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New Data Show CIMZIA(R) (certolizumab pegol) Provides Sustained and Significant Symptom Improvement in Moderate to Severe Crohn's Patients
Date:10/26/2009

nventional treatment in September 2007. Health Canada and the European Commission have both approved CIMZIA in combination with methotrexate (MTX), for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX. UCB is also developing CIMZIA in other autoimmune disease indications. CIMZIA is a registered trademark of UCB PHARMA S.A.

IMPORTANT SAFETY INFORMATION

Risk of Serious Infections

Patients treated with CIMZIA are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. CIMZIA should be discontinued if a patient develops a serious infection or sepsis. Reported infections include:

  • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before CIMZIA use and during therapy. Treatment for latent infection should be initiated prior to CIMZIA use.
  • Invasive fungal infections, including histoplasmosis , coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness .
  • Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with CIMZIA should be carefully considered prior to initiating th
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SOURCE UCB
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