Background
Methods
Subjects
Biomarker analysis
Statistical analysis
Results
Baseline demographics
Patients (n=55) | |
---|---|
HLA-B27 positive (%) | 53 (96%) |
Gender (male/female) (%) | 45 (82%)/10 (18%) |
Age, years (IQR) | 40 (32–48) |
Disease duration (IQR) | 5.5 (2.0–10.0) |
Baseline NSAID use (%) | 47 (85%) |
Infliximab/etanercept/adalimumab | 37 (67%)/12 (22%)/6 (11%) |
ASDAS | 3.9 (3.0–4.5) |
BASDAI (0–100) | 55.0 (44.0–72.8) |
Swollen joint count (0–28) | 0 (0-8) |
Serum CRP (mg/L) | 27.6 (1.2–162.0) |
Patients with a SpA feature, n (%) | 24 (44%) patients with 1 SpA feature 4 (7%) patients with 2 SpA features 2 (4%) patients with 3 SpA features |
Peripheral arthritis (%) | 12 (22%) |
Psoriasis (%) | 12 (22%) |
History of anterior uveitis (%) | 11 (20%) |
History of inflammatory bowel disease (%) | 3 (5%) |
Changes in PRO-C1, C6M, EL-NE, VICM, and CRP during TNF-α inhibitory therapy
Association of PRO-C1, PRO-C3, C6M, VICM, and CRP with improvement in ASDAS
Biomarker | Baseline to week 22 | Baseline to week 46 | ||||||
---|---|---|---|---|---|---|---|---|
No improvement (n=17) | Clinically important improvement (n=10) | Major improvement (n=23) | P-value | No improvement (n=11) | Clinically important improvement (n=13) | Major improvement (n=17) | P value | |
PRO-C1 Median (IQR) | 0.1 (− 32.8, 7.8) | 7.6 (− 3.5, 16.0) | 29.5 (9.2, 44.7) | 0.006 | 0.1 (− 32.6, 8.8) | 28.4 (5.9, 47.3) | 33.8 (6.5, 52.3) | 0.006 |
PRO-C3 Median (IQR) | − 13.1 (− 32.4, − 3.2) | 3.2 (− 3.9, 9.0) | 12.6 (− 1.4, 32.9) | 0.008 | 6.3 (− 3.9, 25.5) | − 3.9 (− 16.0, 13.2) | 5.7 (− 2.2, 29.0) | 0.573 |
PRO-C4 Median (IQR) | 10.2 (− 12.7, 20.3) | − 14.0 (− 24.3, 10. 6) | − 15.6 (− 37.5, 0.9) | 0.114 | 3.6 (− 22.5, 15.7) | 17.7 (− 15.6, 22.4) | − 24.2 (− 43.0, − 8.4) | 0.048 |
PRO-C6 Median (IQR) | − 6.7 (− 13.9, 0.0) | 0.3 (− 13.2, 10.7) | 7.6 (− 6.4, 23.6) | 0.063 | 0.3 (− 2.5, 17.5) | 7.6 (− 12.3, 17.3) | 6.2 (− 6.9, 21.4) | 0.915 |
C3M Median (IQR) | 7.9 (− 3.1, 18.9) | 20.4 (11.3, 22.2) | 2.9 (− 14.4, 11.8) | 0.152 | 11.1 (0.7, 19.7) | 8.3 (− 3.1, 20.9) | 2.9 (− 14.3, 9.8) | 0.318 |
C4M Median (IQR) | − 7.2 (− 14.8, 8.8) | 5.0 (− 22.3, 16.4) | − 6.8 (− 11.4, 6.9) | 0.899 | − 2.0 (− 9.1, 5.9) | − 11.5 (− 30.8, − 7.7) | − 0.3 (− 9.7, 11.1) | 0.153 |
C6M Median (IQR) | 12.4 (− 34.8, 22.3) | − 20.2 (− 29.8, 19.9) | − 54.3 (− 70.8, − 30.1) | < 0.001 | 12.0 (− 25.4, 37.1) | − 1.9 (− 43.2, 22.3) | − 62.1 (− 73.7, − 30.0) | 0.007 |
C7M Median (IQR) | − 26.9 (− 31.1, 35.3) | − 33.5 (− 64.5, − 17.1) | − 32.2 (− 55.4, 0.0) | 0.192 | − 29.1 (− 43.6, 41.0) | − 26.9 (− 39.0, 0.0) | − 46.6 (− 56.9, − 4.5) | 0.447 |
C10C Median (IQR) | 2.8 (− 9.3, 17.6) | 17.4 (5.3, 23.9) | 2.1 (− 6.1, 15.5) | 0.216 | 19.7 (10.1, 22.7) | 0.5 (− 9.9, 12.4) | 4.0 (− 4.7, 14.5) | 0.165 |
CRPM Median (IQR) | − 2.3 (− 8.6, 5.1) | − 1.3 (− 4.8, 20.5) | 2.5 (− 16.3, 15.1) | 0.541 | 5.1 (− 0.8, 23.0) | − 5.1 (− 9.1, 1.4) | − 1.1 (− 25.4, 10.4) | 0.248 |
EL-NE Median (IQR) | 0.0 (− 17.2, 9.1) | 1.2 (0.0, 24.9) | 0.0 (− 33.1, 0.0) | 0.108 | 0.0 (− 8.6, 1.4) | 0.0 (− 30.0, 29.3) | 0.0 (− 31.7, 0.0) | 0.414 |
VICM Median (IQR) | 29.1 (− 17.3, 107.4) | − 72.1 (− 80.1, − 58.0) | − 43.3 (− 65.3, − 0.7) | < 0.001 | 0.0 (− 35.8, 47.8) | − 34.7 (− 64.9, − 18.8) | − 63.8 (− 69.7, − 37.9) | 0.044 |
CRP Median (IQR) | − 1.7 (− 4.93 to − 0.63) | − 9.2 (− 24.80–5.30) | − 24.9 (− 61.40 to − 12.70) | <0.001 | 12.3 (8.00–27.68) | − 1.50 (9.500–5.58) | − 7.00 (65.25–1.25) | <0.001 |
Association of PRO-C1 and C6M with BASDAI response
Biomarker | Week 22 response | Week 46 response | ||||
---|---|---|---|---|---|---|
Non-responders n=19 | Responders n=36 | p-value | Non-responders n=12 | Responders n=37 | p-value | |
PRO-C1 Median (IQR) | − 3.1 (− 33.2, 13.9) | 14.2 (5.1, 36.1) | 0.020 | 6.2 (− 15.4, 24.1) | 12.8 (1.5, 36.1) | 0.432 |
PRO-C3 Median (IQR) | − 6.0 (− 27.6, 8.4) | 4.0 (− 11.0, 28.6) | 0.186 | − 1.4 (− 17.0, 25.5) | 6.5 (− 11.0, 28.6) | 0.552 |
PRO-C4 Median (IQR) | − 12.7 (− 28.1, 28.9) | − 8.1 (− 25.3, 17.8) | 0.832 | − 11.9 (− 29.2, 10.1) | − 8.4 (− 25.7, 22.4) | 0.710 |
PRO-C6 Median (IQR) | − 2.5 (− 13.8, 8.7) | − 0.4 (− 12.1, 19.1) | 0.349 | − 0.4 (− 16.0, 19.9) | 0.2 (− 12.4, 14.2) | 0.868 |
C3M Median (IQR) | 15.3 (− 7.1, 21.9) | 4.5 (− 9.2, 15.0) | 0.331 | 5.7 (− 8.9, 20.4) | 6.0 (− 9.5, 16.4) | 0.739 |
C4M Median (IQR) | 2.7 (− 14.2, 15.1) | − 6.8 (− 13.7, 5.5) | 0.517 | − 11.3 (− 14.8, 2.4) | − 6.4 (− 12.2, 6.7) | 0.421 |
C6M Median (IQR) | − 3.7 (− 39.0, 32.1) | − 32.0 (− 63.7, 4.5) | 0.049 | − 9.9 (− 56.3, 48.2) | − 30.6 (− 53.9, 17.1) | 0.485 |
C7M Median (IQR) | − 29.1 (− 42.5, 34.8) | − 28.9 (− 54.5, 8.4) | 0.737 | − 22.2 (− 56.1, 39.6) | − 30.0 (− 51.5, 0.0) | 0.642 |
C10C Median (IQR) | 9.2 (− 9.2, 21.0) | 2.4 (− 5.5, 15.0) | 0.873 | 13.4 (− 4.3, 22.4) | 2.1 (− 8.7, 14.5) | 0.403 |
CRPM Median (IQR) | − 1.8 (− 11.0, 6.8) | − 3.6 (− 14.7, 16.3) | 0.854 | 1.5 (− 8.2, 10.7) | − 4.2 (− 13.1, 10.6) | 0.490 |
EL-NE Median (IQR) | 0.0 (0.0, 11.6) | 0.0 (− 31.9, 0.9) | 0.222 | 0.2 (0.0, 23.1) | 0.0 (− 32.6, 8.0) | 0.212 |
VICM Median (IQR) | − 17.3 (− 63.6, 49.1) | − 36.3 (− 66.0, 9.4) | 0.559 | − 16.1 (− 70.3, 27.8) | − 37.9 (− 64.9, 42.3) | 0.926 |
CRP Median (IQR) | − 56.7 (− 82.66–26.78) | − 83.64 (− 94.10–58.75) | 0.086 | 183.3 (− 33.81–458.11) | − 9.5 (60.34–120.71) | 0.456 |
Association of PRO-C1, PRO-C4, C6M, and C7M with SPARCC MRI sacroiliac joint and spine inflammation scores
Biomarker | SPARCC, baseline | SPARCC, week 22 | SPARC, week 46 |
---|---|---|---|
PRO-C1 | |||
ρ | 0.086 | − 0.318 | − 0.285 |
p-value | 0.542 | 0.021 | 0.050 |
PRO-C3 | |||
ρ | − 0.012 | − 0.110 | 0.135 |
p-value | 0.933 | 0.436 | 0.360 |
PRO-C4 | |||
ρ | 0.279 | 0.317 | 0.216 |
p-value | 0.043 | 0.021 | 0.144 |
PRO-C6 | |||
ρ | 0.031 | − 0.187 | − 0.110 |
p-value | 0.825 | 0.184 | 0.457 |
C3M | |||
ρ | − 0.006 | 0.222 | 0.235 |
p-value | 0.966 | 0.113 | 0.108 |
C4M | |||
ρ | − 0.070 | 0.081 | 0.281 |
p-value | 0.623 | 0.568 | 0.056 |
C6M | |||
ρ | 0.496 | 0.297 | 0.034 |
p-value | 0.0002 | 0.031 | 0.818 |
C7M | |||
ρ | 0.130 | 0.379 | 0.319 |
p-value | 0.355 | 0.005 | 0.029 |
C10C | |||
ρ | 0.018 | 0.112 | 0.170 |
p-value | 0.897 | 0.425 | 0.255 |
CRPM | |||
ρ | − 0.169 | 0.152 | 0.170 |
p-value | 0.227 | 0.283 | 0.247 |
EL-NE | |||
ρ | − 0.088 | − 0.011 | 0.228 |
p-value | 0.530 | 0.935 | 0.119 |
VICM | |||
ρ | 0.158 | − 0.153 | − 0.228 |
p-value | 0.258 | 0.273 | 0.123 |
CRP | |||
ρ | − 0.205 | 0.263 | − 0.228 |
p-value | 0.153 | 0.057 | 0.123 |