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New Study Demonstrated ACTEMRA(R) (tocilizumab) Inhibited Progression of Joint Damage in Rheumatoid Arthritis Patients
Date:10/25/2008

rienced a reduction in disease signs and symptoms at one year compared with patients treated with placebo plus methotrexate. At 52 weeks, 56 percent, 36 percent and 20 percent of RA patients treated with ACTEMRA 8 mg/kg plus methotrexate achieved ACR20, ACR50 and ACR70(2), respectively, and 47 percent, 29 percent and 16 percent of patients in the ACTEMRA 4 mg/kg arm achieved these ACR scores, respectively. In contrast, 25 percent, 10 percent and 4 percent of patients in the control group achieved ACR20, ACR50 and ACR70, respectively. Disease remission (DAS28 <2.6)(3) was demonstrated in 47 percent and 30 percent of patients treated with ACTEMRA 8 mg/kg and 4 mg/kg, respectively, at week 52 compared with 8 percent of patients treated with placebo plus methotrexate.

"We've seen in previous studies that patients treated with ACTEMRA experienced an improvement in the signs and symptoms of RA and achieved remission according to the DAS28 criteria more often than with DMARDs," said Kenneth Bahrt, M.D., Global Medical Director, Autoimmunity, Roche. "The LITHE study not only confirmed these data, but for the first time demonstrated that ACTEMRA also significantly inhibited the progression of structural joint damage in patients with RA."

At one year, the study also showed that there was improved physical function following treatment with ACTEMRA, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).(4)

About the LITHE Study

LITHE (TociLIzumab Safety and THE Prevention of Structural Joint Damage), a three-arm, randomized, double-blind, placebo-controlled study, was designed to evaluate the efficacy and safety of ACTEMRA (8 mg/kg or 4 mg/kg) plus methotrexate compared with placebo plus methotrexate in RA patients for the prevention of structural joint damage, improvement in physical function and disease signs and symptoms. Patients received either ACTEMRA

intravenously every four weeks plus methotrexate weekly or place
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SOURCE Hoffmann-La Roche Inc.
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