Certolizumab pegol (Cimzia, UCB Group) approved for Crohn's disease

June 16, 2008

FDA approves new biologic to reduce symptoms of Crohn's disease

Tips to remember: Cimzia

Certolizumab's approval was based on two safety and efficacy studies in adult patients with moderately to severely active CD. In one trial, at weeks six and 26 of treatment, the proportion of clinical responders was significantly greater for patients treated with certolizumab compared with patients receiving placebo (p<0.05). At week 26, there was also a statistically greater number of patients who reached clinical remission in the certolizumab-treated group versus placebo.

The prescribing information recommends starting certolizumab initially as a 400-mg subcutaneous injection at weeks 0, 2, and 4. If a response occurs, additional 400-mg doses should be given every four weeks. Certolizumab should not be started during an active infection and, if the infection develops during treatment, the therapy should be discontinued if the infection becomes serious.

Postmarketing data show that TNF-blockers have caused viral, bacterial, fungal, and protozoal infections in all organ systems. Hepatitis B virus (HBV) carriers should be monitored during and for several months after therapy is finished. If reactivation of HBV should occur, treatment should be stopped and antiviral therapy begun. Patients should also be tested for latent tuberculosis infection before treatment begins. Cases of lymphoma and other malignancies have been observed in patients receiving TNF-blockers; however, the potential role of TNF-blocker therapy in the development of these malignancies is unknown, according to UCB. In addition, TNF-blockers have been associated with new onset or exacerbation of demyelinating disease and should be used with caution in patients with pre-existing or recent-onset demyelinating disorders, such as multiple sclerosis.

Wall, who is also an associate professor of pharmacy practice at Drake University College of Pharmacy and Health Sciences, believes that certolizumab will probably be used in CD patients who have failed or cannot tolerate infliximab and/or adalimumab. "The convenience of a once-monthly injection, and the decreased risk of infusion reactions, may make it an attractive choice in some CD patients," he said.