TY - JOUR
T1 - Retrospective Analysis of Safety of Vedolizumab in Patients With Inflammatory Bowel Diseases
AU - Meserve, Joseph
AU - Aniwan, Satimai
AU - Koliani-Pace, Jenna L.
AU - Shashi, Preeti
AU - Weiss, Aaron
AU - Faleck, David
AU - Winters, Adam
AU - Chablaney, Shreva
AU - Kochhar, Gursimran
AU - Boland, Brigid S.
AU - Singh, Siddharth
AU - Hirten, Robert
AU - Shmidt, Eugenia
AU - Hartke, Justin G.
AU - Chilukuri, Prianka
AU - Bohm, Matthew
AU - Sagi, Sashidhar Varma
AU - Fischer, Monika
AU - Lukin, Dana
AU - Hudesman, David
AU - Chang, Shannon
AU - Gao, Youran
AU - Sultan, Keith
AU - Swaminath, Arun
AU - Gupta, Nitin
AU - Kane, Sunanda
AU - Loftus, Edward V.
AU - Shen, Bo
AU - Sands, Bruce E.
AU - Colombel, Jean Frederic
AU - Siegel, Corey A.
AU - Sandborn, William J.
AU - Dulai, Parambir S.
N1 - Publisher Copyright:
© 2019 AGA Institute
PY - 2019/7
Y1 - 2019/7
N2 - 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.
AB - 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.
KW - AE
KW - Drug
KW - IBD
KW - α4β7 Integrin
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UR - http://www.scopus.com/inward/citedby.url?scp=85067303409&partnerID=8YFLogxK
U2 - 10.1016/j.cgh.2018.09.035
DO - 10.1016/j.cgh.2018.09.035
M3 - Article
C2 - 30268561
AN - SCOPUS:85067303409
SN - 1542-3565
VL - 17
SP - 1533-1540.e2
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 8
ER -