Spondyloarthritis & psoriatic arthritis
Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies
Authors' 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.
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 (data-cut: July 2023 for phase III)
- Participants
- 848 vs 1,409
- Comparison
- Bimekizumab 160 mg every 4 weeks in axSpA and in PsA
- axSpAn = 848
- PsAn = 1,409
- Outcome
- Treatment-emergent adverse events (TEAEs), EAIR/100 PY
Methodological detailsintegrated safety analysis
- Integrated safety analysis
Main finding
As reported in the abstract
TEAE incidence (EAIR/100 PY)
axSpA
129.6
EAIR/100 PY
PsA
126.9
EAIR/100 PY
Safety
| Outcome | axSpA | PsA |
|---|---|---|
| Study discontinuations due to TEAEs (EAIR/100 PY) | EAIR/100 PY 2.4 | EAIR/100 PY 2.9 |
| SARS-CoV-2 (COVID-19) infection (EAIR/100 PY) | EAIR/100 PY 9.9 | EAIR/100 PY 9.9 |
| Nasopharyngitis (EAIR/100 PY) | EAIR/100 PY 8.4 | EAIR/100 PY 6.8 |
| Upper respiratory tract infection (EAIR/100 PY) | EAIR/100 PY 5.0 | EAIR/100 PY 5.7 |
| Oral candidiasis (EAIR/100 PY)Most cases were mild/moderate | EAIR/100 PY 3.5 | EAIR/100 PY 3.8 |
| Oral candidiasis leading to study discontinuation (EAIR/100 PY) | EAIR/100 PY 0.2 | EAIR/100 PY 0.3 |
| Serious opportunistic infections (EAIR/100 PY) | EAIR/100 PY 0 | EAIR/100 PY 0.1 |
| Hepatic events (EAIR/100 PY) | EAIR/100 PY 5.3 | EAIR/100 PY 5.0 |
Serious opportunistic infections (EAIR/100 PY)
- No active tuberculosis
Adjudicated IBD, uveitis, adjudicated MACE, adjudicated suicidal ideation/behaviour
- EAIRs were low
Original publication
Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies. RMD Open. Published 10 March 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →