New Crohn's Disease Drug Shows Promise
WEDNESDAY July 18, 2007 -- A new drug against Crohn's disease may be of real help to people who don't respond well to existing medications, two new studies show.
Certolizumab pegol, which works in a similar fashion to standard medicines, isn't on the market yet and hasn't been approved by the U.S. Food and Drug Administration. Still, "it may at some time offer another option for patients," said University of Louisville associate professor of medicine Dr. Gerald W. Dryden Jr., who studies Crohn's disease and is familiar with the new research.
Crohn's disease causes inflammation in the intestines and other parts of the body. It typically causes cramps and diarrhea, and other symptoms are possible.
In the United States, young people in their 20s and 30s seem to be most susceptible, but scientists appear to be far from fully understanding the disease.
Prednisone, a steroid that dampens the immune system, is often the first line of treatment, Dryden said. In moderate-to-severe cases, doctors often turn to two drugs that appear to tinker with a protein called tumor necrosis factor (TNF) alpha, which has also been linked to the inflammation caused by the disease.
The introduction of the first anti-TNF drug, infliximab (Remicade), revolutionized the treatment of Crohn's disease, wrote Dr. James Lewis, an associate professor of medicine and epidemiology at the University of Pennsylvania, in a commentary accompanying the two studies. Another drug, adalimumab (Humira), is now available.
The problem? They can both cause side effects. Also, "none of the currently available medications are effective at inducing remission in all patients," Lewis said in an interview. "Even the most effective medications typically induce a sustained remission in well less than 50 percent of patients."
That forces many patients to turn to surgery.
Enter the new drug, certolizumab pegol, which is being developed by the pharmaceutical company UCB Pharma. The company helped pay for the two new studies, which are published in the July 19 issue of the New England Journal of Medicine.
In one of the studies, 668 patients with moderate-to-severe Crohn's disease received 400 milligrams of the injectable drug three times over four weeks. Those who responded were assigned to more of the drug or a placebo.
According to the team led by Dr. Stefan Schreiber of Christian Albrechts University in Kiel, Germany, 48 percent of patients who showed an early response to the drug were still in remission in the 26th week after staying on the drug. In comparison, just 29 percent of patients who responded to the drug early but were then assigned to a placebo later went into remission.
In the other study, this time led by Dr. William Sandborn of the Mayo Clinic in Rochester, Minn., 662 patients took the drug or a placebo three times over a four-week period and then once every four weeks. Patients had a better short-term result if they took the drug, but the long-term remission rates were nearly identical between the two groups.
In other words, the two studies of the same drug produced somewhat different results. Still, commentary author Lewis wrote that they suggest that the drug is an "effective therapy."
If approved, the drug would offer an alternative to the two existing similar drugs, he said. "It appears that patients who lose response to or become intolerant of one anti-TNF medication may respond to another anti-TNF medication. Thus, we may ultimately see patients switching between the different anti-TNF medications."
Dryden, the University of Louisville professor, said that the new drug's convenience may appeal to patients. It may need to be injected only once every month, a procedure that could be done at home, compared to other drugs that must be administered more often, he said.
According to Lewis, it's unlikely that studies will measure the new drug and the two old ones against each other, meaning they may end up being prescribed based on their perceived effectiveness, cost, and ease of use.
Learn more about Crohn's disease from the U.S. National Institute of Diabetes and Digestive and Kidney Diseases.
Posted: July 2007