Table 3

Clinical and radiological outcomes at week 52 per treatment arm in the low-risk group according to an ITT analysis after LOCF imputation

MTX-TSUCOBRA Slim (low risk)p ValueΔ MTX-TSU vs COBRA Slim (95% CI)
Number of patients4743
DAS28(CRP) change2.1±1.72.1±1.90.9900.0 (−0.8 to 0.7)
Remission57.4%67.4%0.329−10.0% (−28.6% to 9.8%)
Low disease activity76.6%81.4%0.577−5.8% (−21.1% to 12.3%)
Good EULAR response57.4%60.5%0.771−3.0% (−22.4% to 16.8%)
Moderate EULAR response78.7%76.7%0.8221.9% (−14.9 to 19.2%)
HAQ change0.5±0.60.6±0.70.832−0.1 (−0.4 to 0.2)
Clinically meaningful HAQ change59.6%55.8%0.8761.6% (−18.1% to 21.3%)
HAQ=029.8%48.8%0.064−19.1% (−37.3% to 1.0%)
(n) X-ray pairs BL3434
Baseline SvdH score0.7±1.10.9±1.50.536−0.2 (−0.8 to 0.5)
(n) X-ray pairs BL and W523128
Change SvdH BL-W520.2±0.30.3±0.50.257−0.1 (−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.