Ustekinumab Is Efficacious for Induction and Maintenance of UC

Ustekinumab Is Efficacious for Induction and Maintenance of UC

Monika Fischer, MD, FASGE reviewing Sands BE, et al. N Engl J Med 2019 Sep 26.

Ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, is currently available in the U.S. for induction and maintenance of remission in moderate to severe Crohn’s disease. 

In phase 3 of the UNIFI trial, 961 patients with ulcerative colitis (UC) were randomized to either a 130 mg or 6 mg/kg intravenous induction dose of ustekinumab. Only patients who responded to induction at 8 weeks were further randomized to subcutaneous maintenance injections of 90 mg either every 8 weeks or every 12 weeks. At week 8, the proportion of patients in clinical remission was the same in the 130-mg group (15.6%) and the 6-mg/kg group (15.5%) and was significantly higher compared to that in the placebo group (5.3%, P<0.001). At 44 weeks, the proportion of patients in clinical remission on the dosing every 12 weeks (38.4%) or 8 weeks (43.8%) was higher than the clinical remission rate among those assigned to a placebo (24.0%) (P=0.002 and P<0.001, respectively). Antibodies were detected in only 4.5% of patients. It is noteworthy that 7 out of 825 patients on ustekinumab were diagnosed with various types of cancer. Ustekinumab was more efficacious than a placebo in inducing and maintaining clinical remission (at 8 and 44 weeks) in moderate to severe active UC.

Ustekinumab will soon enrich our armamentarium of injectable medications for UC. Time will tell where to position ustekinumab in the treatment paradigm.

Monika Fischer, MD, FASGE


Sands BE, Sandborn WJ, Panaccione R, et al; UNIFI Study Group. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2019;381:1201-1214. (

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