Characteristics of patients with RA who agreed to or declined ADA discontinuation at the start of HOPEFUL-2
| Measurement Items | All | ADA continuation | ADA discontinuation | ||||||
|---|---|---|---|---|---|---|---|---|---|
| ADA continuation | ADA discontinuation | p Value | Intensive therapy | Standard therapy | p Value | Intensive therapy | Standard therapy | p Value | |
| (n=73) | (n=80) | (n=34) | (n=39) | (n=42) | (n=38) | ||||
| Sex, female, n (%) | 62 (84.9%) | 67 (83.8%) | >0.999 | 31 (91.2%) | 31 (79.5%) | 0.202 | 38 (90.5%) | 29 (76.3%) | 0.129 |
| Age | 57.3±13.9 | 54.6±12.0 | 0.115 | 58.6±12.9 | 56.2±14.7 | 0.475 | 53.6±10.7 | 55.6±13.4 | 0.394 |
| Disease duration (years) | 1.3±0.4 | 1.3±0.3 | 0.523 | 1.3±0.3 | 1.3±0.5 | 0.565 | 1.2±0.3 | 1.3±0.4 | 0.124 |
| MTX dose (mg/w) | 6.9±1.8 | 7.1±1.9 | 0.485 | 6.5±1.4 | 7.3±2.1 | 0.010* | 7.0±2.0 | 7.3±1.8 | 0.282 |
| PSL use, n (%) | 20 (27.4%) | 20 (25.0%) | 0.854 | 7 (20.6%) | 13 (33.3%) | 0.295 | 8 (19.0%) | 12 (31.6%) | 0.210 |
| TJC28 | 0.7±1.1 | 1.0±1.9 | 0.740 | 0.5±0.8 | 0.9±1.3 | 0.151 | 1.2±2.3 | 0.8±1.4 | 0.518 |
| SJC28 | 1.1±1.7 | 0.4±0.9 | 0.004** | 1.0±1.5 | 1.1±1.8 | 0.609 | 0.5±1.0 | 0.3±0.8 | 0.547 |
| EGA (VAS, mm) | 8.0±8.5 | 7.5±7.0 | 0.372 | 7.6±9.0 | 8.2±8.1 | 0.468 | 8.0±7.3 | 7.0±6.7 | 0.746 |
| PGA (VAS, mm) | 9.1±8.9 | 8.2±10.7 | 0.493 | 6.8±7.3 | 11.2±9.6 | 0.021* | 7.5±8.5 | 9.0±12.8 | 0.548 |
| Pain VAS | 8.3±7.4 | 8.3±10.2 | 0.914 | 7.0±7.6 | 9.5±7.2 | 0.061 | 7.5±7.4 | 9.2±12.6 | 0.618 |
| CRP (mg/dL) | 0.2±0.4 | 0.1±0.2 | 0.140 | 0.2±0.2 | 0.3±0.5 | 0.484 | 0.1±0.1 | 0.1±0.2 | 0.431 |
| ESR (mm/h) | 20.9±15.0 | 18.5±13.0 | 0.412 | 20.0±13.9 | 21.6±16.1 | 0.881 | 19.8±12.6 | 17.1±13.4 | 0.156 |
| DAS28–4ESR | 2.5±0.8 | 2.4±0.8 | 0.176 | 2.4±0.7 | 2.6±0.8 | 0.160 | 2.5±0.7 | 2.2±0.8 | 0.078 |
| DAS28–4CRP | 1.9±0.5 | 1.7±0.6 | 0.132 | 1.7±0.5 | 2.0±0.6 | 0.084 | 1.8±0.6 | 1.7±0.6 | 0.560 |
| HAQ | 0.205±0.268 | 0.203±0.293 | 0.546 | 0.129±0.161 | 0.272±0.322 | 0.072 | 0.220±0.281 | 0.184±0.309 | 0.326 |
| EROSION | 5.8±6.0 | 7.9±11.5 | 0.115 | 3.9±4.2 | 7.4±6.9 | 0.006** | 7.1±14.1 | 8.8±7.8 | 0.041* |
| JSN | 4.6±5.3 | 8.6±14.5 | 0.201 | 2.2±2.1 | 6.6±6.4 | 0.001** | 7.5±15.8 | 9.8±13.0 | 0.132 |
| mTSS | 10.3±10.2 | 16.5±24.7 | 0.099 | 6.1±5.7 | 14.0±11.8 | <0.001** | 14.6±29.3 | 18.6±18.4 | 0.039* |
| MMP-3 (mg/mL) | 62.9±61.6 | 59.6±47.3 | 0.994 | 53.2±36.1 | 71.4±76.8 | 0.674 | 63.6±48.6 | 55.2±46.1 | 0.232 |
| RF (U/mL) | 66.8±97.5 | 43.1±53.4 | 0.670 | 45.1±86.3 | 85.7±103.7 | 0.024* | 43.0±42.5 | 43.2±63.9 | 0.347 |
| ACPA (U/mL) | 181.3±269.1 | 226.4±638.6 | 0.338 | 119.3±233.0 | 235.4±289.2 | 0.035* | 197.7±307.9 | 258.1±874.0 | 0.032* |
RF (+): ADA continuation, 41 patients (56.2%); discontinuation, 49 patients (61.3%).
ACPA (+): ADA continuation, 56 patients (76.7%); discontinuation, 66 patients (82.5%).
Data are reported as means±SD, unless otherwise indicated. Statistical significance was assessed by Fisher's exact test for categorical data and the Wilcoxon rank sum test for continuous data.
*p<0.05, **p<0.01, ***p<0.001: Intensive therapy versus Standard therapy.
ACPA, anticyclic citrullinated peptide antibody; CRP, C reactive protein; DAS28, disease activity score 28; EGA, evaluator global assessment; ESR, erythrocyte sedimentation rate; HAQ, Health Assessment Questionnaire; JSN, joint space narrowing; MMP-3, matrix metalloproteinase-3; mTSS, modified total sharp score; MTX, methotrexate; PGA, patient global assessment; PSL, prednisolone; RF, rheumatoid factor; SJC, swollen joint count; TJC, tender joint count; VAS, visual analogue scale.