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Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases
| Content Provider | Scilit |
|---|---|
| Author | Meserve, Joseph Aniwan, Satimai Koliani-Pace, Jenna L. Shashi, Preeti Weiss, Aaron Faleck, David Winters, Adam Chablaney, Shreva Kochhar, Gursimran Boland, Brigid S. Singh, Siddharth Hirten, Robert Shmidt, Eugenia Hartke, Justin G. Chilukuri, Prianka Bohm, Matthew Sagi, Sashidhar Varma Fischer, Monika Lukin, Dana Hudesman, David Chang, Shannon Gao, Youran Sultan, Keith Swaminath, Arun Gupta, Nitin Kane, Sunanda Loftus, Edward V. Shen, Bo Sands, Bruce E. Colombel, Jean-Frederic Siegel, Corey A. Sandborn, William J. Dulai, Parambir S. |
| Copyright Year | 2018 |
| Description | Journal: Clinical Gastroenterology and Hepatology 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 |
| Related Links | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6594363/pdf http://www.cghjournal.org/article/S1542356518310267/pdf |
| ISSN | 15423565 |
| e-ISSN | 15427714 |
| DOI | 10.1016/j.cgh.2018.09.035 |
| Journal | Clinical Gastroenterology and Hepatology |
| Issue Number | 8 |
| Volume Number | 17 |
| Language | English |
| Publisher | Elsevier BV |
| Publisher Date | 2018-09-27 |
| Access Restriction | Open |
| Subject Keyword | Journal: Clinical Gastroenterology and Hepatology Gastroenterology and Hepatology Α4β7 Integrin Crohn's Disease Confidence Interval Inflammatory Bowel Disease Interquartile Range Odds Ratio Patient-years of Exposure Patient-years of Follow-up Tumor Necrosis Factor Ulcerative Colitis |
| Content Type | Text |
| Resource Type | Article |
| Subject | Hepatology Gastroenterology |
