Clinical and radiological outcomes at week 52 per treatment arm in the low-risk group according to an ITT analysis after LOCF imputation
| MTX-TSU | COBRA Slim (low risk) | p Value | Δ MTX-TSU vs COBRA Slim (95% CI) | |
|---|---|---|---|---|
| Number of patients | 47 | 43 | ||
| DAS28(CRP) change | 2.1±1.7 | 2.1±1.9 | 0.990 | 0.0 (−0.8 to 0.7) |
| Remission | 57.4% | 67.4% | 0.329 | −10.0% (−28.6% to 9.8%) |
| Low disease activity | 76.6% | 81.4% | 0.577 | −5.8% (−21.1% to 12.3%) |
| Good EULAR response | 57.4% | 60.5% | 0.771 | −3.0% (−22.4% to 16.8%) |
| Moderate EULAR response | 78.7% | 76.7% | 0.822 | 1.9% (−14.9 to 19.2%) |
| HAQ change | 0.5±0.6 | 0.6±0.7 | 0.832 | −0.1 (−0.4 to 0.2) |
| Clinically meaningful HAQ change | 59.6% | 55.8% | 0.876 | 1.6% (−18.1% to 21.3%) |
| HAQ=0 | 29.8% | 48.8% | 0.064 | −19.1% (−37.3% to 1.0%) |
| (n) X-ray pairs BL | 34 | 34 | ||
| Baseline SvdH score | 0.7±1.1 | 0.9±1.5 | 0.536 | −0.2 (−0.8 to 0.5) |
| (n) X-ray pairs BL and W52 | 31 | 28 | ||
| Change SvdH BL-W52 | 0.2±0.3 | 0.3±0.5 | 0.257 | −0.1 (−0.3 to 0.1) |
DAS28(CRP), 28 Joint disease activity score calculated with C-reactive protein; DAS28(CRP) change, DAS score on baseline minus DAS score on week 52; remission was defined as DAS28(CRP) <2.6; low disease activity was defined as DAS(CRP) ≤3.2; good EULAR response was defined as low disease activity with a DAS28(CRP) change >1.2; moderate EULAR response was defined as DAS28(CRP) change >1.2 or a DAS28(CRP) ≤5.1 and a DAS28(CRP) change between 0.6 and 1.2; HAQ, health assessment questionnaire; HAQ change, baseline HAQ minus week 52 HAQ; clinically meaningful HAQ change was defined as a HAQ change >0.22. Data are presented as mean±SD or as percentages. Statistical analysis was performed by χ2 or Kruskal-Wallis test. A p value <0.05 was considered to be statistically significant. Δ, difference; CI, CIs (calculated by the Newcombe method for differences between proportions). An ITT analysis was performed in the clinical analysis. SvdH, sharp van der Heijde score; BL, baseline; (n) X-ray pairs BL and W52, number of available X-rays at baseline. Radiographic images were scored via the SvdH score method. Safety analysis; no imputation of missing data was done. Data are presented as mean±SD.
ITT, intention-to-treat; MTX, methotrexate; TSU, tight step-up.