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Poster Session A

Spondyloarthritis (SpA) including psoriatic arthritis (PsA)

Session: (0510–0542) Spondyloarthritis Including Psoriatic Arthritis – Treatment Poster I: AxSpA

0511: Long-term Safety and Tolerability of Bimekizumab in Patients with Axial Spondyloarthritis and Psoriatic Arthritis: Results from Pooled Phase 2b/3 Studies

Sunday, November 12, 2023
9:00 AM – 11:00 AM PT
Location: Poster Hall
On Demand In Person

    Abstract Poster Presenter(s)

  • Philip Mease, MD

    Rheumatologist, Director of Rheumatology Research, Clinical Professor Director of Rheumatology Research Swedish Medical Center/Providence-St Joseph Health
    Swedish Medical Center/Providence St. Joseph Health
    Seattle, WA, United States

    Disclosure(s): AbbVie: Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Acelyrin: Consultant (Ongoing); Aclaris: Consultant (Ongoing); Amgen: Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Boehringer Ingelheim: Consultant (Ongoing); Bristol Myers Squibb: Consultant (Ongoing), Grant/Research Support (Ongoing); Eli Lilly: Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Galapagos: Consultant (Ongoing); Gilead: Consultant (Ongoing); GlaxoSmithKline: Consultant (Ongoing); Inmagene: Consultant (Ongoing); Janssen: Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); MoonLake Pharma: Consultant (Ongoing); Novartis: Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Pfizer: Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Sun Pharma: Consultant (Ongoing), Grant/Research Support (Ongoing); UCB Pharma: Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Ventyx: Consultant (Ongoing); Xinthera: Consultant (Ongoing)

Philip J. Mease1, Denis Poddubnyy2, Ana-Maria Orbai3, Richard B. Warren4, Carmen Fleurinck5, Rajan Bajracharya6, Barbara Ink6, Ute Massow7, Vishvesh Shende6, Julie Shepherd-Smith6, Luke Peterson8, Katy White6, Robert BM Landewé9 and Lianne Gensler10, 1Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA, 2Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité – Universitätsmedizin Berlin, Berlin, Germany, 3Johns Hopkins University School of Medicine, Division of Rheumatology, Baltimore, MD, 4Dermatology Centre, Northern Care Alliance NHS Foundation Trust; NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom, 5UCB Pharma, Oosterzele, Belgium, 6UCB Pharma, Slough, United Kingdom, 7UCB Pharma, Monheim am Rhein, Germany, 8UCB Pharma, Raleigh, NC, 9Amsterdam Rheumatology & Clinical Immunology Center, Amsterdam and Zuyderland MC, Herleen, Netherlands, 10University of California San Francisco, Department of Medicine, Division of Rheumatology, San Francisco, CA

Background/Purpose: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL‑17F in addition to IL‑17A. A previous analysis of pooled safety data from the placebo-controlled period of four phase 3 trials was conducted in patients (pts) with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) to Week (Wk) 16.1 Here, we present long-term pooled safety data for BKZ in axSpA and PsA pt populations, across phase 2b/3 trials and all study periods.

Methods: We report two pooled analyses, each comprising three phase 2b/3 trials, and their open-label extensions, in pts with active axSpA (non-radiographic [nr]-axSpA and radiographic [r]-axSpA, i.e., ankylosing spondylitis)2 and active PsA, respectively (Figure).1,3–5

The number, proportion, and exposure-adjusted incidence rates (EAIRs) per 100 pt-years (PY) of treatment-emergent adverse events (TEAEs) are reported for all pts who received ≥1 dose of BKZ 160 mg every four weeks (Q4W). Data are reported to the most recent data-cut (July 2022) across all treatment periods.

Results: The axSpA and PsA safety pools included 848 pts (2034.4 PY) and 1,407 pts (2590.8 PY), respectively. The most frequently reported TEAEs in pts with axSpA and PsA were nasopharyngitis, SARS-CoV-2 infection, and upper respiratory tract infection (Table). See Table for safety topics of interest.

Fungal infections were reported in 375 pts (axSpA: 161 [19.0%]; PsA: 214 [15.2%]), leading to discontinuation in 19 pts (7 axSpA [0.8%], 12 PsA [0.9%]); no fungal infections were systemic in nature. Most fungal infections were oral, and the vast majority of oral fungal infections were mild to moderate in severity (axSpA: 162 [99.4%]; PsA: 231 [99.6%]). Two pts experienced severe oral fungal infections (axSpA: 1 [0.1%]; PsA: 1 [0.1%]), which resolved in both cases with treatment. Candida fungal infections were seen in a similar proportion of pts with axSpA and PsA (Table).

Serious infections and infestations occurred in 59 pts (axSpA: 29 [3.4%]; PsA: 30 [2.1%], Table). One serious fungal infection (oropharyngeal candidiasis) was reported in a pt with PsA (1 [< 0.1%]), which resolved with treatment (further details provided in Table).

Adjudicated IBD (definite or probable) occurred in 16 pts with axSpA (EAIR/100 PY: 0.8) and 7 pts with PsA (EAIR/100 PY: 0.3). Uveitis occurred in 25 pts with axSpA (EAIR/100 PY: 1.2), while no uveitis cases were reported in pts with PsA (Table).

Fourteen pts experienced an adjudicated major adverse cardiovascular event (axSpA: 4 [EAIR/100 PY: 0.2]; PsA: 10 [EAIR/100 PY: 0.4]). Five pts experienced events adjudicated as suicidal ideation/behavior (axSpA: 3 [EAIR/100 PY: 0.1]; PsA: 2 [EAIR/100 PY: 0.1]), while no cases of active tuberculosis were reported (Table).

Conclusion: The long-term safety profile of BKZ in pts with axSpA and PsA is consistent with prior studies.1 As expected, due to inhibition of IL-17, oral candidiasis featured among the safety signals reported.

References: 1. Poddubnyy D. Ann Rheum Dis. 2023;82(suppl 1); 2.Boel A. Ann Rheum Dis. 2019;78:1545–9; 3. Baraliakos X. Arthritis Rheumatol. 2022;74(suppl 9); 4. Ritchlin C. Arthritis Rheumatol. 2022;74(suppl 9); 5. Merola J. Ann Rheum Dis. 2022;81:167–9.


Figure. Two safety pools (axSpA, PsA) of patients treated with BKZ 160 mg Q4W from phase 2b/3 studies


Table. Summary of TEAEs


P. Mease: AbbVie, 2, 5, 6, Acelyrin, 2, Aclaris, 2, Amgen, 2, 5, 6, Boehringer Ingelheim, 2, Bristol Myers Squibb, 2, 5, Eli Lilly, 2, 5, 6, Galapagos, 2, Gilead, 2, GlaxoSmithKline, 2, Inmagene, 2, Janssen, 2, 5, 6, MoonLake Pharma, 2, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Sun Pharma, 2, 5, UCB Pharma, 2, 5, 6, Ventyx, 2, Xinthera, 2; D. Poddubnyy: AbbVie, 2, 5, 6, Biocad, 2, BMS, 6, Eli Lilly, 2, 5, 6, Gilead, 2, GSK, 2, MoonLake, 2, MSD, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Samsung Bioepis, 2, UCB Pharma, 2, 6; A. Orbai: AbbVie, 5, Amgen, 5, BMS, 2, Janssen, 2, 5, Sanofi, 2, UCB Pharma, 2; R. Warren: AbbVie, 2, 5, 6, Almirall, 2, 5, 6, Amgen, 2, 5, 6, Arena, 2, 6, Astellas, 2, 6, Avillion, 2, 6, Biogen, 2, 6, BMS, 2, 6, Boehringer Ingelheim, 2, 6, Celgene, 2, 5, DiCE, 6, Eli Lilly, 2, 5, 6, GSK, 2, 6, Janssen, 2, 5, 6, LEO Pharma, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Sanofi, 2, 6, Sun Pharma, 6, UCB Pharma, 2, 5, 6, Union, 6; C. Fleurinck: UCB Pharma, 3; R. Bajracharya: UCB Pharma, 3, 11; B. Ink: AbbVie, 11, GSK, 11, UCB Pharma, 3, 11; U. Massow: UCB Pharma, 3; V. Shende: UCB Pharma, 3; J. Shepherd-Smith: UCB Pharma, 3; L. Peterson: UCB Pharma, 3, 11; K. White: UCB Pharma, 3, 12, Shareholder; R. Landewé: AbbVie, 2, 5, AstraZeneca, 2, BMS, 2, Eli Lilly, 2, Novartis, 2, 5, Pfizer, 2, 5, Rheumatology Consultancy BV, 12, Owner, UCB Pharma, 2, 5; L. Gensler: AbbVie, 2, Acelyrin, 2, Eli Lilly, 2, Fresenius Kabi, 2, Janssen, 2, Novartis, 2, 5, Pfizer, 2, UCB Pharma, 2, 5.