Joseph Meserve1, Satimai Aniwan2, Jenna L Koliani-Pace3, Preeti Shashi4, Aaron Weiss5, David Faleck1, Adam Winters6, Shreva Chablaney6, Gursimran Kochhar4, Brigid S Boland1, Siddharth Singh1, Robert Hirten6, Eugenia Shmidt7, Justin G Hartke8, Prianka Chilukuri8, Matthew Bohm8, Sashidhar Varma Sagi8, Monika Fischer8, Dana Lukin5, David Hudesman9, Shannon Chang9, Youran Gao10, Keith Sultan10, Arun Swaminath11, Nitin Gupta12, Sunanda Kane13, Edward V Loftus13, Bo Shen14, Bruce E Sands6, Jean-Frederic Colombel6, Corey A Siegel3, William J Sandborn1, Parambir S Dulai15. 1. Department of Gastroenterology, University of California, San Diego, La Jolla, California. 2. Department of Gastroenterology, Mayo Clinic, Rochester, Minnesota; Department of Gastroenterology, Thai Red Cross Society, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand. 3. Department of Gastroenterology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire. 4. Department of Gastroenterology, Cleveland Clinic Foundation, Cleveland, Ohio. 5. Department of Gastroenterology, Montefiore Medical Center, New York, New York. 6. Department of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York. 7. Department of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Gastroenterology, University of Minnesota, Minneapolis, Minnesota. 8. Department of Gastroenterology, Indiana University, Indianapolis, Indiana. 9. Department of Gastroenterology, New York University, New York, New York. 10. Department of Gastroenterology, North Shore University Hospital, Manhasset, New York. 11. Department of Gastroenterology, Lenox Hill Hospital, New York, New York. 12. Department of Gastroenterology, University of Mississippi, Jackson, Mississippi. 13. Department of Gastroenterology, Mayo Clinic, Rochester, Minnesota. 14. Department of Gastroenterology, Thai Red Cross Society, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand. 15. Department of Gastroenterology, University of California, San Diego, La Jolla, California. Electronic address: pdulai@ucsd.edu.
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.
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.
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