Patients enrolled in randomized controlled trials do not represent the inflammatory bowel disease patient population

Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association
Christina HaAsher Kornbluth

Abstract

Multiple randomized controlled trials (RCTs) have been conducted to determine therapeutic efficacy of the biological agents for the inflammatory bowel diseases (IBD). However, the external validity of findings from RCTs might be compromised by their stringent selection criteria. We investigated the proportion of patients encountered during routine clinical practice who would qualify for enrollment into a pivotal RCT of biological agents for IBD. We performed a retrospective cohort study of adult patients with moderate-severe IBD who presented to a tertiary referral center. Inclusion and exclusion criteria were extracted from published RCTs of biologics approved by the Food and Drug Administration and applied to the study population. Only 31.1% of 206 patients with IBD (34% with Crohn's disease [CD], 26% with ulcerative colitis) would have been eligible to participate in any of the selected RCTs. Patients would have been excluded because they had stricturing or penetrating CD, took high doses of steroids, had comorbidities or prior exposure to biologics, or received topical therapies. Of the trial-ineligible patients with ulcerative colitis, 23.3% had colectomies, and 31.7% received infliximab, with a 63.2% response rate. Approx...Continue Reading

References

Jun 6, 2002·Lancet·Stephen B HanauerUNKNOWN ACCENT I Study Group
Aug 2, 2003·American Heart Journal·Frederick A MasoudiHarlan M Krumholz
Aug 6, 2004·The New England Journal of Medicine·David N JuurlinkDonald A Redelmeier
Nov 4, 2005·The New England Journal of Medicine·William J SandbornUNKNOWN Evaluation of Natalizumab as Continuous Therapy (ENACT-2) Trial Group
Dec 13, 2005·The New England Journal of Medicine·Paul RutgeertsJean Frédéric Colombel
Mar 22, 2007·JAMA : the Journal of the American Medical Association·Harriette G C Van SpallRobert A Fowler
May 9, 2007·Gastroenterology·Stephan R TarganUNKNOWN International Efficacy of Natalizumab in Crohn's Disease Response and Remission (ENCORE) Trial Group
Jul 20, 2007·The New England Journal of Medicine·William J SandbornUNKNOWN PRECISE 1 Study Investigators
Sep 10, 2010·The New England Journal of Medicine·Klaus R Herrlinger, Eduard F Stange

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Citations

Apr 4, 2014·World Journal of Gastroenterology : WJG·Petra A GolovicsPeter L Lakatos
Oct 23, 2013·European Journal of Clinical Pharmacology·Anton PottegårdSøren Ilsøe Moreno
Aug 12, 2014·Gastroenterology Clinics of North America·Parambir S DulaiLaurent Peyrin-Biroulet
Dec 18, 2013·Journal of Crohn's & Colitis·Klaus R Herrlinger, Eduard F Stange
Aug 27, 2014·Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver·Michael D MandelPeter L Lakatos
Dec 19, 2015·Journal of Crohn's & Colitis·Emily E VivioMatthew A Ciorba
Jan 23, 2016·Expert Opinion on Drug Safety·Konstantinos PapamichaelLaurent Peyrin-Biroulet
Dec 18, 2013·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Themistocles Dassopoulos, Dario Sorrentino
Oct 11, 2013·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Wallace Crandall
Aug 6, 2013·Surgery for Obesity and Related Diseases : Official Journal of the American Society for Bariatric Surgery·David ArterburnUNKNOWN CROSSROADS Study Team
Sep 25, 2012·Gastroenterology·Geert D'HaensUNKNOWN International Organization for Inflammatory Bowel Diseases (IOIBD) and the Clinical Trial Committee Clincom of the European
Jun 27, 2012·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Geert D'Haens
Apr 24, 2012·Alimentary Pharmacology & Therapeutics·F ZorziL Biancone
Jul 1, 2014·Cardiovascular Therapeutics·Lovisa HäggLars Johansson
Mar 6, 2016·Journal of Crohn's & Colitis·Julia SalleronLaurent Peyrin-Biroulet
Apr 3, 2016·Alimentary Pharmacology & Therapeutics·D C BaumgartUNKNOWN Vedolizumab Germany Consortium
Aug 30, 2014·Digestive and Liver Disease : Official Journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver·Stephan R VavrickaLuc Biedermann
Mar 4, 2015·Internal Medicine Journal·S P CostelloUNKNOWN Australian Inflammatory Bowel Disease Association (AIBDA)
Oct 29, 2014·The Australian & New Zealand Journal of Obstetrics & Gynaecology·Arushi MadanAmanda Henry
Jul 16, 2015·American Journal of Respiratory and Critical Care Medicine·Laurie PahusUNKNOWN COBRA consortium
Jun 11, 2014·Best Practice & Research. Clinical Gastroenterology·Gerassimos J Mantzaris
Mar 24, 2016·Gastroenterología y hepatología·Daniel GinardFrancesc Casellas
Mar 21, 2016·Journal of Crohn's & Colitis·Piotr DziechciarzJaroslaw Kierkuś
Jun 15, 2016·The American Journal of Gastroenterology·Parambir S DulaiJean-Frederic Colombel
Oct 1, 2016·Expert Review of Clinical Immunology·Daniela PuglieseAlessandro Armuzzi
Dec 15, 2016·Expert Opinion on Biological Therapy·Fabio Salvatore MacalusoMario Cottone
Feb 24, 2017·Journal of Managed Care & Specialty Pharmacy·William MalatestinicAndre Araujo
Apr 28, 2017·Alimentary Pharmacology & Therapeutics·W A ByeS P L Travis
Aug 19, 2015·United European Gastroenterology Journal·Thomas KlagJan Wehkamp
Sep 15, 2017·International Journal of Molecular Sciences·Loris Riccardo LopetusoAlfredo Papa
Oct 19, 2016·Inflammatory Bowel Diseases·Subrata GhoshBrandee Pappalardo
Sep 7, 2016·Inflammatory Bowel Diseases·Hans H HerfarthJames D Lewis
Aug 20, 2015·Inflammatory Bowel Diseases·Edward SheltonVijay Yajnik
Aug 18, 2017·Inflammatory Bowel Diseases·Thomas KlagJan Wehkamp

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