Table 5.
OPTION | RADIATE | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
TCZ 4 mg/kg + MTX | TCZ 8 mg/kg + MTX | Placebo + MTX | TCZ 4 mg/kg + MTX | TCZ 8 mg/kg + MTX | Placebo + MTX | |||||||
Week 24 | N = 213 | N = 205 | N = 204 | N = 161 | N = 170 | N = 158 | ||||||
Component (mean) | Baseline | Week | Baseline | Week | Baseline | Week | Baseline | Week | Baseline | Week | Baseline | Week |
24* | 24* | 24 | 24* | 24* | 24 | |||||||
Number of tender joints (0–68) | 33 | 19 | 32 | 14.5 | 33 | 25 | 31 | 21 | 32 | 17 | 30 | 30 |
−7.0 (−10.0, −4.1) | −9.6 (−12.6, −6.7) | −10.8 (−14.6, −7.1) | −15.1 (−18.8, −11.4) | |||||||||
Number of swollen joints (0−66) | 20 | 10 | 19.5 | 8 | 21 | 15 | 19.5 | 13 | 19 | 11 | 19 | 18 |
−4.2 (−6.1, −2.3) | −6.2 (−8.1 −4.2) | −6.2 (−9.0, −3.5) | −7.2 (−9.9, −4.5) | |||||||||
Pain† | 61 | 33 | 60 | 30 | 57 | 43 | 63.5 | 43 | 65 | 33 | 64 | 48 |
−11.0 (−17.0, −5.0) | −15.8 (−21.7, −9.9) | −12.4 (−22.1, −2.1) | −23.9 (−33.7, −14.1) | |||||||||
Patient global assessment† | 66 | 34 | 65 | 31 | 64 | 45 | 70 | 46 | 70 | 36 | 71 | 51 |
−10.9 (−17.1, −4.8) | −14.9 (−20.9, −8.9) | −10.0 (−20.3, 0.3) | −17.4 (−27.8, −7.0) | |||||||||
Physician global assessment† | 64 | 26 | 64 | 23 | 64 | 32 | 66.5 | 39 | 66 | 28 | 67.5 | 43 |
−5.6 (−10.5, −0.8) | −9.0 (−13.8, −4.2) | −10.5 (−18.6, −2.5) | −18.2 (−26.3, −10.0) | |||||||||
Disability index (HAQ)‡ | 1.64 | 1.01 | 1.55 | 0.96 | 1.55 | 1.21 | 1.67 | 1.39 | 1.75 | 1.34 | 1.70 | 1.58 |
−0.18 (−0.34, −0.02) | −0.21 (−0.37, −0.05) | −0.25 (−0.42, −0.09) | −0.34 (−0.51, −0.17) | |||||||||
CRP (mg/dl) | 2.79 | 1.17 | 2.61 | 0.25 | 2.36 | 1.89 | 3.11 | 1.77 | 2.80 | 0.28 | 3.705 | 3.06 |
−1.30 (−2.0, −0.59) | −2.156 (−2.86, −1.46) | −1.34 (−2.5, −0.15) | −2.52 (−3.72, −1.32) |
MTX, methotrexate; TCZ, tocilizumab; ACR, American College of Rheumatology; HAQ, Health Assessment Questionnaire; CRP, C-reactive protein.
Data shown is mean at week 24, difference in adjusted mean change from baseline compared with placebo + MTX at week 24 and 95% confidence interval for that difference.
Visual analog scale: 0 = best, 100 =worst.
Health Assessment Questionnaire: 0 = best, 3= worst; 20 questions; 8 categories: dressing and grooming, arising, eating, walking.