Evidence map›Paper›PMID 39213145›Full record

SynthesisJournal of managed care & specialty pharmacy2024

Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review.

Peter M Irving, Peter Hur, Raju Gautam, Xiang Guo, Severine Vermeire

Abstract readSystematic Review
In one paragraph

Synthesis in Journal of managed care & specialty pharmacy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

5 authors.

Peter M IrvingGastroenterology, Guy's and St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.
Peter HurPfizer Inc, New York City, NY.
Raju GautamEVERSANA Pvt. Ltd., Mumbai, Maharashtra, India, now with ConnectHEOR, London, United Kingdom.
Xiang GuoPfizer Inc, Collegeville, PA.
Severine VermeireDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEffectiveness and safety of advanced therapies for ulcerative colitis (UC) warrant assessment in the real world.

objectiveTo perform a systematic review and summarize real-world evidence of advanced therapies approved for moderate-to-severe UC.

methodsA systematic literature review was conducted using real-world studies of biologics or small molecules in UC using Embase, MEDLINE, and MEDLINE-In Process databases. Only products approved in any jurisdiction during the search were included. English-language full-papers (January 2005 to February 2022) and congress abstracts (January 2019 to February 2022) were included. Studies with less than 30 patients or only biologic-naive patients were excluded.

resultsA total of 139 studies were included out of 3,930 identified articles (75%, published between 2019 and 2022; 64%, retrospective observational; 53%, from 5 countries [Italy, United States, Spain, United Kingdom, and Belgium]). Most studies were single agent (highest: vedolizumab = 50, tofacitinib = 24, and adalimumab = 18), and rates of clinical remission (CR) and adverse events varied widely. From the published comparative effectiveness studies (16), the rates of CR were numerically higher with vedolizumab vs anti-tumor necrosis factor (TNF)-α agents. Compared with vedolizumab, the effectiveness of tofacitinib was numerically greater in CR (occasionally significant). Rates of steroid-free CR were comparable between ustekinumab and tofacitinib. Infliximab was the most effective anti-TNFα agent, as reported by 2 studies. Remarkably, adverse events were similar across therapies in comparative studies.

conclusionsVedolizumab and tofacitinib were the most assessed therapies. In comparative studies, remission rates were numerically higher with tofacitinib vs vedolizumab and for vedolizumab vs anti-TNFα. Tofacitinib was comparable with ustekinumab for steroid-free CR. Safety was comparable across therapies. Future studies should explore the literature gaps identified, including limited comparative studies with small sample sizes, variations in study designs and patient characteristics, varied definitions of CR, and limited use of patient-reported outcome measures in real-world settings.

Indexed as

Colitis, UlcerativeAntibodies, Monoclonal, HumanizedGastrointestinal AgentsHumansPiperidinesPyrimidinesSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal AgentsPiperidinesPyrimidinestofacitinibvedolizumab

Identifiers

PMID39213145
PMCPMC11365571

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.