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Stelara Efficacious in Phase III Crohn’s Disease Trial

Product is found to be significantly better than placebo

Positive results have been reported in a study of ustekinumab (Stelara, Johnson and Johnson) as a treatment for Crohn’s disease, a potential new indication for the drug.

Ustekinumab is already approved to treat plaque psoriasis and psoriatic arthritis. The new trial included 628 patients who received either a single infusion of 130 mg of ustekinumab, a ustekinumab infusion of 6 mg per kilogram of weight, or a placebo.

As reported by Reuters, after six weeks, 52% of those in the 130-mg group and 56% in the 6-mg/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% in the placebo group. In addition, 31% of the ustekinumab 130-mg group and 40% in the other dosing arm achieved clinical remission by week 8 of the study, versus 20% for placebo. The results were found 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 ustekinumab in those who failed anti-TNF therapy. In addition to reductions in signs and symptoms of disease, ustekinumab patients reported significant improvements in the Inflammatory Bowel Disease Questionnaire, a health-related quality of life measure, researchers said. The rate of serious side effects, including infections, was similar for ustekinumab and placebo.

Source: Reuters, October 19, 2015.

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