Jul 21 2007
According to two new studies the drug certolizumab has proved to be a safe and effective treatment for moderate-to-severe Crohn's disease.
Crohn's disease affects an estimated 500,000 people in the United States; is an inflammatory disorder that affects the small and large intestines and causes abdominal pain, fever, nausea, vomiting, diarrhea, cramps and excessive weight loss; it has no known medical cure.
It is usually treated with drugs but when a severe flare-up occurs surgery may be the only option.
Certolizumab's works in much the same way as infliximab (Remicade) and adalimumab (Humira), by blocking a chemical called tumor necrosis factor but because certolizumab has a different construction it is less likely to destroy certain immune cells.
The two studies called Pegylated Antibody Fragment Evaluation in Crohn's Disease: Safety and Efficacy (PRECISE) used certolizumab pegol in two trials on 638 adults with moderate-to-severe Crohn's disease; the patients were monitored for a period of 26 weeks.
In PRECISE 1, patients given certolizumab at weeks 0, 2, 4 and then every 4 weeks had significantly higher response rates at weeks 6 and 26 compared with patients who were given a placebo.
PRECISE 2 examined the drug as continued therapy for patients who already showed a treatment response.
Lead author Dr. William J. Sandborn, from the Mayo Clinic in Rochester, Minnesota, and his colleagues say no significant differences were seen between the groups in remission rates at week 26 and serious side effects, including infections, were uncommon with certolizumab and occurred with similar frequency as with placebo.
The researchers say the findings from PRECISE 2 suggest that continued certolizumab therapy is effective in maintaining the treatment response and achieving remission.
Some experts however say that though the findings are encouraging, certolizumab may not be the most effective drug for patients with Crohn's disease, and more trials are needed which compares other drugs with certolizumab.
Certolizumab pegol is not yet approved by the Food and Drug Administration (FDA).
The Mayo Clinic is involved in clinical trials examining the safety and effectiveness of using certolizumab pegol to treat Crohn’s disease symptoms beyond six months.
The studies were funded, in part, by UCB Pharma, which hopes to market the drug as CIMZIA and are published in the current issue of the New England Journal of Medicine.