Evidence map›Paper›PMID 36946138›Full record

ArticleInflammatory bowel diseases2024

Matching-Adjusted Indirect Comparisons of Filgotinib vs Vedolizumab, Tofacitinib, and Ustekinumab for Moderately to Severely Active Ulcerative Colitis.

Xiaoyan Lu, Zheng-Yi Zhou, Yiqiao Xin, Min-Jung Wang, Emma Gray, Vipul Jairath, James Oliver Lindsay

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Inflammatory bowel diseases, 2024. 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 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed, 8 citations in OpenAlex.

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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 4 institutions in 4 countries.

Xiaoyan LuGalapagos NV, Romainville, France.ORCID 0000-0002-5592-7239
Zheng-Yi ZhouAnalysis Group, Boston, MA, USA.
Yiqiao XinAnalysis Group, Boston, MA, USA.
Min-Jung WangAnalysis Group, Boston, MA, USA.
Emma GrayAnalysis Group, Boston, MA, USA.
Vipul JairathSchulich School of Medicine and Dentistry, Western University, London, ON, Canada.ORCID 0000-0001-8603-898X
James Oliver LindsayThe Royal London Hospital, Barts Health NHS Trust, London, United Kingdom.
Analysis Group (United States) · USGalapagos (France) · FRQueen Mary University of London · GBWestern University · CA

Funding

Analysis Group, Inc
6 · The paper itself

Abstract

backgroundWhere head-to-head trials are lacking, indirect comparative effectiveness can aid treatment decisions. We conducted matching-adjusted indirect comparisons of clinical outcomes with filgotinib vs recently approved comparators (vedolizumab, tofacitinib, ustekinumab) in patients with moderately to severely active ulcerative colitis (UC).

methodsIndividual patient data from the SELECTION trial (NCT02914522) for filgotinib 200 mg were weighted to match average baseline characteristics of active treatment and placebo arms in comparator trials. Efficacy outcomes were compared for biologic-naive and biologic-experienced subgroups in induction and maintenance populations, if data were available. Safety and health-related quality of life outcomes were compared in the overall maintenance population.

resultsFilgotinib had a similar effect on efficacy outcomes compared with tofacitinib, ustekinumab, and subcutaneous vedolizumab in both the induction and maintenance populations. Filgotinib showed improved clinical response vs intravenous (IV) vedolizumab (odds ratio, 2.4; 95% confidence interval [CI], 1.0 to 5.5; P < .05) among the biologic-experienced induction population, and improved corticosteroid-free clinical remission (odds ratio, 15.2; 95% CI, 1.6 to 139.9; P < .05) among the biologic-naive maintenance population. Improved efficacy outcomes were reported with filgotinib compared with ustekinumab among the maintenance population. Higher estimates of serious adverse events were reported for filgotinib compared with vedolizumab IV 300 mg and tofacitinib 5 mg; however, imbalances were noted in their placebo groups. Health-related quality of life outcomes were similar between filgotinib and comparators.

conclusionsMatching-adjusted indirect comparison results suggest superiority of filgotinib 200 mg over vedolizumab IV in terms of clinical response and corticosteroid-free clinical remission in certain patient populations, noting small sample sizes and wide CIs, which may aid the selection of advanced therapies for moderately to severely active UC. A potential increased risk of serious adverse events was reported for filgotinib 200 mg vs vedolizumab IV and tofacitinib 5 mg, but findings should be interpreted with caution owing to underlying imbalances observed between the placebo groups of SELECTION and comparator trials.

Indexed as

Biological ProductsColitis, UlcerativeAntibodies, Monoclonal, HumanizedHumansPiperidinesPyridinesPyrimidinesQuality of LifeTreatment OutcomeTriazolesUstekinumabAntibodies, Monoclonal, HumanizedBiological ProductsGLPG0634PiperidinesPyridinesPyrimidinestofacitinibTriazolesUstekinumabvedolizumabfilgotinibMAICulcerative colitis

Identifiers

PMID36946138
PMCPMC10769800
OpenAlexW4353014971

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.