Evidence map›Paper›PMID 41314667›Full record

Trial reportRMD open2025

Sustained improvements in spinal pain, morning stiffness, fatigue, sleep, physical function and overall health-related quality of life with bimekizumab in patients with axial spondyloarthritis: 2-year results from two phase 3 studies.

Helena Marzo-Ortega, Victoria Navarro-Compan, Maureen Dubreuil, Philip J Mease, Marina Magrey, Martin Rudwaleit, Maria-Antonietta D'Agostino, Karl Gaffney, Jonathan Kay, Christine de la Loge and 4 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized 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 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

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

  1. Pooled it
  2. Trial
  3. Article
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

14 authors.

Helena Marzo-OrtegaNIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK h.marzo-ortega@leeds.ac.uk.ORCID 0000-0002-9683-3407
Victoria Navarro-CompanDepartment of Rheumatology, La Paz University Hospital, IdiPaz, Madrid, Spain.ORCID 0000-0002-4527-852X
Maureen DubreuilSection of Rheumatology, Boston University School of Medicine, Boston, Massachusetts, USA.
Philip J MeaseSwedish Medical Center, Providence St. Joseph Health and University of Washington, Seattle, Washington, USA.ORCID 0000-0002-6620-0457
Marina MagreyCase Western Reserve University, University Hospitals, Cleveland, Ohio, USA.
Martin RudwaleitDepartment of Internal Medicine and Rheumatology, Bielefeld University, Medical School and University Medical Center, Klinikum Bielefeld, Bielefeld, Germany.ORCID 0000-0001-5445-548X
Maria-Antonietta D'AgostinoDepartment of Rheumatology, Università Cattolica del Sacro Cuore, Roma, Italy.
Karl GaffneyNorfolk and Norwich University Hospital NHS Trust, Norwich, UK.ORCID 0000-0002-7863-9176
Jonathan KayDivision of Rheumatology, Department of Medicine, UMass Chan Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA.ORCID 0000-0002-8970-4260
Christine de la LogeUCB, Brussels, Belgium.
Ute MassowUCB, Monheim am Rhein, Germany.
Vanessa TaiebUCB, Colombes, France.
Tom VauxUCB, Slough, UK.
Atul DeodharDivision of Arthritis and Rheumatic Diseases, Oregon Health & Science University, Portland, Oregon, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the long-term effect of bimekizumab, a dual inhibitor of IL-17A and IL-17F, on patient-reported symptoms, function and health-related quality of life (HRQoL) in patients with axial spondyloarthritis (axSpA) from phase 3 studies and their open-label extension.

methodsBE MOBILE 1 (non-radiographic-axSpA) and 2 (radiographic-axSpA) comprised 16-week double-blind placebo-controlled and 36-week maintenance periods. From week 16, all patients received subcutaneous bimekizumab 160 mg every 4 weeks. At week 52, eligible patients could enrol in the open-label extension BE MOVING and continue bimekizumab treatment. Spinal pain (rated on a numerical rating scale from 0 (no pain) to 10 (maximum pain)), morning stiffness (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) average of Q5/6), fatigue (BASDAI Q1; Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale), sleep quality (Medical Outcomes Study (MOS) Sleep Scale Index II), physical function (Bath Ankylosing Spondylitis Functional Index (BASFI)) and HRQoL (36-Item Short Form Survey (SF-36) physical component summary (PCS)/mental component summary (MCS); Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire) were reported to week 104.

resultsIn total, 494/586 (84.3%) patients entered BE MOVING at week 52; 456 completed week 104. Patients reported substantial changes from baseline to week 104 in total spinal pain (-4.3), nocturnal spinal pain (-4.3), morning stiffness (-4.3) and fatigue (BASDAI Q1: -3.4; FACIT-Fatigue: +9.9). Over half reported total and nocturnal spinal pain scores ≤3 at week 104. Similar improvements to week 104 were shown in sleep (MOS-Sleep Scale: +10.2), physical function (BASFI: -2.9) and HRQoL (SF-36 PCS: +12.4; ASQoL: -5.6).

conclusionsBimekizumab treatment resulted in sustained improvements in patient-reported symptoms and their impacts across the full disease spectrum of axSpA over 2 years, underscoring its long-term potential for improving patients' daily lives. TRIAL REGISTRATION NUMBERS: NCT03928704, NCT03928743, NCT04436640.

Indexed as

Antibodies, Monoclonal, HumanizedAxial SpondyloarthritisFatigueQuality of LifeAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedPain MeasurementSeverity of Illness IndexSleepTreatment OutcomeAntibodies, Monoclonal, HumanizedbimekizumabAxial SpondyloarthritisFatigueHealth-Related Quality Of LifePainPatient Reported Outcome Measures

Identifiers

PMID41314667
PMCPMC12706112

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.