@entity75 in XXXX @entity1 with inadequate responses to @entity1499 : results from the double-blind treatment phase of a randomized placebo-controlled trial of tocilizumab safety and prevention of @entity75 at one year.

@entity1 @entity75 @entity1500 @entity1499 @entity309
OBJECTIVE: To assess the efficacy and safety of tocilizumab plus @entity1499 ( @entity1500 ) versus @entity1500 alone in preventing @entity75 and improving physical function and disease activity in @entity1 with moderate-to-severe @entity309 and inadequate responses to @entity1500 . METHODS: A total of 1,196 @entity1 were enrolled in a 2-year, randomized, double-blind, placebo-controlled trial. @entity1 received tocilizumab (8 mg/kg or 4 mg/kg) or placebo every 4 weeks plus @entity1500 . Rescue treatment was available from week 16. Results from year 1 are presented. RESULTS: Mean change in the total Genant-modified Sharp score was 0.29 and 0.34 with tocilizumab 8 mg/kg plus @entity1500 and 4 mg/kg plus @entity1500 , respectively, versus 1.13 with placebo plus @entity1500 (P < 0.0001 for both comparisons). Analysis of variance of the area under the curve for change from baseline in the disability index of the Health Assessment Questionnaire showed greater decreases with tocilizumab 8 mg/kg and 4 mg/kg (-144.1 and -128.4 units, respectively) than with placebo (-58.1 units; P < 0.0001 for both comparisons). Proportions of @entity1 with American College of Rheumatology 20%, 50%, and 70% improvement and with Disease Activity Score in 28 joints remission were higher in those receiving 8 mg/kg tocilizumab than in those receiving placebo (P < 0.0001 for all comparisons). The safety profile of tocilizumab was consistent with the profiles in previous studies. Infections were the most common adverse and serious adverse events. CONCLUSION: The findings of this study show that tocilizumab plus @entity1500 results in greater inhibition of joint damage and improvement in physical function than does @entity1500 alone. Tocilizumab has a well-characterized safety profile.
