Trial reportRMD open2026
Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies.
Trial report in RMD open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 10 registered trials, which are not on this map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Active Psoriatic Arthritis
A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects With Psoriatic Arthritis
A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
A Multicenter, Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis
Who cites it
1 citing paper in PubMed.
- Biologic and targeted synthetic therapies in ankylosing spondylitis: a pharmacological review.Frontiers in pharmacology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo present updated integrated safety analyses of bimekizumab in patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA).
methodsSafety 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).
results848 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.
conclusionTEAE 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.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.