Univariate analysis of treatment failure according to treatment (intention-to-treat population with treatment outcome defined)
| TCZ/PDN response (n=86) | TCZ/PDN failure (n=44) | P value | PBO/PDN response (n=27) | PBO/PDN failure (n=67) | P value | |
| Patient-related features | ||||||
| Age, years, mean (SD) | 68.7 (8.2) | 69.2 (8.8) | 0.79 | 67.4 (8.4) | 68.8 (7.4) | 0.43 |
| Female sex, n (%) | 61 (70.9) | 37 (84.1) | 0.99 | 13 (48.1) | 58 (86.6) | <0.0001 |
| White, n (%) | 84 (97.7) | 43 (97.7) | 0.29 | 26 (96.3) | 66 (98.5) | 0.50 |
| BMI, mean (SD) | 26.1 (4.4) | 25.7 (4.9) | 0.66 | 26.0 (4.1) | 25.7 (4.3) | 0.72 |
| Disease-related features | ||||||
| At the time of GCA diagnosis, n (%) | ||||||
| Headaches | 65 (75.6) | 28 (63.6) | 0.15 | 18 (66.7) | 42 (62.7) | 0.72 |
| Scalp tenderness | 30 (34.9) | 18 (40.9) | 0.50 | 10 (37.0) | 20 (29.9) | 0.50 |
| Jaw claudication | 24 (27.9) | 18 (40.9) | 0.13 | 6 (22.2) | 26 (38.8) | 0.12 |
| GCA-related vision loss | 5 (5.8) | 4 (9.1) | 0.49 | 3 (11.1) | 6 (9.0) | 0.75 |
| PMR symptoms | 48 (55.8) | 31 (70.5) | 0.11 | 14 (51.9) | 47 (70.1) | 0.093 |
| Positive temporal artery biopsy | 50/59 (84.7) | 27/27 (100.0) | 0.032 | 16/17 (94.1) | 44/49 (89.8) | 0.59 |
| Imaging demonstrating LVV | 44/49 (89.8) | 21/25 (84.0) | 0.47 | 12/13 (92.3) | 29/36 (80.6) | 0.33 |
| At study baseline | ||||||
| New-onset disease, n (%) | 45 (52.3) | 21 (47.7) | 0.62 | 16 (59.3) | 29 (43.3) | 0.16 |
| GCA duration, weeks, mean (SD) | 42.4 (80.8) | 40.9 (76.0) | 0.92 | 23.6 (51.2) | 51.8 (79.8) | 0.093 |
| ESR, mm/hour, mean (SD) | 23.6 (18.3) | 22.6 (16.7) | 0.77 | 19.1 (16.3) | 28.2 (22.7) | 0.063 |
| CRP, mg/dL, mean (SD) | 6.9 (12.1) | 10.9 (23.7) | 0.21 | 5.7 (7.4) | 9.0 (19.5) | 0.40 |
| Treatment-related features | ||||||
| Baseline prednisone dose, mg/day, mean (SD) | 36.3 (12.9) | 34.3 (14.2) | 0.42 | 34.8 (15.2) | 35.3 (13.1) | 0.88 |
| Patient-reported outcomes | ||||||
| PtGA: mm, mean (SD) | 38.6 (26.4) | 54.3 (20.5) | 0.0008 | 38.0 (28.8) | 42.8 (28.1) | 0.46 |
| FACIT-Fatigue scale, mean (SD) | 38.8 (10.8) | 32.0 (10.7) | 0.0008 | 39.4 (10.2) | 31.6 (13.9) | 0.011 |
| SF-36 PCS, mean (SD) | 44.2 (8.4) | 39.9 (8.3) | 0.0076 | 47.2 (8.7) | 40.7 (9.9) | 0.0044 |
| SF-36 MCS, mean (SD) | 46.0 (11.7) | 42.1 (14.6) | 0.11 | 46.4 (12.4) | 39.8 (13.4) | 0.033 |
| EQ-5D score, mean (SD) | 0.8 (0.2) | 0.7 (0.2) | 0.027 | 0.8 (0.2) | 0.7 (0.2) | 0.14 |
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; LVV, large vessel vasculitis; 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.