Baseline characteristics of patients with GCA who met criteria for treatment response or failure
PBO/PDN* (n=94) | TCZ/PDN* (n=130) | All patients* (n=224) | |
Age, years | 68.4 (7.7) | 68.9 (8.4) | 68.7 (8.1) |
Female, n (%) | 71.0 (75.5) | 98.0 (75.4) | 169.0 (75.4) |
GCA duration, weeks | 43.7 (73.6) | 41.9 (78.9) | 42.7 (76.6) |
Newly diagnosed disease, n (%) | 45.0 (47.9) | 66.0 (50.8) | 111.0 (49.6) |
Cranial symptoms only or cranial and PMR symptoms, n (%) | 75.0 (79.8) | 103.0 (79.2) | 178.0 (79.5) |
PMR symptoms only, n (%) | 19.0 (20.2) | 27.0 (20.8) | 46.0 (20.5) |
Cranial symptoms only, n (%) | 33.0 (35.1) | 51.0 (39.2) | 84.0 (37.5) |
Baseline prednisone dose, mg/day, n (%) | 35.2 (13.7) | 35.7 (13.3) | 35.5 (13.4) |
Baseline prednisone dose ≤30 mg/day, n (%) | 48.0 (51.1) | 64.0 (49.2) | 112.0 (50.0) |
CRP, mg/L | 8.0 (16.9) | 8.2 (17.0) | 8.1 (16.9) |
ESR, mm/hour | 25.6 (21.4) | 23.2 (17.7) | 24.2 (19.4) |
PtGA, 100 mm VAS | 41.4 (28.2) | 43.9 (25.6) | 42.8 (26.7) |
EQ-5D score | 0.7 (0.2) | 0.7 (0.2) | 0.7 (0.2) |
FACIT-Fatigue score | 33.8 (13.4) | 36.5 (11.2) | 35.4 (12.2) |
SF-36 MCS | 41.7 (13.4) | 44.7 (12.8) | 43.4 (13.1) |
SF-36 PCS | 42.5 (10.0) | 42.8 (8.6) | 42.7 (9.2) |
Data are shown as mean (SD) unless specified otherwise.
*Does not include the 26 patients (seven TCZ/PDN, 19 PBO/PDN) who were non-responders for reasons other than treatment failure (see supplementary table 2) for reasons for non-response in this group).
CRP, C reactive protein; EQ-5D, EuroQol 5-D; ESR, erythrocyte sedimentation rate; FACIT, Functional Assessment of Chronic Illness Therapy; GCA, giant cell arteritis; MCS, Mental Component Summary; PBO/PDN, placebo+prednisone; PCS, Physical Component Summary; PMR, polymyalgia rheumatica; PtGA, Patient Global Assessment of Disease Activity; SF-36, 36-Item Short Form Survey; TCZ/PDN, tocilizumab+prednisone; VAS, visual analogue scale.