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A Closer Look at New FDA Actions: Cimzia

Monica Holmberg, PharmD
Published Online: Sunday, February 1, 2009   [ Request Print ]


Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.


UCB Inc's Cimzia

The FDA has approved Cimzia (certolizumab pegol) for the treatment of adults with moderate-to-severe Crohn's disease.1 Cimzia is indicated to reduce the signs and symptoms and maintain response in patients who have not optimally responded to conventional Crohn's disease treatment options.2 Cimzia is marketed by UCB Inc and promoted as the first and only pegylated anti-tumor necrosis factor (TNF)-a to be approved for this indication.3

Crohn's disease is a chronic inflammatory disorder of the gastrointestinal (GI) tract. Although it can occur in any part of the GI tract, the ileum is the most common area affected. Symptoms include abdominal pain, diarrhea, rectal bleeding, weight loss, arthritis, skin problems, and fever. Blockages, fistulas, and fissures often develop and may become infected; serious cases may require medications and/or surgery. Other common complications include nutritional deficiencies, arthritis, skin problems, inflammation of the eyes or mouth, kidney stones, gallstones, or disease of the liver and biliary system.4

Mechanism of Action

TNF-a is a proinflammatory cytokine in which Cimzia selectively binds and neutralizes, thus exerting its anti-inflammatory effect.2

Clinical Trials

Two double-blind, randomized, placebo-controlled studies assessed the efficacy and safety of Cimzia in adult patients with moderate-to-severe active Crohn's disease.

Study CD1 included 662 patients and compared placebo with Cimzia 400 mg at weeks 0, 2, and 4 and every 4 weeks thereafter for a total duration of 24 weeks. There was a statistically significantly greater response rate in the Cimzia patients at weeks 6 and 26, compared with patients in the placebo group.

Study CD2> included patients who had been using and responded to Cimzia for 6 weeks; patients using Cimzia without a response at this point were withdrawn from the study. This group was then randomized to either continuation treatment with Cimzia or placebo. At weeks 6 and 26, there was a statistically significantly greater response and remission rate in the Cimzia patients, compared with the placebo group.2

Dosage

Cimzia should be administered as 2 subcutaneous injections of 200 mg each (400 mg total dose) at weeks 2 and 4. If clinical response is achieved, Cimzia should be continued as a maintenance therapy at a dose of 400 mg subcutaneously every 4 weeks.2

Warnings and Precautions

Cimzia carries a boxed warning regarding the risk for serious infections. Treatment with Cimzia should not be initiated during an active infection. Tuberculosis, fungal infections, and other opportunistic infections have been noted in patients using Cimzia; in some cases, these infections have been fatal. Patients should be evaluated for tuberculosis and its risk factors both prior to and throughout treatment with Cimzia.

In patients who are chronic carriers of the hepatitis B virus, the use of Cimzia may increase the risk of reactivation. Clinical trials with TNF blockers have demonstrated an increased incidence of malignancy, compared with the control group. Hypersensitivity and neurologic reactions and a lupuslike syndrome have occurred in patients using Cimzia. Pancytopenia and aplastic anemia have been reported in patients using TNF blockers. Cimzia should not be used with anakinra, as the combination may predispose the patient to the development of a serious infection. Patients using Cimzia should not receive live vaccines. Cimzia should be used with caution in patients with heart failure. Cimzia is not approved for use in pediatric patients. Cimzia is a pregnancy category B drug. Its use in breast-feeding has not been studied.2

Patient Education

Patients should understand that treatment with Cimzia might suppress the immune system. Pharmacists should make sure patients can recognize and identify the signs and symptoms of tuberculosis and other serious infections and will immediately report to their health care provider if any signs or symptoms occur.5

Patients should be aware that treatment with Cimzia may increase the risk for lymphoma and other malignancies. Any other changes in health (heart disease, neurologic disease, autoimmune disorders, bruising, bleeding, or persistent fever) should be reported to a health care provider immediately.2

Headache, upper respiratory infections, urinary tract infections, abdominal pain, injection site reactions, and nausea are the most commonly reported side effects from treatment with Cimzia.1,2 Cimzia was approved with a Medication Guide; patients should read this guide prior to beginning therapy and periodically throughout treatment with Cimzia.1

References

  1. FDA approves Cimzia to treat Crohn?s disease. FDA Web site. www.fda.gov/bbs/topics/news/2008/new01821.html. Accessed July 2008.
  2. Cimzia [package insert]. Smyran, GA: UCB Inc; 2008. www.cimzia.com/pdf/CIMZIA%20PI%20032008.pdf. Accessed July 2008.
  3. Cimzia approved in the US for the treatment of moderate to severe Crohn's Disease [press release]. www.ucb-group.com/news/3384.asp. Accessed July 2008.
  4. Crohn?s disease. www.digestive.niddk.nih.gov/ddiseases/pubs/crohns/Crohn.pdf. Accessed July 2008.
  5. Cimzia medication guide. www.cimzia.com/pdf/MedicationGuide.pdf. Accessed July 2008.
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