Clinical, functional and structural outcomes of patients including those who failed to achieve stable LDA at week 52
| All | ADA continuation | ADA discontinuation | p Value | |
|---|---|---|---|---|
| (n=188)† | (n=92) | (n=96) | ||
| Week 0 | ||||
| DAS28-CRP | 5.8±0.9 | 5.8±0.9 | 5.8±0.9 | 0.772 |
| HAQ | 1.131±0.704 | 1.181±0.722 | 1.078±0.684 | 0.454 |
| mTSS | 13.7±15.5 | 10.8±15.3 | 16.5±24.8 | 0.096 |
| Week 52 | ||||
| DAS28-CRP | 2.1±0.9 | 2.2±0.9 | 2.1±0.9 | 0.123 |
| DAS28<2.6 n (%) | 136 (72.3%) | 64 (69.6%) | 72 (75.0%) | 0.420 |
| DAS28<3.2 n (%) | 159 (84.6%) | 77 (83.7%) | 82 (85.4%) | 0.841 |
| HAQ‡ | 0.248±0.307 | 0.258±0.296 | 0.239±0.321 | 0.379 |
| HAQ≤0.5 n/N (%) | 137/160 (85.6%) | 73/83 (88.0%) | 64/77 (83.1%) | 0.500 |
| mTSS‡ | 16.0±17.1 | 14.0±17.7 | 17.9±24.9 | 0.301 |
| ΔmTSS≤0.5 n/N (%) | 92/164 (56.1%) | 42/79 (53.2%) | 50/85 (58.8%) | 0.530 |
| Week 104 | ||||
| DAS28-CRP | 2.2±1.1 | 2.0±0.9 | 2.5±1.2 | 0.006** |
| DAS28<2.6 n (%) | 128 (68.1%) | 70 (76.1%) | 58 (60.4) | 0.028* |
| DAS28<3.2 n (%) | 155 (82.4%) | 84 (91.3%) | 71 (74%) | 0.002** |
| HAQ‡ | 0.222±0.339 | 0.193±0.291 | 0.253±0.384 | 0.610 |
| HAQ≤0.5 n/N (%) | 135/160 (84.4%) | 72/83 (86.7%) | 63/77 (81.8%) | 0.514 |
| mTSS‡ | 16.7±18.9 | 14.9±19.6 | 18.3±25.1 | 0.276 |
| ΔmTSS≤0.5 (52–104) n/N (%) | 117/164 (71.3%) | 56/79 (70.9%) | 61/85 (71.8%) | >0.999 |
| ΔmTSS≤0.5 (0–104) n/N (%) | 83/164 (50.6%) | 40/79 (50.6%) | 43/85 (50.6%) | >0.999 |
Data are reported as means±SD, unless otherwise indicated.
*p<0.05, **p<0.01. ADA discontinuation versus ADA continuation.
†Of 220 patients who agreed to participate in the HOPEFUL-2 study, 188 were eligible for the analysis of disease activity using DAS28-CRP.
‡Patients with baseline HOPEFUL-2 data only were excluded from the analysis. Statistical significance was assessed by Fisher's exact test for categorical data and the Wilcoxon rank sum test for continuous data.
CRP, C reactive protein; DAS28, disease activity score 28; HAQ, Health Assessment Questionnaire; mTSS, modified total sharp score.