Background
Methods
Study population
Inclusion criteria for the present study
Outcomes
Statistical analysis
Results
Patient disposition and baseline characteristics
Parameter | Number of patients | PLR (n = 146) | SLR (n = 270) | AE (n = 125) | Other (n = 91) |
p Value |
---|---|---|---|---|---|---|
Male sex, % | 632 | 47.3 | 56.3 | 46.4 | 52.8 | 0.20 |
Age, years | 632 | 43.8 ± 10.5 | 44.4 ± 11.1 | 44.1 ± 12.3 | 45.0 ± 13.1 | 0.87 |
Radiographic axSpA, % | 454 | 54.4 | 69.2 | 65.8 | 82.1 | 0.003 |
HLA-B27–positive, % | 510 | 43.2 | 67.1 | 64.3 | 71.0 | <0.001 |
Elevated CRP, % | 361 | 30.4 | 34.2 | 42.7 | 29.2 | 0.33 |
ASDAS-CRP | 316 | 3.4 ± 0.8 | 3.1 ± 0.9 | 3.0 ± 1.1 | 2.7 ± 1.0 | <0.001 |
ASDAS-ESR | 289 | 3.1 ± 0.8 | 2.8 ± 0.8 | 2.8 ± 1.2 | 2.6 ± 1.2 | 0.03 |
BASDAI | 348 | 6.0 ± 1.8 | 5.2 ± 2.0 | 4.9 ± 2.3 | 4.5 ± 2.3 | <0.001 |
BASFI | 345 | 4.6 ± 2.5 | 4.1 ± 2.5 | 3.7 ± 2.5 | 2.8 ± 2.3 | 0.001 |
BASMI | 288 | 2.1 ± 1.9 | 2.3 ± 2.0 | 2.4 ± 2.1 | 2.7 ± 1.9 | 0.36 |
Peripheral arthritis, % | 629 | 41.4 | 37.0 | 31.7 | 30.8 | 0.26 |
Enthesitis heel, % | 632 | 42.5 | 31.9 | 26.4 | 24.2 | 0.01 |
Smokers, % | 602 | 67.6 | 57.2 | 69.0 | 50.0 | 0.01 |
DMARDs, % | 632 | 21.2 | 24.1 | 12.0 | 24.2 | 0.03 |
NSAIDs, % | 632 | 62.3 | 54.4 | 48.0 | 39.6 | 0.003 |
BMI, kg/m2
| 608 | 26.3 ± 4.9 | 25.6 ± 4.9 | 25.9 ± 4.7 | 25.7 ± 4.7 | 0.58 |
Years of education | 596 | 13.0 ± 3.0 | 13.5 ± 3.0 | 13.3 ± 2.9 | 14.1 ± 3.2 | 0.07 |
Parameter | Number of patients | PLR (n = 110) | SLR (n = 220) | AE (n = 88) | Other (n = 70) |
p Value |
---|---|---|---|---|---|---|
Male sex, % | 488 | 47.3 | 60.9 | 53.4 | 55.7 | 0.12 |
Age, years | 488 | 42.8 ± 10.2 | 43.2 ± 10.9 | 42.3 ± 11.8 | 44.2 ± 13.4 | 0.77 |
Radiographic axSpA, % | 388 | 66.7 | 77.4 | 82.5 | 87.9 | 0.02 |
HLA-B27–positive, % | 442 | 51.6 | 73.7 | 75.0 | 78.3 | <0.001 |
Elevated CRP, % | 285 | 34.8 | 37.0 | 52.0 | 30.8 | 0.15 |
ASDAS-CRP | 256 | 3.4 ± 0.9 | 3.1 ± 0.9 | 3.0 ± 1.2 | 2.7 ± 1.1 | 0.003 |
ASDAS-ESR | 233 | 3.2 ± 0.8 | 2.8 ± 0.8 | 2.8 ± 1.2 | 2.7 ± 1.2 | 0.08 |
BASDAI | 275 | 6.1 ± 1.9 | 5.1 ± 2.0 | 4.7 ± 2.4 | 4.6 ± 2.3 | <0.001 |
BASFI | 274 | 4.7 ± 2.5 | 4.1 ± 2.5 | 3.5 ± 2.4 | 3.0 ± 2.2 | 0.002 |
BASMI | 228 | 2.1 ± 1.7 | 2.3 ± 2.0 | 2.7 ± 2.3 | 2.9 ± 2.0 | 0.27 |
Peripheral arthritis, % | 487 | 36.7 | 35.5 | 26.1 | 21.4 | 0.06 |
Enthesitis heel, % | 488 | 40.0 | 33.2 | 26.1 | 22.9 | 0.06 |
Smokers, % | 471 | 73.4 | 58.4 | 72.3 | 55.7 | 0.01 |
DMARDs, % | 488 | 20.0 | 22.7 | 9.1 | 17.1 | 0.03 |
NSAIDs, % | 488 | 62.7 | 54.5 | 50.0 | 35.7 | 0.01 |
BMI, kg/m2
| 478 | 26.1 ± 4.6 | 25.7 ± 4.8 | 26.0 ± 4.7 | 26.2 ± 4.8 | 0.88 |
Years of education | 463 | 13.0 ± 3.2 | 13.5 ± 3.0 | 13.0 ± 2.9 | 13.9 ± 3.2 | 0.23 |
Drug retention
Patients with a clinical diagnosis of axSpAa
| Patients fulfilling the ASAS axSpA classification criteriab
| |||||
---|---|---|---|---|---|---|
HR | 95 % CI |
p Value | HR | 95 % CI |
p Value | |
SLR vs. PLR | 0.56 | 0.42–0.75 | <0.001 | 0.58 | 0.42–0.81 | 0.002 |
Female vs. male | 0.94 | 0.71–1.24 | 0.65 | 0.90 | 0.64–1.25 | 0.53 |
Age | 1.00 | 0.99–1.02 | 0.73 | 1.00 | 0.99–1.02 | 0.93 |
Cept → mAbc
| 1.11 | 0.79–1.55 | 0.56 | 1.17 | 0.78–1.73 | 0.45 |
mAb → Ceptc
| 1.11 | 0.80–1.56 | 0.54 | 1.24 | 0.84–1.82 | 0.28 |
2007–2010 vs. before 2006 | 1.26 | 0.50–3.12 | 0.63 | 1.18 | 0.47–2.96 | 0.73 |
2010–2015 vs. before 2006 | 1.58 | 0.63–3.99 | 0.33 | 1.44 | 0.57–3.67 | 0.44 |
Clinical response
Response criterion | Analysis | Number of patients | All | PLR | SLR | AE | Other |
p Valuea
|
p Valueb
|
---|---|---|---|---|---|---|---|---|---|
Patients with a clinical diagnosis of axSpA | |||||||||
ASDAS-ESR <2.1 | Response/tolerance | 184 | 28.8 | 11.1 | 38.9 | 26.2 | 38.9 | 0.01 | 0.002 |
ASDAS-ESR <2.1 | Per protocol | 124 | 42.7 | 21.7 | 50.8 | 35.5 | 63.6 | 0.04 | 0.02 |
ASDAS-ESR <1.3 | Response/tolerance | 184 | 14.7 | 4.4 | 21.5 | 9.5 | 22.2 | 0.03 | 0.01 |
ASDAS-ESR <1.3 | Per protocol | 124 | 21.8 | 8.7 | 28.8 | 12.9 | 36.4 | 0.07 | 0.08 |
ASAS-PR | Response/tolerance | 227 | 11.0 | 2.0 | 12.5 | 13.7 | 16.7 | 0.08 | 0.04 |
ASAS-PR | Per protocol | 146 | 17.1 | 4.2 | 17.4 | 18.4 | 33.3 | 0.12 | 0.17 |
Patients fulfilling the ASAS axSpA classification | |||||||||
ASDAS-ESR <2.1 | Response/tolerance | 148 | 31.1 | 9.1 | 40.9 | 29.0 | 38.9 | 0.01 | 0.001 |
ASDAS-ESR <2.1 | Per protocol | 100 | 46.0 | 18.8 | 55.1 | 37.5 | 63.6 | 0.04 | 0.02 |
ASDAS-ESR <1.3 | Response/tolerance | 148 | 16.2 | 3.0 | 22.7 | 12.9 | 22.2 | 0.045 | 0.02 |
ASDAS-ESR <1.3 | Per protocol | 100 | 24.4 | 6.2 | 30.6 | 16.7 | 36.4 | 0.13 | 0.09 |
ASAS-PR | Response/tolerance | 179 | 11.7 | 0.0 | 12.5 | 16.7 | 18.5 | 0.03 | 0.03 |
ASAS-PR | Per protocol | 106 | 18.1 | 0.0 | 17.5 | 21.4 | 35.7 | 0.05 | 0.10 |