UNITI-1 included 741 patients with primary or secondary nonresponse to TNF antagonists or who had unacceptable side effects, whilst UNITI-2 included 628 patients in whom conventional therapy failed or unacceptable side effects occurred. Patients who completed these induction trials participated in IM-UNITI, in which 397 patients who had a response to ustekinumab were randomised to subcutaneous maintenance injections of 90mg ustekinumab (every 8 or every 12 weeks) or placebo.
The rates of response at week 6 among patients on IV ustekinumab 130mg or ~ 6mg/kg were significantly higher than placebo group (UNITI-1: 34.3%, 33.7%, and 21.5%, respectively, p≤0.003 for both comparisons with placebo; UNITI-2, 51.7%, 55.5%, and 28.7%, respectively, p<0.001 for both doses). In the groups on maintenance doses of ustekinumab every 8 weeks or every 12 weeks, 53.1% and 48.8%, respectively, were in remission at week 44, vs. 35.9% on placebo (p=0.005 and p=0.04, respectively). Within each trial, adverse-event rates were similar among treatment groups.
Ustekinumab was recently approved in EU for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.