Spondyloarthritis & psoriatic arthritis
Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies
Authors' 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.
Study context
- Population
- Adults with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) who received ≥1 dose of bimekizumab 160 mg every 4 weeks in six phase IIb/III studies (to the July 2022 data-cut for phase III)six studies
- Participants
- 848 vs 1,407
- Comparison
- axSpA vs PsA
- axSpAn = 848
- PsAn = 1,407
- Outcome
- Long-term safety: Treatment-emergent adverse events (TEAEs) as EAIR/100 PY
Methodological detailssix integrated phase IIb/III studies, pooled safety data, exposure-adjusted incidence rates
- Six integrated phase IIb/III studies
- Pooled safety data
- Exposure-adjusted incidence rates
Pooled result
As reported in the abstract
TEAEs, EAIR/100 PY
Safety
Study discontinuation due to TEAEs
SARS-CoV-2 (COVID-19) infection
Nasopharyngitis
Upper respiratory tract infection
Oral candidiasis · most events were mild/moderate
BKZ discontinuation due to oral candidiasis
Systemic fungal infections and active tuberculosis
- None reported
- 0
Adjudicated IBD, uveitis, adjudicated MACE, adjudicated suicidal ideation/behaviour
- EAIRs were low
Original publication
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. Published 6 April 2025. doi:10.
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