Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases.

Abstract

BACKGROUND & AIMS:

There are few real-world data on the safety of vedolizumab for treatment of Crohn's disease (CD) or ulcerative colitis (UC). We quantified rates and identified factors significantly associated with infectious and non-infectious adverse events in clinical practice.

METHODS:

We performed a retrospective review of data from a multicenter consortium database (from May 2014 through June 2017). Infectious and non-infectious adverse events were defined as those requiring antibiotics, hospitalization, vedolizumab discontinuation, or resulting in death. Rates were quantified as proportions and events per 100 patient years of exposure (PYE) or follow up (PYF). We performed multivariable logistic regression analyses to identify factors significantly associated with events and reported as odds ratios (OR) with 95% CIs.

RESULTS:

Our analysis comprised 1087 patients (650 with CD and 437 with UC; 55% female; median age, 37 years) with 861 PYE and 955 PYF. Infections were observed in 68 patients (6.3%; 7.9 per 100 PYE, 7.1 per 100 PYF); gastrointestinal infections (n = 31, 2.4 per 100 PYE, 2.2 per 100 PYF) and respiratory infections (n = 14, 1.6 per 100 PYE, 1.5 per 100 PYF) were the most common. Arthralgias were the most common non-infectious adverse events (n = 31, 2.9%; 3.6 per 100 PYE). Two patients developed malignancies (squamous cell skin cancer and colorectal cancer; 0.23 per 100 PYE, 0.21 per 100 PYF). Active smoker status (OR, 3.39) and number of concomitant immunosuppressive agents (corticosteroids or immunomodulators; OR, 1.72 per agent) used were independently associated with infections.

CONCLUSION:

In a retrospective cohort study of patients with IBD, we found vedolizumab to be well tolerated with an overall favorable safety profile. Active smoking and concomitant use of immunosuppressive agents were independently associated with infections.

• Authors: Joseph Meserve, Satimai Aniwan, Jenna L Koliani-Pace, Preeti Shashi, Aaron Weiss, David Faleck, Adam Winters, Shreva Chablaney, Gursimran Kochhar, Brigid S Boland, Siddharth Singh, Robert Hirten, Eugenia Shmidt, Justin G Hartke, Prianka Chilukuri, Matthew Bohm, Sashidhar Varma Sagi, Monika Fischer, Dana Lukin, David Hudesman, Shannon Chang, Youran Gao, Keith Sultan, Arun Swaminath, Nitin Gupta, Sunanda Kane, Edward V Loftus Jr, Bo Shen, Bruce E Sands, Jean-Frederic Colombel, Corey A Siegel, William J Sandborn, Parambir S Dulai
• Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 17 Issue 8 Pg. 1533-1540.e2 (07 2019) ISSN: 1542-7714 [Electronic] United States
• PMID: 30268561 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antibodies, Monoclonal, Humanized
• Gastrointestinal Agents
• vedolizumab

Topics

• Adult
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Female
• Gastrointestinal Agents (therapeutic use)
• Humans
• Inflammatory Bowel Diseases (drug therapy)
• Male
• Middle Aged
• Remission Induction (methods)
• Retrospective Studies
• Treatment Outcome