Evidence map›Paper›PMID 38754125›Full record

Trial reportRheumatology (Oxford, England)2024

Effect of bimekizumab on patient-reported disease impact in patients with psoriatic arthritis: 1-year results from two phase 3 studies.

Laure Gossec, Ana-Maria Orbai, Maarten de Wit, Laura C Coates, Alexis Ogdie, Barbara Ink, Jason Coarse, Jérémy Lambert, Vanessa Taieb, Dafna D Gladman

3 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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
NCT03896581 phase3completednot on this map

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

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2022Enrolled400ConditionsPsoriatic ArthritisArmsBimekizumab, Placebo
NCT04009499 phase3completednot on this map

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

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2026Enrolled1,131ConditionsPsoriatic ArthritisArmsBimekizumab
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Psoriatic Arthritis: Developments in 2025.Mediterranean journal of rheumatology · 2026
    Review
  4. Review
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Laure GossecSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.ORCID 0000-0002-4528-310X
Ana-Maria OrbaiDivision of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID 0000-0001-8644-8567
Maarten de WitPatient Research Partner, Stichting Tools, Amsterdam, The Netherlands.
Laura C CoatesNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford and Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford, UK.ORCID 0000-0002-4756-663X
Alexis OgdiePerelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.ORCID 0000-0002-4639-0775
Barbara InkUCB Pharma, Slough, UK.
Jason CoarseUCB Pharma, Morrisville, NC, USA.
Jérémy LambertUCB Pharma, Colombes, France.
Vanessa TaiebUCB Pharma, Colombes, France.
Dafna D GladmanSchroeder Arthritis Institute, Krembil Research Institute, Toronto Western Hospital, University Health Network, University of Toronto, ON, Canada.

Funding

Costello Medical UKGood Publication Practice GPP3UCB Pharma
6 · The paper itself

Abstract

objectivesTo evaluate 1-year bimekizumab efficacy in PsA from the patient perspective using the 12-item PsA Impact of Disease (PsAID-12) questionnaire.

methodsBE OPTIMAL (NCT03895203; biologic DMARD [bDMARD]-naïve), BE COMPLETE (NCT03896581; inadequate response/intolerance to TNF inhibitors [TNFi-IR]) and BE VITAL (NCT04009499; open-label extension) assessed bimekizumab 160 mg every 4 weeks in patients with PsA. Post hoc analyses of patient-reported disease impact, assessed by the PsAID-12 questionnaire, are reported to 1 year (collected to Week 40 in BE COMPLETE).

resultsOverall, 1,112 total patients were included (698 bimekizumab, 414 placebo). Rapid improvements observed with bimekizumab treatment at Week 4 continued to Week 16 and were sustained to 1 year. At 1 year, mean (SE) change from baseline in PsAID-12 total score was comparable between bimekizumab-randomized patients and patients who switched to bimekizumab at Week 16 (bDMARD-naïve bimekizumab -2.3 [0.1], placebo/bimekizumab -2.2 [0.1]; TNFi-IR bimekizumab -2.5 [0.1], placebo/bimekizumab -2.2 [0.2]). Proportions of bimekizumab-randomized patients achieving clinically meaningful within-patient improvement (≥3-point decrease from baseline) at Week 16 were sustained to 1 year (bDMARD-naïve 49.0%; TNFi-IR 48.5%) and were similar for placebo/bimekizumab patients (bDMARD-naïve 44.4%; TNFi-IR 40.6%). Across studies and arms, 35.3% to 47.8% of patients had minimal or no symptom impact at 1 year. Improvements were observed to 1 year across all single-item domains, including pain, fatigue and skin problems.

conclusionBimekizumab treatment resulted in rapid and sustained clinically meaningful improvements in disease impact up to 1 year in bDMARD-naïve and TNFi-IR patients with PsA.

trial registrationBE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499 (ClinicalTrials.gov).

Indexed as

Antibodies, Monoclonal, HumanizedArthritis, PsoriaticPatient Reported Outcome MeasuresAdultAntirheumatic AgentsDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic Agentsbimekizumabbimekizumabhealth-related QoLPROMPsArheumatologySeverity of Illness Index

Identifiers

PMID38754125
PMCPMC11371372

What OpenQuestion holds

Textmetadata
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.