Enbrel

[etanercept]

Immunosuppression

Anti-TNF therapies, including ENBREL®, 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 ENBREL®, 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 ENBREL® 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 ENBREL® in patients with immunosuppression or chronic infections have not been evaluated.

Immunizations

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Most psoriatic arthritis patients receiving ENBREL® 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 ENBREL®. The clinical significance of this is unknown. Patients receiving ENBREL® may receive concurrent vaccinations, except for live vaccines. No data are available on the secondary transmission ofinfection by live vaccines in patients receiving ENBREL® (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 ENBREL® therapy. Patientswith a significant exposure to varicella virus should temporarily discontinue ENBREL® therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
Autoimmunity

Treatment with ENBREL® 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 ENBREL®. If a patient develops symptoms and findingssuggestive of a lupus-like syndrome following treatment with ENBREL®, treatment should be discontinued and the patient should be carefully evaluated.

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