The Real-World Effectiveness and Safety of Vedolizumab for Moderate–Severe Crohn’s Disease: Results From the US VICTORY Consortium : Official journal of the American College of Gastroenterology | ACG

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ORIGINAL CONTRIBUTIONS: INFLAMMATORY BOWEL DISEASE

The Real-World Effectiveness and Safety of Vedolizumab for Moderate–Severe Crohn’s Disease: Results From the US VICTORY Consortium

Dulai, Parambir S MD1; Singh, Siddharth MD, MS1,2; Jiang, Xiaoqian PhD2; Peerani, Farhad MD3; Narula, Neeraj MD3; Chaudrey, Khadija MD4; Whitehead, Diana MD5; Hudesman, David MD6; Lukin, Dana MD7; Swaminath, Arun MD8; Shmidt, Eugenia MD3; Wang, Shuang PhD2; Boland, Brigid S MD1; Chang, John T MD1; Kane, Sunanda MD4; Siegel, Corey A MD, MS5; Loftus, Edward V MD4; Sandborn, William J MD1; Sands, Bruce E MD3; Colombel, Jean-Frederic MD3

Author Information

1Division of Gastroenterology, University of California San Diego, La Jolla, California, USA

2Department of Biomedical Informatics, University of California San Diego, La Jolla, California, USA

3Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA

4Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minneapolis, USA

5Division of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA

6Division of Gastroenterology, New York University (NYU), New York, New York, USA

7Division of Gastroenterology, Montefiore Medical Center, New York, New York, USA

8Division of Gastroenterology, NSLIJ Lenox Hill, New York, New York, USA

Correspondence: Parambir S. Dulai, MD, Division of Gastroenterology, University of California, San Diego, 9500 Gilman Drive, La Jolla, California 92093, USA. E-mail: [email protected]

SUPPLEMENTARY MATERIAL accompanies this paper at https://links.lww.com/AJG/A684, https://links.lww.com/AJG/A686, https://links.lww.com/AJG/A689, https://links.lww.com/AJG/A691, https://links.lww.com/AJG/A693, https://links.lww.com/AJG/A696, https://links.lww.com/AJG/A698

Received 02 February 2016; accepted 02 April 2016

Guarantor of the article: Parambir S. Dulai, MD.

Author contributions: Study concept and design: P.S.D. Acquisition of data: P.S.D., S.S., F.P., N.N., K.C., D.W., D.H., D.L., A.S., and E.S. Analysis and interpretation of data: P.S.D., S.S., X.J., and S.W. Drafting of the manuscript: P.S.D. and S.S. Critical revision of the manuscript for important intellectual content: B.S.B., J.T.C., S.K., C.A.S., E.V.L., W.J.S., B.E.S., and J.-F.C. Approval of the final manuscript: All authors. Study supervision: C.A.S., E.V.L., W.J.S., and J.-F.C.

Financial support: P.S.D. is supported by a training grant through the National Institute of Diabetes and Digestive and Kidney Diseases (5T32DK007202). S.S. is partly supported through the National Library of Medicine training grant (T15LM011271). X.J. and S.W. are supported through the National Human Genome Research Institute (R00HG008175) and National Library of Medicine (R00LM011392, R21LM012060). F.P. is supported by the CCC-CIHR-CAG Fellowship Award. B.S.B. is supported by a career development award through the Crohn’s and Colitis Foundation of America. J.T.C. is supported by the NIH (DK093507).

Potential competing interests: P.S.D., S.S., X.J., F.P., N.N., K.C., D.W., D.H., D.L., A.S., E.S., J.T.C., and S.W. have no conflicts or potential competing interests. B.S.B. has received research support from Takeda. S.K. has served on an advisory board for ABIM, has consulted for AbbVie and 11Health, and has received research support from UCB. C.A.S. has served on advisory boards or as a consultant for AbbVie, Amgen, Lilly, Janssen, Salix, Sandoz, Pfizer, Prometheus, Takeda, Theradiag, and UCB, has been a speaker for CME activities for AbbVie, Janssen, and Takeda, and has received grant support from AbbVie, Janssen, Salix, Takeda, and UCB. E.V.L. has consulted for Takeda, UCB, Janssen, AbbVie, Genentech, Celgene, Theradiag, Sun Pharmaceuticals, Seres Therapeutics, and Bristol-Myers Squibb, and has received research support from Takeda, UCB, Janssen, AbbVie, Genentech, Amgen, Pfizer, Gilead, Receptos, and Robarts Clinical Trials. W.J.S. reports grant support, personal fees, and non-financial support from Pfizer during the conduct of the study; grant support from Pfizer, Exact Sciences, Amgen, the American College of Gastroenterology, and the Broad Foundation; grant support and personal fees from Prometheus Laboratories, AbbVie, Boehringer Ingelheim, Takeda, Atlantic Pharmaceuticals, Janssen, Bristol-Myers Squibb, Genentech, and Nutrition Science Partners; and personal fees from Kyowa Hakko Kirin, Millennium Pharmaceuticals, Celgene Cellular Therapeutics, Santarus, Salix Pharmaceuticals, Catabasis Pharmaceuticals, Vertex Pharmaceuticals, Warner Chilcott, Gilead Sciences, Cosmo Pharmaceuticals, Ferring Pharmaceuticals, Sigmoid Biotechnologies, Tillotts Pharma, Am Pharma BV, Dr August Wolff, Avaxia Biologics, Zyngenia, Ironwood Pharmaceuticals, Index Pharmaceuticals, Nestle, Lexicon Pharmaceuticals, UCB Pharma, Orexigen, Luitpold Pharmaceuticals, Baxter Healthcare, Ferring Research Institute, Amgen, Novo Nordisk, Mesoblast, Shire, Ardelyx, Actavis, Seattle Genetics, MedImmune (AstraZeneca), Actogenix NV, Lipid Therapeutics Gmbh, Eisai, Qu Biologics, Toray Industries, Teva Pharmaceuticals, Eli Lilly, Chiasma, TiGenix, Adherion Therapeutics, Immune Pharmaceuticals, Celgene, Arena Pharmaceuticals, Ambrx, Akros Pharma, Vascular Biogenics, Theradiag, Forward Pharma, Regeneron, Galapagos, Seres Health, Ritter Pharmaceuticals, Theravance, Palatin, Biogen, and the University of Western Ontario (owner of Robarts Clinical Trials) outside the submitted work. B.E.S. reports grant support, personal fees, and non-financial support from Takeda during the conduct of the study; grant support and personal fees from Amgen, MedImmune (AstraZeneca), Celgene, Millennium Pharmaceuticals, Pfizer, Prometheus Laboratories, AbbVie, Takeda, Janssen, Bristol-Myers Squibb; and personal fees from Boehringer Ingelheim, Millennium Pharmaceuticals, Salix Pharmaceuticals, Luitpold Pharmaceuticals, Shire, Lilly, TiGenix, Immune Pharmaceuticals, Arena Pharmaceuticals, Akros Pharma, Forward Pharma, Theravance, Receptos, Vedanta Biosciences, Synergy Pharmaceuticals and Topivert Pharma outside the submitted work. J-F.C. has served as consultant, advisory board member or speaker for AbbVie, ABScience, Amgen, Bristol-Myers, Squibb, Celgene, Celltrion, Danone, Ferring, Genentech, Giuliani SPA, Given Imaging, Immune Pharmaceuticals, Janssen, Kyowa Hakko Kirin Pharma, MedImmune, Merck, Millennium Pharmaceuticals, Navigant Consulting, Neovacs, Nestle, Nutrition Science Partners, Pfizer, Prometheus Laboratories, Protagonist, Receptos, Sano, Schering Plough Corporation, Second Genome, Shire, Takeda, Teva Pharmaceuticals, TiGenix, UCB Pharma, Vertex, and Dr August Wolff GmbH.

American Journal of Gastroenterology 111(8):p 1147-1155, August 2016. | DOI: 10.1038/ajg.2016.236

Abstract

Objectives: 

We assessed the real-world effectiveness and safety of vedolizumab (VDZ) in moderate–severe Crohn’s disease (CD).

Methods: 

Retrospective cohort study of seven medical centers, from May 2014 to December 2015. Adults with moderate-severe CD treated with VDZ, with follow-up after initiation of therapy, were included. Using the multivariable Cox proportional hazard analyses, we identified independent predictors of clinical remission or mucosal healing with VDZ. Rates of serious infection (requiring antibiotics, resulting in discontinuation of VDZ, hospitalization or death) and serious adverse events (discontinuation of VDZ, hospitalization or death) were described quantitatively.

Results: 

We included 212 patients with moderate–severe CD (median age 34 years; 40% male; 90% tumor necrosis factor (TNF)-antagonist exposed) with a median follow-up (IQR) of 39 weeks (25–53). Twelve-month cumulative rates of clinical remission, mucosal healing, and deep remission (clinical remission+mucosal healing) were 35%, 63%, and 26%, respectively. Individuals with prior TNF-antagonist exposure (hazard ratio (HR) 0.40; 95% confidence interval (CI): 0.20–0.81), smoking history (HR 0.47; 95% CI: 0.25–0.89), active perianal disease (HR 0.49; 95% CI: 0.27–0.88), and severe disease activity (HR 0.54; 95% CI: 0.31–0.95) were less likely to achieve clinical remission. Those with prior TNF-antagonist exposure (HR 0.29; 95% CI: 0.12–0.73), and severe disease activity (HR 0.54; 95% CI: 0.31–0.95) were less likely to achieve mucosal healing. During 160 patient years of follow-up (PYF) and 1,433 VDZ infusions, 5 patients developed infusion reactions (3.5 per 1,000 infusions), 21 developed serious infections (13 per 100 PYF), and 17 developed serious adverse events (10 per 100 PYF). A minority of adverse events required discontinuation of therapy (6 per 100 PYF).

Conclusions: 

VDZ is a safe and effective treatment option for moderate–severe CD in routine practice. Clinical remission and deep remission (clinical remission and mucosal healing) can be achieved in 1/3 of individuals, and a minority of individuals require discontinuation of therapy due to adverse events.

© The American College of Gastroenterology 2016. All Rights Reserved.

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