Evidence map›Paper›PMID 39884731›Full record

Trial reportRMD open2025

Safety and efficacy of filgotinib in patients with rheumatoid arthritis: final results of the DARWIN 3 long-term extension study.

Rene Westhovens, Kevin L Winthrop, Arthur Kavanaugh, Maria Greenwald, Lorenzo Dagna, Regina Cseuz, Robin Besuyen, Dick de Vries, Vikas Modgill, Ly Huong Le and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
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 trial NCT02065700 (A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

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
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Review
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  4. Review
  5. 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.

Rene WesthovensDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Center, KU Leuven, Leuven, Belgium renewesthovens@outlook.com.ORCID 0000-0002-3432-3073
Kevin L WinthropSchool of Medicine, Oregon Health and Science University, Portland, Oregon, USA.ORCID 0000-0002-3892-6947
Arthur KavanaughDivision of Rheumatology, Autoimmunity and Inflammation, University of California San Diego, La Jolla, California, USA.ORCID 0000-0001-6942-5830
Maria GreenwaldDepartment of Rheumatology, Desert Medical Advances, Rancho Mirage, California, USA.ORCID 0000-0002-2622-1448
Lorenzo DagnaUnit of Immunology, Rheumatology, Allergy and Rare Diseases (UnIRAR), Department of Internal Medicine, IRCCS San Raffaele Hospital, Milan, Italy.ORCID 0000-0002-7428-315X
Regina CseuzDepartment of Rheumatology, Revita Reumatológiai Kft, Budapest, Hungary.
Robin BesuyenClinical Development, Galapagos BV, Leiden, Netherlands.ORCID 0000-0002-8699-4549
Dick de VriesClinical Development, Galapagos BV, Leiden, Netherlands.ORCID 0000-0002-7637-5840
Vikas ModgillMedical Safety, Galapagos GmbH, Basel, Switzerland.ORCID 0000-0001-9036-5190
Ly Huong LeBiostatistics, Galapagos NV, Mechelen, Belgium.ORCID 0009-0006-6566-2189
Mark C GenoveseClinical Development, Gilead Sciences Inc, Foster City, California, USA.ORCID 0000-0001-5294-4503
Paul EmeryUniversity of Leeds, Leeds Institute of Rheumatic and Musculoskeletal Medicine, Leeds, UK.ORCID 0000-0002-7429-8482
Patrick VerschuerenDepartment of Development and Regeneration, Skeletal Biology and Engineering Research Center, KU Leuven, Leuven, Belgium.ORCID 0000-0002-0340-3580
Rieke AltenDepartment of Internal Medicine and Rheumatology, Schlosspark Klinik, University Medicine Berlin, Berlin, Germany.ORCID 0000-0002-3395-4412

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesDARWIN 3 (ClinicalTrials.gov: NCT02065700) assessed the safety and efficacy of filgotinib in a long-term extension (LTE) of two phase II randomised controlled rheumatoid arthritis (RA) trials.

methodsEligible patients completing the 24-week DARWIN 1 (filgotinib plus methotrexate) and DARWIN 2 (filgotinib monotherapy) trials could enrol. Patients received filgotinib 200 mg/day, except 15 men who received filgotinib 100 mg/day. The primary endpoints were safety and tolerability, which were assessed by the incidence of treatment-emergent adverse events (TEAEs). Safety and efficacy analyses included all enrolled patients who received ≥1 dose of filgotinib in DARWIN 3.

results739 patients entered the LTE. The total patient-years of exposure (PYE) to filgotinib was 3706.3 years; the mean exposure duration was 259.8 weeks. 497 patients (67.3%) discontinued prematurely (including 266 TEAEs and 172 withdrawals due to the patient's decision or 'sponsor request'). Overall exposure-adjusted incidence rate (EAIR) was 67 (95% CI 62 to 72.2)/100 PYE for TEAEs and 3.8 (95% CI 3.2 to 4.5)/100 PYE for serious TEAEs. EAIR of infections was 23.3 (95% CI 21.2 to 25.6)/100 PYE, 1.3 (95% CI 0.9 to 1.7)/100 PYE for serious infections and 1.3 (95% CI 0.9 to 1.7)/100 PYE for herpes zoster. EAIRs of major adverse cardiovascular events (0.19 (95% CI 0.8 to 0.39)/100 PYE) and malignancies (0.6 (95% CI 0.4 to 0.9)/100 PYE) were low. Disease response assessed using non-responder imputation plateaued at LTE week 12 before slowly declining over time, with overall American College of Rheumatology (ACR)20/50/70 response rates of 26.9%/20.2%/14.7% at week 396.

conclusionFilgotinib was well tolerated in patients with RA for up to 8 years. Safety and efficacy profiles were maintained in patients previously receiving either filgotinib plus methotrexate or filgotinib monotherapy.

Indexed as

Antirheumatic AgentsArthritis, RheumatoidPyridinesAdultAgedClinical Trials, Phase II as TopicFemaleHumansMaleMethotrexateMiddle AgedRandomized Controlled Trials as TopicTreatment OutcomeTriazolesAntirheumatic AgentsGLPG0634MethotrexatePyridinesTriazolesAntirheumatic AgentsArthritisArthritis, Rheumatoid

Identifiers

PMID39884731
PMCPMC11784233

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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.