Randomized population (N = 83) | SAR200 + 26W taper (n = 27) | SAR150 + 26W taper (n = 14) | PBO + 52W taper (n = 28) | PBO + 26W taper (n = 14) |
---|---|---|---|---|
Age (years), mean (SD) | 73.4 (8.6) | 67.1 (7.9) | 71.4 (7.7) | 69.5 (5.4) |
Female, n (%) | 23 (85) | 13 (93) | 22 (79) | 9 (64) |
Race, n (%) | ||||
 White | 25 (93) | 11 (79) | 23 (82) | 13 (93) |
 Black or African American | 0 | 1 (7.1) | 0 | 0 |
 Asian | 0 | 0 | 0 | 0 |
 Othera | 2 (7) | 2 (14) | 5 (18) | 1 (7) |
BMI (kg/m2) | ||||
 N | 27 | 14 | 28 | 13 |
 Mean (SD) | 27.2 (5.7) | 27.5 (5.2) | 25.6 (5.0) | 27.8 (4.7)b |
Smoking, n (%) | ||||
 Never | 16 (59) | 12 (86) | 20 (71) | 11 (79) |
 Current | 2 (7) | 1 (7) | 4 (14) | 2 (14) |
 Former | 9 (33) | 1 (7) | 4 (14) | 1 (7) |
GCA, n (%) | ||||
 New onset | 14 (52) | 9 (64) | 17 (61) | 8 (57) |
 Refractory | 13 (48) | 5 (36) | 11 (39) | 6 (43) |
Disease duration (days)c, median (IQR) | 43.0 (36.0; 273.0) | 39.5 (29.0; 219.0) | 41.0 (28.0; 228.5) | 41.5 (34.0; 343.0) |
Presence of unequivocal GCA cranial symptoms, n (%) | 23 (85) | 10 (71) | 22 (79) | 14 (100) |
Presence of unequivocal PMR symptoms, n (%) | 14 (52) | 11 (79) | 16 (57) | 6 (43) |
GCA diagnosis, n (%) | ||||
 N | 26 | 13 | 28 | 14 |
 TAB | 8 (31) | 2 (15) | 5 (18) | 8 (57) |
 Imaging | 18 (69) | 11 (85) | 23 (82) | 6 (43) |
Imaging methodology, n (%)d | ||||
 N | 18 | 11 | 23 | 6 |
 CTA | 1 (6) | 0 | 3 (13.0) | 0 |
 MRA | 1 (6) | 0 | 1 (4) | 1 (17) |
 PET-CT | 3 (17) | 7 (64) | 13 (57) | 4 (67) |
 Ultrasound | 13 (72) | 4 (36) | 6 (26) | 1 (17) |
Prednisone dose at baselinee (mg/day), mean (SD) | 34.5 (17.0) | 35.0 (14.7) | 34.6 (12.9) | 30.5 (15.9) |
Randomization strata, n (%) | ||||
 < 30 mg/day prednisonee | 12 (44) | 6 (43) | 12 (43) | 6 (43) |
  ≥ 30 mg/day prednisonee | 15 (56) | 8 (57) | 16 (57) | 8 (57) |
Baseline CRP (mg/L), median (IQR) | 1.6 (0.8; 3.2) | 5.4 (1.1; 11.2) | 2.2 (1.4; 10.6) | 4.0 (2.8; 6.0) |
Baseline ESR (mm/h), median (IQR) | 10.0 (6.0; 28.0) | 19.5 (7.0; 37.0) | 17.0 (10.0; 50.0) | 20.5 (12.0; 22.0) |