Evidence map›Paper›PMID 30674475›Full record

ArticleAnnals of the rheumatic diseases2019

Incidence rates of inflammatory bowel disease in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis treated with secukinumab: a retrospective analysis of pooled data from 21 clinical trials.

Stefan Schreiber, Jean-Frederic Colombel, Brian G Feagan, Kristian Reich, Atul A Deodhar, Iain B McInnes, Brian Porter, Ayan Das Gupta, Luminita Pricop, Todd Fox

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Article in Annals of the rheumatic diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 104 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
104citing papers in PubMed, 4 pooled it
–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

104 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  17. Divergent T Cell Phenotypes Define Pediatric Crohn's Disease and Ulcerative Colitis.medRxiv : the preprint server for health sciences · 2025
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44 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Stefan SchreiberUniversity Hospital Schleswig Holstein, Christian-Alrechts-University, Kiel, Germany s.schreiber@mucosa.de.
Jean-Frederic ColombelIcahn School of Medicine at Mount Sinai, New York City, New York, USA.
Brian G FeaganRobarts Clinical Trials, Western University, London, Ontario, Canada.
Kristian ReichDermatologikum Berlin and SCIderm Research Institute, Hamburg, Germany.
Atul A DeodharOregon Health & Science University, Portland, Oregon, USA.ORCID 0000-0002-2130-1246
Iain B McInnesUniversity of Glasgow, Glasgow, UK.
Brian PorterNovartis Pharma AG, Basel, Switzerland.
Ayan Das GuptaNovartis Healthcare Pvt. Ltd, Hyderabad, Telangana, India.
Luminita PricopNovartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
Todd FoxNovartis Pharma AG, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesHere, we present the reported incidence rates of inflammatory bowel disease (IBD) in patients receiving treatment with secukinumab for psoriasis (PsO), psoriatic arthritis (PsA) or ankylosing spondylitis (AS), in a pooled analysis of 21 clinical trials.

methodsData from all patients who had received at least one dose of secukinumab were included. Safety analyses were conducted to evaluate cumulative IBD rates as well as per-year rates, by indication. Crohn's disease (CD), ulcerative colitis (UC) and IBD unclassified (IBDU) events were analysed using exposure-adjusted incidence rates (patient incidence rates per 100 patient-years (PY)).

resultsA total of 7355 patients with a cumulative exposure of 16 226.9 PY were included in the pooled analysis. Among 5181 patients with PsO, there were 14 cases of UC, 5 cases of CD and 1 case of IBDU, with exposure adjusted incidence rates (EAIRs) of 0.13, 0.05 and 0.01, respectively. Of these 20 cases, 14 were new-onset. In 1380 patients with PsA, there were 3 cases of UC, 3 cases of CD and 2 cases of IBDU (EAIRs 0.08, 0.08 and 0.05); 7 of these represented new-onset cases. Among 794 patients with AS, there were 4 cases of UC, 8 cases of CD and 1 case of IBDU (EAIRs 0.2, 0.4 and 0.1); 9 were new-onset cases. In the per year analysis, the EAIRs for each indication did not increase over time with secukinumab treatment.

conclusionsIn this pooled secukinumab safety analysis of 7355 patients across 21 clinical trials, cases of IBD events (including CD, UC and IBDU) were uncommon.

Indexed as

Antibodies, Monoclonal, HumanizedArthritis, PsoriaticBiological ProductsColitis, UlcerativeCrohn DiseaseHumansIncidenceInflammatory Bowel DiseasesProduct Surveillance, PostmarketingPsoriasisRandomized Controlled Trials as TopicRetrospective StudiesRisk AssessmentSpondylitis, AnkylosingAntibodies, Monoclonal, HumanizedBiological Productssecukinumabcrohn’s diseaseinflammatory bowel diseasesecukinumabulcerative colitis

Identifiers

PMID30674475
PMCPMC6530077

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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.