Established safety profile evaluated in clinical studies over 10 years
In patients with moderate to severe rheumatoid arthritis or psoriatic arthritis taking ENBREL, malignancy, serious infection, and opportunistic infection rates were similar to rates of the control in the pivotal clinical trials.1
Important Safety Considerations
ENBREL suppresses the immune system and has been associated with serious and sometimes fatal infections, including TB and other opportunistic infections. Other serious and sometimes fatal adverse events including malignancies, neurologic events, hematologic events, congestive heart failure, hepatitis B reactivation, allergic reactions, lupus-like syndrome and autoimmune hepatitis have also been reported. ENBREL is contraindicated in patients with sepsis.
See Important Safety Information for additional information.
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Malignancies
Serious and Opportunistic Infections
Supportive data
In medical studies, ENBREL was shown to be clinically effective in about 2 out of 3 adults with moderate to severe RA at 3 months. ENBREL has been shown to begin working in as few as 2 weeks, and most patients who benefit will do so within 3 months. In another medical study, 55% of patients who were evaluated 5 years after beginning ENBREL therapy had no further progression of joint damage.
In a medical study, ENBREL was shown to be effective in about 50% of psoriatic arthritis patients at 6 months. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.