July 19, 2007 Mayo Clinic researchers have found that certolizumab pegol is an effective treatment for adults with Crohn's disease, according to two new studies. These findings were published in the New England Journal of Medicine. Certolizumab pegol blocks tumor necrosis factor, an important cause of inflammation in Crohn's disease.
Crohn's disease is an inflammatory disorder of the gastrointestinal tract that affects an estimated 500,000 people in the United States. Symptoms include abdominal pain, fever, nausea, vomiting, weight loss and diarrhea. Crohn's disease has no known medical cure. Currently approved therapies that also block tumor necrosis factor include intravenous infusions of infliximab or subcutaneous injections of adalimumab.
"Many patients with Crohn's disease who receive repeated administration of infliximab or adalimumab will eventually stop responding to the therapy," says William Sandborn, M.D., a study author and gastroenterologist at Mayo Clinic. "Therefore, it is important to have a variety of options in this drug class to help patients avoid Crohn's disease symptoms over longer periods of time."
According to Dr. Sandborn, the dosing regimen for certolizumab pegol is more patient-friendly than infliximab or adalimumab, with less frequent subcutaneous injections that can be self-administered.
The first study, led by Dr. Sandborn, set out to determine if certolizumab pegol was effective in easing the symptoms of patients with active Crohn's disease. The study involved 662 adult patients with moderate to severe Crohn's disease, and represents a unique trial design in Crohn's disease. This is the first double-blind, placebo-controlled trial in which a drug that blocks tumor necrosis factor has been evaluated beyond 12 weeks in the treatment of Crohn's disease.
Researchers found that 35 percent of patients who received certolizumab pegol achieved an improvement in their clinical symptoms after six weeks, while 27 percent of patients who received a placebo experienced improved symptoms in the same period. Likewise, after six months, 37 percent of patients who received certolizumab pegol achieved an improvement in their clinical symptoms, compared to 27 percent of patients who received a placebo.
The second study set out to determine if certolizumab pegol was effective as a long-term maintenance therapy for patients with Crohn's disease. It involved 668 patients, of whom 428 (64 percent), responded, or achieved an improvement in their clinical symptoms, after taking certolizumab pegol for six weeks.
The response was maintained for six months in 63 percent of patients receiving certolizumab pegol, while 36 percent of patients who received a placebo from week six to six months experienced improved symptoms in that period. Additionally, clinical remission from symptoms was achieved in 48 percent of patients in the certolizumab pegol group, compared to 29 percent of those in the placebo group.
Certolizumab pegol is not yet approved by the Food and Drug Administration (FDA). One side effect of certolizumab pegol that was observed during the studies, and is seen in other drugs that block tumor necrosis factor, was a small increase in the risk for serious infection, including one case of pulmonary tuberculosis. However, injection-site reactions were very low and patients experienced low rates of antinuclear antibodies, which can occasionally cause lupus-like symptoms when elevated.
"Approximately 25 percent of the patients in these studies had previously been treated with infliximab therapy and had lost response," says Dr. Sandborn. "These studies show that certolizumab pegol could be a new option to treat patients with Crohn's disease, both those who have never been treated before, and those who have lost response to other therapies. Upon FDA approval, the use of certolizumab pegol could significantly improve quality of life for many patients with Crohn's disease."
Mayo Clinic is participating in ongoing clinical trials to examine the safety and effectiveness of using certolizumab pegol to treat Crohn's disease symptoms beyond six months. Each year, physicians at Mayo Clinic's campuses in Arizona, Florida and Minnesota treat approximately 2,000 patients who have Crohn's disease.
This research was funded by UCB Pharma, Inc. Mayo Clinic receives consulting fees from UCB Pharma, Inc. for work performed by Dr. Sandborn. Certolizumab pegol is a product of UCB Pharma, Inc.
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