In a new study on a drug called Stelara (ustekinumab) it was seen that 40% patients with moderate to severe Crohn's disease responded. Stelara, which is already approved to treat psoriasis, is a human interleukin (IL)-12 and IL-23 antagonist marketed by Centocor Ortho Biotech Inc. The study findings were presented at Digestive Disease Week 2011.
For the study 526 patients were recruited and almost half had received TNF-inhibitors in the past, but didn't see a marked improvement in their symptoms. Stelara was given to patients intravenously and their response was measured by the Crohn's Disease Activity Index (CDAI). Of the group that received 6 mg/kg of Stelara, 40% saw a 100 point drop in their CDAI scores. At 22 weeks into the study, about 70% of patients receiving Stelara were still seeing an improvement in their symptoms, compared to 42% who were receiving placebo or dummy.
Stelara was considered to be tolerated well by the patients in the study, and reactions at the IV site were neither common nor serious. The next step for the study of this drug in Crohn's disease is a more advanced Phase 3 study.