J&J blockbuster find late-stage trial success in chronic bowel disease study
Johnson & Johnson announced that its blockbuster drug Stelara was found to be effective in treating ulcerative colitis (UC), a chronic bowel disease, in a late-stage trial.
Researchers evaluated 961 patients after eight weeks of treatment, who were randomly given either a fixed dose of Stelara, an amount based on the patient's weight or placebo. Stelara achieved statistical significance in its primary goal of achieving clinical remissions and the secondary endpoints of clinical responses, endoscopic healing and mean change from an inflammatory bowel disease questionnaire score.
Roughly three times as many patients achieved clinical remission than compared to placebo. Slightly more than a quarter of those treated with Stelara had endoscopic healing and 51 percent on the fixed dose and 62 percent on the weight-dependent dose registered a clinical response compared to 31 percent on placebo.
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.
Read the Reuters report
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