Ustekinumab, a fully human IgG1k monoclonal antibody that binds the p40 subunit shared by interleukin-12 and 23,
is approved in the EU, US, and Canada for the treatment of moderate-to-severe Crohn’s disease. The IM-UNITI study
(through 1 year) and 4-year long-term extension will evaluate efficacy and safety of subcutaneous ustekinumab through
5 years of treatment. Safety and efficacy data through week 96 (2 years of maintenance) are presented. Clinical remission
among subjects still on ustekinumab at week 92 was observed in 79.2 % of patients (ustekinumab 90 mg in
12-week interval) and in 87.1 % of patients (the same dose in 8-week interval).Among randomised patients who entered
long-term extension 4.2% of ustekinumab subjects developed antibodies. No new safety signals were identified.
Most patients in long-term extension (> 80%) are still on ustekinumab at the end of 2nd year.