Johnson & Johnson's Stelara was significantly better than placebo at inducing clinical response and remissions in patients with moderate to severe Crohn's disease. Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract that affects about 700,000 Americans and 250,000 Europeans. Symptoms can include frequent diarrhea, abdominal pain and rectal bleeding. Stelara, a biotech medicine that blocks inflammation, is approved to treat the skin condition scaly plaque psoriasis and a type of arthritis associated with psoriasis.
Subjects in the 628-patient trial received either a single infusion of 130 milligrams of Stelara, a Stelara infusion of 6 mg per kilogram of weight or a placebo. After six weeks, 52 percent of those in the 130 mg group and 56 percent in the 6mg/kg group experienced a clinical response, defined as a reduction from baseline of at least 100 points in the Crohn's Disease Activity Index score. That compared with 29 percent in the placebo group. In addition, 31 percent of the Stelara 130 mg group and 40 percent in the other dosing arm achieved clinical remission by week 8 of the study, versus 20 percent for placebo. The results were deemed to be statistically significant.
Patients in the study had previously failed to be helped by steroids or immunomodulator drugs, such as methotrexate. Another study is testing Stelara in those who failed anti-TNF therapy.
In addition to reductions in signs and symptoms of disease, Stelara patients reported significant improvements in the Inflammatory Bowel Disease. The rate of serious side effects, including infections, was similar for Stelara and placebo.
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