D0382 - Comparison of Surgery Rates in Biologic-Naive Patients With Crohn’s Disease Who Were Treated With Vedolizumab or Ustekinumab: Findings From SOJOURN
Michelle Vu, PharmD, MPH1, Sabyasachi Ghosh, BPharm, MS2, Kandavadivu Umashankar, MS, PharmD2, Benjamin Chastek, MS1, Ninfa Candela, MD2, Laura A. Weber, MS1, Christina Landis, BS, MPH1 1Optum, Eden Prairie, MN; 2Takeda Pharmaceuticals U.S.A., Inc, Lexington, MA
Introduction: Despite advances in medical interventions for Crohn’s disease (CD), a substantial proportion of patients still require major abdominal surgery. However, most data on surgery rates are from patients receiving an anti-tumor necrosis factor α treatment, with little known about the impact of vedolizumab or ustekinumab on CD-related surgery. SOJOURN aimed to investigate the hazard rate and incidence rate of first CD-related surgery on biologic treatment in biologic-naive patients with CD who were treated with vedolizumab or ustekinumab.
Methods: SOJOURN was a retrospective, observational cohort study conducted using administrative claims data from the Optum® Research Database. Adult patients with at least one claim for vedolizumab or ustekinumab between January 1, 2018 and December 31, 2019 were included, with the index date assigned as the date of the first claim for a study drug. Patients were required to have no claims for an advanced therapy in the 6 months before the index date. Follow-up started on the day after the index date and ended on the earliest of the following: discontinuation, switching or initiation of combination treatment, disenrollment, surgery event, or the end of the study period. Kaplan–Meier analysis was used to estimate the time to CD-related surgery. The hazard rate and incidence rate of CD-related surgery was compared between the vedolizumab and ustekinumab cohorts using a Cox proportional hazards model and a Poisson regression model, respectively.
Results: Of 1,122 eligible patients with CD, 578 received vedolizumab and 544 received ustekinumab. During the variable follow-up period, 42 patients receiving vedolizumab and 54 patients receiving ustekinumab underwent surgery (p = 0.111), with a mean time from index date to date of first surgery of 229.9 days and 189.5 days (p = 0.271), respectively. After 1 year of follow-up, 8% of patients receiving vedolizumab and 12% of patients receiving ustekinumab had undergone surgery (logrank p = 0.109; Figure). After adjusting for baseline covariates, vedolizumab was associated with a 34.2% lower hazard rate of surgery (hazard ratio, 0.658; 95% confidence interval [CI], 0.436–0.994; p = 0.047) and a 34.5% lower incidence rate of surgery (rate ratio, 0.655; 95% CI, 0.434–0.988; p = 0.044) than ustekinumab.
Discussion: The results of this real-world analysis of biologic-naive patients with CD suggest that vedolizumab may be more effective than ustekinumab for the reduction of CD-related surgery on biologic treatment.
Figure: Kaplan–Meier curve for time to first Crohn’s disease-related surgery
Kandavadivu Umashankar: Takeda Pharmaceuticals U.S.A., Inc – Supported by a Takeda Pharmaceuticals U.S.A., Inc. fellowship at the time of the study. University of Illinois, Chicago, IL, USA – Former employee.
Michelle Vu, PharmD, MPH1, Sabyasachi Ghosh, BPharm, MS2, Kandavadivu Umashankar, MS, PharmD2, Benjamin Chastek, MS1, Ninfa Candela, MD2, Laura A. Weber, MS1, Christina Landis, BS, MPH1. D0382 - Comparison of Surgery Rates in Biologic-Naive Patients With Crohn’s Disease Who Were Treated With Vedolizumab or Ustekinumab: Findings From SOJOURN, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.
