Evidence map›Paper›PMID 39077886›Full record

ArticleACR open rheumatology2024

Efficacy and Safety of Bimekizumab in Patients With Psoriatic Arthritis With or Without Methotrexate: 52-Week Results From Two Phase 3 Studies.

Iain B McInnes, Philip J Mease, Yoshiya Tanaka, Laure Gossec, M Elaine Husni, Lars Erik Kristensen, Richard B Warren, Barbara Ink, Rajan Bajracharya, Jason Coarse and 1 more

Erratum issued 3 registry-linked trialsAbstract read
In one paragraph

Article in ACR open rheumatology, 2024. 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 3 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

Iain B McInnesCollege of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, United Kingdom.ORCID https://orcid.org/0000-0003-4449-8501
Philip J MeaseSwedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle.ORCID https://orcid.org/0000-0002-6620-0457
Yoshiya TanakaUniversity of Occupational and Environmental Health, Japan, Kitakyushu, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-0807-7139
Laure GossecSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique and AP-HP, Pitié-Salpêtrière Hospital, Paris, France.ORCID https://orcid.org/0000-0002-4528-310X
M Elaine HusniCleveland Clinic, Cleveland, Ohio.ORCID https://orcid.org/0000-0002-3181-4205
Lars Erik KristensenThe Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Denmark.
Richard B WarrenNorthern Care Alliance NHS Foundation Trust and NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom.
Barbara InkUCB Pharma, Slough, United Kingdom.
Rajan BajracharyaUCB Pharma, Slough, United Kingdom.
Jason CoarseUCB Pharma, Morrisville, North Carolina.
Alice B GottliebThe Icahn School of Medicine at Mount Sinai, New York, New York.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objective of this study was to assess 52-week efficacy and safety of bimekizumab in patients with active psoriatic arthritis (PsA) with or without concomitant methotrexate (+/-MTX) treatment at baseline.

methodsWe conducted a post hoc analysis of patients in BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [bDMARD]-naïve), BE COMPLETE (NCT03896581; prior inadequate response or intolerance to tumor necrosis factor inhibitors [TNFi-IR]), and the BE VITAL open-label extension (NCT04009499) study. Patients were randomized to one of the following treatment groups: bimekizumab 160 mg every four weeks, placebo, or a reference drug (adalimumab 40 mg every two weeks; BE OPTIMAL only). From Week 16, placebo-randomized patients received bimekizumab. Missing data were imputed using non-responder imputation, multiple imputation, or worst-category imputation.

resultsThrough Week 52, similar proportions of bimekizumab-treated patients achieved American College of Rheumatology 50% (ACR50) response criteria for both +MTX and -MTX (BE OPTIMAL: 54.4% +MTX, 54.7% -MTX; BE COMPLETE: 56.3% +MTX, 48.0% -MTX). Similar proportions of bimekizumab-treated patients achieved complete skin clearance (Psoriasis Area and Severity Index 100% [PASI100] response) and minimal disease activity in both +MTX and -MTX groups. Similar trends were seen in placebo/bimekizumab-treated patients. Through Week 52, the proportion of bimekizumab-treated patients with ≥1 treatment-emergent adverse event were similar between the +MTX and -MTX groups (BE OPTIMAL 325 of 410 [79.3%] vs 230 of 292 [78.8%], BE COMPLETE 105 of 168 [62.5%] vs 138 of 220 [62.7%]). The safety profile was comparable between subgroups and consistent with the prior safety profile of bimekizumab.

conclusionTreatment with bimekizumab demonstrated consistent, sustained efficacy to 52 weeks in bDMARD-naïve and TNFi-IR patients with PsA and was well tolerated, irrespective of concomitant MTX.

Identifiers

PMID39077886
PMCPMC11557990

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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.