Univariate analysis of treatment failure (intention-to-treat population with treatment outcome defined)
Characteristic | Treatment response (n=113) | Treatment failure (n=111) | P value |
Patient-related features | |||
Age, years, mean (SD) | 68.4 (8.3) | 68.9 (7.9) | 0.64 |
Female sex, n (%) | 74 (65.5) | 95 (85.6) | 0.00051 |
White, n (%) | 110 (97.3) | 109 (98.2) | 0.51 |
BMI, mean (SD) | 26.1 (4.3) | 25.7 (4.5) | 0.52 |
Disease-related features | |||
At the time of GCA diagnosis, n (%) | |||
Headaches | 83 (73.5) | 70 (63.1) | 0.095 |
Scalp tenderness | 40 (35.4) | 38 (34.2) | 0.85 |
Jaw claudication | 30 (26.5) | 44 (39.6) | 0.037 |
GCA-related vision loss | 8 (7.1) | 10 (9.0) | 0.60 |
PMR symptoms | 62 (54.9) | 78 (70.3) | 0.017 |
Positive temporal artery biopsy | 66/76 (86.8) | 71/76 (93.4) | 0.17 |
Imaging demonstrating LVV | 56/62 (90.3) | 50/61 (82.0) | 0.18 |
At study baseline | |||
New-onset disease, n (%) | 61 (54) | 50 (45) | 0.18 |
GCA duration, weeks, mean (SD) | 37.9 (75.1) | 47.5 (78.1) | 0.35 |
ESR, mm/hour, mean (SD) | 22.5 (17.9) | 26.0 (20.7) | 0.18 |
CRP, mg/dL, mean (SD) | 6.6 (11.2) | 9.7 (21.2) | 0.17 |
Treatment-related features | |||
Baseline prednisone dose, mg/day, mean (SD) | 36.0 (13.4) | 34.9 (13.5) | 0.56 |
Patient-reported outcomes | |||
PtGA, mm, mean (SD) | 38.4 (26.8) | 47.4 (25.9) | 0.012 |
FACIT-Fatigue scale, mean (SD) | 39.0 (10.6) | 31.7 (12.7) | <0.0001 |
SF-36 PCS, mean (SD) | 44.9 (8.5) | 40.4 (9.3) | 0.00021 |
SF-36 MCS, mean (SD) | 46.0 (11.8) | 40.7 (13.9) | 0.0023 |
EQ-5D score, mean (SD) | 0.8 (0.2) | 0.7 (0.2) | 0.0064 |
BMI, body mass index; CRP, C reactive protein; EQ-5D, EuroQol-5D; ESR, erythrocyte sedimentation rate; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue scale; GCA, giant cell arteritis; LVV, large vessel vasculitis; MCS, Mental Component Summary; PCS, Physical Component Summary; PMR, polymyalgia rheumatica; PtGA, Patient Global Assessment of Disease Activity; SF-36, 36-Item Short Form Survey.