Is a New Crohn’s Disease Treatment on the Horizon?

vials of medication

Oct. 17, 2012 — A drug used to treat psoriasis may provide a much-needed option for people with bad cases of Crohn’s disease. 

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.”

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Humira Approved for Ulcerative Colitis Treatment

Sept. 28, 2012 — The FDA has approved Abbott’s Humira for the treatment of moderate to severe ulcerative colitis.

Humira (adalimumab) now is approved for both forms of inflammatory bowel disease (IBD): ulcerative colitis and Crohn’s disease.

It was already approved to treat Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, juvenile idiopathic arthritis, and ankylosing spondylitis.

For ulcerative colitis, Humira is approved when other drugs to suppress immune responses haven’t worked.

“Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual’s needs,” says Donna Griebel, MD, director of the FDA’s gastroenterology division. “Today’s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.”

Clinical studies tested Humira in treating ulcerative colitis patients with moderate to very severe disease. Clinical remission — defined as relatively mild disease — happened after eight weeks of Humira treatment in 16.5% to 18.5% of patients, compared to 9.2% to 9.3% of patients given an inactive placebo.

The FDA-approved dosing regimen for Humira for ulcerative colitis begins with an initial dose of 160 milligrams, a second dose two weeks later of 80 mg, and a maintenance dose of 40 mg every other week, thereafter. The drug is given by injection.

Ulcerative colitis patients who do not get clinical remission after eight weeks of treatment should stop taking Humira.

Common side effects of Humira include infections, reactions at the injection site, headache, and rash.

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