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New Long-Term HUMIRA(R) (adalimumab) Data Show Up to Seven-Year Efficacy with Combination Treatment for Rheumatoid Arthritis

Friday, June 13, 2008 General News J E 4
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PARIS, June 13 Seven-year rheumatoid arthritis(RA) data from open-label extension studies show that treatment with Abbott'sHUMIRA(R) (adalimumab) resulted in clinical remission among long-standing RApatients when used in combination with methotrexate (MTX). The percentage ofpatients achieving clinical remission continued to increase after two or moreyears of continuous treatment with combination therapy. These data werepresented at the European League Against Rheumatism (EULAR) annual meeting inParis.

The seven-year HUMIRA data are a combined analysis of open-labelextensions of the ARMADA, DE019, STAR, DE005 and DE037 trials. The open-labelextension period of these studies assessed the measures of efficacy, remissionand change over time in the safety profile in patients with long-standing RAtreated for up to seven years with 40mg of HUMIRA every other week plus MTX.

"Rheumatoid arthritis is a chronic, progressive disease with no cure andusually requires long-term management for patients, so it is reassuring thatHUMIRA has demonstrated up to seven years of efficacy in patients with thisdisease," said Michael E. Weinblatt, M.D., Brigham and Women's Hospital,Boston, and lead investigator.

Seven-Year Clinical Data Summary

A total of 1,469 patients with a history of RA who had continued on fromrandomized, controlled HUMIRA trials were treated with HUMIRA and MTX forgreater than or equal to 30 days and up to seven years in open-label extensionstudies. The average length of exposure to treatment was 47 months.

About Rheumatoid Arthritis

Unlike osteoarthritis, the most common form of arthritis, RA is anautoimmune disease where joints are inflamed, which may lead to damage of thejoints' interior and the surrounding bone. The joints most commonly affectedduring the beginning of the disease are the smaller joints of the fingers,feet and wrists. The elbows, knees, ankles and hips can be affected, but lessoften. Although there is no cure for RA, people continue to seek treatmentsthat not only alleviate the pain and inflammation but also slow diseaseprogression, thereby inhibiting the joint damage that can hinder patients fromperforming daily activities. Five million people worldwide are currentlyliving with RA and most of them are between the ages of 25 and 55.

Important Safety Information

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

Serious infections, sepsis, rare cases of tuberculosis (TB), andopportunistic infections, including fatalities, have been reported with theuse of TNF antagonists, including HUMIRA. Many of the serious infections haveoccurred in patients on concomitant immunosuppressive therapy that, inaddition 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 beinitiated in patients with active infections until infections are controlled.HUMIRA should not be used by patients with active TB or other severeinfections such as sepsis and opportunistic infections. Patients who developnew infections while using HUMIRA should be monitored closely. HUMIRA shouldbe discontinued if a patient develops a new serious infection until infectionsare controlled. Physicians should exercise caution when considering use ofHUMIRA in patients with a history of recurring infection or with underlyingconditions 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 beenfatal. Patients at risk for HBV infection should be evaluated for priorevidence of HBV infection before initiating HUMIRA.

The combinations of HUMIRA and anakinra as
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