Evidence map›Paper›PMID 37540206›Full record

Trial reportJournal of Crohn's & colitis2024

Withdrawal and Re-treatment with Filgotinib in Ulcerative Colitis: Post Hoc Analyses of the Phase 2b/3 SELECTION and SELECTIONLTE Studies.

Séverine Vermeire, Brian G Feagan, Laurent Peyrin-Biroulet, Alessandra Oortwijn, Margaux Faes, Angela de Haas, Gerhard Rogler

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Crohn's & colitis, 2024. 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. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.9field-weighted citation impact, top 13% 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
NCT02914535 phase3active not recruitingnot on this map

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis

TypeinterventionalSponsorAlfasigma S.p.A.Ran2017 to 2026Enrolled1,173ConditionsUlcerative ColitisArmsFilgotinib, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. 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

7 authors at 6 institutions in 5 countries.

Séverine VermeireDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0001-9942-3019
Brian G FeaganAlimentiv Inc., London, Ontario, Canada.
Laurent Peyrin-BirouletUniversity of Lorraine, Inserm, NGERE, Nancy, France.
Alessandra OortwijnGalapagos NV, Leiden, Netherlands.
Margaux FaesGalapagos NV, Mechelen, Belgium.
Angela de HaasGalapagos NV, Leiden, Netherlands.
Gerhard RoglerDepartment of Gastroenterology and Hepatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Galapagos (Netherlands) · NLGalapagos (Belgium) · BEInserm · FRKU Leuven · BEUniversity of Zurich · CHWestern University · CA

Funding

Gilead Sciences
6 · The paper itself

Abstract

BACKGROUND AND

aimsMaintenance treatment for ulcerative colitis may be discontinued for multiple reasons. This post hoc analysis assessed the efficacy and safety of re-treatment with filgotinib, an oral, once-daily, Janus kinase 1 preferential inhibitor, in the phase 2b/3 SELECTION trial and its long-term extension [LTE] study in ulcerative colitis.

methodsPartial Mayo Clinic Score [pMCS] response and remission were evaluated in patients who received induction with filgotinib 200 mg [FIL200] or 100 mg [FIL100], were randomized to treatment withdrawal [placebo] during maintenance, and following disease worsening, were re-treated with open-label FIL200 in the LTE study. Factors were evaluated for association with pMCS remission at LTE week 12, and safety outcomes were reported.

resultsAnalyses included 86 patients [FIL200: n = 51; FIL100: n = 35]. Median time to disease worsening following treatment withdrawal was 15.1 weeks (95% confidence interval [CI]: 9.1-18.7) for FIL200-induced patients and 9.6 weeks [95% CI: 6.3-12.0] for FIL100-induced patients. Three-quarters [75%] of patients achieved a pMCS response within 4-5 weeks of re-treatment in both groups. At LTE week 48, pMCS remission was achieved by 45.1% and 51.4% of FIL200- and FIL100-induced patients, respectively. Factors independently associated with restoring efficacy included no concomitant use of corticosteroids at induction baseline, and high albumin levels, pMCS remission, and endoscopic score at maintenance baseline. No new safety signals were reported among re-treated patients.

conclusionsIn induction responders, re-treatment with FIL200 following temporary withdrawal from therapy restores response and/or remission in the majority of patients within 12 weeks. Re-treatment is well-tolerated. ClinicalTrials.gov identifiers: NCT02914522, NCT02914535.

Indexed as

Colitis, UlcerativeJanus Kinase InhibitorsHumansInduction ChemotherapyPyridinesRemission InductionTreatment OutcomeTriazolesGLPG0634Janus Kinase InhibitorsPyridinesTriazolesFilgotinibre-treatmentulcerative colitis

Identifiers

PMID37540206
PMCPMC10821704
OpenAlexW4385564389

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.