The patients were treated for 36 weeks in the placebo-controlled study. They were given an intravenous dose of ustekinumab at the beginning of the study and a subcutaneous dose every eight weeks. Benefits could be seen as early as six weeks of therapy.
Among patients treated, serious infection was reported in five patients and a basal-cell carcinoma, a form of skin cancer, was reported in one patient.
“These promising initial results are now being followed up and confirmed with additional Phase 3 induction trials—UNITI-1 and UNITI-2. A Phase 3 maintenance trial (IM-UNITI) will also be conducted in which the patients who respond to ustekinumab will receive additional treatment for one year," said Sandborn, director of the Inflammatory Bowel Disease Center at UC San Diego Health System. “Our goal is to increase clinical response and put the disease in remission to improve the patient’s quality of life."
Crohn’s Disease affects approximately 700,000 Americans. There is no cure for the disease, and severe flare ups can result in surgery where the large intestine is removed.
The study was funded by Janssen Research & Development.
The Division of Gastroenterology at UC San Diego Health System is nationally recognized for its care of patients by a multidisciplinary team of specialists in gastroenterology, endoscopy, oncology, surgery, transplantation and radiology. The Inflammatory Bowel Disease Center is dedicated to diagnosing and treating people with IBD from around the world.