Background & Aims: Patients with Crohn's disease (CD), but not ulcerative colitis (UC), of shorter duration have higher rates of response to tumor necrosis factor (TNF) antagonists than patients with longer disease duration. Little is known about the association between disease duration and response to other biologic agents. We aimed to evaluate response of patients with CD or UC to vedolizumab, stratified by disease duration. Methods: We analyzed data from a retrospective, multicenter, consortium of patients with CD (n = 650) or UC (n = 437) treated with vedolizumab from May 2014 through December 2016. Using time to event analyses, we compared rates of clinical remission, corticosteroid-free remission (CSFR), and endoscopic remission between patients with early-stage (≤2 years duration) and later-stage (>2 years) CD or UC. We used Cox proportional hazards models to identify factors associated with outcomes. Results: Within 6 months initiation of treatment with vedolizumab, significantly higher proportions of patients with early-stage CD, vs later-stage CD, achieved clinical remission (38% vs 23%), CSFR (43% vs 14%), and endoscopic remission (29% vs 13%) (P < .05 for all comparisons). After adjusting for disease-related factors including previous exposure to TNF antagonists, patients with early-stage CD were significantly more likely than patients with later-stage CD to achieve clinical remission (adjusted hazard ratio [aHR], 1.59; 95% CI, 1.02–2.49), CSFR (aHR, 3.39; 95% CI, 1.66–6.92), and endoscopic remission (aHR, 1.90; 95% CI, 1.06–3.39). In contrast, disease duration was not a significant predictor of response among patients with UC. Conclusions: Patients with CD for 2 years or less are significantly more likely to achieve a complete response, CSFR, or endoscopic response to vedolizumab than patients with longer disease duration. Disease duration does not associate with response vedolizumab in patients with UC.
Bibliographical noteFunding Information:
Funding This study was supported in part by Takeda Pharmaceuticals U.S.A., Inc. Takeda and Takeda employees had no role in data collection and did not have access to patient-level data used for analyses, which were performed independently. Conflicts of interest These authors disclose the following: Jenna L. Koliani-Pace has received travel support from Takeda. Brigid Boland has received research support from Takeda and Janssen; consulted for AbbVie; and received support from CCFA career development award and UCSD KL2 (1KL2TR001444). Siddharth Singh has received research support from Pfizer; and support from the American College of Gastroenterology and the Crohn's and Colitis Foundation. Eugenia Shmidt has received travel support from Takeda. Karen Lasch is an employee of Takeda Pharmaceuticals U.S.A., Inc. Michelle Luo is an employee of Takeda Pharmaceuticals U.S.A., Inc. David Hudesman has consulted for AbbVie, Janssen, and Takeda. Dana Lukin has consulted for AbbVie, Janssen, and Salix. Keith Sultan has consulted for AbbVie; and received research support from AbbVie, Celgene, Genentech, Pfizer, and Takeda. Corey A. Siegel has consulted for AbbVie, Amgen, Celgene, Janssen, Lilly, Pfizer, Prometheus, Sandoz, and Takeda; is a speaker for CME activities for AbbVie, Janssen, Pfizer, and Takeda; and received grant support from AbbVie, Janssen, Pfizer, and Takeda. Bo Shen has consulted for AbbVie, Janssen, Robarts Clinical Trials, Salix, Takeda, and Theravance. William J. Sandborn has received personal fees from Actavis, ActoGeniX NV, Adheron Therapeutics, Akros Pharma, AM Pharma BV, Ardelyx Inc, Arena Pharmaceuticals, Ambrx Inc, Avaxia Biologics, Baxter Healthcare, Biogen, Catabasis Pharmaceuticals, Celgene, Cellular Therapeutics, Chiasma, Cosmo Pharmaceuticals, Dr. August Wolff, Eisai, Eli Lilly, Ferring Pharmaceuticals, Ferring Research Institute, Forward Pharma, Galapagos, Immune Pharmaceuticals, InDex Pharmaceuticals, Ironwood Pharmaceuticals, Kyowa Hakko Kirin, Lexicon Pharmaceuticals, Lipid Therapeutics GmbH, Luitpold Pharmaceuticals, MedImmune (AstraZeneca), Mesoblast, Millennium Pharmaceuticals, Nestle, Novo Nordisk, Orexigen, Palatin, Qu Biologics, Regeneron, Ritter Pharmaceuticals, Salix Pharmaceuticals, Santarus, Seattle Genetics, Seres Health, Shire, Sigmoid Biotechnologies, Teva Pharmaceuticals, Theradiag, Theravance, TiGenix, Tillotts Pharma, Toray Industries Inc, UCB Pharma, University of Western Ontario (owner of Robarts Clinical Trials), Vascular Biogenics, Vertex Pharmaceuticals, Warner Chilcott, and Zyngenia; grants and personal fees from AbbVie, Amgen, Atlantic Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Genentech, Gilead Sciences, GlaxoSmithKline, Nutrition Science Partners, Prometheus Laboratories, Takeda, Pfizer, and Receptos; grants, personal fees, and nonfinancial support from Janssen; and grants from American College of Gastroenterology, Broad Foundation, and Exact Sciences. Sunanda Kane has consulted for AbbVie, Janssen, Merck, Spherix Health, Pfizer, and UCB; received research support from UCB; and is a Board member of ABIM. Edward V. Loftus, Jr has consulted for Janssen, Takeda, AbbVie, UCB, Amgen, Pfizer, Salix, Mesoblast, Eli Lilly, Celgene, and CVS Caremark; and received research support from Janssen, Takeda, AbbVie, UCB, Amgen, Pfizer, Genentech, Gilead, Receptos, Celgene, MedImmune, Seres Therapeutics, and Robarts Clinical Trials. Bruce E. Sands has consulted and received research support from Amgen, Celgene, Janssen, Pfizer, Prometheus Laboratories, and Takeda; and consulted for AbbVie, Akros Pharma, Arena Pharmaceuticals, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Cowen Services Company, Forest Research Institute, Forward Pharma, Immune Pharmaceuticals, Lilly, Receptos, Salix Pharmaceuticals, Shire, Synergy Pharmaceuticals, Theravance Biopharma R&D, TiGenix, TopiVert Pharma, UCB, Vivelix Pharmaceuticals, Target PharmaSolutions, and Allergan. Jean-Frederic Colombel has consultancy/advisory board membership with AbbVie, Amgen, Boehringer Ingelheim, Celgene Corporation, Celltrion, Enterome, Ferring, Genentech, Janssen & Janssen, MedImmune, Merck & Co, Pfizer, Protagonist, Second Genome, Seres, Takeda, and Theradiag; is a speaker for AbbVie, Ferring, Takeda, and Shire; received research support from AbbVie, Janssen & Janssen, Genentech, and Takeda; and received stock options from Intestinal Biotech Development and Genfit. Parambir S. Dulai has received research support, honorarium, and travel support from Takeda; research support from Pfizer; and serves on the advisory board for Janssen. Ryan Ungaro has consulted and/or is Advisory Board member for Takeda, Pfizer, and Janssen. The other authors disclose no conflicts.
- Inflammatory Bowel Disease
- Monoclonal Antibody Therapy