Walsh N et al. - Tocilizumab, a humanized monoclonal antibody that binds to soluble and membrane-expressed IL-6 receptors significantly improved quality of life in moderate to severe rheumatoid arthritis after 24 weeks. Methods
Study to assess the efficacy of Tocilizumab in RA pts
622 pts were enrolled and randomized to background MTX plus iv tocilizumab, 4 mg/kg or 8 mg/kg, or placebo every 4 wks
All had RA for at least 6 mos, ≥6 swollen joint counts and ≥8 tender joint counts, and CRP of 10 mg/dL or higher or ESR of 28 mm/hr or more
Mean age was 51, mean disease duration was 8 yrs; most were female
Mean MTX dose was 15 mg/wk
Results
Starting at week 4, HAQ-DI scores improved among pts treated with both doses of tocilizumab
By week 24, mean changes in HAQ-DI scores were -0.55 points in the 8-mg/kg group, -0.52 in the 4-mg/kg group, and -0.34 in the placebo group
On the physical component of the SF-36 health survey, mean changes at wk 24 were 9.5 and 9.7 points in the 8-mg/kg and 4-mg/kg groups, respectively, and 5 points in the placebo group
The corresponding changes on the mental component of the SF-36 were 7.3, 5.7, and 2.7 points
For fatigue, a clinically meaningful change from baseline on the FACIT-Fatigue scale of 4 points or more was seen by wk 4 in both active treatment groups
By week 24, changes from baseline were 8.60 and 7.29 points in the 8-mg/kg and 4-mg/kg groups, respectively, and 4.01 in the placebo group
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