Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL) - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue The Lancet Année : 2023

Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL)

Iain B Mcinnes
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Akihiko Asahina
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Laura C Coates
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Robert Landewé
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Joseph F Merola
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Christopher T Ritchlin
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Yoshiya Tanaka
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Alice B Gottlieb
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Richard B Warren
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Barbara Ink
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Deepak Assudani
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Rajan Bajracharya
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Vishvesh Shende
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Jason Coarse
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Philip J Mease
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Résumé

Background Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17A and IL-17F. We assessed the efficacy and safety of bimekizumab in patients with active psoriatic arthritis who were naive to biologic disease-modifying antirheumatic drugs (DMARDs). Methods BE OPTIMAL was a 52-week, phase 3, multicentre, randomised, double-blind, placebo-controlled, active reference (adalimumab) trial done at 135 sites (hospitals, clinics, doctors' offices, and research centres) in 14 countries. Eligible patients were 18 years or older with a documented diagnosis of adult-onset psoriatic arthritis that met the Classification Criteria for Psoriatic Arthritis for at least 6 months before screening. Participants were randomly assigned with an interactive-voice and web-response system on the basis of a predetermined randomisation schedule (3:2:1, stratified by region and bone erosion number at baseline) to bimekizumab 160 mg every 4 weeks, placebo every 2 weeks, or the reference group (adalimumab 40 mg every 2 weeks), all administered subcutaneously. At week 16, patients randomly assigned to placebo switched to bimekizumab 160 mg every 4 weeks. The primary endpoint was the proportion of patients reaching 50% or greater improvement in American College of Rheumatology criteria (ACR50) at week 16 (non-responder imputation). Efficacy analyses included all patients who were randomly assigned (intention-to-treat population); the safety analysis set comprised patients who received one or more doses of treatment. Data are presented to week 24 (preplanned analysis). This trial is registered at ClinicalTrials.gov, NCT03895203.
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Dates et versions

hal-03958098 , version 1 (26-01-2023)

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Iain B Mcinnes, Akihiko Asahina, Laura C Coates, Robert Landewé, Joseph F Merola, et al.. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). The Lancet, 2023, 401 (10370), pp.25-37. ⟨10.1016/S0140-6736(22)02302-9⟩. ⟨hal-03958098⟩
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