Evidence map›Paper›PMID 39890205›Full record

Trial reportRMD open2025

Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and its open-label extension.

Atul Deodhar, Victoria Navarro-Compán, Denis Poddubnyy, Lianne S Gensler, Sofia Ramiro, Tetsuya Tomita, Helena Marzo-Ortega, Carmen Fleurinck, Thomas Vaux, Ute Massow and 3 more

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT02963506 phase2completednot on this map

A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

TypeinterventionalSponsorUCB Biopharma S.P.R.L.Ran2016 to 2018Enrolled303ConditionsAnkylosing SpondylitisArmsPlacebo, Bimekizumab
NCT03355573 phase2completednot on this map

A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis

TypeinterventionalSponsorUCB Biopharma SRLRan2017 to 2022Enrolled255ConditionsAnkylosing SpondylitisArmsBimekizumab
3 · Its place in the literature

Who cites it

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

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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

13 authors.

Atul DeodharDivision of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, Oregon, USA deodhara@ohsu.edu.
Victoria Navarro-CompánDepartment of Rheumatology, IdiPaz, La Paz University Hospital, Madrid, Spain.ORCID 0000-0002-4527-852X
Denis PoddubnyyDepartment of Gastroenterology, Infectious Diseases and Rheumatology, Charite - Universitatsmedizin Berlin, Berlin, Germany.
Lianne S GenslerDepartment of Medicine/Rheumatology, University of California San Francisco, San Francisco, California, USA.
Sofia RamiroDepartment of Rheumatology, Leiden University Medical Center, Leiden, Netherlands.ORCID 0000-0002-8899-9087
Tetsuya TomitaGraduate School of Health Science, Morinomiya University of Medical Sciences, Osaka City, Osaka, Japan.
Helena Marzo-OrtegaNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.ORCID 0000-0002-9683-3407
Carmen FleurinckUCB, Brussels, Belgium.
Thomas VauxUCB, Slough, UK.
Ute MassowUCB, Monheim am Rhein, Germany.
Natasha de PeyrecaveUCB, Brussels, Belgium.
Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, Netherlands.ORCID 0000-0002-5781-158X
Xenofon BaraliakosRheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany.ORCID 0000-0002-9475-9362

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAssess long-term safety, tolerability and efficacy of bimekizumab in ankylosing spondylitis (radiographic axial spondyloarthritis (r-axSpA)).

methodsPatients with active r-axSpA completing the dose-ranging 48-week randomised controlled trial could enrol in the open-label extension, where patients received bimekizumab 160 mg every 4 weeks. Safety (exposure-adjusted incidence rates/100 patient-years (EAIRs)) and efficacy outcomes (binary: non-responder imputation (NRI) and observed case (OC); continuous: multiple imputation (MI)) are presented through 256 weeks.

resultsFrom Weeks 0-256, 289/303 (95.4%) patients had ≥1 treatment-emergent adverse event (TEAE); most frequent were nasopharyngitis (21.8%) and upper respiratory tract infection (14.5%). The EAIR of fungal infections was 7.4 (

conclusionsThe safety profile of bimekizumab after 5 years of treatment remained consistent with previous reports, with no new safety signals identified. 5-year efficacy was sustained in this r-axSpA population following robust disease control achieved at Week 48. TRIAL REGISTRATION NUMBERS: NCT02963506; NCT03355573.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsSpondylitis, AnkylosingAdultFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsbimekizumabAxial SpondyloarthritisDMARDSpondylitis, AnkylosingTreatment

Identifiers

PMID39890205
PMCPMC11792280

What OpenQuestion holds

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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.