Real-World Persistence of Ustekinumab in the Treatment of Inflammatory Bowel Disease

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


Brian Bressler 1Jennifer Jones 2Tracy S H In 3Tommy Lan 4Cristian Iconaru 4John 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.


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.

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