IM-UNITI: Three-year Efficacy, Safety, and Immunogenicity of Ustekinumab Treatment of Crohn's Disease
Research output: Contribution to journal › Article
Colleges, School and Institutes
- Northwestern University and Feinberg School of Medicine, Chicago, Illinois, USA.
- Division of Gastroenterology, Inflammatory Bowel Disease Center, University of California San Diego, La Jolla, California, USA.
- Robarts Clinical Trials, Western University, London, Ontario, Canada.
- Janssen Scientific Affairs, LLC, 800 Ridgeview Drive, Horsham, PA, 19044, USA.
- Janssen Research and Development, LLC, Spring House, PA, USA.
- Icahn School of Medicine, Children's Heart Center, Mount Sinai Hospital, New York, New York, USA.
- University Hospital Gasthuisberg, Leuven, Belgium
- Department of Biochemistry, Stellenbosch University, Stellenbosch, 7600, South Africa
- NIHR Birmingham Biomedical Research Centre, University of Birmingham and University Hospitals Birmingham NHS Foundation Trust
BACKGROUND AND AIMS: Following induction/maintenance treatment in the UNITI/IM-UNITI studies of ustekinumab for Crohn's disease, patients entered a long-term extension for up to 5 years from induction. Efficacy through 152 and safety through 156 weeks are reported.
METHODS: At IM-UNITI Week 44, 567 ustekinumab-treated patients entered the long-term extension and continued to receive blinded subcutaneous ustekinumab on their assigned dose interval, without any subsequent dose adjustment. Placebo-treated patients discontinued after study unblinding [after IM-UNITI Week 44 analyses]. Efficacy data in the long-term extension [LTE] were collected every 12 weeks [q12w] before unblinding and then at q12w/q8w dosing visits.
RESULTS: Through Week 156, 29.6% of ustekinumab-treated patients discontinued. In an intent-to-treat analysis of randomised patients from IM-UNITI Weeks 0-152, 38.0% of ustekinumab induction responders receiving the drug q12w and 43.0% q8w were in remission at Week 152. Among patients entering the long-term extension in their original randomised groups, 61.9% of q12w and 69.5% of q8w patients were in remission at Week 152. Across all ustekinumab-treated patients [randomised and non-randomised] entering the long-term extension, remission rates at Week 152 were 56.3% and 55.1% for q12w and q8w, respectively. Safety events [per 100 patient-years] were similar among all ustekinumab-treated patients entering the long-term extension and placebo [overall adverse events 389.70 vs 444.17; serious adverse events, 18.97 vs 19.54; serious infections, 4.21 vs 3.97]. Rates of antibodies to ustekinumab through Week 156 remained low, 4.6% in all randomised ustekinumab-treated patients; lowest among patients in the original randomised q8w group [2/82, 2.4%].
CONCLUSIONS: Continued treatment with subcutaneous ustekinumab maintained clinical response and remission through 3 years in a majority of patients who responded to induction therapy and was well-tolerated. ClinicalTrials.gov number NCT01369355.
|Number of pages||10|
|Journal||Journal of Crohn's & Colitis|
|Early online date||3 Jun 2019|
|Publication status||Published - Jan 2020|