Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies
Objective To assess the long-term safety profile of bimekizumab (BKZ) in patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA).Methods Safety data pooled from six integrated phase IIb/III studies in axSpA and PsA are reported (to the July 2022 data-cut for phase III) for patien...
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BMJ Publishing Group
2025-04-01
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| author | Robert Landewé Ana-Maria Orbai Philip J Mease Denis Poddubnyy Lianne S Gensler Vishvesh Shende Richard B Warren Luke Peterson Alexander Marten Ute Massow Katy White Barbara Ink Rajan Bajracharya Myriam Manente |
| author_facet | Robert Landewé Ana-Maria Orbai Philip J Mease Denis Poddubnyy Lianne S Gensler Vishvesh Shende Richard B Warren Luke Peterson Alexander Marten Ute Massow Katy White Barbara Ink Rajan Bajracharya Myriam Manente |
| author_sort | Robert Landewé |
| collection | DOAJ |
| description | Objective To assess the long-term safety profile of bimekizumab (BKZ) in patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA).Methods Safety data pooled from six integrated phase IIb/III studies in axSpA and PsA are reported (to the July 2022 data-cut for phase III) for patients who received ≥1 dose of BKZ 160 mg every 4 weeks. Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rate per 100 patient-years (EAIR/100 PY).Results The axSpA and PsA safety pools included 848 (total BKZ exposure: 2034.4 PY) and 1407 patients (2590.8 PY), respectively. TEAEs occurred at an EAIR/100 PY of 136.9 in axSpA and 139.6 in PsA; study discontinuation due to TEAEs was low (axSpA: 2.7/100 PY; PsA: 3.1/100 PY). The three most frequently reported TEAEs were SARS-CoV-2 (COVID-19) infection (axSpA: 7.8/100 PY; PsA: 8.8/100 PY), nasopharyngitis (axSpA: 8.2/100 PY; PsA: 7.7/100 PY) and upper respiratory tract infection (axSpA: 5.0/100 PY; PsA: 5.6/100 PY). EAIR/100 PY of oral candidiasis was 3.7 in axSpA and 4.2 in PsA; most events were mild/moderate. EAIR of BKZ discontinuation due to oral candidiasis was low (both axSpA and PsA: 0.3/100 PY). No systemic fungal infections or cases of active tuberculosis were reported. EAIRs of adjudicated definite/probable inflammatory bowel disease, uveitis, adjudicated major adverse cardiovascular events and adjudicated suicidal ideation/behaviour were low.Conclusion Overall, BKZ demonstrated good tolerability, with TEAE EAIRs comparable between axSpA and PsA cohorts, remaining stable over extended treatment periods. No new safety signals were identified.Trial registration numbers NCT02963506 (BE AGILE); NCT03355573 (BE AGILE 2); NCT03928704 (BE MOBILE 1); NCT03928743 (BE MOBILE 2); NCT04436640 (BE MOVING); NCT02969525 (BE ACTIVE); NCT03347110 (BE ACTIVE 2); NCT03895203 (BE OPTIMAL); NCT03896581 (BE COMPLETE); NCT04009499 (BE VITAL). |
| format | Article |
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| institution | OA Journals |
| issn | 2056-5933 |
| language | English |
| publishDate | 2025-04-01 |
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| spelling | doaj-art-7721da079a7d4fa3828d4e99d0705cb52025-08-20T02:26:03ZengBMJ Publishing GroupRMD Open2056-59332025-04-0111210.1136/rmdopen-2024-005026Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studiesRobert Landewé0Ana-Maria Orbai1Philip J Mease2Denis Poddubnyy3Lianne S Gensler4Vishvesh Shende5Richard B Warren6Luke Peterson7Alexander Marten8Ute Massow9Katy White10Barbara Ink11Rajan Bajracharya12Myriam Manente13Zuyderland MC, Heerlen, The NetherlandsDivision of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USADepartment of Rheumatology, Swedish Medical Center/Providence St. Joseph Health, Seattle, Washington, USADivision of Rheumatology, Department of Medicine, University Health Network and University of Toronto, Toronto, Ontario, CanadaDepartment of Medicine/Rheumatology, University of California, San Francisco, San Francisco, California, USAUCB, Slough, UKDermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, UKUCB, Morrisville, North Carolina, USAUCB, Monheim am Rhein, GermanyUCB, Monheim am Rhein, GermanyUCB, Slough, UKUCB, Slough, UKUCB, Slough, UKUCB, Braine-l`Alleud, BelgiumObjective To assess the long-term safety profile of bimekizumab (BKZ) in patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA).Methods Safety data pooled from six integrated phase IIb/III studies in axSpA and PsA are reported (to the July 2022 data-cut for phase III) for patients who received ≥1 dose of BKZ 160 mg every 4 weeks. Treatment-emergent adverse events (TEAEs) are reported using exposure-adjusted incidence rate per 100 patient-years (EAIR/100 PY).Results The axSpA and PsA safety pools included 848 (total BKZ exposure: 2034.4 PY) and 1407 patients (2590.8 PY), respectively. TEAEs occurred at an EAIR/100 PY of 136.9 in axSpA and 139.6 in PsA; study discontinuation due to TEAEs was low (axSpA: 2.7/100 PY; PsA: 3.1/100 PY). The three most frequently reported TEAEs were SARS-CoV-2 (COVID-19) infection (axSpA: 7.8/100 PY; PsA: 8.8/100 PY), nasopharyngitis (axSpA: 8.2/100 PY; PsA: 7.7/100 PY) and upper respiratory tract infection (axSpA: 5.0/100 PY; PsA: 5.6/100 PY). EAIR/100 PY of oral candidiasis was 3.7 in axSpA and 4.2 in PsA; most events were mild/moderate. EAIR of BKZ discontinuation due to oral candidiasis was low (both axSpA and PsA: 0.3/100 PY). No systemic fungal infections or cases of active tuberculosis were reported. EAIRs of adjudicated definite/probable inflammatory bowel disease, uveitis, adjudicated major adverse cardiovascular events and adjudicated suicidal ideation/behaviour were low.Conclusion Overall, BKZ demonstrated good tolerability, with TEAE EAIRs comparable between axSpA and PsA cohorts, remaining stable over extended treatment periods. No new safety signals were identified.Trial registration numbers NCT02963506 (BE AGILE); NCT03355573 (BE AGILE 2); NCT03928704 (BE MOBILE 1); NCT03928743 (BE MOBILE 2); NCT04436640 (BE MOVING); NCT02969525 (BE ACTIVE); NCT03347110 (BE ACTIVE 2); NCT03895203 (BE OPTIMAL); NCT03896581 (BE COMPLETE); NCT04009499 (BE VITAL).https://rmdopen.bmj.com/content/11/2/e005026.full |
| spellingShingle | Robert Landewé Ana-Maria Orbai Philip J Mease Denis Poddubnyy Lianne S Gensler Vishvesh Shende Richard B Warren Luke Peterson Alexander Marten Ute Massow Katy White Barbara Ink Rajan Bajracharya Myriam Manente Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies RMD Open |
| title | Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies |
| title_full | Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies |
| title_fullStr | Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies |
| title_full_unstemmed | Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies |
| title_short | Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies |
| title_sort | long term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis pooled results from integrated phase iib iii clinical studies |
| url | https://rmdopen.bmj.com/content/11/2/e005026.full |
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