Table 1: Baseline data (Safety Analysis population; n = 77).
Baseline data | Group A TCZ plus MTX | Group B TCZ plus placebo | Total |
n = 32 | n = 33 | n = 77a | |
Age | 57.8 ± 11.9 | 57.2 ± 10.8 | 57.3 ± 10.9 |
Female | 26 (81.3%) | 25 (75.8%) | 61 (79.2%)b |
Body weight (kg; mean, min, max) | 75.1 (52.0-120.0) | 74.3 (52.0-112.2) | 74.6 (52.0-120.0) |
ESR (1st hour) ) | 16.58 (± 12.25) | 19.36 (± 10.26) | 19.26 (± 12.15) |
CRP (mg/dl) | 1.25 (± 3.35) | 1.15 (± 2.49) | 1.42 (± 2.29) |
RF pos. (%) | 19 (63.3%) | 22 (73.3%) | 49 (68.1%)c |
ACPA pos (%) | 18 (60%) | 20 (64.5%) | 44 (69.3%) |
DAS28 | 3.83 ± 0.51 | 3.94 ± 0.54 | 3.91 ± 0.54 |
VAS-Fatigue (mm) | 35.59 ± 25.47 | 41.27 ± 28.17 | 39.26 ± 26.36 |
Patient's Assessment of Pain (VAS; mm) | 39.41 ± 24.99 | 36.52 ± 24.40 | 39.47 ± 24.10 |
Patient's Global Assessment of Disease Activity (VAS; mm) | 38.63 ± 19.79 | 38.24 ± 21.07 | 39.69 ± 19.98 |
Investigator's Global Assessment of Disease Activity (VAS; mm) | 26.53 ± 12.35 | 25.09 ± 12.83 | 24.99 ± 12.20 |
CDAI | 13.55 ± 4.52 | 12.70 ± 4.24 | 13.00 ± 4.38 |
SDAI | 14.26 ± 4.35 | 13.26 ± 4.40 | 13.66 ± 4.31 |
HAQ-DI | 0.81 ± 0.72 | 0.81 ± 0.55 | 0.85 ± 0.63 |
RADAI-5 | 4.17 ± 2.17 | 4.28 ± 1.86 | 4.29 ± 2.01 |
SF-12 Physical Standardised Value | 41.13 ± 8.77 | 39.91 ± 7.14 | 40.09 ± 7.95 |
SF-12 Mental Standardised Value | 47.22 ± 10.93 | 43.93 ± 11.38 | 45.18 ± 11.01 |
TSQM Effectiveness | 55.11 ± 21.09 | 46.06 ± 23.58 | 49.66 ± 23.38 |
TSQM Side-Effects | 98.61 ± 7.22 | 80.65 ± 29.99 | 88.25 ± 24.15 |
TSQM Convenience | 86.01 ± 17.99 | 73.12 ± 23.66 | 76.45 ± 22.18 |
TSQM Global Satisfaction | 64.81 ± 23.68 | 62.44 ± 28.33 | 62.58 ± 24.93 |
Except otherwise specified values are expressed as means ± SD; CDAI: Clinical Disease Activity Index; DAS28: Disease Activity Score 28; HAQ-DI: Health Assessment Questionnaire Disability Index; RF: Rheumatoid Factor; RADAI-5: Rheumatoid Arthritis Disease Activity Index 5; SDAI: Simplified Disease Activity Index; SF-12: 12-Item Short Form Health Survey; TSQM: Treatment Satisfaction Questionnaire for Medication; VAS: Visual Analogue Scale.
aNot randomised: n = 12, bNot randomised female: n = 10, cNot randomised RF pos: n = 7.