Enbrel

[etanercept]

Immunosuppression

Anti-TNF therapies, including ENBRELŪ, affect host defenses against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses. In a study of 49 patients with RA treated with ENBRELŪ, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cellpopulations. The impact of treatment with ENBRELŪ on the development and course of malignancies, as well as active and/or chronic infections, is not fully understood (seeWARNINGS: Malignancies, ADVERSE REACTIONS: Infections, and Malignancies). The safety and efficacy of ENBRELŪ in patients with immunosuppression or chronic infections have not been evaluated.

Immunizations

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Most psoriatic arthritis patients receiving ENBRELŪ were able to mount effective B-cell immune responses to pneumococcal polysaccharide vaccine, but titers in aggregate were moderately lower and fewer patients had two-fold rises in titers compared to patients not receiving ENBRELŪ. The clinical significance of this is unknown. Patients receiving ENBRELŪ may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission ofinfection by live vaccines in patients receiving ENBRELŪ (see PRECAUTIONS:Immunosuppression). It is recommended that JRA patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating ENBRELŪ therapy. Patientswith a significant exposure to varicella virus should temporarily discontinue ENBRELŪ therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Autoimmunity

Treatment with ENBRELŪ may result in the formation of auto antibodies (see ADVERSEREACTIONS: Autoantibodies) and, rarely, in the development of a lupus-like syndrome (seeADVERSE REACTIONS: Adverse Reaction Information from Spontaneous Reports) which may resolve following withdrawal of ENBRELŪ. If a patient develops symptoms and findingssuggestive of a lupus-like syndrome following treatment with ENBRELŪ, treatment should be discontinued and the patient should be carefully evaluated.

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