The Early Experience With Vedolizumab in the United States

Background Post-marketing studies of new inflammatory bowel disease (IBD) therapies are needed to establish clinical effectiveness and safety in clinical practice. We aimed to describe the U.S. experience with vedolizumab in a commercially insured population. Methods We conducted a retrospective cohort study in Quintiles-IMS Legacy PharMetrics Adjudicated Claims Database from May 2014 to June 2016. We included new vedolizumab users with Crohn disease (CD) and ulcerative colitis (UC) between 18 and 64 years with ≥12 months of continuous enrollment prior to initiating vedolizumab. Outcomes included treatment persistence >14 weeks, late steroid use, IBD-related surgery and infections associated with hospitalization. We built multivariable regression models to identify predictors of treatment persistence and late steroid use. Results We identified 269 CD and 187 UC vedolizumab initiators. Only 60% of CD patients and 56% of UC patients remained on vedolizumab after 14 weeks without IBD-related hospitalization, surgery, and corticosteroid use. There were no significant predictors of treatment persistence. Steroid use in the first 2 months of vedolizumab initiation was a significant predictor of late steroid use in CD (odds ratio: 23.34; 95% confidence interval: 5.10–153.89). In the 6 months after vedolizumab initiation, 1.9% of CD and 5.9% of UC patients had an IBD-related surgery. Serious infections were <4%. Conclusions These data reflect the early U.S. experience with vedolizumab. The population-level response to vedolizumab therapy is just >50%. Steroids at the time of vedolizumab initiation is the strongest predictor of late steroid use in CD. Rates of surgery and serious infections are low.