Evidence map›Paper›PMID 42536126›Full record

ArticleRheumatology and therapy2026

Filgotinib in Moderate to Severe Rheumatoid Arthritis in a Real-World Setting: Up to 6-Month Effectiveness, Patient-Reported Outcomes, and Persistence, and up to 24-Month Safety from More than 1400 Patients in the FILOSOPHY and PARROTFISH Studies.

Gerd R Burmester, James Galloway, Karen Bevers, Jérôme Avouac, Susana Romero-Yuste, Roberto F Caporali, Neil Betteridge, Carole Van der Donckt, Thomas P A Debray, Ouafia Tandjaoui Bouzid and 1 more

2 registry-linked trialsAbstract read
In one paragraph

Article in Rheumatology and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

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

NCT04871919 active not recruitingnot on this map

A Prospective, Non-interventional Study of the Effectiveness, Safety, and Health Related Outcomes in Patients With Moderate to Severe Active Rheumatoid Arthritis Receiving Filgotinib

TypeobservationalSponsorAlfasigma S.p.A.Ran2021 to 2028Enrolled1,304ConditionsRheumatoid ArthritisArmsFilgotinib
NCT05323591 completednot on this map

A Prospective, Non-interventional Study in Patients With Moderate to Severe Active Rheumatoid Arthritis in France Receiving Filgotinib for 2 Years

TypeobservationalSponsorAlfasigma S.p.A.Ran2022 to 2026Enrolled155ConditionsRheumatoid ArthritisArmsFilgotinib
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

11 authors.

Gerd R BurmesterDepartment of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Berlin, Germany. gerd.burmester@charite.de.ORCID http://orcid.org/0000-0001-7518-1131
James GallowayCentre for Rheumatic Diseases, King's College London, London, UK.ORCID http://orcid.org/0000-0002-1230-2781
Karen BeversDepartment of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands.ORCID http://orcid.org/0000-0001-8543-1237
Jérôme AvouacRheumatology A Department, Hôpital Cochin, AP-HP Centre, Université Paris Cité, Paris, France.ORCID http://orcid.org/0000-0002-2463-218X
Susana Romero-YusteDepartment of Rheumatology, University Hospital Complex of Pontevedra, Pontevedra, Spain.ORCID http://orcid.org/0000-0002-3589-6877
Roberto F CaporaliDepartment of Clinical Sciences and Community Health, University of Milan, Milan, Italy.ORCID http://orcid.org/0000-0001-9300-6169
Neil BetteridgeNeil Betteridge Associates, London, UK.ORCID http://orcid.org/0000-0001-8844-1158
Carole Van der DoncktMedical Affairs, Alfasigma Belgium BV, Mechelen, Belgium.ORCID http://orcid.org/0009-0007-5463-4315
Thomas P A DebrayBiostatistics, Alfasigma S.p.A., Bologna, Italy.ORCID http://orcid.org/0000-0002-1790-2719
Ouafia Tandjaoui BouzidMedical Affairs, Alfasigma Belgium BV, Mechelen, Belgium.ORCID http://orcid.org/0009-0008-2754-4215
Patrick VerschuerenDepartment of Rheumatology, University Hospital Leuven and Skeletal Biology and Engineering Research Center, Department of Development and Regeneration, KU Leuven, Leuven, Belgium.ORCID http://orcid.org/0000-0002-0340-3580

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionFILOSOPHY (NCT04871919) and PARROTFISH (NCT05323591) are ongoing, prospective observational European phase 4 studies of filgotinib in patients with rheumatoid arthritis (RA) in a real-world setting. We report the study design, baseline characteristics, and interim results for disease activity measures, patient-reported outcomes (PROs), and treatment persistence up to 6 months and safety up to 24 months.

methodsEligible patients had moderate to severe RA and were prescribed filgotinib for the first time in daily practice. In this interim analysis, measures include the proportion of patients achieving low disease activity (LDA), according to Disease Activity Score for 28 joint count using C-reactive protein (DAS28-CRP) or Clinical Disease Activity Index (CDAI), and the proportion achieving a clinically meaningful change from baseline in visual analog scale (VAS) pain (≥ 10 mm reduction) and in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score (≥ 4.0 increase). Treatment persistence was estimated using the Kaplan-Meier method. Treatment-emergent adverse events (TEAEs) are reported.

resultsFrom May 2021 to April 2025, 1431 patients initiated filgotinib treatment; 93.0% had completed at least 6 months of follow-up (median follow-up 706 days). Improvements in DAS28-CRP and CDAI occurred from month 1. By month 6, DAS28-CRP ≤ 2.6 was reported for 58.1% (494/850) of patients and CDAI remission for 25.7% (221/859). The proportion with LDA was 71.4% (607/850) based on DAS28-CRP and 69.8% (600/859) based on CDAI. The proportion with a clinically meaningful change from baseline in VAS pain and FACIT-Fatigue score was 44.1% (178/404) and 43.8% (176/402), respectively, at week 1, increasing to 69.6% (227/326) and 62.5% (202/323), respectively, at month 6. Treatment persistence (95% CI) at month 6 was 84.0% (82.0, 85.8). Up to month 24, the exposure-adjusted incidence rates per 100 patient-years of exposure (95% CI) of any TEAEs and serious TEAEs were 89.8 (84.1, 95.8) and 9.4 (8.0, 10.8), respectively.

conclusionInterim data from FILOSOPHY/PARROTFISH showed improvement of disease activity from month 1 and PROs from week 1, high treatment persistence at 6 months, and no new safety signals. These findings continue to support the safety and effectiveness of filgotinib in daily clinical practice.

trial registrationClinicalTrials.gov: NCT04871919 (2021-04-29), NCT05323591(2022-04-05).

Indexed as

FilgotinibPatient-reported outcomesReal-world studyRheumatoid arthritisSafetyTreatment persistence

Identifiers

PMID42536126
PMCPMC13624248

What OpenQuestion holds

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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.