Baseline characteristics | Full analysis set | Per-protocol set | ||||
---|---|---|---|---|---|---|
Full dose (n = 60) | Dose reduction (n = 60) | Total (n = 120) | Full dose (n = 55) | Dose reduction (n = 58) | Total (n = 113) | |
Gender (male), n (%) | 53 (88.3) | 49 (81.7) | 102 (85.0) | 48 (87.3) | 47 (81.0) | 95 (84.1) |
Age (years), mean (SD) | 46.2 (13.7) | 43.7 (12.4) | 44.9 (13.1) | 47.2 (13.6) | 43.6 (12.4) | 45.6 (13.0) |
BMI, mean (SD) | 25.9 (3.4) | 25.8 (3.8) | 25.9 (3.6) | 25.8 (3.4) | 25.9 (3.8) | 25.9 (3.6) |
Years from diagnosis, median (P25, P75) | 10.4 (7.1, 20.8) | 9.3 (5.2, 17.6) | 10.0 (5.9, 19.8) | 10.4 (7.1, 22.6) | 9.3 (5.0, 19.0) | 10.0 (5.9, 20.3) |
ASAS criteria for sacroilitis, n (%) | 58 (96.7) | 59 (98.3) | 117 (97.5) | 53 (96.4) | 57 (98.3) | 110 (97.3) |
ASDAS-CRP, median (P25, P75) | 0.7 (0.5, 1.1) | 0.7 (0.5, 1.1) | 0.7 (0.5, 1.1) | 1.1 (0.8, 3.5) | 1.0 (0.7, 1.9) | 1.1 (0.7, 2.0) |
BASDAI, median (P25, P75) | 1.0 (0.6, 1.7) | 1.0 (0.2, 1.4) | 1.0 (0.4, 1.6) | 1.0 (0.6, 1.7) | 1.0 (0.2, 1.4) | 1.0 (0.4, 1.6) |
VAS nocturnal axial pain, mean (SD) | 0.85 (1.0) | 1.03 (1.16) | 0.94 (1.09) | 0.84 (1.01) | 1.02 (1.15) | 0.93 (1.08) |
IGA, median (P25, P75) | 1.0 (0.0, 2.0) | 1.0 (0.0, 1.0) | 1.0 (0.0, 1.0) | 1.0 (0.0, 2.0) | 1.0 (0.0, 1.0) | 1.0 (0.0, 1.0) |
PGA, median (P25, P75) | 1.0 (0.0, 2.0) | 1.0 (0.0, 2.0) | 1.0 (0.0, 2.0) | 1.0 (0.0, 2.0) | 1.0 (0.0, 1.0) | 1.0 (0.0, 1.0) |
Current TNFi, n (%) | ||||||
Adalimumab | 24 (40.0) | 23 (38.3) | 47 (39.2) | 22 (40.0) | 22 (37.9) | 44 (38.9) |
Etanercept | 21 (35.0) | 20 (33.3) | 41 (34.2) | 19 (34.5) | 19 (32.8) | 38 (33.6) |
Golimumab | 4 (6.7) | 5 (8.3) | 9 (7.5) | 4 (7.3) | 5 (8.6) | 9 (8.0) |
Infliximab | 11 (18.3) | 12 (20.0) | 23 (19.2) | 10 (18.2) | 12 (20.7) | 22 (19.5) |
N of previous TNFi, n (%) | ||||||
None | 50 (83.3) | 44 (73.3) | 94 (78.3) | 46 (83.6) | 42 (72.41) | 88 (77.9) |
One | 10 (16.7) | 11 (18.3) | 21 (17.5) | 9 (16.4) | 11 (19.0) | 20 (17.7) |
Two | 0 (0.0) | 5 (8.3) | 5 (4.2) | 0 (0.0) | 5 (8.6) | 5 (4.4) |
NSAID use, n (%) | 16 (26.7) | 14 (23.3) | 28 (24.8) | 15 (27.3) | 13 (22.4) | 28 (24.8) |