IM-UNITI: 3 Year Efficacy, Safety, and Immunogenicity of Ustekinumab Treatment of Crohn's Disease.

Hanauer, Stephen B and Sandborn, William J and Feagan, Brian G and Gasink, Christopher and Jacobstein, Douglas and Zou, Bin and Johanns, Jewel and Adedokun, Omoniyi J and Sands, Bruce E and Rutgeerts, Paul and de Villiers, Willem J S and Colombel, Jean-Frédéric and Ghosh, Subrata (2019) IM-UNITI: 3 Year Efficacy, Safety, and Immunogenicity of Ustekinumab Treatment of Crohn's Disease. Journal of Crohn's & colitis. ISSN 1876-4479.

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Abstract

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 LTE were collected every 12 weeks (q12w) prior to 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 randomized patients from IM-UNITI Week 0-152, 38.0% of ustekinumab induction responders receiving drug q12w and 43.0% q8w were in remission at Week 152. Among patients entering the long-term extension in their original randomized groups, 61.9% of q12w and 69.5% of q8w patients were in remission at Week 152. Across all ustekinumab-treated patients (randomized and non-randomized) entering the long-term extension, remission rates at Week 152 were 56.3% and 55.1% for q12w and q8w, respectively.

CONCLUSION

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.

Item Type: Article
Subjects: WI Digestive system. Gastroenterology
Divisions: Planned IP Care > Gastroentrology
Depositing User: Miss Emily Johnson
Date Deposited: 10 Jun 2019 10:39
Last Modified: 10 Jun 2019 10:39
URI: http://www.repository.heartofengland.nhs.uk/id/eprint/2148

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