Stelara meets in Crohn's maintenance study

The Janssen Research and Development unit of Johnson & Johnson (NYSE:JNJ) said Stelara ustekinumab produced sustained remissions in the Phase III IM-UNITI maintenance trial to treat Crohn's disease, meeting the study's primary endpoint. The human mAb that inhibits IL-12 and IL-23 is under FDA and EMA review in the indication, and is already approved to treat plaque psoriasis and psoriatic arthritis.

IM-UNITI enrolled patients who responded to Stelara in the eight-week, Phase III UNITI-1 and UNITI-2 studies. In the maintenance trial, patients received Stelara every eight weeks for 44 weeks; every 12 weeks for 44 weeks; or placebo. After a total of 52 weeks, 53% of patients receiving the more frequent dosage and 49% in the less frequently dosed group were in clinical remission, vs. 36% for placebo (p=0.005 for the more frequent dose, p=0.04 for the less frequent group). ...