Medical College of Wisconsin
CTSICores SearchResearch InformaticsREDCap

The Early Experience with Vedolizumab in the United States Crohn's & Colitis 360 Kochar, B., Jiang, Y., Winn, A., Barnes, E. L., Martin, C. F., Long, M. D., & Kappelman, M. D. (2019). The Early Experience with Vedolizumab in the United States. Crohn's & Colitis 360.

Date

08/29/2019

Abstract

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–June 2016. We included new vedolizumab users with Crohn’s disease (CD) and ulcerative colitis (UC) between 18-64 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 two months of vedolizumab initiation was a significant predictor of late steroid use in CD (OR: 23.34; 95%CI: 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.

Author List

Bharati Kochar; Yue Jiang; Aaron N Winn; Edward L Barnes; Christopher F Martin; Millie D Long; Michael D Kappelman

Author

Aaron Winn PhD Assistant Professor in the School of Pharmacy Administration department at Medical College of Wisconsin


View Online
jenkins-FCD Prod-482 91ad8a360b6da540234915ea01ff80e38bfdb40a