Evidence map›Paper›PMID 36928705›Full record

ArticleJournal of Crohn's & colitis2023

Efficacy of Filgotinib in Patients with Ulcerative Colitis by Line of Therapy in the Phase 2b/3 SELECTION Trial.

Iris Dotan, Brian G Feagan, Virginia Taliadouros, Alessandra Oortwijn, Christine Rudolph, Angela de Haas, Eva Santermans, Jeremy Hsieh, Laurent Peyrin-Biroulet, Toshifumi Hibi

Erratum issued Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article 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. An erratum has been issued. 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 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.5field-weighted citation impact, top 10% 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

10 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. [Small Molecule Therapy for Inflammatory Bowel Disease: JAK Inhibitors and S1PR Modulators].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024
    Review
  9. Article
  10. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 7 countries.

Iris DotanDivision of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel.
Brian G FeaganAlimentiv, London, ON, Canada.
Virginia TaliadourosGalapagos NV, Leiden, The Netherlands.
Alessandra OortwijnGalapagos NV, Leiden, The Netherlands.
Christine RudolphGalapagos NV, Leiden, The Netherlands.
Angela de HaasGalapagos NV, Mechelen, Belgium.
Eva SantermansGalapagos NV, Mechelen, Belgium.
Jeremy HsiehGilead Sciences, Inc., Foster City, CA, USA.
Laurent Peyrin-BirouletUniversity of Lorraine, Inserm, NGERE, Nancy, France.
Toshifumi HibiCenter for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Galapagos (Netherlands) · NLGalapagos (Belgium) · BEGilead Sciences (United States) · USInserm · FRKitasato Institute Hospital · JPTel Aviv University · ILWestern University · CA

Funding

Galapagos NVGilead Sciences, Inc
6 · The paper itself

Abstract

BACKGROUND AND

aimsThe efficacy of new therapies for ulcerative colitis [UC] is usually influenced by previous biologic use. These post hoc analyses of SELECTION, a placebo-controlled phase 2b/3 trial in patients with moderately to severely active UC, evaluated the efficacy of filgotinib, an oral Janus 1 kinase preferential inhibitor, with respect to prior biologic failure.

methodsThe effect of filgotinib 200 mg (FIL200) relative to placebo was compared in biologic-naïve and biologic-failed patient groups, and in further subgroups by number of failed biologics [1 or >1], biologic mechanism of action [MoA] classes [1 or 2] and tumour necrosis factor [TNF] antagonists [1 or >1]. Odds ratios [ORs] for clinical remission at week 10 [induction] and hazard ratios [HRs] for protocol-specific disease worsening [PSDW] from week 11 to week 58 [maintenance] were calculated.

resultsAt week 10, FIL200-treated patients were more likely to achieve clinical remission than placebo-treated patients in the biologic-naïve (OR [95% confidence interval, CI]: 1.98 [1.14-3.44]) and biologic-failed (3.91 [1.33-11.48]) groups. During maintenance, FIL200-treated patients had a reduced risk of PSDW in the biologic-naïve (HR [95% CI]: 0.22 [0.11-0.44]) and biologic-failed (0.22 [0.12-0.40]) groups, and in all biologic-failed subgroups (except >1 TNF antagonist failure). The data suggest that the likelihood of PSDW at week 58 increased with increasing numbers of failed biologics.

conclusionsFIL200 induced and maintained benefits relative to placebo regardless of previous biologic use; however, the estimated therapeutic benefit was greatest in biologic-naïve patients and patients previously treated with one biologic or biologic MoA class. [ClinicalTrials.gov: NCT02914522].

Indexed as

Biological ProductsColitis, UlcerativeJanus Kinase InhibitorsHumansPyridinesTriazolesBiological ProductsGLPG0634Janus Kinase InhibitorsPyridinesTriazolesFilgotinibpositioningulcerative colitis

Identifiers

PMID36928705
PMCPMC10441561
OpenAlexW4327574690

What OpenQuestion holds

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LicenceCC BY
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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.