Background
Methods
Study design
Assessment of effectiveness
Assessment of safety
Statistical analysis
Results
Patients
ADA continuation group (n = 61) | ADA discontinuation group (n = 74) |
p Valueb
| ADA continuation group |
p Valueb
| ADA discontinuation group |
p Valueb
| |||
---|---|---|---|---|---|---|---|---|---|
Intensive therapy (ADA + MTX) (n = 28) | Standard therapy (MTX alone) (n = 33) | Intensive therapy (ADA + MTX) (n = 37) | Standard therapy (MTX alone) (n = 37) | ||||||
Female sex, n (%) | 52 (85.2) | 61 (82.4) | 0.82 | 25 (89.3) | 27 (81.8) | 0.49 | 33 (89.2) | 28 (75.7) | 0.22 |
Age, years | 58.3 ± 13.6 | 54.5 ± 12.4 | 0.06 | 59.5 ± 12.5 | 57.3 ± 14.5 | 0.58 | 53.4 ± 11.2 | 55.5 ± 13.6 | 0.41 |
Disease duration, years | 1.3 ± 0.4 | 1.2 ± 0.3 | 0.35 | 1.3 ± 0.3 | 1.3 ± 0.5 | 0.46 | 1.2 ± 0.3 | 1.3 ± 0.3 | 0.20 |
MTX dose, mg/week | 6.9 ± 1.8 | 7.1 ± 1.9 | 0.51 | 6.5 ± 1.4 | 7.3 ± 2.0 | 0.03c
| 7.0 ± 2.0 | 7.3 ± 1.8 | 0.19 |
Steroid use, n (%) | 17 (27.9) | 17 (23.0) | 0.55 | 7 (25.0) | 10 (30.3) | 0.78 | 5 (13.5) | 12 (32.4) | 0.10 |
TJC28 score | 0.7 ± 1.1 | 1.0 ± 2.0 | 0.93 | 0.4 ± 0.7 | 0.9 ± 1.3 | 0.08 | 1.3 ± 2.4 | 0.8 ± 1.4 | 0.39 |
SJC28 score | 1.0 ± 1.7 | 0.4 ± 0.9 | 0.006d
| 1.1 ± 1.6 | 1.0 ± 1.9 | 0.24 | 0.5 ± 1.0 | 0.3 ± 0.8 | 0.57 |
CRP, mg/dl | 0.2 ± 0.3 | 0.1 ± 0.2 | 0.93 | 0.2 ± 0.2 | 0.2 ± 0.3 | 0.10 | 0.1 ± 0.1 | 0.1 ± 0.2 | 0.33 |
ESR, mm/h | 18.8 ± 14.2 | 18.3 ± 13.0 | 0.88 | 18.0 ± 13.1 | 19.5 ± 15.3 | 0.90 | 19.4 ± 12.5 | 17.2 ± 13.5 | 0.23 |
EGA score (VAS, mm) | 8.2 ± 8.8 | 7.6 ± 7.1 | 0.81 | 8.8 ± 9.5 | 7.7 ± 8.3 | 0.73 | 8.1 ± 7.5 | 7.1 ± 6.7 | 0.73 |
PGA score (VAS, mm) | 9.0 ± 9.0 | 8.5 ± 11.0 | 0.27 | 6.8 ± 7.1 | 10.8 ± 10.1 | 0.08 | 7.7 ± 8.9 | 9.2 ± 12.9 | 0.46 |
Pain score (VAS, mm) | 8.2 ± 7.5 | 8.5 ± 10.5 | 0.56 | 6.8 ± 7.3 | 9.4 ± 7.6 | 0.13 | 7.6 ± 7.6 | 9.4 ± 12.7 | 0.51 |
DAS28-ESR | 2.5 ± 0.8 | 2.4 ± 0.8 | 0.42 | 2.4 ± 0.6 | 2.6 ± 0.8 | 0.28 | 2.5 ± 0.8 | 2.2 ± 0.8 | 0.08 |
DAS28-CRP | 1.8 ± 0.5 | 1.7 ± 0.6 | 0.23 | 1.8 ± 0.5 | 1.9 ± 0.5 | 0.35 | 1.8 ± 0.6 | 1.7 ± 0.6 | 0.52 |
HAQ-DI score | 0.193 ± 0.273 | 0.199 ± 0.303 | 0.68 | 0.125 ± 0.167 | 0.250 ± 0.329 | 0.20 | 0.213 ± 0.296 | 0.186 ± 0.313 | 0.57 |
Erosion score | 6.0 ± 7.7 | 7.1 ± 9.7 | 0.08 | 4.3 ± 4.8 | 7.3 ± 9.3 | 0.12 | 6.7 ± 12.3 | 7.5 ± 6.1 | 0.09 |
JSN score | 3.4 ± 3.6 | 6.7 ± 13.1 | 0.31 | 2.2 ± 1.8 | 4.5 ± 4.4 | 0.04c
| 5.4 ± 15.1 | 8.1 ± 10.8 | 0.01c
|
mTSS | 9.4 ± 10.4 | 13.9 ± 21.9 | 0.09 | 6.5 ± 5.9 | 11.8 ± 12.6 | 0.04c
| 12.1 ± 27.2 | 15.6 ± 15.0 | 0.02c
|
MMP-3 (ng/ml) | 55.2 ± 44.1 | 60.7 ± 48.1 | 0.63 | 52.7 ± 31.9 | 57.4 ± 52.6 | 0.80 | 65.5 ± 49.9 | 56.0 ± 46.5 | 0.21 |
RF (U/ml) | 62.8 ± 90.8 | 42.6 ± 51.8 | 0.85 | 50.6 ± 94.1 | 73.1 ± 88.1 | 0.11 | 41.8 ± 35.3 | 43.4 ± 64.8 | 0.26 |
ACPA (U/ml) | 169.3 ± 257.8 | 216.2 ± 654.8 | 0.41 | 116.0 ± 255.0 | 214.6 ± 255.1 | 0.02c
| 167.6 ± 285.4 | 264.8 ± 885.0 | 0.10 |
Changes in DAS28-CRP and sustainability of LDA
Factors affecting sustainability of LDA
LDA at week 208 (n = 59) | Failed LDA at week 208 (n = 15) |
p Value b
| |||
---|---|---|---|---|---|
Mean | SD | Mean | SD | ||
Female sex, n (%) | 49 | 83.1 | 12 | 80.0 | 1.0000 |
Age, years | 54.1 | 11.5 | 55.8 | 15.9 | 0.4675 |
Disease duration, years | 1.3 | 0.3 | 1.2 | 0.3 | 0.4079 |
MTX dose, mg/week | 7.3 | 2.0 | 6.5 | 1.6 | 0.2432 |
Steroid use, n (%) | 14 | 23.7 | 3 | 20.0 | 1.0000 |
TJC28 | 0.9 | 2.0 | 1.3 | 1.9 | 0.2210 |
SJC28 | 0.4 | 0.9 | 0.4 | 0.9 | 0.9329 |
CRP, mg/dl | 0.1 | 0.2 | 0.2 | 0.1 | 0.0026c
|
ESR, mm/h | 16.4 | 11.2 | 25.9 | 16.7 | 0.0154d
|
EGA | 7.2 | 6.9 | 9.1 | 8.0 | 0.4145 |
PGA | 7.2 | 8.4 | 13.5 | 17.5 | 0.1600 |
Pain VAS | 7.5 | 7.8 | 12.6 | 17.2 | 0.3242 |
DAS28-ESR | 2.3 | 0.7 | 2.8 | 0.9 | 0.0113d
|
DAS28-CRP | 1.7 | 0.6 | 2.0 | 0.7 | 0.0715 |
HAQ | 0.197 | 0.298 | 0.208 | 0.330 | 0.9240 |
Erosion | 6.5 | 5.4 | 9.7 | 18.9 | 0.7467 |
JSN | 6.3 | 9.1 | 8.3 | 23.5 | 0.1199 |
mTSS | 12.8 | 12.8 | 18.0 | 42.2 | 0.2390 |
MMP-3, ng/ml | 59.0 | 47.4 | 67.8 | 51.9 | 0.2475 |
RF | 32.3 | 33.0 | 83.1 | 85.3 | 0.0077c
|
ACPA, U/ml | 113.4 | 237.9 | 620.5 | 1334.9 | 0.0113d
|
Clinical and functional remission
Structural remission
Safety
ADA continuation group (n = 79) | ADA discontinuation group (n = 93) |
p Valueb
| |
---|---|---|---|
Any adverse event | 26 (32.9) | 9 (9.7) | <0.001 |
Serious adverse event | 3 (3.8) | 1 (1.1) | 0.33 |
Infectious adverse event | 9 (11.4) | 4 (4.3) | 0.09 |
Serious infection | 1 (1.3) | 0 (0.0) | NA |
Bronchiolitis | 1 (1.3) | 0 (0.0) | NA |