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Rapid and Long-term Clinical Responses Observed in Rheumatoid Arthritis Patients Taking Cimzia® (certolizumab pegol), According to Data Being Highlighted During ACR Meeting
Date:11/5/2010

ignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which certolizumab pegol is a member.  Certolizumab pegol is not indicated for use in pediatric patients.Serious and sometimes fatal infection due to bacterial, mycobacterial, invasive fungal, viral or other opportunistic pathogens has been reported in patients receiving TNF-blocking agents.  Among opportunistic infections, tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis were the most common.  Treatment with certolizumab pegol should not be initiated in patients with an active infection, including clinically important localized infections.  Certolizumab pegol should be discontinued if a patient develops a serious infection or sepsis.  Patients who develop a new infection during treatment with certolizumab pegol should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated.  Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic.

MalignanciesDuring controlled and open-labeled portions of certolizumab pegol studies of Crohn's disease and other diseases, malignancies (excluding non-melanoma skin cancer) were observed at a rate of 0.5 per 100 patient-years among 4,650 certolizumab pegol-treated patients versus a rate of 0.6 per 100 patient-years among 1,319 placebo-treated patients.  In studies of certolizumab pegol for Crohn's disease and other investigational uses, there was one case of lymphoma among 2,657 certolizumab pegol-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients.  In certolizumab pegol RA clinical trials (placebo-controlled and open
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