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The NEJM reports the results of a one year trial wherein ustekinumab (UST) was shown to be effective at inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. Ustekinumab, currently approved for use in psoriasis, psoriatic arthritis and Crohn's disease, is a monoclonal antibody against the p40 subunit of interleukin-12 and interleukin-23.
The study included 961 patients with moderate-to-severe ulcerative colitis who received intravenous placebo (PBO) or UST as 8-week induction therapy and 44-week maintenance therapy in patients. The primary end point was clinical remission (defined as a total score of ≤2 on the Mayo scale).
At the end of 8 weeks, clinical remission was significantly higher with ustekinumab 130 mg (15.6%) or 6 mg/kg (15.5%) than that placebo (5.3%) (P<0.001).
Responders to induction therapy also had higher clinical remission rates at week 44 with 90 mg subcutaneous UST (q 12 wks) (38.4%) or every 8 weeks (43.8%) than among those assigned to placebo (24.0%) (P=0.002 and P<0.001, respectively).
Serious adverse events were similar between UST and PBO. At one year there were two deaths and cancers in the 825 UST treated patients compared to no deaths and one cancer for the 319 patients on PBO.