disorders, Interleukins, spondyloarthritis

Session Information

Date: Tuesday, November 14, 2023

Title: Abstracts: Spondyloarthritis Including Psoriatic Arthritis – Treatment III: AxSpA

Session Type: Abstract Session

Session Time: 4:00PM-5:30PM

Background/Purpose: Acute anterior uveitis (‘uveitis’), or ‘iritis’, is a common extra-musculoskeletal manifestation among patients (pts) with axial spondyloarthritis (axSpA).¹ IL-17 has been implicated in the pathogenesis of uveitis; however, inhibition of IL-17A alone may not be optimal for the management of uveitis.² Here, we report the incidence of uveitis following inhibition of IL-17A in addition to IL‑17F with bimekizumab (BKZ) in pts with axSpA.

Methods: Data were pooled for pts randomized to BKZ or placebo (PBO) in the double-blind treatment period (DBTP) of the phase (ph)3 studies BE MOBILE 1 (NCT03928704; non-radiographic [nr]-axSpA) and 2 (NCT03928743; radiographic [r]-axSpA i.e., ankylosing spondylitis).^3,4 Data were pooled separately for all pts treated with BKZ 160mg every 4 weeks (Q4W) in BE MOBILE 1, BE MOBILE 2, BE MOVING (NCT04436640; open-label extension [OLE] of BE MOBILE 1 and 2), and the ph2b study BE AGILE (NCT02963506; r-axSpA)⁵ and its OLE BE AGILE 2 (NCT03355573). Uveitis treatment-emergent adverse events (TEAEs) were identified using the preferred terms “autoimmune uveitis”, “iridocyclitis”, “iritis”, and “uveitis”, and were reported as both incidence and exposure adjusted incidence rates (EAIRs) per 100 pt years (PY) for all pts who received ≥1 BKZ dose.

Results: Baseline characteristics were reflective of a pt population with moderate to severe axSpA (Table). In the DBTP of BE MOBILE 1 and 2, uveitis TEAEs occurred in 11/237 pts randomized to PBO (4.6%; EAIR/100 PY [95% CI]: 15.4 [7.7, 27.5]) and 2/349 (0.6%; 1.8 [0.2, 6.7]) pts randomized to BKZ (% difference [95% CI]: 4.07 [1.71, 7.60]); Figure). In the 45 PBO-randomized (19.0%) and 52 BKZ-randomized (14.9%) pts with history of uveitis, uveitis TEAEs occurred in 20.0% (EAIR/100 PY [95% CI]: 70.4 [32.2, 133.7]) and 1.9% (6.2 [0.2, 34.8]) of pts, respectively. In the pooled ph2b/3 trial data, total BKZ exposure was 2,034.4 PY (N=848); 130 (15.3%) pts had history of uveitis. Uveitis TEAEs occurred in 25 pts overall (2.9%; EAIR/100 PY [95% CI]: 1.2 [0.8, 1.8]) and 14 pts with history of uveitis (10.8%; 4.6 [2.5, 7.7]; Figure). All uveitis TEAEs were mild/moderate; one event led to discontinuation.

Conclusion: The incidence rate of uveitis TEAEs was lower to Wk 16 in axSpA pts randomized to BKZ 160 mg Q4W vs PBO. In the largest pool of ph2b/3 data available at the time of this report, the incidence rate of uveitis with BKZ 160 mg Q4W remained low at 1.2/100 PY.

References:1.Robinson PC. Arthritis Rheumatol. 2015;67(1):140–51; 2. Dick AD. J Opthalmol 2013;120(4):777–87; 3. Boel A. Ann Rheum Dis 2019;78:1545–9; 4. Baraliakos X. Arthritis Rheumatol 2022;74 (suppl 9); 5. van der Heijde D. Ann Rheum Dis 2020;79:595–604.

Figure. Pooled incidence of uveitis TEAEs (EAIR/100 PY [95% CI]) stratified by history of uveitis in patients randomized to BKZ 160 mg Q4W or PBO in the DBTP (Weeks 0–16) of the phase 3 trials BE MOBILE 1 and 2, and all patients treated with BKZ 160 mg Q4W in phase 2b/3 trials.

Table. Baseline characteristics

Disclosures: M. Rudwaleit: AbbVie, 2, 6, Boehringer Ingelheim, 6, Chugai, 6, Eli Lilly, 2, 6, Janssen, 6, Novartis, 2, 6, Pfizer, 6, UCB Pharma, 2, 6; M. Brown: Clementia, 2, Grey Wolf Therapeutics, 2, Incyte, 2, Ipsen, 2, Novartis, 6, Pfizer, 2, Regeneron, 2, UCB Pharma, 5, Xinthera, 2; F. Van Gaalen: AbbVie, 12, Personal fees, BMS, 12, Personal fees, Eli Lilly, 12, Personal fees, Jacobus Stichting, 5, MSD, 12, Personal fees, Novartis, 5, 12, Fees, Stichting ASAS, 5, Stichting Vrienden van Sole Mio, 5, UCB Pharma, 5; N. Haroon: AbbVie, 2, Eli Lilly, 2, Janssen, 2, Novartis, 2, UCB Pharma, 2; L. Gensler: AbbVie, 2, Acelyrin, 2, Eli Lilly, 2, Fresenius Kabi, 2, Janssen, 2, Novartis, 2, 5, Pfizer, 2, UCB Pharma, 2, 5; C. Fleurinck: UCB Pharma, 3; A. Marten: UCB Pharma, 3; U. Massow: UCB Pharma, 3; N. De Peyrecave: UCB Pharma, 3; T. Vaux: UCB Pharma, 3; K. White: UCB Pharma, 3, 12, Shareholder; A. Deodhar: AbbVie, 2, 5, Amgen, 2, Aurinia, 2, Bristol Myers Squibb, 2, 5, Celgene, 5, Eli Lilly, 2, 5, Janssen, 2, 6, MoonLake, 2, 5, Novartis, 2, 5, 6, Pfizer Inc, 2, 5, 6, UCB, 2, 5; I. van der Horst-Bruinsma: AbbVie, 2, 5, 12, Fees for lectures, BMS, 12, Fees for lectures, Eli Lilly, 2, MSD, 2, 5, 12, Fees for lectures, Novartis, 2, Pfizer, 5, UCB Pharma, 2, 5.

To cite this abstract in AMA style:

Rudwaleit M, Brown M, Van Gaalen F, Haroon N, Gensler L, Fleurinck C, Marten A, Massow U, De Peyrecave N, Vaux T, White K, Deodhar A, van der Horst-Bruinsma I. Low Uveitis Rates in Patients with Axial Spondyloarthritis Treated with Bimekizumab: Pooled Results from Phase 2b/3 Trials [abstract]. Arthritis Rheumatol. 2023; 75 (suppl 9). https://acrabstracts.org/abstract/low-uveitis-rates-in-patients-with-axial-spondyloarthritis-treated-with-bimekizumab-pooled-results-from-phase-2b-3-trials/. Accessed .

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