Evidence map›Paper›PMID 36756874›Full record

Trial reportJournal of Crohn's & colitis2023

Filgotinib Improved Health-Related Quality of Life and Led to Comprehensive Disease Control in Individuals with Ulcerative Colitis: Data from the SELECTION Trial.

Stefan Schreiber, Brian G Feagan, Laurent Peyrin-Biroulet, Séverine Vermeire, Margaux Faes, Kristina Harris, Alessandra Oortwijn, Patrick Daniele, Haridarshan Patel, Silvio Danese

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of Crohn's & colitis, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02914522 (Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
5.6field-weighted citation impact, top 4% 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.

NCT02914522 phase3completednot on this map

Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

TypeinterventionalSponsorGilead SciencesRan2016 to 2020Enrolled1,351ConditionsUlcerative ColitisArmsFilgotinib, PTM filgotinib
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
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  6. Article
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  8. Article
  9. Observational
  10. Review
  11. Article
  12. Article
  13. Focus on Filgotinib in Rheumatoid Arthritis: A Trial-Based Review.Mediterranean journal of rheumatology · 2024
    Review
  14. Review
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 8 institutions in 6 countries.

Stefan SchreiberUniversity Hospital Schleswig-Holstein, Kiel, Germany.
Brian G FeaganAlimentiv Inc., London, Ontario, Canada.
Laurent Peyrin-BirouletDepartment of Gastroenterology, University of Lorraine, CHRU-Nancy, Nancy, France.
Séverine VermeireDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, KU Leuven, Leuven, Belgium.ORCID 0000-0001-9942-3019
Margaux FaesGalapagos NV, Mechelen, Belgium.
Kristina HarrisGalapagos NV, Milan, Italy.
Alessandra OortwijnGalapagos NV, Leiden, Netherlands.
Patrick DanieleCytel Health Canada, Toronto, Canada.
Haridarshan PatelGalapagos NV, Mechelen, Belgium.
Silvio DaneseGastroenterology and Endoscopy, IRCCS Ospedale San Raffaele, Milan, Italy.ORCID 0000-0001-7341-1351
Galapagos (Belgium) · BEGalapagos (Netherlands) · NLHealth Canada · CAInserm · FRKU Leuven · BEUniversity Hospital Schleswig-Holstein · DEVita-Salute San Raffaele University · ITWestern University · CA

Funding

Gilead Sciences Inc
6 · The paper itself

Abstract

BACKGROUND AND

aimsUlcerative colitis [UC] impacts patients' health-related quality of life [HRQoL]. We assessed HRQoL and an exploratory patient-level composite endpoint ('Comprehensive Disease Control' [CDC]) in individuals receiving filgotinib [an oral JAK1 preferential inhibitor] in the SELECTION trial.

methodsIn SELECTION [NCT02914522], a double-blind, randomized, placebo-controlled, phase 2b/3 trial, adults with moderately to severely active UC received once-daily filgotinib 200 mg, filgotinib 100 mg or placebo for 11 weeks in Induction Study A [biologic-naïve] or B [biologic-experienced]. Filgotinib responders [week 10 clinical remission/response] were re-randomized to their filgotinib regimen or placebo for the 48-week Maintenance Study. We assessed week 10 and week 58 SF-36, EQ-5D, WPAI and IBDQ scores. Achievement of CDC (patient-level partial Mayo Clinic Score [pMCS] remission [pMCS ≤2, no individual rectal bleeding, stool frequency or physician's global assessment subscore >1], endoscopic improvement [endoscopic subscore ≤1], faecal calprotectin <150 µg/g and IBDQ score ≥170) and its association with HRQoL and histological outcomes were also explored.

resultsAnalyses included 382 biologic-naïve and 404 biologic-experienced patients. Filgotinib 200 mg induced and maintained improvements vs placebo in SF-36, EQ-5D, WPAI and IBDQ scores, and restored HRQoL by week 10. Proportionally more filgotinib 200 mg- than placebo-treated patients achieved CDC at weeks 10 and 58 [p < 0.01]. CDC was associated with clinically important improvements in HRQoL and histological remission over both periods.

conclusionsFilgotinib 200 mg results in short- and long-term improvements in HRQoL. High-level improvement of HRQoL relates to a stringent composite endpoint suggesting meaningful disease control in a subset of filgotinib-treated individuals.ClinicalTrials.gov identifier: NCT02914522.

Indexed as

Biological ProductsColitis, UlcerativeJanus Kinase InhibitorsAdultDouble-Blind MethodHumansPyridinesQuality of LifeTriazolesBiological ProductsGLPG0634Janus Kinase InhibitorsPyridinesTriazolesClinical trialsquality of lifesocio-economical and psychological endpoints

Identifiers

PMID36756874
PMCPMC10274306
OpenAlexW4319656338

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.