Psoriasis Drug May Help People With Crohn's Disease: Study
Researchers from the University of California, San Diego School of Medicine found Stelara (ustekinumab) blocks two proteins known to cause inflammation. Crohn's disease patients with moderate-to-severe cases of the debilitating inflammatory bowel disease experienced improvements after six weeks of treatment, the team noted.
One specialist not connected to the study welcomed the results.
"This study confirms an earlier study showing that ustekinumab can be an effective therapy," said Dr. Bruce Sands, professor of medicine at the Mount Sinai School of Medicine in New York City. "Given the large unmet need for these individuals with refractory [hard-to-treat] Crohn's disease, these results are a great step forward," he said.
Roughly 700,000 Americans are currently affected by Crohn's disease, which can cause diarrhea, intestinal bleeding and weight loss as well as complications, such as bowel obstruction and abscesses. There is currently no known cure for the condition, the study authors noted in a university news release.
"Our biggest challenge in treating patients with Crohn's disease is managing patients whose bodies are resistant to [drugs known as] tumor necrosis factor (TNF) inhibitors such as Remicade, Humira and Cimzia," study lead author Dr. William Sandborn, chief of the division of gastroenterology at the UC San Diego School of Medicine, explained in the release.
About one-third of the patients do not respond to treatment with TNF inhibitors, which help regulate the body's immune system and inflammation. Another third of patients experience only a transient response to these drugs, the study authors noted.
However, Stelara works differently in that it "blocks two proteins that cause inflammation, interleukin 12 and 23," Sandborn explained. So, the new finding "is a significant first step towards a new treatment option for these patients," he said.
The study involved 526 people from 12 different countries with moderate-to-severe Crohn's disease. Participants were at least 18 years old, were diagnosed at least three months before the study began, and were treated with either Stelara or an inactive placebo over a 36-week period.
Initially, the patients were given one intravenous dose. Another dose was injected every eight weeks.
Five patients developed serious infections and one participant was diagnosed with a form of skin cancer, the researchers noted.
The study was funded by Stelara's maker, Janssen Biotech, Inc.
The "promising" results of the trial will be examined further in phase 3 trials "in which the patients who respond to ustekinumab will receive additional treatment for one year," added 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."
Another Crohn's expert said the study shows promise, especially for people who don't respond to TNF inhibitors -- but more research may be needed.
"Given the relatively short follow-up in the current study, it will be especially interesting to see if those who responded to treatment in the study continue to do so over a longer period of time," said Dr. Keith Sultan, a gastroenterologist at North Shore University Hospital in Manhasset, N.Y.
The study was published in the Oct. 18 issue of the New England Journal of Medicine.
The U.S. National Institutes of Health provides more information on Crohn's disease.
Posted: October 2012
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