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.

Monika Fischer, MD, FASGE

CITATION(S)

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. (https://doi.org/10.1056/NEJMoa1900750)