Adv Ther. 2023 Oct;40(10):4421-4439. doi: 10.1007/s12325-023-02611-0. Epub 2023 Jul 28.

Brian Bressler ¹, Jennifer Jones ², Tracy S H In ³, Tommy Lan ⁴, Cristian Iconaru ⁴, John K Marshall ⁵

Author information

¹Department of Medicine, University of British Columbia, Vancouver, Canada.

²Department of Medicine, Dalhousie University, Halifax, Canada.

³Janssen Inc., Toronto, ON, Canada.

⁴IQVIA Solutions Canada Inc., Kirkland, Québec, Canada.

⁵Department of Medicine and Farncombe Family Digestive Health Research Institute, McMaster University, 1280 Main Street West (Room 2F59), Hamilton, ON, L8S 4K1, Canada. marshllj@mcmaster.ca.

Abstract

Introduction: There is an urgent need to understand the long-term real-world effectiveness of ustekinumab (UST) in the treatment of Crohn's disease (CD), fistulizing CD (FCD), and ulcerative colitis (UC). Persistence on treatment is commonly used as a surrogate measure of real-world treatment response. This study aims to estimate the long-term real-world persistence of UST in adult patients with CD, FCD, and UC.

Methods: A retrospective study was conducted in patients with CD, FCD, and UC treated with UST through a national patient support program in Canada. Treatment persistence was described using the Kaplan-Meier method, and the impact of patient characteristics on persistence was explored through stratified analyses and multivariable Cox proportional hazards models.

Results: Persistence rates for 8724 patients with CD were 82.9%, 71.4%, 64.1%, and 59.7% at 1, 2, 3, and 4 years, respectively. Similarly, persistence rates for 276 patients with FCD were 84.1%, 70.9%, 64.9%, and 63.1% at 1, 2, 3, and 4 years, respectively. Persistence rates for 1291 patients with UC were 76.5% at 1 year and 69.5% at 1.5 years. When stratified by prior IBD-indicated biologic experience, persistence was numerically higher in biologic-naïve patients across all disease cohorts. A Cox proportional hazards model confirmed that this difference was significant in patients with CD (hazard ratio: 0.72; confidence interval: [0.65-0.79]).

Conclusions: This study estimated long-term persistence in a large population of patients with IBD. At 1 year, over three-fourths of patients remained on UST treatment in all disease cohorts, and over half of patients remained on treatment at 4 years in CD and FCD patients. Biologic-naïve status was significantly associated with higher persistence in patients with CD.