Table 1.
Characteristics | Baseline (week 0) | Week 12 | Week 24 | P value (week 12 vs. 0) | P value (week 24 vs. 0) |
---|---|---|---|---|---|
Core set measures | |||||
PhGA-VAS, median (range) | 5 (4, 5.5) | 2.5 (2, 4) | 2.25 (1.25, 3.75) | < 0.001 | 0.002 |
PGA-VAS, median (range) | 5 (3.5, 7) | 3 (2, 4) | 2 (1, 3.5) | < 0.001 | 0.002 |
MMT-8 (0–150), median (range) | 129 (120, 141) | 135 (126, 143) | 140 (128, 145) | 0.017 | 0.043 |
HAQ-DI (1–3), median (range) | 2 (0.4, 5) | 2 (0.15, 3.15) | 2 (0.15, 3.15) | 0.007 | 0.277 |
Extramuscular disease, VAS (0–10) | 5 (4, 6) | 3 (2, 4) | 2 (1, 3.5) | 0.001 | 0.008 |
ALT, median (range) | 15 (11, 23.5) | 14 (10, 18) | 13.5 (11, 22.5) | 0.209 | 0.609 |
AST, median (range) | 23 (18, 31) | 18 (14, 23) | 20.5 (17, 26.5) | 0.004 | 0.35 |
LDH, median (range) | 228 (162.5, 256) | 188 (149, 251) | 205 (181, 245) | 0.023 | 0.638 |
CK, median (range) | 125 (51.5, 331) | 67 (49.5, 208) | 102 (10.1, 168) | 0.005 | 0.875 |
CDASI-a (0–100), median (range) | 7 (4.5, 13) | 2 (0, 7) | 1 (0, 3) | < 0.001 | 0.006 |
CDASI-d (0–32), median (range) | 1 (0, 8.5) | 0 (0, 8.5) | 0 (0, 8.5) | 0.180 | 0.972 |
Fatigue-VAS (0–10), median (range) | 2 (1, 4.5) | 2 (0.5, 3.5) | 1 (0.5, 2.5) | 0.015 | 0.167 |
Mechanic’s hands, n (%) | 5 (27.78) | 1 (5.56) | 2 (11.11) | 0.125 | 0.206 |
Heliotrope rash, n (%) | 10 (55.56) | 1 (5.56) | 2 (11.11) | 0.004 | 0.017 |
Gottron’s sign/papules, n (%) | 9 (50) | 3 (16.67) | 3 (16.67) | 0.031 | 0.031 |
V sign, n (%) | 4 (22.22) | 0 (0) | 1 (5.56) | 0.125 | 0.148 |
Shawl sign, n (%) | 1 (5.56) | 0 (0) | 0 (0) | > 0.99 | > 0.99 |
Periungual erythema, n (%) | 5 (27.78) | 1 (5.56) | 1 (5.56) | 0.125 | 0.125 |
Arthritis, n (%) | 4 (22.22) | 2 (11.11) | 4 (22.22) | 0.500 | > 0.99 |
ILD, n (%) | 10(55.56) | 10 (55.56) | 10 (55.56) | > 0.99 | > 0.99 |
Malignancy, n (%) | 0 (0) | 0 (0) | 0 (0) | > 0.99 | > 0.99 |
ESR, median (range) | 14 (6.25, 22.25) | 23 (7.5, 29.5) | 13.5 (7.25, 23) | 0.398 | 0.9 |
CRP, median (range) | 0.74 (0, 2.68) | 1.9 (0, 10.25) | 0.5 (0, 0.95) | 0.715 | 0.225 |
C3, median (range) | 0.89 (0, 1.05) | 1 (0, 1.05) | 0.9 (0, 1.03) | 0.008 | 0.507 |
C4, median (range) | 0.19 (0.17, 0.23) | 0.21 (0.18, 0.29) | 0.2 (0.17, 0.23) | 0.006 | 0.576 |
Prednisone, median (range) | 12.25 (5, 15) | 10 (4.37, 15) | 10 (2.5, 12.5) | 0.016 | 0.013 |
Total HRCT score, median (range) | 82 (25, 397.5) | – | 53 (10, 360) | – | 0.125 |
Data are presented as median (IQR), mean ± SD or n (%)
IIMs idiopathic inflammatory myopathies, PhGA physician’s global assessment of disease, VAS visual analog scale, PGA patient’s global assessment of disease, MMT-8 Manual Muscle Test-8, HAQ-DI the health assessment questionnaire disability index, ALT alanine transaminase, AST aspartate transaminase, LDH lactate dehydrogenase, CK creatinine kinase, CDASI-a Cutaneous Dermatomyositis Disease Area and Severity Index Activity Score, CDASI-d Cutaneous Dermatomyositis Disease Area and Severity Index Damage Score. MDAAT myositis disease activity assessment tool. ILD, interstitial lung disease, ESR erythrocyte sedimentation rate, CRP C-reactive protein, C3 complement 3, C4 complement 4, HRCT high-resolution computed tomography