Evidence map›Paper›PMID 31177099›Full record

Trial reportAnnals of the rheumatic diseases2019

Efficacy and safety of bimekizumab as add-on therapy for rheumatoid arthritis in patients with inadequate response to certolizumab pegol: a proof-of-concept study.

Sophie Glatt, Peter C Taylor, Iain B McInnes, Georg Schett, Robert Landewé, Dominique Baeten, Lucian Ionescu, Foteini Strimenopoulou, Mark I L Watling, Stevan Shaw

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

Trial report in Annals of the rheumatic diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02430909 (A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects With Moderate-to-Severe Rheumatoid Arthritis), which is not on this map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 6% 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.

NCT02430909 phase2completednot on this map

A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects With Moderate-to-Severe Rheumatoid Arthritis

TypeinterventionalSponsorUCB CelltechRan2015 to 2017Enrolled159ConditionsRheumatoid ArthritisArmsBimekizumab, Certolizumab Pegol, Placebo
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. [Advanced Combination Therapy in Inflammatory Bowel Disease].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2026
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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

10 authors at 5 institutions in 3 countries.

Sophie GlattTranslational Medicine, UCB Pharma, Slough, UK Sophie.Glatt@ucb.com.ORCID 0000-0002-4369-3922
Peter C TaylorBotnar Research Centre, University of Oxford, Oxford, UK.ORCID 0000-0001-7766-6167
Iain B McInnesInstitute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK.
Georg SchettDepartment of Internal Medicine 3, Friedrich Alexander University Erlangen-Nurnberg and Universitatsklinikum Erlangen, Erlangen, Germany.ORCID 0000-0001-8740-9615
Robert LandewéUniversity Medical Centre, Amsterdam Rheumatology and Immunology Center, The Netherlands and Zuyderland Medical Centre, Heerlen, The Netherlands.
Dominique BaetenUniversity Medical Centre, Amsterdam Rheumatology and Immunology Center, The Netherlands and Zuyderland Medical Centre, Heerlen, The Netherlands.
Lucian IonescuPatient Value Practices Development and Medical, UCB Pharma, Slough, UK.
Foteini StrimenopoulouNew Medicines, UCB Pharma, Slough, UK.
Mark I L WatlingTranslational Medicine, UCB Pharma, Slough, UK.
Stevan ShawTranslational Medicine, UCB Pharma, Slough, UK.
UCB Pharma (United Kingdom) · GBZuyderland Medisch Centrum · NLFriedrich-Alexander-Universität Erlangen-Nürnberg · DEUniversity of Glasgow · GBUniversity of Oxford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveEvaluate the efficacy and safety of dual neutralisation of interleukin (IL)-17A and IL-17F with bimekizumab, a monoclonal IgG1 antibody, in addition to certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA) and inadequate response (IR) to certolizumab pegol.

methodsDuring this phase 2a, double-blind, proof-of-concept (PoC) study (NCT02430909), patients with moderate-to-severe RA received open-label CZP 400 mg at Weeks 0, 2 and 4, and 200 mg at Week 6. Patients with IR at Week 8 (Disease Activity Score 28-joint count C-reactive protein (DAS28(CRP))>3.2) were randomised 2:1 to CZP (200 mg every 2 weeks (Q2W)) plus bimekizumab (240 mg loading dose then 120 mg Q2W) or CZP plus placebo. The primary efficacy and safety variables were change in DAS28(CRP) between Weeks 8 and 20 and incidence of treatment-emergent adverse events (TEAEs).

resultsOf 159 patients enrolled, 79 had IR at Week 8 and were randomised to CZP plus bimekizumab (n=52) or CZP plus placebo (n=27). At Week 20, there was a greater reduction in DAS28(CRP) in the CZP-IR plus bimekizumab group compared with the CZP-IR plus placebo group (99.4% posterior probability). The most frequent TEAEs were infections and infestations (CZP plus bimekizumab, 50.0% (26/52); CZP plus placebo, 22.2% (6/27)).

conclusionsPoC was confirmed based on the rapid decrease in disease activity achieved with 12 weeks of CZP plus bimekizumab. No unexpected or new safety signals were identified when neutralising IL-17A and IL-17F in patients with RA concomitantly treated with CZP, but the rate of TEAEs was higher with dual inhibition.

Indexed as

AdultAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidCertolizumab PegolDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHumansMaleMaximum Tolerated DoseMiddle AgedPatient SafetyRemission InductionAntibodies, Monoclonal, HumanizedAntirheumatic AgentsbimekizumabCertolizumab Pegolanti-tnfDAS28dmards (biologic)rheumatoid arthritistreatment

Identifiers

PMID31177099
PMCPMC6691864
OpenAlexW2954168359

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.