Evidence map›Paper›PMID 32253184›Full record

Trial reportAnnals of the rheumatic diseases2020

Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study.

Désirée van der Heijde, Lianne S Gensler, Atul Deodhar, Xenofon Baraliakos, Denis Poddubnyy, Alan Kivitz, Mary Katherine Farmer, Dominique Baeten, Nadine Goldammer, Jason Coarse and 2 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2020. 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 trial NCT02963506 (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), which is not on this map. Cited by 78 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 6 pooled it
16.1field-weighted citation impact, top 1% of its field
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
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 6 syntheses or guidelines pooled it, 129 citations in OpenAlex.

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  16. Mechanical Strain-Programmed SDC1Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Article
  17. Mucosal-Associated Invariant T Cells in Rheumatic Diseases.Arthritis & rheumatology (Hoboken, N.J.) · 2026
    Review
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  20. Article

18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 5 countries.

Désirée van der HeijdeDepartment of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands mail@dvanderheijde.nl.ORCID 0000-0002-5781-158X
Lianne S GenslerUniversity California San Francisco, San Francisco, California, USA.
Atul DeodharOregon Health & Science University, Portland, Oregon, USA.
Xenofon BaraliakosRheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany.ORCID 0000-0002-9475-9362
Denis PoddubnyyDepartment of Rheumatology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin and Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.ORCID 0000-0002-4537-6015
Alan KivitzAltoona Center for Clinical Research, Duncansville, Pennsylvania, USA.
Mary Katherine FarmerUCB Pharma, Raleigh, North Carolina, USA.
Dominique BaetenDepartment of Clinical Immunology and Rheumatology, UCB Pharma, Slough, UK.
Nadine GoldammerUCB Pharma, Monheim am Rhein, Germany.
Jason CoarseUCB Pharma, Raleigh, North Carolina, USA.
Marga OortgiesenUCB Pharma, Raleigh, North Carolina, USA.
Maxime DougadosDepartment of Rheumatology, Université de Paris, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.
UCB Pharma (United States) · USAltoona Center for Clinical Research · USGerman Rheumatism Research Centre · DEInserm · FRLeiden University Medical Center · NLOregon Health & Science University · USRheumazentrum Ruhrgebiet · DEUCB Pharma (Germany) · DEUCB Pharma (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesBimekizumab selectively neutralises both interleukin (IL)-17A and IL-17F. We report efficacy and safety in a phase IIb dose-ranging study in patients with active ankylosing spondylitis (AS).

methodsAdults with AS (fulfilling modified New York criteria) were randomised 1:1:1:1:1 to bimekizumab 16 mg, 64 mg, 160 mg, 320 mg or placebo every 4 weeks for 12 weeks (double-blind period). At week 12, patients receiving bimekizumab 16 mg, 64 mg or placebo were re-randomised 1:1 to bimekizumab 160 mg or 320 mg every 4 weeks to week 48; other patients continued on their initial dose (dose-blind period). The primary end point was Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 12 (non-responder imputation (NRI) for missing data).

results303 patients were randomised: bimekizumab 16 mg (n=61), 64 mg (n=61), 160 mg (n=60), 320 mg (n=61) or placebo (n=60). At week 12, significantly more bimekizumab-treated patients achieved ASAS40 vs placebo (NRI: 29.5%-46.7% vs 13.3%; p<0.05 all comparisons; OR vs placebo 2.6-5.5 (95% CI 1.0 to 12.9)). A significant dose-response was observed (p<0.001). The primary end point was supported by all secondary efficacy outcomes. At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients. During the double-blind period, treatment-emergent adverse events occurred in 26/60 (43.3%) patients receiving placebo and 92/243 (37.9%) receiving bimekizumab.

conclusionsBimekizumab provided rapid and sustained improvements in key outcome measures in patients with active AS, with no unexpected safety findings versus previous studies. TRIAL REGISTRATION NUMBER: NCT02963506.

Indexed as

AdultAntibodies, Monoclonal, HumanizedBiomarkersDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleEuropeFemaleFollow-Up StudiesHumansInterleukin-17InternationalityMaleMaximum Tolerated DoseMiddle AgedReference ValuesAntibodies, Monoclonal, HumanizedbimekizumabBiomarkersIL17A protein, humanIL17F protein, humanInterleukin-17ankylosing spondylitisDMARDs (biologic)spondyloarthritistreatment

Identifiers

PMID32253184
PMCPMC7213320
OpenAlexW3014565220

What OpenQuestion holds

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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.