A Closer Look at New FDA Actions: Cimzia

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

UCB Inc's Cimzia

The FDA has approved Cimzia (certolizumabpegol) for the treatment ofadults with moderate-to-severe Crohn'sdisease.¹ Cimzia is indicated to reducethe signs and symptoms and maintainresponse in patients who have notoptimally responded to conventionalCrohn's disease treatment options.²Cimzia is marketed by UCB Inc andpromoted as the first and only pegylatedanti-tumor necrosis factor (TNF)-a tobe approved for this indication.³

Crohn's disease is a chronic inflammatorydisorder of the gastrointestinal(GI) tract. Although it can occur in anypart of the GI tract, the ileum is themost common area affected. Symptomsinclude abdominal pain, diarrhea, rectalbleeding, weight loss, arthritis, skinproblems, and fever.Blockages, fistulas,and fissures often develop and maybecome infected; serious cases mayrequire medications and/or surgery.Other common complications includenutritional deficiencies, arthritis, skinproblems, inflammation of the eyes ormouth, kidney stones, gallstones, or diseaseof the liver and biliary system.⁴

Mechanism of Action

TNF-a is a proinflammatory cytokinein which Cimzia selectively binds andneutralizes, thus exerting its anti-inflammatoryeffect.²

Clinical Trials

Two double-blind, randomized, placebo-controlledstudies assessed the efficacyand safety of Cimzia in adult patientswith moderate-to-severe active Crohn'sdisease.

Study CD1 included 662 patients andcompared placebo with Cimzia 400 mgat weeks 0, 2, and 4 and every 4 weeksthereafter for a totalduration of 24 weeks.There was a statisticallysignificantlygreater responserate in the Cimziapatients at weeks 6and 26, comparedwith patients in theplacebo group.

Study CD2> includedpatients whohad been using andresponded to Cimziafor 6 weeks; patients using Cimzia withouta response at this point were withdrawnfrom the study. This group wasthen randomized to either continuationtreatment with Cimzia or placebo. Atweeks 6 and 26, there was a statisticallysignificantly greater response andremission rate in the Cimzia patients,compared with the placebo group.²

Dosage

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

Warnings and Precautions

Cimzia carries a boxed warning regardingthe risk for serious infections. Treatmentwith Cimzia should not be initiated duringan active infection. Tuberculosis,fungal infections, and other opportunisticinfections have been noted in patientsusing Cimzia; in some cases, these infectionshave been fatal. Patients should beevaluated for tuberculosis and its riskfactors both prior to and throughouttreatment with Cimzia.

In patients who are chronic carriers ofthe hepatitis B virus, the use of Cimziamay increase the risk of reactivation.Clinical trials with TNF blockers havedemonstrated an increased incidence ofmalignancy, compared with the controlgroup. Hypersensitivity and neurologicreactions and a lupuslike syndromehave occurred in patients using Cimzia.Pancytopenia and aplastic anemia havebeen reported in patients using TNFblockers. Cimzia should not be usedwith anakinra, as the combination maypredispose the patient to the developmentof a serious infection. Patientsusing Cimzia should not receive livevaccines. Cimzia should be used withcaution in patients with heart failure.Cimzia is not approved for use in pediatricpatients. Cimzia is a pregnancy categoryB drug. Its use in breast-feedinghas not been studied.²

Patient Education

Patients should understand that treatmentwith Cimzia might suppress theimmune system. Pharmacists shouldmake sure patients can recognize andidentify the signs and symptoms oftuberculosis and other serious infectionsand will immediately report totheir health care provider if any signs orsymptoms occur.⁵

Patients should be aware that treatmentwith Cimzia may increase the riskfor lymphoma and other malignancies.Any other changes in health (heart disease,neurologic disease, autoimmunedisorders, bruising, bleeding, or persistentfever) should be reported to ahealth care provider immediately.²

Headache, upper respiratory infections,urinary tract infections, abdominalpain, injection site reactions, andnausea are the most commonly reportedside effects from treatment withCimzia.^1,2 Cimzia was approved with aMedication Guide; patients should readthis guide prior to beginning therapyand periodically throughout treatmentwith Cimzia.¹

References

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