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 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.
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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)
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