Ustekinumab, an antibody proven to treat the skin condition psoriasis, has now shown positive results in decreasing the debilitating effects of Crohn's Disease, say researchers at the University of California San Diego School of Medicine.

The study appeared in the Oct. 18 issue of theNew England Journal of Medicine.

Results from the clinical trial showed ustekinumab (Stelara) increased clinical response and remission in patients suffering from moderate-to-severe Crohn's Disease—a form of inflammatory bowel disease that can lead to a variety of distressing symptoms, including diarrhea, intestinal bleeding, and weight loss. Serious complications such as bowel obstruction and abscesses also can occur.

"Our biggest challenge in treating patients with Crohn's Disease is managing patients whose bodies are resistant to tumor necrosis factor (TNF) inhibitors such as Remicade, Humira, and Cimzia," says Dr. William Sandborn, principal investigator and chief of the division of gastroenterology at the UC San Diego School of Medicine. "Ustekinumab blocks two proteins that cause inflammation, interleukin 12 and 23. This finding is a significant first step towards a new treatment option for these patients."

One-third of patients with moderate to severe Crohn's Disease don't respond to current treatment with TNF inhibitors, which regulates the body's immune system and inflammation. Another one-third of patients only have a temporary response.

About 530 patients were part of the randomized trial, which was conducted in 12 countries. Eligible patients were at least 18 years of age and had a confirmed diagnosis of Crohn's Disease for at least three months.

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.

Researchers will conduct an additional maintenance trial in which the patients who respond to ustekinumab will receive additional treatment for one year, says Sandborn, who is also 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," he says.

Crohn's Disease affects about 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 has 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 the disease from around the world, providing patient access to clinical trials for the newest therapies and advanced surgical techniques for the treatment of this condition.