Evidence map›Paper›PMID 37747626›Full record

ArticleRheumatology and therapy2023

Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis.

Alejandro Balsa, Siegfried Wassenberg, Yoshiya Tanaka, Anne Tournadre, Hans-Dieter Orzechowski, Vijay Rajendran, Udo Lendl, Pieter-Jan Stiers, Chris Watson, Roberto Caporali and 2 more

7 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Rheumatology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 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
2.9field-weighted citation impact, top 9% 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.

NCT01888874 phase2completednot on this map

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

TypeinterventionalSponsorLakefront Biotherapeutics NVRan2013 to 2015Enrolled599ConditionsRheumatoid ArthritisArmsGLPG0634, Placebo
NCT01894516 phase2completednot on this map

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone

TypeinterventionalSponsorLakefront Biotherapeutics NVRan2013 to 2015Enrolled287ConditionsRheumatoid ArthritisArmsGLPG0634, Placebo
NCT02065700 phase2completednot on this map

A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis

TypeinterventionalSponsorLakefront Biotherapeutics NVRan2014 to 2023Enrolled739ConditionsRheumatoid ArthritisArmsFilgotinib
NCT02873936 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

TypeinterventionalSponsorGilead SciencesRan2016 to 2018Enrolled449ConditionsRheumatoid ArthritisArmsFilgotinib, Placebo to match filgotinib, csDMARDs
NCT02886728 phase3completednot on this map

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy

TypeinterventionalSponsorGilead SciencesRan2016 to 2019Enrolled1,252ConditionsRheumatoid ArthritisArmsFilgotinib, Placebo to match filgotinib, MTX, Placebo to match MTX
NCT02889796 phase3completednot on this map

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

TypeinterventionalSponsorGilead SciencesRan2016 to 2019Enrolled1,759ConditionsRheumatoid ArthritisArmsFilgotinib, Placebo to match filgotinib, Adalimumab, Placebo to match adalimumab, MTX
NCT03025308 phase3completednot on this map

A Multicenter, Open-label, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects With Rheumatoid Arthritis

TypeinterventionalSponsorAlfasigma S.p.A.Ran2017 to 2025Enrolled2,731ConditionsRheumatoid ArthritisArmsFilgotinib, Placebo to match filgotinib
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. 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

12 authors at 8 institutions in 7 countries.

Alejandro BalsaRheumatology Service, Hospital La Paz Institute for Health Research (IdiPAZ), Universidad Autónoma de Madrid, Paseo de la Castellana 261, 28046, Madrid, Spain. alejandro.balsa@salud.madrid.org.ORCID http://orcid.org/0000-0001-8070-7062
Siegfried WassenbergDepartment of Rheumatology, Rheumazentrum Ratingen, Ratingen, Germany.
Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health Japan, Kitakyushu, Japan.ORCID http://orcid.org/0000-0002-0807-7139
Anne TournadreRheumatology Service, Clermont Ferrand University Hospital, Clermont-Ferrand, France.ORCID http://orcid.org/0000-0002-5025-0214
Hans-Dieter OrzechowskiMedical Affairs, Galapagos Biopharma Deutschland GmbH, Munich, Germany.ORCID http://orcid.org/0000-0001-7374-6899
Vijay RajendranClinical Research, Galapagos NV, Mechelen, Belgium.
Udo LendlMedical Affairs, Galapagos Biopharma Deutschland GmbH, Munich, Germany.
Pieter-Jan StiersBiostatistics, Galapagos NV, Mechelen, Belgium.
Chris WatsonMedical Affairs, Galapagos Biotech Ltd, Cambridge, UK.ORCID http://orcid.org/0009-0007-9887-6092
Roberto CaporaliDepartment of Clinical Sciences and Community Health, The University of Milan and ASST G. Pini-CTO Hospital, Milan, Italy.
James GallowayCentre for Rheumatic Diseases, King's College London, London, UK.ORCID http://orcid.org/0000-0002-1230-2781
Patrick VerschuerenDepartment of Rheumatology, University Hospital Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-0340-3580
Galapagos (Belgium) · BECentre Hospitalier Universitaire de Clermont-Ferrand · FRFachklinik 360° · DEHospital Universitario La Paz · ESKing's College London · GBKU Leuven · BEUniversity of Milan · ITUniversity of Occupational and Environmental Health Japan · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis post hoc analysis of the phase 3 rheumatoid arthritis (RA) filgotinib clinical trial program assessed the effect of filgotinib on body mass index (BMI) in patients with RA and the impact of BMI on the efficacy and safety of filgotinib.

methodsFINCH 1-3 were randomized, double-blind, active- or placebo-controlled phase 3 trials of filgotinib 100 and 200 mg in patients with RA (N = 3452). BMI assessments included the mean change from baseline in BMI and the proportion of patients whose BMI increased by incremental thresholds. Efficacy measures included American College of Rheumatology (ACR) 20/50/70 response and low disease activity/remission according to Disease Activity Score 28 using C-reactive protein. The exposure-adjusted incident rate (EAIR) of adverse events (AEs) was assessed by baseline BMI, using integrated data from the FINCH 1-4 and the phase 2 DARWIN 1-3 studies (total filgotinib exposure = 8085 patient-years).

resultsMean change from baseline in BMI over time was similar across treatment arms. In most patients, BMI increased by ≤ 1 or 2 kg/m

conclusionsFilgotinib did not lead to substantial changes in BMI, and BMI did not appear to affect the efficacy of filgotinib.

trial registrationClinicalTrials.gov identifiers: NCT02889796, NCT02873936, NCT02886728, NCT03025308, NCT01888874, NCT01894516, NCT02065700.

Indexed as

Body mass indexClinical trialDMARDFilgotinibInterventional studyJAK inhibitorRheumatoid arthritis

Identifiers

PMID37747626
PMCPMC10654312
OpenAlexW4387002719

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 1 more above

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.