Two Pivotal Phase III Studies for Roche's ACTEMRA(TM) (tocilizumab) Demonstrate Significant Improvement in Rheumatoid Arthritis Symptoms
2007 NOV 19 -- Data from two pivotal multinational Phase III clinical trials demonstrating that Roche's ACTEMRA(TM) (tocilizumab) significantly improved the signs and symptoms of rheumatoid arthritis (RA) patients who failed to adequately respond to anti-rheumatic therapies -- also known as disease modifying agents (DMARDs) -- will be highlighted at the American College of Rheumatology (ACR) Annual Scientific Meeting in Boston, November 6-11. Late-breaking data results from the TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy) trial and OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial will both be featured in oral presentations. Additionally, study results of the OPTION trial will be featured at an ACR press conference on Saturday, November 10 at 8:30 a.m. "We are very encouraged by the findings of this new TOWARD data which suggest ACTEMRA plus DMARDs demonstrates significant improvement in RA symptoms compared with DMARDs alone," said Mark C. Genovese, M.D., lead study investigator of the TOWARD trial and Associate Professor of Medicine at Stanford University School of Medicine. "The data from both studies further establish the efficacy of ACTEMRA and confirm that inhibiting interleukin-6 (IL-6) receptor is a novel method of reducing RA symptoms." In the TOWARD trial, 61% of patients in the ACTEMRA plus DMARDs arm achieved a 20% reduction in RA symptoms compared with 25% of patients in the placebo arm (p<0.0001) at 24 weeks. Within two weeks there was a measurably higher ACR20 response with ACTEMRA than the control arm. In the OPTION trial, 59% of patients in the ACTEMRA 8 mg/kg plus methotrexate arm experienced a 20% reduction in symptoms versus 27% of patients in the placebo arm (p<0.0001) at 24 weeks. Data from the two studies showed that more than half of patients experienced at least a 20% reduction in RA symptoms (ACR20) in the ACTEMRA plus DMARD therapies groups compared to the placebo plus DMARD therapies groups. ACTEMRA was generally well tolerated in both studies; the most common adverse events reported more frequently in the ACTEMRA arm were upper respiratory tract infections, headache, nasopharyngitis, and hypertension. "It is vital that physicians have a variety of treatment options to offer patients to treat this debilitating and chronic disease," said Josef Smolen, M.D., lead investigator of the OPTION trial and Professor of Medicine at the University Clinic for Internal Medicine in Vienna, Austria. "ACTEMRA may offer a novel approach to help patients who may not be achieving sufficient relief from standard therapies like methotrexate." Keywords: Adverse Drug Reactions, Adverse Drug Effect, Adverse Drug Event, Adverse Drug Reaction, Arthritis, Chronic Disease, Clinical Trial Research, Headache, Immunotherapy, Methotrexate, Monoclonal Antibodies, Neurology, Respiratory Tract Infections, Rheumatoid Arthritis, Rheumatology, Therapy, Treatment, Roche. This article was prepared by Pain & Central Nervous System Week editors from staff and other reports. Copyright 2007, Pain & Central Nervous System Week via NewsRx.com.
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