Ustekinumab use in Crohn’s disease: a Canadian tertiary care centre experience

Abstract

Objectives: Real world data regarding clinical response to ustekinumab in Crohn’s disease is lacking. We report our experience of ustekinumab use using a novel subcutaneous (SC) induction strategy and aim to identify predictors of response.

Materials and Methods: A retrospective, observational study of compassionate ustekinumab use in Crohn’s disease was conducted with the use of a standard or high dose SC induction protocol. Symptomatic response was assessed after 3 months (short-term), and if remaining on therapy, within 3–12 months (medium-term) and at least 12 months (long-term). Endoscopic or radiologic response was assessed when available. Survival analysis of time to failure (cessation of ustekinumab) and multivariate logistic regression to identify predictors of response were performed.

Results: Seventy-nine patients commenced ustekinumab, with six patients lost to follow-up and five asymptomatic at baseline. Symptomatic response was assessed in 68 patients; 56% (38) of patients had a short-term symptomatic response. Type of preceding anti-TNF response was the only significant predictor of short-term response, with primary non-response being a strong predictor. In the medium-term, symptomatic response occurred in 72% (30/42) of patients and endoscopic or radiologic response was achieved in 72% (26/36) of patients assessed. The median time to failure was 22 months. Maintenance dose escalation to 90 mg every 4 weeks was successful in three of 16 patients.

Conclusions: Fifty-six percent of patients had short-term symptomatic response, with a history of primary non-response to prior anti-TNF therapy being a predictor of response. Dose escalation had only modest benefit.

Keywords:

• Ustekinumab
• Crohn’s disease
• predictors of response
• biologics
• inflammatory bowel disease

Acknowledgements

Dr Terry Lee is acknowledged for his overseeing of the statistical analysis.

Disclosure statement

A Greenup: No disclosures

G Rosenfeld: Speaker: Abbvie, Takeda, Shire, Janssen, Pfizer

Advisory Board: Merck, Abbvie, Takeda, Shire and Janssen

Educational Grant: Janssen, Abbvie

B Bressler: Advisor/Speaker: Shire, Ferring, Janssen, Abbvie, Takeda, Actavis, Advisor: Amgen, Pendopharm, Genentech, Celltrion, Pfizer, Allergan. Research support: Janssen, Abbvie, GSK, BMS, Amgen, Genentech, Merck, RedHill Biopharm, BI, Qu Biologic, Celgene, Alvine. Stock Options: Qu Biologic

Additional information

Funding

There was no specific funding received for this study.