Common Drug Review Clinical Review Report

In addition to CADTH staff, the review team included a clinical expert in gastroenterology who provided input on the conduct of the review and the interpretation of findings The information in this document is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of he [...] This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. [...] The product monograph recommends that, in patients who have responded to treatment with ustekinumab, corticosteroids may be reduced or discontinued in accordance with standard of care.4 The objective of this report is to perform a systematic review of the beneficial and harmful effects of ustekinumab in accordance with the Health Canada–approved indication for the treatment of Crohn’s disease. [...] The results from the UNITI studies and IM-UNITI are the focus of the CDR review; results from the induction phase of CERTIFI were considered supportive. [...] April 2017 CDR CLINICAL REVIEW REPORT FOR STELARA Clinical Response The primary outcome for the UNITI induction studies was achieved: the proportion of patients with a clinical response at week 6 was statistically significantly higher in the ustekinumab groups (33.7% and 55.5%) than in the placebo groups (21.5% and 28.7%) in UNITI-1 and UNITI-2, respectively (Table 1).