Clinical and radiological outcomes at week 52 per treatment arm in the high-risk group according to an ITT analysis after LOCF imputation
| COBRA Classic | COBRA Slim (high risk) | COBRA Avant Garde | p Value | Δ COBRA Classic vs COBRA Slim (95% CI) | Δ COBRA Avant Garde vs COBRA Slim (95% CI) | |
|---|---|---|---|---|---|---|
| Number of patients | 98 | 98 | 93 | |||
| DAS28(CRP) change | 2.5±1.5 | 2.3±1.4 | 2.3±1.5 | 0.329 | 0.2 (−0.2 to 0.6) | 0.0 (−0.4 to 0.4) |
| Remission | 64.3% | 60.2% | 62.4% | 0.840 | 4.0% (−9.4% to 17.3%) | 1.9% (−11.6% to 15.3%) |
| Low disease activity | 74.5% | 75.5% | 79.6% | 0.684 | −1.0% (−13.0% to 11.0%) | −5.1% (−16.8% to 6.9%) |
| Good EULAR response | 67.3% | 68.4% | 67.7% | 0.995 | −1.0% (−13.9% to 11.9%) | −0.6% (−13.7% to 12.4%) |
| Moderate EULAR response | 84.7% | 88.8% | 88.2% | 0.654 | −4.1% (−13.8% to 5.6%) | −0.6% (−10.6% to 8.7%) |
| HAQ change | 0.7±0.7 | 0.5±0.7 | 0.6±0.7 | 0.368 | 0.2 (−0.0 to 0.4) | 0.0 (−0.1 to 0.2) |
| Clinically meaningful HAQ change | 68.4% | 70.4% | 71.7% | 0.877 | −2.0% (−14.8% to 10.7%) | 1.3% (−11.5% to 14.0) |
| HAQ=0 | 37.8% | 36.7% | 44.1% | 0.533 | 1.0% (−12.3% to 14.3%) | 7.4% (−6.5% to 20.8%) |
| (n) X-ray pairs BL | 82 | 75 | 78 | |||
| Baseline SvdH score | 1.3±2.1 | 1.3±2.5 | 1.0±1.5 | 0.895 | −0.1 (−0.8 to 0.64) | 0.4 (−0.3 to 1.0) |
| (n) X-ray pairs BL and W52 | 74 | 68 | 68 | |||
| Change SvdH BL-W52 | 0.3±0.5 | 0.4±1.1 | 0.3±0.6 | 0.819 | −0.2 (−0.4 to 0.1) | 0.1 (0.2 to 0.4) |
HAQ, health assessment questionnaire; ITT, intention-to-treat.