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Table 2 Baseline characteristics of patients

From: Non-inferiority of dose reduction versus standard dosing of TNF-inhibitors in axial spondyloarthritis

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)
  1. n number, SD standard deviation, P25 percentile 25, P75 percentile 75, BMI body mass index, ASAS Assessment of Spondyloarthritis International Society, ASDAS-CRP Ankylosing Spondylitis Disease Activity Score including C-reactive protein, BASDAI Bath Ankylosing Spondylitis Disease Activity Index; VAS patient’s rating of nocturnal axial pain by visual analogue scale ranging from 0 (none) to 10 (worst), PGA Patient Global Assessment of disease activity rated from 0 (best) to 10 (worst), IGA Investigator’s Global Assessment of disease activity rated from 0 (best) to 10 (worst), TNFi TNF inhibitor, NSAID non-steroidal anti-inflammatory drug
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