(Reuters) - Johnson & Johnson said on Tuesday its blockbuster drug Stelara was found to be effective in treating a chronic bowel disease in a late-stage trial.
Two doses of Stelara, already approved for psoriasis, psoriatic arthritis and Crohn’s disease, was tested in 961 patients with moderate-to-severe ulcerative colitis (UC) who had failed prior therapy.
Both 6 mg/kg and 130 mg doses of the intravenous treatment showed 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 autoimmune disease lupus.
Ulcerative colitis, which affects about 38,000 people in the United States annually, is a chronic condition causing abdominal pain, intestinal ulcers, bloody diarrhea and weight loss.
Current treatments include Pfizer Inc’s Xelijanz, an oral treatment for adults patients with moderate-to-severe UC, and Merck & Co’s Renflexis.
(This story has been refilled to correct the dosage to 130 mg, not 130 mg/kg in paragraph 3)
Reporting by Manogna Maddipatla in Bengaluru; Editing by Sriraj Kalluvila