New Data Suggest CIMZIA(R) (Certolizumab Pegol) Active in Treating Moderate to Severe Crohn's Patients With Fistulizi...(CIMZIA(R) for patients identified as car...)

Date:12/5/2008

CIMZIA(R) for patients identified as carriers of HBV. Patients who are carriers of HBV and require treatment with CIMZIA(R) should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, discontinue CIMZIA(R) and initiate effective anti-viral therapy with appropriate supportive treatment.

During controlled and open-labeled portions of CIMZIA(R) studies of Crohn's disease and other investigational uses, malignancies were observed at a rate (95% confidence interval) of 0.6 (0.4, 0.8) per 100 patient-years among 4,650 CIMZIA(R)-treated patients verses a rate of 0.6 (0.2, 1.7) per 100 patient-years among 1,319 placebo-treated patients. The size of the control group and limited duration of the controlled portions of the studies preclude the ability to draw firm conclusions. In studies of CIMZIA(R) for Crohn's disease and other investigational uses, there was one case of lymphoma among 2,657 CIMZIA(R)-treated patients and one case of Hodgkin lymphoma among 1,319 placebo-treated patients. The potential role of TNF blocker therapy in the development of malignancies is not known.

Symptoms compatible with hypersensitivity reactions, including angioedema, dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported rarely following CIMZIA(R)administration. If such reactions occur, discontinue further administration of CIMZIA(R)and institute appropriate therapy.

Use of TNF blockers, including CIMZIA(R), has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Rare cases of neurological disorders, including seizure disorder, optic neuritis, and peripheral neuropathy have been reported in p
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