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| |  Tocilizumab Boosts Outcomes in Patients With Rheumatoid Arthritis Refractory to TNF-Antagonists: Presented at EULAR By Jill Stein PARIS -- June 15, 2008 -- Tocilizumab plus methotrexate is effective in patients with rheumatoid arthritis (RA) with inadequate response to tumour necrosis factor (TNF)-antagonist therapy, researchers announced on June 14 at EULAR 2008, the Annual Congress of the European League Against Rheumatism. The results are from the phase 3 trial, known as Research on Actemra Determining Efficacy After Anti-TNF Failure (RADIATE), which was conducted at 128 sites in 13 countries in North America and western Europe. Tocilizumab is an anti-interleukin (IL)-6 receptor monoclonal antibody. "The trial is the first to document the efficacy of tocilizumab plus methotrexate in patients with an inadequate response to TNF-antagonist treatment," said principal investigator Paul Emery, MD, University of Leeds, Leeds, United Kingdom. For the trial, 499 patients were randomised to treatment with placebo, tocilizumab 8 mg/kg, or tocilizumab 4mg/kg, administered intravenously every 4 weeks, plus methotrexate, for 24 weeks. The patients were 18 years or older with moderate to severe rheumatoid arthritis and had failed to respond to, or were intolerant of, at least one TNF-antagonist within the previous year. The 3 groups were similar with respect to baseline demographic and RA characteristics. The primary endpoint was the percentage of patients achieving American College of Rheumatology 20% symptom improvement criteria (ACR20) response. Overall, 50% of patients in the tocilizumab 8 mg/kg plus methotrexate arm achieved ACR20 versus 10% of patients receiving placebo infusions plus weekly methotrexate, P < .0001. Also, 29% and 4% of the 2 groups, respectively, achieved ACR50 (P < .0001) and 12% and 1% achieved ACR70 (P = .0002). In addition, 30.1% of patients assigned to tocilizumab plus methotrexate achieved a Disease Activity Score (DAS) 28 of less than 2.6, which is indicative of disease remission, versus 1.6% of patients assigned to methotrexate as solo therapy. Patients responded regardless of the most recently failed TNF-antagonist or the number of unsuccessful treatments. Benefit was seen within 2 to 4 weeks of tocilizumab 8-mg/kg treatment and was generally well tolerated with a safety profile consistent with the agent's mechanism of action and immunomodulatory properties of IL-6 inhibition. Rheumatoid arthritis is a chronic, immune-mediated, systemic disease that affects roughly 1% of the population. Funding for the study was provided by Roche. [Presentation Title: Tocilizumab (TCZ) Significantly Improves Disease Outcomes in Patients With Rheumatoid Arthritis Whose Anti-TNF Therapy Failed: The RADIATE Study. Abstract OP-251]
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