Evidence map›Paper›PMID 39215949›Full record

ArticleRheumatology and therapy2024

Safety and Efficacy of Bimekizumab in Patients with Psoriatic Arthritis: 2-Year Results from Two Phase 3 Studies.

Philip J Mease, Joseph F Merola, Yoshiya Tanaka, Laure Gossec, Iain B McInnes, Christopher T Ritchlin, Robert B M Landewé, Akihiko Asahina, Barbara Ink, Andrea Heinrichs and 4 more

Erratum issued 3 registry-linked trialsAbstract read
In one paragraph

Article in Rheumatology and therapy, 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 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Observational
  9. Article
  10. Uveitis in Psoriatic Arthritis: A Comprehensive Review.European journal of rheumatology · 2025
    Article
  11. Article
  12. Review
  13. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

Philip J MeaseDepartment of Rheumatology, Providence-Swedish Medical Center and University of Washington, Seattle, WA, USA. pmease@philipmease.com.ORCID http://orcid.org/0000-0002-6620-0457
Joseph F MerolaHarvard Medical School, Brigham and Women's Hospital, Boston, MA, USA.ORCID http://orcid.org/0000-0001-6514-4353
Yoshiya TanakaThe First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.ORCID http://orcid.org/0000-0002-0807-7139
Laure GossecSorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France.ORCID http://orcid.org/0000-0002-4528-310X
Iain B McInnesCollege of Medical Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.ORCID http://orcid.org/0000-0002-6462-4280
Christopher T RitchlinAllergy, Immunology & Rheumatology Division, University of Rochester Medical School, Rochester, NY, USA.ORCID http://orcid.org/0000-0002-2602-1219
Robert B M LandewéAmsterdam Rheumatology & Clinical Immunology Center, Amsterdam, and Zuyderland MC, Heerlen, The Netherlands.ORCID http://orcid.org/0000-0002-0577-6620
Akihiko AsahinaDepartment of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.
Barbara InkUCB Pharma, Slough, UK.
Andrea HeinrichsUCB Biosciences GmbH, Monheim, Germany.
Rajan BajracharyaUCB Pharma, Slough, UK.
Vishvesh ShendeUCB Pharma, Slough, UK.
Jason CoarseUCB Pharma, Morrisville, NC, USA.
Laura C CoatesNuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, Oxford University Hospitals NHS Trust, University of Oxford and Oxford Biomedical Research Centre, Oxford, UK.ORCID http://orcid.org/0000-0002-4756-663X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPsoriatic arthritis (PsA) is a chronic inflammatory disease requiring long-term treatment. Bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated tolerability and sustained clinical efficacy for up to 1 year for patients with PsA. Here, we report the longer-‍term safety and efficacy of bimekizumab up to 2 years.

methodsBE OPTIMAL (biologic disease-modifying antirheumatic drug [bDMARD]-naïve) and BE COMPLETE (prior inadequate response/intolerance to tumor necrosis factor inhibitors [TNFi-IR]) assessed subcutaneous bimekizumab 160 mg every 4 weeks in patients with PsA. BE OPTIMAL included a reference arm (adalimumab 40 mg every 2 weeks); patients switched to bimekizumab at week 52 with no washout between treatments. BE OPTIMAL week 52 and BE COMPLETE week 16 completers were eligible for the BE VITAL open-label extension. Efficacy outcomes are reported to week 104/100 (BE OPTIMAL/BE COMPLETE).

resultsA total of 710/852 (83.3%) bDMARD-naïve and 322/400 (80.5%) TNFi-IR patients completed week 104/100. Up to 104 weeks, patients treated with bimekizumab in BE OPTIMAL and BE COMPLETE had treatment-emergent adverse event incidence rates (exposure-adjusted incidence rate/100 patient-years) of 179.9 (95% CI 166.9, 193.7) and 100.3 (89.2, ‍112.4), respectively. The proportion of patients achieving efficacy outcomes (≥ 50% improvement from baseline in American College of Rheumatology [ACR] response criteria, 100% improvement from baseline in Psorisis Area and Severity Index [PASI], minimal disease activity [MDA]) was sustained in all patients from week 52 to week 104/100.

conclusionsBimekizumab was well tolerated for up to 2 years of treatment and no new safety signals were observed. Sustained clinical efficacy was observed up to 2 years in bDMARD-naïve and TNFi-IR patients with active PsA. Patients switching from adalimumab to bimekizumab demonstrated further improvement in skin and nail symptoms, and sustained efficacy in joint symptoms.

trial registrationBE OPTIMAL (NCT03895203), BE COMPLETE (NCT03896581), BE VITAL (NCT04009499).

Indexed as

bDMARD-naïveBimekizumabEfficacyPsoriatic arthritisSafetyTNFi-‍inadequate responders

Identifiers

PMID39215949
PMCPMC11422409

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.