Low Uveitis Rates in Patients with Axial Spondyloarthritis or Psoriatic Arthritis Treated with Bimekizumab: Long-Term Results from Phase 2b/3 Trials

Irene E. van der Horst-Bruinsma¹, Matthew A. Brown², Floris van Gaalen³, Nigil Haroon⁴, Lianne S Gensler⁵, Alexander Marten⁶, Myriam Manente⁷, George Stojan⁸, Thomas Vaux⁹, Katy White⁹, Atul Deodhar¹⁰ and Martin Rudwaleit¹¹, ¹Department of Rheumatology, Radboud University Medical Centre, Nijmegen, Netherlands, ²Genomics England, London, United Kingdom, ³LUMC, Leiden, Zuid-Holland, Netherlands, ⁴Department of Medicine/Rheumatology, University Health Network, Schroeder Arthritis Institute, University of Toronto, Toronto, ON, Canada, ⁵Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, CA, ⁶UCB Pharma, Monheim am Rhein, Germany, ⁷UCB Pharma, Braine-l'Alleud, Belgium, ⁸UCB Pharma, Atlanta, GA, ⁹UCB Pharma, Slough, United Kingdom, ¹⁰Division of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, OR, ¹¹University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany

Meeting: ACR Convergence 2024

Keywords: Psoriatic arthritis, spondyloarthritis

Session Information

Date: Monday, November 18, 2024

Title: SpA Including PsA – Treatment Poster III

Session Type: Poster Session C

Session Time: 10:30AM-12:30PM

Background/Purpose: Acute anterior uveitis (‘uveitis’) is a common extra-musculoskeletal manifestation in patients (pts) with spondyloarthritis (SpA), and incidence varies with SpA type and disease duration.^1,2,3 Interleukin (IL)-17 has been implicated in the pathogenesis of uveitis; however, previous data have not demonstrated the efficacy for IL-17A inhibition alone in managing the condition.^4,5 The exposure-adjusted incidence rate (EAIR) per 100 pt-years (PY) of uveitis was lower in pts with axial SpA (axSpA) randomized to bimekizumab (BKZ; 1.8/100 PY), a dual IL-17A/F inhibitor, versus placebo (15.4/100 PY) after 16 weeks.⁶ Here, we report long-term incidence of uveitis following BKZ treatment in pts with axSpA or psoriatic arthritis (PsA).

Methods: Safety data are reported for two pools, each comprising three phase 2b/3 (ph2b/3) studies and their open-label extensions, in pts with active axSpA (non-radiographic and radiographic axSpA) and active PsA, respectively (Figure 1).

Uveitis events were identified using the preferred terms “autoimmune uveitis”, “iridocyclitis”, “iritis”, and “uveitis”, coded according to MedDRA v19.0; note that “acute anterior uveitis” was not a specific preferred term available in MedDRA v19.0. Uveitis rates and EAIRs/100 PY for pts who received ≥1 BKZ 160 mg dose are reported (data cut-off: July 2023).

Results: Pts with axSpA (N=848) had a mean age (standard deviation [SD]) of 40.3 (11.9) years, and pts with PsA (N=1,409) had a mean age (SD) of 49.3 (12.4) years, with a mean time since diagnosis (SD) of 6.1 (7.8) and 7.0 (8.0) years, respectively. Of pts with axSpA, 130 (15.3%) had a history of uveitis; 21 (1.5%) pts with PsA had a history of uveitis. The majority of pts with axSpA were HLA-B27 positive (717/848 [84.6%]).

In pts with axSpA across the pooled ph2b/3 axSpA trial data, BKZ exposure was 2,514 PY. Uveitis occurred in 31/848 (3.7%; EAIR [95% CI]: 1.3/100 PY [0.9, 1.8]) pts overall and in 18/130 (13.8%; 4.8/100 PY [2.8, 7.6]) pts with history of uveitis. In pts without a history of uveitis, 13/718 (1.8%; 0.6/100 PY [0.3, 1.1]) pts had uveitis events (Figure 2). All events were mild/moderate, one led to treatment discontinuation.

Incidence of uveitis in pts with PsA was low across the pooled ph2b/3 PsA trial data (total BKZ exposure: 3,656 PY); uveitis occurred in three (0.2%; 0.1/100 PY [0.0, 0.2]) pts overall; one had a history of uveitis. No uveitis events led to treatment discontinuation.

Conclusion: Across 2,514 PY in pts with axSpA and 3,656 PY in pts with PsA, the long-term data suggest that the incidence of uveitis in pts treated with BKZ remains low.

References: 1. Robinson PC. Arthritis Rheumatol. 2015;67:140–51; 2. López-Medina C. RMD Open 2019;5:e001108; 3. Delmás A. RMD Open 2023;9:e002781; 4. Dick AD. J. Opthalmol. 2013;120:777–87; 5. Kwon OC. Rheumatol. 2024;keae003; 6. Rudwaleit M. Ann Rheum Dis. 2023;82:614–5; 7. Baraliakos X. Ann Rheum Dis. 2024;83:199–213. 8. Mease PJ. Arthritis Rheumatol. 2023;75(suppl 9). Abstract 0511.

Figure 1. Two safety pools (axSpA, PsA) of patients treated with BKZ 160 mg Q4W across six phase 2b/3 studies and their open-label extensions

Figure 2. Incidence of uveitis (EAIR/100 PY [95% CI]) in patients with axSpA stratified by history of uveitis

Disclosures: I. van der Horst-Bruinsma: AbbVie, 2, 5, 12, Fees received for lectures, BMS, 12, Fees received for lectures, Eli Lilly, 2, MSD, 2, 5, 12, Fees received for lectures, Novartis, 2, Pfizer, 5, 12, Fees received for lectures, UCB Pharma, 2, 5; M. Brown: Clementia, 2, Grey Wolf Therapeutics, 2, Incyte, 2, Ipsen, 2, Novartis, 6, Pfizer, 2, 6, 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, 2, 5, Stichting ASAS, 5, Stichting Vrienden van Sole Mio, 5, UCB Pharma, 5; N. Haroon: AbbVie, 2, Novartis, 2, UCB Pharma, 2; L. Gensler: AbbVie/Abbott, 2, Acelyrin, 2, Eli Lilly, 2, Fresenius Kabi, 2, Janssen, 2, MoonLake, 2, Novartis, 2, 5, Pfizer, 2, 5, UCB, 2, 5; A. Marten: UCB Pharma, 3; M. Manente: UCB Pharma, 3, 11; G. Stojan: UCB Pharma, 3, 11; T. Vaux: UCB Pharma, 3, 12, Shareholder; K. White: UCB Pharma, 3, 11; A. Deodhar: AbbVie, 2, 5, 6, BMS, 2, 5, 6, Eli Lilly, 2, 5, 6, Janssen, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, UCB Pharma, 2, 5, 6; 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.

To cite this abstract in AMA style:

van der Horst-Bruinsma I, Brown M, van Gaalen F, Haroon N, Gensler L, Marten A, Manente M, Stojan G, Vaux T, White K, Deodhar A, Rudwaleit M. Low Uveitis Rates in Patients with Axial Spondyloarthritis or Psoriatic Arthritis Treated with Bimekizumab: Long-Term Results from Phase 2b/3 Trials [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/low-uveitis-rates-in-patients-with-axial-spondyloarthritis-or-psoriatic-arthritis-treated-with-bimekizumab-long-term-results-from-phase-2b-3-trials/. Accessed .

« Back to ACR Convergence 2024

ACR Meeting Abstracts - https://acrabstracts.org/abstract/low-uveitis-rates-in-patients-with-axial-spondyloarthritis-or-psoriatic-arthritis-treated-with-bimekizumab-long-term-results-from-phase-2b-3-trials/