RMD open · 2026
Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies.
Клиническое исследование II фазыКлиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Mease Philip J, Merola Joseph F, Magrey Marina, Nash Peter, Poddubnyy Denis, Lebwohl Mark, Bajracharya Rajan, Ink Barbara, Marten Alexander, Manente Myriam, Peterson Luke, White Katy, Gensler Lianne S
Аннотация
OBJECTIVE: To present updated integrated safety analyses of bimekizumab in patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA).
METHODS: Safety data pooled from six phase IIb/III studies in axSpA and PsA (data-cut: July 2023 for phase III) reported for patients who received ≥1 dose of bimekizumab 160 mg every 4 weeks. Treatment-emergent adverse events (TEAEs) were reported using exposure-adjusted incidence rate per 100 patient-years (EAIR/100 PY).
RESULTS: 848 patients with axSpA (total exposure: 2513.8 PY) and 1409 patients with PsA (3655.9 PY) were included. TEAE incidence (EAIR/100 PY) was 129.6 in axSpA and 126.9 in PsA. Study discontinuations due to TEAEs were infrequent (EAIR/100 PY for axSpA: 2.4; PsA: 2.9). The most frequent TEAEs were SARS-CoV-2 (COVID-19) infection (EAIR/100 PY for axSpA: 9.9; PsA: 9.9), nasopharyngitis (EAIR/100 PY for axSpA: 8.4; PsA: 6.8) and upper respiratory tract infection (EAIR/100 PY for axSpA: 5.0; PsA: 5.7). EAIR/100 PY for oral candidiasis was 3.5 in axSpA and 3.8 in PsA; most cases were mild/moderate, with few leading to study discontinuation (EAIR/100 PY for axSpA: 0.2; PsA: 0.3). Serious opportunistic infections were infrequent (EAIR/100 PY for axSpA: 0; PsA: 0.1), with no active tuberculosis. EAIR/100 PY for hepatic events was 5.3 in axSpA and 5.0 in PsA. EAIRs for adjudicated definite/probable inflammatory bowel disease, uveitis, adjudicated major adverse cardiovascular events and adjudicated suicidal ideation/behaviour were low.
CONCLUSION: TEAE EAIRs were similar between axSpA and PsA. Bimekizumab demonstrated tolerability up to 5 years (2 years in phase III); no new safety signals were identified.
TRIAL REGISTRATION NUMBERS: NCT02963506; NCT03355573; NCT03928704; NCT03928743; NCT04436640; NCT02969525; NCT03347110; NCT03895203; NCT03896581; NCT04009499.
METHODS: Safety data pooled from six phase IIb/III studies in axSpA and PsA (data-cut: July 2023 for phase III) reported for patients who received ≥1 dose of bimekizumab 160 mg every 4 weeks. Treatment-emergent adverse events (TEAEs) were reported using exposure-adjusted incidence rate per 100 patient-years (EAIR/100 PY).
RESULTS: 848 patients with axSpA (total exposure: 2513.8 PY) and 1409 patients with PsA (3655.9 PY) were included. TEAE incidence (EAIR/100 PY) was 129.6 in axSpA and 126.9 in PsA. Study discontinuations due to TEAEs were infrequent (EAIR/100 PY for axSpA: 2.4; PsA: 2.9). The most frequent TEAEs were SARS-CoV-2 (COVID-19) infection (EAIR/100 PY for axSpA: 9.9; PsA: 9.9), nasopharyngitis (EAIR/100 PY for axSpA: 8.4; PsA: 6.8) and upper respiratory tract infection (EAIR/100 PY for axSpA: 5.0; PsA: 5.7). EAIR/100 PY for oral candidiasis was 3.5 in axSpA and 3.8 in PsA; most cases were mild/moderate, with few leading to study discontinuation (EAIR/100 PY for axSpA: 0.2; PsA: 0.3). Serious opportunistic infections were infrequent (EAIR/100 PY for axSpA: 0; PsA: 0.1), with no active tuberculosis. EAIR/100 PY for hepatic events was 5.3 in axSpA and 5.0 in PsA. EAIRs for adjudicated definite/probable inflammatory bowel disease, uveitis, adjudicated major adverse cardiovascular events and adjudicated suicidal ideation/behaviour were low.
CONCLUSION: TEAE EAIRs were similar between axSpA and PsA. Bimekizumab demonstrated tolerability up to 5 years (2 years in phase III); no new safety signals were identified.
TRIAL REGISTRATION NUMBERS: NCT02963506; NCT03355573; NCT03928704; NCT03928743; NCT04436640; NCT02969525; NCT03347110; NCT03895203; NCT03896581; NCT04009499.