Drug Topics - June 16, 2008 - (Page 22)

22 DRUG TOPICS JUNE 16, 2008 www.drugtopics.com Rx Care First therapy in new class approved for Crohn’s disease Heidi Belden, Pharm.D. 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 Tips to remember: Cimzia disorders, such as multiple sclerosis. The recommended dose of Cimzia is 400 mg injected subcuWall, who is also an associate professor taneously initially and at weeks two and four. Subsequent dosing of pharmacy practice at Drake University is 400 mg once-monthly. College of Pharmacy and Health Sciences, Cimzia should not be given with live vaccines. believes that certolizumab will probably Cimzia may interfere with aPTT test results. be used in CD patients who have failed or cannot tolerate infliximab and/or adalimHypersensitivity reactions have been reported following Cimumab. “The convenience of a once-monthly zia administration. injection, and the decreased risk of infusion Cimzia should not be used with anakinra (Kineret, Amgen) reactions, may make it an attractive choice due to increased risk of serious infection. in some CD patients,” he said. A new once-monthly biologic will now offer patients with Crohn’s disease (CD) another treatment option. Certolizumab pegol, to be marketed as Cimzia from UCB Group, received Food & Drug Administration approval for the reduction of signs and symptoms of the disease and to maintain clinical response in adult patients with moderate to severe active disease who have had an inadequate response to conventional therapy. According to the manufacturer, certolizumab is the first and only pegylated anti-tumor necrosis factor alpha (anti-TNF-a) for this indication. The biologic is a recombinant humanized antibody Fab fragment with specificity for human TNF-a that is conjugated to polyethylene glycol. “TNF-a is a potent proinflammatory cytokine that is responsible for mediating much of the pathophysiology of Crohn’s disease,” said Geoffrey C. Wall, Pharm.D., BCPS, CGP, a clinical pharmacist at the Iowa Inflammatory Bowel Disease Center in Des Moines. “Unlike other existing biologics that also bind TNF-a [i.e., infliximab (Remicade, Centocor) and adalimumab (Humira, Abbott)], certolizumab is not a complete antibody, and consists of only the part of the antibody that binds TNF-a. This fragment has been bound to polyethylene glycol to increase its duration of action,” he explained. In fact, Cimzia utilizes Nektar’s PEGylation technology platform which, according to the company, increases a product’s bioavailability and decreases immunogenicity and dosing frequency. Certolizumab’s approval was based on two safety and efficacy studies in adult patients New Biologic http://www.drugtopics.com

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Drug Topics - June 16, 2008 Contents Latebreakers Letters Latebreakers in Depth Pharmacists Lose in Final ESRD Rule New Drug Helps Palliative Patients on Opioids Take Care of Business Oral Treatment Reduces Multiple Sclerosis Flare-ups Beware of Inflammatory Masses From Implantable Infusion Systems Safer Therapeutic Options Emerging for Atrial Fibrillation Congressional Committee Chair Calls for Action Against Hospital Infections This Software System Helps Hospitals Manage Anticoagulation Therapy Rx Care Community Practice JP at Large Self-Care Cover Story Long-Term Care Chains and Business Technology Technology Update Continuing Education New Products Advertisers Index Classified Viewpoint

Drug Topics - June 16, 2008

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