By Denise Mann
WebMD Health News
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Reviewed by Louise Chang, MD
In the new study, some people with moderate to severe Crohn's given Stelara (ustekinumab) began to see improvements in their symptoms within six weeks.
Crohn's disease is an inflammatory bowel disease marked by inflammation and damage of any part of the digestive tract.
Inflammation plays a central role in both Crohn's and the skin disease psoriasis. Stelara blocks two proteins that promote inflammation. A commonly used class of drugs for Crohn's blocks the activity of another protein that promotes inflammation called tumor necrosis factor (TNF). Treatments in this class include Cimzia, Humira, and Remicade.
But not everyone with Crohn's is helped by TNF drugs, and some who do well at first stop responding to them.
"About 60% of people with Crohn's disease will have an initial response to TNF drugs and of those, half will lose their response over the course of the year," says researcher William J. Sandborn, MD. He is the chief of the division of gastroenterology at the University of California San Diego School of Medicine. They can still try additional TNF drugs if they haven't been helped by one, but surgery is often their last resort, he says.
The new findings are "very encouraging and bode well that this drug will eventually become a new treatment option for people with Crohn's," Sandborn says.
As of now, Stelara is being studied in clinical trials of Crohn's disease across the U.S.
The new study included 526 people with moderate to severe Crohn's that was resistant to TNF-blocker drugs. Some participants were given one intravenous dose of Stelara, and another dose was injected every eight weeks for 36 weeks; other participants were given a placebo.
Some people given the new drug began to improve within six weeks of therapy. Those who responded to Stelara after the initial dose were more likely to enter remission at 22 weeks.
Six people treated with Stelara developed a serious infection, and one person developed basal cell skin cancer. Both infections and skin cancer are also considered risks with the TNF-blockers due to how these drugs affect the immune system.
New Options Needed for Crohn's Disease
"The current agents are effective, but not in everyone," says Gary Lichtenstein, MD. He is the director of the inflammatory bowel disease program at the Hospital of the University of Pennsylvania in Philadelphia.
This study looks at the "[person] who doesn't respond to TNF drugs, and the new drug may help them avoid surgery," he says.
Crohn's is an extremely debilitating disease for many people. "They lose a lot of days from work, it affects their social life, and they are always looking for bathrooms," he says. "It is a horrible disease and can be very aggressive."
Symptoms range in severity and may include:
- Chronic diarrhea, often bloody and containing mucus or pus
- Weight loss
- Abdominal pain and tenderness
- Feeling of a mass or fullness in the abdomen
- Rectal bleeding
In the future, Stelara may also be tried before TNF blockers among people with Crohn's. "We know it is effective for people who have failed TNF drugs, and I can imagine that it would also be effective for people who didn't fail them."
Burton Korelitz, MD, says that the more drugs doctors have with which to treat Crohn's, the better for patients. He is the chief emeritus and director of clinical research in the division of gastroenterology at Lenox Hill Hospital in New York City.
Crohn's disease doesn't have a cure. "There is always room for another good drug right up until the time that we understand the cause of the disease and can tailor therapy to the cause in each patient."
The findings appear in the Oct. 18, 2012, issue of the New England Journal of Medicine. Stelara manufacturer Janssen Research and Development provided support for the new study.
SOURCES: William J. Sandborn, MD, chief, division of gastroenterology, University of California San Diego School of Medicine. Gary Lichtenstein, MD, director, Inflammatory Bowel Disease Program, Hospital of the University of Pennsylvania, Philadelphia. Burton Korelitz, MD, Chief Emeritus, director of clinical research, division of gastroenterology, Lenox Hill Hospital, New York. Sandborn, W.J. New England Journal of Medicine, Oct. 18, 2012.
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