{
  "abstract": "Objective To present updated integrated safety analyses of bimekizumab in patients with axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA).Methods Safety 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).Results 848 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.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.Trial registration numbers NCT02963506; NCT03355573; NCT03928704; NCT03928743; NCT04436640; NCT02969525; NCT03347110; NCT03895203; NCT03896581; NCT04009499.",
  "authors": [
    {
      "affiliations": [
        "Department of Rheumatology, Providence-Swedish Medical Center, Seattle, Washington, USA",
        "University of Washington, Seattle, Washington, USA"
      ],
      "name": "Philip J Mease"
    },
    {
      "affiliations": [
        "Department of Dermatology and Department of Medicine, Division of Rheumatology, UT Southwestern Medical Center, Dallas, Texas, USA"
      ],
      "name": "Joseph F Merola"
    },
    {
      "affiliations": [
        "Case Western Reserve University, University Hospitals, Cleveland, Ohio, USA"
      ],
      "name": "Marina Magrey"
    },
    {
      "affiliations": [
        "School of Medicine, Griffith University, Brisbane, Queensland, Australia"
      ],
      "name": "Peter Nash"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Department of Medicine, University of Toronto and University Health Network, Toronto, Ontario, Canada",
        "Department of Gastroenterology, Infectious Diseases and Rheumatology, Charité– Universitätsmedizin Berlin, Berlin, Germany",
        "Department of Epidemiology, German Rheumatism Research Centre, Berlin, Germany"
      ],
      "name": "Denis Poddubnyy"
    },
    {
      "affiliations": [
        "Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Mark Lebwohl"
    },
    {
      "affiliations": [
        "UCB, Slough, UK"
      ],
      "name": "Rajan Bajracharya"
    },
    {
      "affiliations": [
        "UCB, Slough, UK"
      ],
      "name": "Barbara Ink"
    },
    {
      "affiliations": [
        "UCB, Monheim am Rhein, Germany"
      ],
      "name": "Alexander Marten"
    },
    {
      "affiliations": [
        "UCB, Braine-l’Alleud, Belgium"
      ],
      "name": "Myriam Manente"
    },
    {
      "affiliations": [
        "UCB, Morrisville, North Carolina, USA"
      ],
      "name": "Luke Peterson"
    },
    {
      "affiliations": [
        "UCB, Slough, UK"
      ],
      "name": "Katy White"
    },
    {
      "affiliations": [
        "Department of Medicine/Rheumatology, University of California, San Francisco, San Francisco, California, USA"
      ],
      "name": "Lianne S Gensler"
    }
  ],
  "title": "Bimekizumab longer-term safety profile in adult patients with axial spondyloarthritis or psoriatic arthritis: an updated analysis of six phase IIb/III clinical studies",
  "uid": "ebd69b9d-d875-57be-8796-bb7099da2772"
}