J&J's Stelara Succeeds in Ulcerative Colitis Study

By Reuters Staff

October 10, 2018

(Reuters) - Johnson & Johnson said on Tuesday its blockbuster drug Stelara (ustekinumab) was found to be effective in treating ulcerative colitis (UC) in a late-stage trial.

Two doses of Stelara, already approved for psoriasis, psoriatic arthritis and Crohn's disease, were tested in 961 patients with moderate-to-severe UC who had failed prior therapy.

A single infusion of either 6 mg/kg or 130 mg yielded clinical remission in significantly more patients, compared with those on placebo, after eight weeks, the company said.

The treatment and the placebo arms reported similar proportion of side effects, with one patient on the 6 mg/kg dose dying following excessive bleeding, J&J said.

The patient had no prior history of high blood pressure or cirrhosis, the drugmaker said.

"More than half of UC patients have not experienced remission with currently available treatment options," the study's lead investigator Bruce Sands said.

Stelara, which brought in sales of $1.34 billion in the second quarter of 2018, is also being tested in the autoimmune disease lupus.