AB0881 LONG-TERM SAFETY AND TOLERABILITY OF BIMEKIZUMAB IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS AND PSORIATIC ARTHRITIS: RESULTS FROM POOLED PHASE 2B/3 STUDIES
Authors: P. J. Mease, D. Poddubnyy, A. M. Orbai, R. B. Warren, C. Fleurinck, R. Bajracharya, B. Ink, U. Massow, V. Shende, J. Shepherd-Smith, L. Peterson, K. White, R. Landewé, L. S. Gensler
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL) 17F in addition to IL 17A. <h3>Objectives:</h3> To present long-term pooled safety data for BKZ in axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) patient (pt) populations, across phase 2b/3 trials and all study periods. <h3>Methods:</h3> 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) [<sup>1]</sup> and active PsA, respectively (Figure 1). <sup>[2,3–5</sup>] The number, proportion and exposure-adjusted incidence rates per 100 pt-years (EAIR/100 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. <h3>Results:</h3> 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 1). See Table 1 for safety topics of interest. Fungal infections were reported in 161 (19.0%) pts with axSpA (EAIR/100 PY: 9.2); and 214 (15.2%) with PsA (EAIR/100 PY: 9.2), of which 19 pts discontinued (7 axSpA [0.8%], 12 PsA [0.9%]); no fungal infections were systemic. Most fungal infections were oral, of which the vast majority 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 1). Serious infections and infestations occurred in 29 (3.4%) pts with axSpA (EAIR/100 PY: 1.5) and 30 (2.1%) with PsA (EAIR/100 PY: 1.2; Table 1). One serious fungal infection (oropharyngeal candidiasis) was reported in a pt with PsA (1 [&lt;0.1%]), which resolved with treatment (further details in Table 1). 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) and no cases in pts with PsA (Table 1). Fourteen pts experienced an adjudicated major adverse cardiovascular event (axSpA: 4 [EAIR/100 PY: 0.2]; PsA: 10 [EAIR/100 PY: 0.4]) and five pts experienced events adjudicated as suicidal ideation/behaviour (axSpA: 3 [EAIR/100 PY: 0.1]; PsA: 2 [EAIR/100 PY: 0.1]) (Table 1). No cases of suicide or active tuberculosis were reported in axSpA or PsA. <h3>Conclusion:</h3> The long-term safety profile of BKZ in pts with axSpA and PsA is consistent with prior studies.<sup>2</sup> As expected, due to inhibition of IL-17, oral candidiasis featured among the safety signals reported. <h3>REFERENCES:</h3> [1] Boel A. Ann Rheum Dis. 2019;78:1545–9; 2. Poddubnyy D. Ann Rheum Dis. 2023;82(suppl 1); 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. <h3>Acknowledgements:</h3> Funded by UCB Pharma. Medical writing support provided by Costello Medical and funded by UCB Pharma. <h3>Disclosure of Interests:</h3> Philip J. Mease Speaker for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma, Consulting fees from AbbVie, Acelyrin, Aclaris, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Moonlake Pharma, Novartis, Pfizer, Sun Pharma, Takeda, UCB Pharma and Ventyx, Grant/research support from AbbVie, Acelyrin, Amgen, BMS, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma, Denis Poddubnyy Speaker for AbbVie, BMS, Eli Lilly, MSD, Novartis, Pfizer and UCB Pharma, Consulting fees from AbbVie, Biocad, Eli Lilly, Gilead, GSK, Moonlake, MSD, Novartis, Pfizer, Samsung Bioepis and UCB Pharma, Grant/research support from AbbVie, Eli Lilly, MSD, Novartis and Pfizer, Ana-Maria Orbai Consulting fees from BMS, Janssen, Sanofi and UCB Pharma, Research grants paid to Johns Hopkins University from AbbVie, Amgen and Janssen, Richard B. Warren Honoraria from Astellas, DiCE, GSK and Union Therapeutics, Consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi and UCB Pharma, Research grants paid to institution from AbbVie, Almirall, Janssen, LEO Pharma, Novartis and UCB Pharma, Carmen Fleurinck Shareholder of UCB Pharma, Employee of UCB Pharma, Rajan Bajracharya Shareholder of UCB Pharma, Employee of UCB Pharma, Barbara Ink Shareholder of AbbVie, GSK and UCB Pharma, Employee of UCB Pharma, Ute Massow Employee of UCB Pharma, Vishvesh Shende Employee of UCB Pharma, Julie Shepherd-Smith Employee of UCB Pharma, Luke Peterson Shareholder of UCB Pharma, Employee of UCB Pharma, Katy White Employee of UCB Pharma, Shareholder of UCB Pharma, Robert Landewé Owner of Rheumatology Consultancy BV, an AMS company under Dutch law, Consultancy fees from AbbVie, AstraZeneca, BMS, Eli Lilly, Novartis, Pfizer and UCB Pharma, Research grants from AbbVie, Pfizer, Novartis and UCB Pharma, Lianne S Gensler Consulting fees from AbbVie, Acelyrin, Eli Lilly, Fresenius Kabi, Janssen, Novartis, Pfizer and UCB Pharma, Grants paid to institution from Novartis and UCB Pharma.