Is it time to include older adults in inflammatory bowel disease trials? A call for action.

The therapeutic management of older patients with inflammatory bowel disease (IBD) is challenging, particularly because of the absence of evidence-based guidelines for these patients, who seem to frequently be excluded from clinical trials. In this systematic review we investigated the exclusion of older patients with IBD from phase 3 studies registered on PubMed and ClinicalTrials.gov, by assessing the upper limit of age exclusion criteria and the percentage of patients older than 65 years included in the trials. Exclusion criteria other than age were also recorded, and comorbidities were analysed separately. Our review of 222 phase 3 studies shows that older patients are frequently excluded from IBD clinical trials because of their age, which was used as an exclusion criterion in 129 (58%) of the 222 assessed trials. Of the 32 trials that detailed the percentage of included patients who were 65 years or older, only 763 (5·4%) patients of the 14 124 patients included were older than 65 years. In addition to age, patients were also excluded because of comorbidities (mainly renal, hepatic, and cardiovascular, and used as an exclusion criterion in 76% of trials), a history of dysplasia (45% of trials), and previous treatment for IBD (19% of trials). We propose a three-step process that should enable the inclusion of all older patients in IBD clinical trials, regardless of their age, comorbidities, and frailty.

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Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests BC reports lecture fees from AbbVie, Amgen, Ferring Pharmaceuticals, Janssen Pharmaceuticals, and Takeda; and consulting fees from Celltrion and Janssen Pharmaceuticals. VJ has received consulting and advisory board fees from AbbVie, Alimentiv (formerly Robarts Clinical Trials), Arena Pharmaceuticals, Asahi Kasei Pharma, Asieris Pharmaceuticals, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring Pharmaceuticals, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead Sciences, Janssen Pharmaceuticals, Merck, Mylan, Pandion, Pendopharm, Pfizer, Protagonist Therapeutics, Reistone Biopharma, Roche, Sandoz, Second Genome, Takeda, Teva Pharmaceuticals, and Topivert Pharma; and speaker's fees from AbbVie, Ferring Pharmaceuticals, Galapagos, Janssen Pharmaceuticals, Pfizer, Shire, and Takeda. SD has served as a consultant for Schering-Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring Pharmaceuticals, Genentech, Grünenthal, Johnson & Johnson, Millennium Takeda, Merck Sharp & Dohme, Nikkiso Europe, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma, and Vifor; and as a speaker for Pfizer, Takeda, AbbVie, and Janssen Pharmaceuticals. EL reports research grants from Janssen Pharmaceuticals, Pfizer, Ferring Pharmaceuticals, Dr Falk Pharma, AbbVie, and Takeda; educational grants from AbbVie, Janssen Pharmaceuticals, Fresenius Kabi, and Takeda; speaker's fees from AbbVie, Dr Falk Pharma, Ferring Pharmaceuticals, Janssen Pharmaceuticals, Pfizer, Galapagos, and Takeda; advisory board membership of AbbVie, Celgene, Ferring Pharmaceuticals, Janssen Pharmaceuticals, Bristol Myers Squibb, Pfizer, Takeda, Galapagos, Gilead Sciences, Arena Pharmaceuticals, and Eli Lilly; and has served as a consultant for AbbVie. LP-B reports personal fees from Galapagos, AbbVie, Janssen Pharmaceuticals, Genentech, Ferring Pharmaceuticals, Tillots Pharma, Pharmacosmos, Celltrion, Takeda, Boerhinger Ingelheim, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Alma Bio Therapeutics, Sterna Biologicals, Nestlé, Inotrem, Enterome, Allergan, Merck Sharp & Dohme, Roche, Arena Pharmaceuticals, Gilead Sciences, Hikma Pharmaceuticals, Amgen, Bristol Myers Squibb, Vifor Pharma, Norgine, Mylan, Eli Lilly, Fresenius Kabi, Oppilan Pharma, Sublimity Therapeutics, Applied Molecular Transport, OSE Immunotherapeutics, Enthera, Theravance, and Pandion Therapeutics; grants from AbbVie, Merck Sharp & Dohme, Takeda, and Fresenius Kabi; and stock options for Clinical Trials Mobile Application. SV and AB declare no competing interests.