Evidence map›Paper›PMID 35441398›Full record

ArticleAlimentary pharmacology & therapeutics2022

Safety of sequential biological therapy in inflammatory bowel disease: results from a tertiary referral centre.

Annick Moens, Nasim Sadat Seyed Tabib, Vera Ballet, João Sabino, Séverine Vermeire, Marc Ferrante

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In one paragraph

Article in Alimentary pharmacology & therapeutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 34% 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

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Annick MoensDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0003-4826-6839
Nasim Sadat Seyed TabibDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Vera BalletDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
João SabinoDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Séverine VermeireDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Marc FerranteDepartment of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0003-1492-0716
Catholic University of America · USKU Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBiologicals represent the cornerstone of treatment for moderate-to-severe inflammatory bowel diseases (IBD). Many patients cycle between biologicals when encountering loss of response or adverse events.

aimTo assess the occurrence of serious infections and malignancies with exposure to several (classes of) biologicals.

methodsWe performed a retrospective cohort study in a tertiary referral centre including consecutive IBD patients exposed to adalimumab, infliximab, ustekinumab or vedolizumab between 1996 and 2019. All serious infections and malignancies, as well as potential confounders, were accounted for.

resultsIn total, 1575 patients were included with a median (interquartile range) follow-up of 10 (6-16) years and a duration of biological therapy of 71 (39-112) months. Incidence rates of serious infections were 3.4 per 100 patients' years (PY) in the post-biological setting. Serious infections after biological exposure were associated with systemic steroids in monotherapy (hazard ratio 2.96 [95% confidence interval 1.78-4.93], p < 0.0001), combination therapy of systemic steroids and a biological (2.44 [1.37-4.34], p = 0.002), female gender (1.25 [1.04-1.51], p = 0.02), and prior serious infections in the pre-biological setting (1.42 [1.03-1.96], p = 0.03). Malignancy rates were 1.06 per 100PY in the post-biological setting and increased with older age at biological initiation (1.04 [1.02-1.05], p < 0.0001). The risk for serious infections or malignancies was independent of type and number of biologicals to which the patient was exposed.

conclusionThis study shows that the sequential use of biological therapy in IBD does not seem to convey an overall higher risk of serious infections or malignancies, but that underlying more refractory disease seems to increase this risk.

Indexed as

Biological FactorsBiological TherapyInflammatory Bowel DiseasesInfliximabNeoplasmsChronic DiseaseFemaleHumansInfectionsMaleRetrospective StudiesRiskTertiary Care CentersBiological FactorsInfliximab

Identifiers

PMID35441398
OpenAlexW4224240963

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Registered trials

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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.