Evidence map›Paper›PMID 37696588›Full record

Trial reportAnnals of the rheumatic diseases2023

Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study.

Christopher T Ritchlin, Laura C Coates, Iain B McInnes, Philip J Mease, Joseph F Merola, Yoshiya Tanaka, Akihiko Asahina, Laure Gossec, Alice B Gottlieb, Richard B Warren and 5 more

Erratum issued Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Annals of the rheumatic diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03895203 (A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference), which is not on this map. Cited by 36 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 3 pooled it
10.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT03895203 phase3completednot on this map

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

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2022Enrolled852ConditionsPsoriatic ArthritisArmsBimekizumab, Adalimumab, Placebo
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Tumor necrosis factor (TNF) inhibitors for psoriatic arthritis.The Cochrane database of systematic reviews · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 13 institutions in 5 countries.

Christopher T RitchlinAllergy, Immunology & Rheumatology Division, University of Rochester Medical School, University of Rochester, Rochester, New York, USA christopher_ritchlin@urmc.rochester.edu.ORCID 0000-0002-2602-1219
Laura C CoatesNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK.ORCID 0000-0002-4756-663X
Iain B McInnesCollege of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Philip J MeaseSwedish Medical Center and Providence St. Joseph Health, University of Washington, Seattle, Washington, USA.ORCID 0000-0002-6620-0457
Joseph F MerolaBrigham and Women's Hospital, Department of Dermatology, Harvard Medical School, Boston, Massachusetts, USA.
Yoshiya TanakaFirst Department of Internal Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Fukoka, Japan.ORCID 0000-0002-0807-7139
Akihiko AsahinaDepartment of Dermatology, Jikei University School of Medicine, Tokyo, Japan.
Laure GossecINSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université, Paris, France.ORCID 0000-0002-4528-310X
Alice B GottliebDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Richard B WarrenDermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, UK.
Barbara InkUCB Pharma, Slough, UK.
Rajan BajracharyaUCB Pharma, Slough, UK.
Vishvesh ShendeUCB Pharma, Slough, UK.
Jason CoarseUCB Pharma, Morrisville, North Carolina, USA.
Robert Bm LandewéAmsterdam Rheumatology & Clinical Immunology Center, Amsterdam, The Netherlands.ORCID 0000-0002-0577-6620
UCB Pharma (United Kingdom) · GBBrigham and Women's Hospital · USIcahn School of Medicine at Mount Sinai · USInserm · FRJikei University School of Medicine · JPManchester Academic Health Science Centre · GBNuffield Orthopaedic Centre · GBSwedish Medical Center · USUCB Pharma (United States) · USUniversity of Glasgow · GBUniversity of Occupational and Environmental Health Japan · JPUniversity of Rochester Medical Center · USZuyderland Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesBimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. BKZ treatment has demonstrated superior efficacy versus placebo (PBO) at Week 16 in biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with active psoriatic arthritis (PsA). Here, we report long-term efficacy and safety to Week 52.

methodsBE OPTIMAL comprised a 16-week, double-blind, PBO-controlled period, then 36 weeks treatment-blind. Patients were randomised 3:2:1 to subcutaneous BKZ 160 mg every 4 weeks, PBO with switch to BKZ at Week 16, or reference arm (adalimumab (ADA) 40 mg every 2 weeks). Efficacy outcomes included the American College of Rheumatology (ACR) response criteria 20/50/70, Psoriasis Area and Severity Index (PASI) 75/90/100 in patients with baseline psoriasis affecting ≥3% body surface area and minimal disease activity (MDA); non-responder imputation.

resultsACR20/50/70, PASI75/90/100 and MDA responses were sustained with BKZ to Week 52, consistent with results observed at Week 16. Patients who switched to BKZ at Week 16 demonstrated improvements in efficacy with similar results to BKZ-randomised patients by Week 52.To Week 52, 555/702 (79.1%) patients had ≥1 treatment-emergent adverse event (TEAE) during BKZ treatment; 113/140 (80.7%) on ADA. On BKZ, 46 (6.6%) patients had serious TEAEs. 54 (7.7%)

conclusionsThe efficacy of BKZ in bDMARD-naïve patients with PsA was sustained from Week 16 to Week 52. BKZ was well tolerated with no new safety signals observed. TRIAL REGISTRATION NUMBER: NCT03895203.

Indexed as

Antirheumatic AgentsArthritis, PsoriaticBiological ProductsPsoriasisAdalimumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansSeverity of Illness IndexTreatment OutcomeAdalimumabAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntirheumatic AgentsbimekizumabBiological Productsarthritis, psoriaticbiological therapypsoriatic arthritis

Identifiers

PMID37696588
PMCPMC10579478
OpenAlexW4386615476

What OpenQuestion holds

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LicenceCC BY-NC
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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.