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 today's issue of 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.