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. 2023 Jul 1;118(7):1285-1288.
doi: 10.14309/ajg.0000000000002215. Epub 2023 Feb 8.

Patients With Crohn's Disease and Permanent Ileostomy Are Universally Excluded From Clinical Trials: A Systematic Review

Sudheer K Vuyyuru  1 , Florian Rieder  2   3 , Virginia Solitano  1 , Tran M Nguyen  4 , Eileen Crowley  5 , Neeraj Narula  6 , Siddharth Singh  7 , Christopher Ma  8   9 , Vipul Jairath  1   4   10
Affiliations

Patients With Crohn's Disease and Permanent Ileostomy Are Universally Excluded From Clinical Trials: A Systematic Review

Sudheer K Vuyyuru et al. Am J Gastroenterol. .

Abstract

Introduction: We performed a systematic review to investigate whether patients with Crohn's disease (CD) and permanent ileostomy (PI) have been included in clinical trials evaluating biologics and small molecules.

Methods: MEDLINE, Embase and Cochrane library (CENTRAL) data bases were searched from inception to May 16, 2022 for placebo controlled induction and/or maintenance randomized controlled trials assessing biologics and oral small molecules in adult patients with active CD.

Results: Of the 81 induction and maintenance trials assessing biologics and oral small molecules in CD, none permitted the enrollment of patients with PI. Patients with CD and PI have been universally excluded from pharmaceutical trials of biologics and small molecules to date.

Discussion: There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures enabling the inclusion of patients with CD and PI into clinical trials.

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Conflict of interest statement

CONFLICTS OF INTEREST

Potential competing interests: S.K.V.: none. F.R. is consultant to Adnovate, Agomab, Allergan, AbbVie, Arena, Boehringer-Ingelheim, Celgene/BMS, CDISC, Celsius, Cowen, Ferring, Galapagos, Galmed, Genentech, Gilead, Gossamer, Guidepoint, Helmsley, Horizon Therapeutics, Image Analysis Limited, Index Pharma, Jannsen, Koutif, Mestag, Metacrine, Mopac, Morphic, Organovo, Origo, Pfizer, Pliant, Prometheus Biosciences, Receptos, RedX, Roche, Samsung, Surmodics, Surrozen, Takeda, Techlab, Theravance, Thetis, UCB, Ysios, and 89Bio. V.S. and T.M.N.: none. E.C.: has received institutional research support from AbbVie and consulting fees from Alimentiv and Sanofi. N.N.: has received honoraria from Janssen, Abbvie, Takeda, Pfizer, Merck, Sandoz, Fresenius Kabi, Innomar, Iterative Scopes, and Ferring. S.S.: has received institutional research support from Pfizer and AbbVie (in the last 24 months) and personal fees from Pfizer for ad hoc grant review. C.M. has received consulting fees from AbbVie, Alimentiv, Amgen, AVIR Pharma, BioJAMP, Bristol Myers Squibb, Celltrion, Ferring, Fresenius Kabi, Janssen, McKesson, Mylan, Takeda, Pendopharm, Pfizer, Roche; speaker’s fees from AbbVie, Amgen, AVIR Pharma, Alimentiv, Bristol Myers Squibb, Ferring, Fresenius Kabi, Janssen, Takeda, Pendopharm, and Pfizer; royalties from Springer Publishing; research support from Ferring and Pfizer. V.J. has received has received consulting/advisory board fees from AbbVie, Alimentiv, Arena pharmaceuticals, Asahi Kasei Pharma, Asieris, Astra Zeneca, Bristol Myers Squibb, Celltrion, Eli Lilly, Ferring, Flagship Pioneering, Fresenius Kabi, Galapagos, GlaxoSmithKline, Genentech, Gilead, Janssen, Merck, Mylan, Pandion, Pendopharm, Pfizer, Protagonist, Reistone Biopharma, Roche, Sandoz, Second Genome, Takeda, Teva, Topivert, Ventyx, and Vividion; and speaker’s fees from Abbvie, Ferring, Galapagos, Janssen Pfizer Shire, Takeda, and Fresenius Kabi.

Figures

Figure 1.
Figure 1.
PRISMA diagram showing study selection.
See this image and copyright information in PMC

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