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CIMZIA(R) (Certolizumab Pegol) Provides Long-Term Benefit Without Dose Escalation in Crohn's Disease Patients
Date:10/7/2008

ing pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. UCB is developing CIMZIA in rheumatoid arthritis and other autoimmune disease indications. CIMZIA was approved in April 2008 for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to conventional therapy. CIMZIA is a registered trademark of UCB PHARMA S.A. For full prescribing information, please visit http://www.ucb-group.com.

Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, and other opportunistic infections, have been observed in patients receiving CIMZIA. Some of these infections have been fatal. Anti-tuberculosis treatment of patients with latent tuberculosis infection reduces the risk of reactivation in patients receiving treatment with TNF blockers such as CIMZIA. However, active tuberculosis has developed in patients receiving CIMZIA whose tuberculin test was negative. Evaluate patients for tuberculosis risk factors and test for latent tuberculosis infection prior to initiating CIMZIA and during therapy. Initiate treatment of latent tuberculosis infection prior to therapy with CIMZIA. Monitor patients receiving CIMZIA for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection. Consider anti-tuberculosis therapy prior to initiation of CIMZIA in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.

Serious infections, sepsis, and cases of opportunistic infections, including fatalities, have been reported in patients receiving TNF blockers, including CIMZIA. Infections have been reported in patients receiving CIMZIA alone or in conjunction with immunosuppressive age
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