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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

 Formal drug interaction studies have not been performed with rituximab or natalizumab; however because of the nature of the adverse events seen with these combinations with TNF blocker therapy, similar toxicities may also result from the use of certolizumab pegol in these combinations.  Therefore, the combination of certolizumab pegol with anakinra, abatacept, rituximab, or natalizumab is not recommended.  Interference with certain coagulation assays has been detected in patients treated with certolizumab pegol.  There is no evidence that certolizumab pegol therapy has an effect on in vivo coagulation.  Certolizumab pegol may cause erroneously elevated aPTT assay results in patients without coagulation abnormalities.

AutoimmunityTreatment with certolizumab pegol may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome.  Discontinue treatment if symptoms of lupus-like syndrome develop.

ImmunizationsDo not administer live vaccines or attenuated vaccines concurrently with certolizumab pegol.

Adverse ReactionsIn controlled Crohn's clinical trials, the most common adverse events that occurred in greater than or equal to 5% of certolizumab Pegol patients (n=620) and more frequently than with placebo (n=614) were upper respiratory infection (20% certolizumab pegol, 13% placebo), urinary tract infection (7% certolizumab pegol, 6% placebo), and arthralgia (6% certolizumab pegol, 4% placebo).  The proportion of patients who discontinued treatment due to adverse reactions in the controlled clinical studies was 8% for certolizumab pegol and 7% for placebo.

In controlled RA clinical trials, the most common adverse events that occurred in greater than or equal to 3% of patients taking certolizumab pegol 200mg every other week with concomitant methotrexate (n=640) and more frequently than with placebo with concomitant methotrexate (n=324) were upper respir
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