WebMD Health News
Louise Chang, MD
July 18, 2007 -- Two new studies show that a new drug called Cimzia may ease symptoms of Crohn's disease.
Cimzia hasn't been approved by the FDA yet. Patients would give themselves injections of the drug, which targets an inflammatory chemical called tumor necrosis factor (TNF) alpha.
The two new studies, published in The New England Journal of Medicine, highlight Cimzia's clinical trials in Crohn's disease patients.
The first study included 662 people with moderate to severe Crohn's disease. Half of the patients got Cimzia shots every two weeks for the first month, and then one shot per month for the rest of the six-month study.
For comparison, the other patients got sham shots (placebo) on the same dosing schedule. Patients in both groups kept diaries about their Crohn's symptoms and got regular checkups.
At the end of the study, Crohn's symptoms had eased for 23% of the Cimzia group, compared with 16% of those in the placebo group.
Cimzia had a "modest improvement in the response rate, as compared with the placebo," write the researchers. They included William Sandborn, MD, of the gastroenterology and hepatology division of the Mayo Clinic in Rochester, Minn.
However, patients taking Cimzia weren't more likely to achieve remission from Crohn's disease than those taking the placebo.
The second study focused on maintaining improvements in Crohn's disease symptoms over six months.
The researchers included Stefan Schreiber, MD, of the Hospital for General Internal Medicine at Christian Albrechts University in Kiel, Germany.
They studied 668 people with moderate to severe Crohn's disease.
The study lasted for six months. For the first month, all of the patients got Cimzia shots every other week. During that time, Crohn's symptoms improved for nearly two-thirds of the patients.
After that, Schreiber's team focused only on the patients who had shown improvement with Cimzia treatment.
The researchers put the patients on a maintenance plan -- a monthly shot of Cimzia or a placebo.
Patients taking Cimzia were more likely to maintain their improvement in Crohn's symptoms during the six-month study, compared with those taking the placebo.
Infection risk may be higher with anti-TNF drugs.
In Schreiber's study, serious infections (including one case of tuberculosis) occurred in 3% of the Cimzia group, compared with less than 1% of the placebo group.
In Sandborn's study, serious infections were reported in 2% of Cimzia patients and less than 1% of those taking the placebo shots.
Both studies were funded by UCB Pharma, which makes Cimzia. Both sets of researchers note financial ties to various drug companies, including UCB Pharma.
"If the drug is ultimately approved, where will it fit into current treatment strategies?" asks editorialist James Lewis, MD, MSCE, in The New England Journal of Medicine.
Lewis works at the University of Pennsylvania's medical school. He writes that ideally, researchers would do studies that directly compare anti-TNF drugs for Crohn's disease.
"Unfortunately, it is unlikely that such comparative trials will be conducted," writes Lewis.
Lewis notes financial ties to various drug companies, but not to UCB Pharma.
SOURCES: Sandborn, W. The New England Journal of Medicine, July 19,
2007; vol 357: pp 228-238. Schreiber, S. The New England Journal of
Medicine, July 19, 2007; vol 357: pp 239-250. Lewis, J. The New England
Journal of Medicine, July 19, 2007; vol 357: pp 296-298. News release, Mayo
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