Evidence map›Paper›PMID 32640990›Full record

ArticleBMC gastroenterology2020

Real-world clinical effectiveness and safety of vedolizumab and anti-tumor necrosis factor alpha treatment in ulcerative colitis and Crohn's disease patients: a German retrospective chart review.

Ulf Helwig, Michael Mross, Stefan Schubert, Heinz Hartmann, Alina Brandes, Dara Stein, Christian Kempf, Jana Knop, Sarah Campbell-Hill, Robert Ehehalt

Open access · goldAbstract read
In one paragraph

Article in BMC gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
3.6field-weighted citation impact, top 7% 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.

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

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 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

10 authors at 6 institutions in 3 countries.

Ulf HelwigGastroenterology Private Practice, Neue Donnerschweer Str. 30, 26123, Oldenburg, Germany. helwig@internisten-ol.de.
Michael MrossGastroenterology Private Practice, Berlin, Germany.
Stefan SchubertGastroenterology Private Practice, Berlin, Germany.
Heinz HartmannGastroenterology Private Practice, Herne, Germany.
Alina BrandesTakeda Pharma Vertrieb GmbH & Co. KG, Berlin, Germany.
Dara SteinEvidera, London, UK.
Christian KempfTakeda Pharmaceuticals International AG, Zurich, Switzerland.
Jana KnopTakeda Pharma Vertrieb GmbH & Co. KG, Berlin, Germany.
Sarah Campbell-HillTakeda International - UK Branch, London, UK.
Robert EhehaltGastroenterology Outpatient Clinic, Heidelberg, Germany.
Takeda (Germany) · DEBerufsverband Niedergelassener Gynäkologischer Onkologen · DEEVRAZ (United Kingdom) · GBTakeda (Switzerland) · CHTakeda (United Kingdom) · GBUniversity Hospital Heidelberg · DE

Funding

Takeda Pharmaceuticals None
6 · The paper itself

Abstract

backgroundReal-world comparisons of biologic treatment outcomes for ulcerative colitis (UC) or Crohn's disease (CD) patients are limited. We sought to evaluate the real-world effectiveness of vedolizumab (VDZ) and anti-tumor necrosis factor alpha (anti-TNFα) in UC and CD patients in Germany.

methodsA retrospective chart review (15 sites) investigated UC and CD patients who were biologic-treatment naïve (biologic-naïve) or had received no more than one prior anti-TNFα before initiating treatment with VDZ or anti-TNFα between 15 July 2014 and 20 October 2015. Kaplan-Meier analyses assessed time to first chart-documented clinical remission (CR) and symptom resolution (UC: rectal bleeding [RB], stool frequency [SF]; CD: abdominal pain [AP], liquid stools [LS]) and outcome duration.

resultsA total of 133 UC (76 VDZ; 57 anti-TNFα) and 174 CD (69 VDZ; 105 anti-TNFα) patients were included. By Week 26, estimated cumulative rates of patients achieving CR or symptom resolution with VDZ vs anti-TNFα treatment were for UC: CR, 53.7% vs 31.7%; RB, 66.8% vs 55.8%; and SF, 59.8% vs 50.7%, respectively; and for CD: CR, 14.4% vs 32.8%; AP, 62.5% vs 56.0%; and LS, 29.9% vs 50.3%, respectively. Outcomes were sustained similarly between treatments, except RB (VDZ vs anti-TNFα: median 38.1 vs 15.1 weeks, P = 0.03). Treatment-related adverse events occurred in 5.3% vs 7.0% (UC) and 8.7% vs 19.0% (CD) of VDZ vs anti-TNFα patients, respectively.

conclusionsAlthough there were differences in CR, symptom resolution, and safety profiles, real-world data support both VDZ and anti-TNFα as effective treatment options in UC and CD.

Indexed as

Colitis, UlcerativeCrohn DiseaseAntibodies, Monoclonal, HumanizedGastrointestinal AgentsGermanyHumansRemission InductionRetrospective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedGastrointestinal AgentsvedolizumabCrohn’s diseaseInflammatory bowel diseaseOutcomes researchReal-world evidenceUlcerative colitisVedolizumab

Identifiers

PMID32640990
PMCPMC7341567
OpenAlexW3041424716

What OpenQuestion holds

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LicenceCC BY
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.