Johnson & Johnson said its blockbuster drug Stelara was effective in treating a chronic bowel disease in a late-stage trial evaluating patients who did not respond to other therapies.
A phase 3 clinical study called Unifi compared two intravenous doses of the drug against placebo in treating moderate to severe ulcerative colitis, a disease that causes long-lasting inflammation and ulcers in the digestive tract and the large intestine.
Of the 961 patients that were evaluated after eight weeks, 15.6% of those that received a standard 130-milligram dose and 15.5% of those that received a dose tied to their weight had clinical remission and showed no sign of the disease. This compares to 5.3% for those that took a placebo.
After undergoing endoscopy, 26.3% and 27% of patients treated with the two doses of Stelara had experienced healing, respectively. About 13.8% of those that took placebo achieved the same result.
Meanwhile, 51.3% and 61.8% of subjects that were treated with the two doses of Stelara achieved a clinical response, respectively. This compares to 31.3% of patients receiving placebo.
J&J said one patient under the 6-milligram/kilogram dosage died during the treatment due to liver damage, while other side effects were consistent through the three arms of the study.
The findings will be presented at the American College of Gastroenterology Scientific Meeting 2018 scheduled for later today.
Stelara secured $2.4 billion in sales for the first six months of 2018, a 33% increase year over year, and the drug is already approved for plaque psoriasis, psoriatic arthritis and Crohn's disease.