Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies - PubMed
12 hours ago
- #Axial Spondyloarthritis
- #Psoriatic Arthritis
- #Bimekizumab
- Updated safety analysis of bimekizumab in axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) patients.
- Data pooled from six phase IIb/III studies with a dose of 160 mg every 4 weeks.
- Total exposure: 2513.8 patient-years (PY) for axSpA (848 patients) and 3655.9 PY for PsA (1409 patients).
- Treatment-emergent adverse events (TEAEs) incidence rates were 129.6/100 PY (axSpA) and 126.9/100 PY (PsA).
- Most frequent TEAEs: COVID-19 infection (9.9/100 PY), nasopharyngitis (8.4/100 PY axSpA, 6.8/100 PY PsA), and upper respiratory tract infection (5.0/100 PY axSpA, 5.7/100 PY PsA).
- Oral candidiasis rates were 3.5/100 PY (axSpA) and 3.8/100 PY (PsA), mostly mild/moderate with few discontinuations.
- Serious opportunistic infections were rare (0/100 PY axSpA, 0.1/100 PY PsA), with no active tuberculosis cases.
- Hepatic events: 5.3/100 PY (axSpA) and 5.0/100 PY (PsA).
- Low rates of inflammatory bowel disease, uveitis, major adverse cardiovascular events, and suicidal ideation/behavior.
- No new safety signals identified; bimekizumab demonstrated tolerability up to 5 years (2 years in phase III).