134–136 The fact that the 5 mg dose approved in the USA and Japan just misses statistical significance for inhibition of joint damage progression compared with placebo at 12 months (p=0.06) 137 did not preclude the Task Force from recognising its structural efficacy, given significant radiological differences at this dose in another trial. 138 However, little is currently known about its long-term safety.
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EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update.
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The other arms, tocilizumab monotherapy (8 mg/kg) and tocilizumab (4 mg/kg) in combination with MTX, showed superiority mainly in reaching the primary clinical end point (DAS28–erythrocyte sedimentation rate <2.6, a measure confounded by placing a high weight on acute phase reactant levels 121 ), with only numeric differences in most of the clinical and functional secondary end points, most of which did not reach statistical significance.