Evidence map›Paper›PMID 41125403›Full record

Trial reportRMD open2025

Sustained resolution of enthesitis and peripheral arthritis over 104 weeks with bimekizumab in axial spondyloarthritis.

Sofia Ramiro, Denis Poddubnyy, Philip J Mease, Clementina López-Medina, Mindy Kim, Ute Massow, Vanessa Taieb, Tue Wenzel Kragstrup, Dennis McGonagle

3 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
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 3 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03928704 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2023Enrolled274ConditionsNonradiographic Axial SpondyloarthritisArmsBimekizumab, Placebo
NCT03928743 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis

TypeinterventionalSponsorUCB Biopharma SRLRan2019 to 2022Enrolled332ConditionsAnkylosing SpondylitisArmsBimekizumab, Placebo
NCT04436640 phase3active not recruitingnot on this map

A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis

TypeinterventionalSponsorUCB Biopharma SRLRan2020 to 2026Enrolled508ConditionsAxial Spondyloarthritis, Ankylosing Spondylitis, r-axSpa, Nr-axSpaArmsBimekizumab
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

9 authors.

Sofia RamiroDepartment of Rheumatology, Leiden University Medical Center, Leiden, Netherlands sofiaramiro@gmail.com.ORCID 0000-0002-8899-9087
Denis PoddubnyyDivision of Rheumatology, Department of Medicine, University Health Network and University of Toronto, Toronto, Ontario, Canada.
Philip J MeaseDepartment of Rheumatology, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA.ORCID 0000-0002-6620-0457
Clementina López-MedinaReina Sofia University Hospital, IMIBIC and University of Cordoba, Cordoba, Spain.ORCID 0000-0002-2309-5837
Mindy KimUCB, Atlanta, GA, USA.
Ute MassowUCB, Monheim am Rhein, Germany.
Vanessa TaiebUCB, Colombes, France.
Tue Wenzel KragstrupDepartment of Biomedicine, Aarhus University, Aarhus, Denmark.ORCID 0000-0002-6439-397X
Dennis McGonagleAcademic Unit for the Musculoskeletal Diseases, Leeds Teaching Hospitals NHS Trust, Leeds, UK.ORCID 0000-0001-7715-8226

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBimekizumab (BKZ), a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated 2-year efficacy in non-radiographic axial spondyloarthritis (nr-axSpA) and radiographic axSpA (r-axSpA) phase III studies.

objectiveAssess the impact of BKZ on peripheral manifestations to week 104 of those studies.

methodsBE MOBILE 1 (nr-axSpA) and 2 (r-axSpA) each comprised a 16-week double-blind, placebo-controlled period, then all received BKZ 160 mg every 4 weeks for 36 weeks. Patients not meeting withdrawal criteria could enter a combined open-label extension. We report change in enthesitis (Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)) in patients with baseline MASES>0, peripheral arthritis (swollen joint count (SJC)/Disease Activity Index for Psoriatic Arthritis (DAPSA)) in patients with baseline SJC>0 and proportions achieving DAPSA disease states to week 104. Resolution of enthesitis (MASES=0)/arthritis (SJC=0) is reported to week 104 for those with baseline enthesitis/arthritis. We also report associations between peripheral manifestation resolution (MASES=0/SJC=0) and week 104 clinical outcomes in those with baseline enthesitis/arthritis.

resultsAt baseline, 186/254 (73.2%) and 88/254 (34.6%) patients with nr-axSpA had enthesitis (MASES>0) and arthritis (SJC>0), respectively, compared with 199/332 (59.9%) and 66/332 (19.9%) patients with r-axSpA. Pooled BKZ/placebo-randomised patients with enthesitis (nr-axSpA/r-axSpA) showed average MASES improvement from 4.8/4.3 (baseline) to 1.6/1.3 (week 52) and 1.6/1.0 (week 104). Pooled BKZ/placebo-randomised patients with arthritis showed average SJC improvement from 4.0/4.5 (baseline) to 1.2/0.7 (week 52) and 0.9/0.6 (week 104). Over 60% of patients achieved DAPSA low disease activity/remission by week 52. Over 40%/60% patients achieved resolution of enthesitis (MASES=0)/arthritis (SJC=0) at week 104; enthesitis resolution was associated with larger improvements in week 104 clinical outcomes for patients with r-axSpA.

conclusionBKZ resulted in sustained improvements in peripheral manifestations to 2 years across the full disease spectrum of axSpA.

Indexed as

Antibodies, Monoclonal, HumanizedAntirheumatic AgentsAxial SpondyloarthritisEnthesopathyAdultDouble-Blind MethodFemaleHumansInterleukin-17MaleMiddle AgedSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedAntirheumatic AgentsbimekizumabInterleukin-17Ankylosing SpondylitisAxial SpondyloarthritisBiological TherapyInflammationInterleukin-17

Identifiers

PMID41125403
PMCPMC12550279

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.