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. 2025 Apr 6;11(2):e005026. doi: 10.1136/rmdopen-2024-005026.

Abstract

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).

Keywords: axial spondyloarthritis; biological therapy; psoriatic arthritis.

Publication types

  • Meta-Analysis

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized* / administration & dosage
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Antirheumatic Agents* / administration & dosage
  • Antirheumatic Agents* / adverse effects
  • Antirheumatic Agents* / therapeutic use
  • Arthritis, Psoriatic* / drug therapy
  • Axial Spondyloarthritis* / drug therapy
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Female
  • Humans
  • Male
  • Middle Aged
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents
  • bimekizumab

Associated data

  • ClinicalTrials.gov/NCT02963506
  • ClinicalTrials.gov/NCT03928743
  • ClinicalTrials.gov/NCT04009499
  • ClinicalTrials.gov/NCT03928704
  • ClinicalTrials.gov/NCT02969525
  • ClinicalTrials.gov/NCT03895203
  • ClinicalTrials.gov/NCT03355573
  • ClinicalTrials.gov/NCT03896581
  • ClinicalTrials.gov/NCT03347110
  • ClinicalTrials.gov/NCT04436640