Sa1123 Infusion-Related Reactions With Vedolizumab Treatment in Patients With UC or CD During the GEMINI 1 and GEMINI 2 Clinical Trials

Abstract

Introduction: Infections are an important concern in patients with inflammatory bowel diseases (IBD; Crohn's disease (CD), ulcerative colitis (UC)) treated with immunosuppressive therapy. This is particularly so in those with significant co-morbidity, a population commonly excluded from clinical trials. Diabetes affects 9.3% of Americans and in increasing in prevalence. Infections commonly complicate diabetes which has itself been hypothesized to have an immunosuppressive effect. However, whether it confers additional risk of infections over immunomodulator therapy has not been examined previously. Methods: Using a validated, multi-institutional IBD cohort, we identified all patients who received at least one prescription for immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate). We identified diabetes and infections according to the corresponding ICD-9 codes. Our primary outcome was infection within 1 year of the first prescription of the immunomodulator. Multivariate logistic regression was used to estimate the independent association between diabetes and infection adjusting for relevant confounders including age, gender, comorbidity, and confounding medications. Results: Our study included 2,766 patients receiving at least one prescription for immunomodulators among whom 210(8%) developed an infectious complication within 1 year of the first prescription. Patients who developed an infection were likely to be older (46 years vs. 41 years, p < 0.001), female (58% vs. 52%), and have one or more additional comorbidity (95% vs. 70%). They were also more likely to have received a prescription for steroids (62 vs. 31%) but similar in initiation of anti-TNF therapy within that year (22% vs. 19%). Only 8% of those without an infection had diabetes compared to 19% of those who developed an infection within 1 year (p < 0.001) ( Figure). The most common infections in both groups were sepsis, pneumonia, cellulitis, and urinary tract infection. In multivariate analysis, diabetes was independently associated with a nearly twofold increase in risk of infections (OR 1.76, 95% CI 1.17 2.64) despite adjusting for age, other comorbidity, and medications. Conclusions: Diabetes is an independent risk factor for infection in IBD patients using immunomodulator therapy. Counseling and monitoring for such risks in addition to ensuring appropriate prophylaxis against preventable infections may help improve patient outcomes.