Ustekinumab is a monoclonal antibody against IL-12 and IL-23. Three phase III trials have now shown that ustekinumab is effective as an induction and maintenance therapy for Crohn's disease. In two 8 week induction trials, UNIT-1 (n = 741) and UNIT-2 (n = 628), patients with moderate to severe Crohn's disease received either placebo or a single intravenous dose of ustekinumab. In both trials, those receiving one of two doses of ustekinumab had a significantly (P ≤0.003) higher rate of response after 6 weeks than placebo. Patients who responded then participated in the IM-UNITI trial (n = 397), receiving maintenance subcutaneous injections of either ustekinumab or placebo. After 44 weeks, significantly more patients receiving ustekinumab were in remission than placebo (P = 0.005 and P = 0.04 for 8 week and 12 week regimens, respectively). Adverse events were similar among all treatment groups.
Feagan, B. G. et al. Ustekinumab as induction and maintenance therapy for Crohn's disease. N. Engl. J. Med. http://dx.doi.org/10.1056/NEJMoa1602773 (2016)
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Dickson, I. Ustekinumab therapy for Crohn's disease. Nat Rev Gastroenterol Hepatol 14, 4 (2017). https://doi.org/10.1038/nrgastro.2016.202
Scientific Reports (2019)