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Abbott's HUMIRA(R) Receives Positive Opinion From EMEA for Treatment of Moderate to Severe Plaque Psoriasis
Date:11/16/2007

ally appears in patients between the ages of 15 and 25. Psoriasis affects an estimated 125 million people worldwide, with approximately 25 percent of patients experiencing moderate to severe disease. The severity of the disease varies from person to person. Psoriasis can be a very isolating disease and people with psoriasis may suffer from poor self-image and even depression.

Important Safety Information

Globally, prescribing information varies; refer to the individual country product label for complete information.

Serious infections, sepsis, rare cases of tuberculosis (TB), and opportunistic infections, including fatalities, have been reported with the use of TNF antagonists, including HUMIRA. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease could predispose them to infections. Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.

TNF-blocking agents have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of the virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating HUMIRA.

The combination of HUMIRA and anakinra is not recommended.

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SOURCE Abbott
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