In rheumatoid arthritis patients, this is approximately 3-fold higher than expected in the general population. In the combined clinical trial population for rheumatoid arthritis and Crohn?s disease, this is approximately 6-fold higher than expected in the general population. Rates in clinical trials for REMICADE cannot be compared to rates of clinical trials of other TNF blockers and may not predict rates observed in a broader patient population. Patients with Crohn's disease or rheumatoid arthritis, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma. The potential role of TNFa-blocking therapy in the development of malignancies is not known (see ADVERSE REACTIONS, Malignancies). No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving REMICADE; thus additional caution should be exercised in considering REMICADE treatment of these patients. PRECAUTIONS Autoimmunity Treatment with REMICADE may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with REMICADE, treatment should be discontinued (see ADVERSE REACTIONS, Autoantibodies/Lupus-like Syndrome). Vaccinations No data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines in patients receiving anti-TNF therapy. It is recommended that live vaccines not be given concurrently. | ||||
Email this article
Printer friendly
Bookmark this pageadvertisement
