TABLE 1.
Baseline | Week 12 | Week 24 | |
Age, Median (range) years | 53 (35–73) | ||
% of female | 73% | ||
Disease duration, mean (range) years | 8 (2–28) | ||
RF positive | 59 | ||
ACPA positive | 55 | ||
RF positive/ACPA positive | 55 | ||
RF positive/ACPA negative | 11 | ||
RF negative/ACPA negative | 14 | ||
Concomitant DMARD (patients) | 60 TCZ, 20 ADA | ||
Concomitant Steroid (patients) | 36 TCZ, 11 ADA | ||
Number of Previous DMARD | 3 (Methotrexate, Leflunomide, Azathioprine) | ||
Patients with Rituximab therapy | 0 | ||
Patients completed the TCZ study | 60 | 58 | 53 |
Patients completed the ADA study | 20 | 20 | 19 |
Tocilizumab (n = 60) | n = 60 | n = 58 | n = 53 |
DAS28 score (mean ± SD) | 5.16 ± 1.31 | 3.22 ± 1.31ψ | 2.65 ± 1.22ψ |
CRP, mg/dl (mean ± SEM) | 0.59 ± 0.09 | 0.14 ± 0.05ψ | 0.08 ± 0.03ψ |
ESR, mm/hour (mean ± SEM) | 29.41 ± 3.15 | 9.06 ± 1.30ψ | 7.11 ± 0.84 ψ |
Patient’s VAS. (mean ± SEM) | 58.21 ± 4.16 | 46.97 ± 4.21 ψ | 33.21 ± 4.74 ψ |
Adalimumab (n = 20) | n = 20 | n = 20 | n = 19 |
DAS28 score (mean ± SD) | 4.78 ± 0.9 | 2.43 ± 0.71 ψ | 1.91 ± 0.61 ψ |
CRP, mg/dl (mean ± SEM) | 0.88 ± 0.4 | 0.25 ± 0.05ψ | 0.12 ± 0.04 ψ |
ESR, mm/hour (mean ± SEM) | 26.67 ± 6.1 | 12.86 ± 3.3ψ | 8.57 ± 1.7 ψ |
Patient’s VAS (mean ± SEM) | 57.14 ± 7.3 | 26.43 ± 7.5 ψ | 19.29 ± 2.9 ψ |
The primary endpoint of the study was a reduction in the Disease Activity Score in 28 joints (DAS28) at week 24. Except where indicated, values are the mean ± SEM. RF, rheumatoid factor; ACPA, anti-citrullinated peptide/protein antibody; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; and VAS, visual analog scale (100-mm). ΨP < 0.05 vs baseline.