OBJECTIVES: The efficacy of tocilizumab (TCZ), an anti- @entity10497 antibody, has not previously been evaluated in a population consisting exclusively of @entity1 with early @entity309 ( @entity309 ). METHODS: In a double-blind randomised controlled trial (FUNCTION), 1162 @entity1499 ( @entity6822 )-naive @entity1 with early progressive @entity309 were randomly assigned (1:1:1:1) to one of four treatment groups: 4   mg/kg TCZ+ @entity6822 , 8   mg/kg TCZ+ @entity6822 , 8   mg/kg TCZ+placebo and placebo+ @entity6822 (comparator group). The primary outcome was remission according to Disease Activity Score using 28 joints (DAS28-erythrocyte sedimentation rate (ESR) <2.6) at week 24. Radiographic and physical function outcomes were also evaluated. We report results through week 52. RESULTS: The intent-to-treat population included 1157 @entity1 . Significantly more @entity1 receiving 8   mg/kg TCZ+ @entity6822 and 8   mg/kg TCZ+placebo than receiving placebo+ @entity6822 achieved DAS28-ESR remission at week 24 (45% and 39% vs 15%; p<0.0001). The 8   mg/kg TCZ+ @entity6822 group also achieved significantly greater improvement in radiographic disease progression and physical function at week 52 than did @entity1 treated with placebo+ @entity6822 (mean change from baseline in van der Heijde-modified total Sharp score, 0.08 vs 1.14 (p=0.0001); mean reduction in Health Assessment Disability Index, -0.81 vs -0.64 (p=0.0024)). In addition, the 8   mg/kg TCZ+placebo and 4   mg/kg TCZ+ @entity6822 groups demonstrated clinical efficacy that was at least as effective as @entity6822 for these key secondary endpoints. Serious adverse events were similar among treatment groups. Adverse events resulting in premature withdrawal occurred in 20% of @entity1 in the 8   mg/kg TCZ+ @entity6822 group. CONCLUSIONS: TCZ is effective in combination with @entity6822 and as monotherapy for the treatment of @entity1 with early @entity309 . TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, number NCT01007435.

Tocilizumab in early progressive XXXX : FUNCTION, a randomised controlled trial.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity6822 :: ('D008727', 'Chemical') :: ['MTX'] @entity10497 :: ('3570', 'Gene') :: ['interleukin-6 receptor'] @entity1499 :: ('MESH:D008727', 'Chemical') :: ['methotrexate'] @entity309 :: ('MESH:D001172', 'Disease') :: ['rheumatoid arthritis', 'RA']
@entity309 :: (MESH:D001172,Disease) :: ['rheumatoid arthritis']
