New Study Reveals Tocilizumab In Monotherapy Significantly Improves Signs And Symptoms Of Active RA

Results from a 24 week study, investigating the safety and efficacy of tocilizumab (an anti-IL6 receptor monoclonal antibody) monotherapy in patients with active rheumatoid arthritis and an inadequate response to methotrexate, has been announced today at the Annual European Congress of Rheumatology in Amsterdam, Netherlands.



The double blind phase III study used ACR20 (An improvement of 20% in rheumatoid arthritis signs and symptoms according to American College of Rheumatology criteria) at 24 weeks as a primary endpoint with additional endpoints measured according to a variety of scales (ACR50, ACR70, EULAR response, ACR-N AUC). Safety was assessed by adverse events and clinical laboratory results.



Of 127 patients enrolled, 125 patients received at least one dose of the study drugs (61 patients in the tocilizumab group vs. 64 patients in the methotrexate group). Baseline characteristics were similar between groups with a mean age of 50.8 years and mean disease duration of 8.7 years.



At 24 weeks, ACR20 response rate was statistically significantly higher in the tocilizumab group than in the methotrexate group (80.3% vs. 25.0%, p







Table of results:



DAS28 changes and EULAR response* at 24 weeks

? Treatment Baseline DAS28

(Mean) DAS28 changes

at 24 wks (Mean) Good

(%) Good+Moderate

(%) Remission**

(%)

------------

tocilizumab

8 mg/kg 6.073 -3.295 65.5 96.6 43.1

MTX

8 mg/week 6.183 -1.069 3.2 39.7 1.6

p-value Not Significant p