Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases.
Publication Date
2018
Journal Title
Clin Gastroenterol Hepatol
Abstract
BACKGROUND & AIMSThere 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.METHODSWe performed a retrospective review of data from a multi-center 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.RESULTSOur 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.CONCLUSIONIn 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.
Volume Number
17
Issue Number
8
Pages
1533-1540
Document Type
Article
Status
Faculty, Northwell Resident
Facility
School of Medicine; Northwell Health
Primary Department
Gastroenterology
PMID
DOI
10.1016/j.cgh.2018.09.035