International ACTEMRA Rheumatoid Arthritis Study Highlighted in The Lancet

Friday, March 21, 2008 General News
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NUTLEY, N.J., March 20 Patients with rheumatoid arthritistreated with Roche's ACTEMRA(TM) (tocilizumab) experienced significant andrapid reduction in the signs and symptoms of their disease, according to astudy published in this week's issue of The Lancet. Results from the OPTION(TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial -- aPhase III international study -- demonstrated that RA patients achievedgreater improvement of symptoms and a higher quality-of-life with ACTEMRA, aninterleukin-6 (IL-6) receptor inhibitor, in combination with methotrexate,compared with methotrexate plus placebo.

"Results of this pivotal study convincingly demonstrate that tocilizumabcan effectively and rapidly diminish the painful and debilitating effects ofrheumatoid arthritis," said Josef Smolen, M.D., lead investigator of theOPTION trial and Professor of Medicine at the Department of Internal Medicineat the Medical University of Vienna, Austria. "These trial findings aresignificant because we know that many rheumatoid arthritis patients continueto experience symptoms of joint pain, stiffness, physical disability andfatigue, despite treatment with existing therapies."

About OPTION Study

In the OPTION trial, a three-arm, double-blind, controlled Phase IIIstudy, 623 patients were randomized to receive ACTEMRA intravenously (either4mg/kg or 8mg/kg) every four weeks plus methotrexate weekly or placeboinfusions plus methotrexate weekly. The study was conducted in 73 trial sitesin 17 countries outside the United States.

At 24 weeks, 58.5% of ACTEMRA patients (8mg/kg) achieved a 20% reductionin RA symptoms (ACR20)(1), compared with 26.5% of patients in placebo plusmethotrexate patients. In the study, 43.9% of patients treated with ACTEMRA(8mg/kg) plus methotrexate achieved at least a 50% (ACR50) reduction insymptoms compared to 10.8% of patients receiving placebo and methotrexate;ACR70 was achieved in 22% of the treatment group versus 2% in the controlgroup. A rapid decrease in disease activity (DAS28)(2) was seen as early astwo weeks in a greater proportion of patients treated with ACTEMRA plusmethotrexate, with 27.5% achieving DAS28 less than or equal to 2.6 by 24weeks.

Additionally, results showed that 80% of patients in the ACTEMRA (8mg/kg)plus methotrexate group responded with moderate to good improvements in RAsymptoms, according to the EULAR response criteria(3), compared with 35% forthose treated with placebo and methotrexate at 24 weeks. ACTEMRA was generallywell tolerated; the most common adverse events reported more frequently in theACTEMRA arms of the OPTION trial were upper respiratory tract infection,nasopharyngitis and headache.

The OPTION trial also assessed physical function and quality-of-life atbaseline and every four weeks thereafter. Patients receiving ACTEMRA achievedsignificantly greater improvement in areas of fatigue and mental function at24 weeks, and achieved normal levels of hemoglobin and C-reactive protein(CRP), a marker of inflammation due to RA, compared with patients receivingplacebo plus methotrexate.

"We are very encouraged by the findings of the study as they furtherestablish the role of ACTEMRA and its unique blockade of IL-6 receptors as apotential new biologic treatment option for patients with RA," said LarsBirgerson, M.D., Ph.D, Vice President, Global Head Medical Affairs, Roche.

About ACTEMRA(TM) (tocilizumab)

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibitingmonoclonal antibody. Studies suggest that reducing the activity of IL-6, oneof several key cytokines involved in the inflammatory process, may reduceinflammation of the joints and relieve certain systemic effects of RA. Theextensive clinical development program conducted by Roche includes fiveclinical studies and has enrolled more than 4,000 patients in 40 countries,including the

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