Maxime Verhoeven

126 Chapter 6 Supplementary Table S5 shows the outcome of the sensitivity analysis using all patients who were included in U-Act-Early (n=317, based on imputed data). The TCZ strategy groups showed an improved mean difference in DAS28 compared with the MTX strategy group during the first year (TCZ+MTX vs MTX; -0.87 [95%CI-1.15;-0.59], TCZ vs. MTX; -0.85 [95%CI-1.13;-0.57]) and during the second year (TCZ+MTX vs MTX; -0.53 [95%CI-0.91;- 0.14], TCZ vs. MTX; -0.55 [95%CI-0.91;-0.20]). No statistical significant differences were shown during the post-trial follow-up period between the initial strategy groups. The second sensitivity analysis shows outcomes of the components of the DAS28 using data of all patients included in the follow-up study (n=226). An improvement in VAS was found between TCZ+MTX vs. MTX (mean difference -0.47 [95%CI -0.90;-0.04]) during the first year. The TCZ strategy groups showed an improved mean difference in square root transformed values for SJC28 during the first year (TCZ+MTX vs MTX; -0.31 [95%CI-0.43;-0.18], TCZ vs. MTX; -0.16 [95%CI-0.29;-0.03]) and during the second year (TCZ+MTX vs MTX; -0.26 [95%CI -0.37;-0.14], TCZ vs. MTX; -0.13 [95%CI -0.25;-0.01]). Besides, an improved mean difference in square root transformed values for TJC28 were shown for the TCZ strategy groups during the first year (TCZ+MTX vs MTX; -0.24 [95%CI -0.51;-0.08], TCZ vs. MTX; -0.17 [95%CI -0.33;-0.01]) and during the second year (TCZ+MTX vs MTX; -0.21 [95%CI -0.37;-0.05]). Supplementary Table S5 Sensitivity analyses based on imputed data (n=317) for DAS28 over time and based on observed data (n=226) for components of DAS28. Period Strategy comparisons Mean differences 95%CI of mean differences P-value Change in DAS28 between initial treatment strategy groups over 5 years and at the end of every year (n=317) 1 TCZ+MTX vs. MTX TCZ vs. MTX - 0.87 - 0.85 - 1.15 to - 0.59 - 1.13 to - 0.57 <0.01 <0.01 2 TCZ+MTX vs. MTX TCZ vs. MTX - 0.53 - 0.55 - 0.91 to - 0.14 - 0.91 to - 0.20 0.01 <0.01 3 TCZ+MTX vs. MTX TCZ vs. MTX - 0,37 - 0.41 - 0.83 to 0.08 - 0.83 to 0.00 0.12 0.06 4 TCZ+MTX vs. MTX TCZ vs. MTX - 0,32 - 0.37 - 0.80 to 0.16 - 0.80 to 0.06 0.20 0.11 5 TCZ+MTX vs. MTX TCZ vs. MTX - 0,37 - 0.41 - 0.77 to 0.24 - 0.78 to 0.13 0.31 0.17 Change in VAS between initial treatment strategy groups at the end of every year (n=226) 1 TCZ+MTX vs. MTX TCZ vs. MTX TCZ+MTX vs. TCZ -0.47 -0.21 -0.26 -0.90 to -0.04 -0.63 to 0.22 -0.68 to 0.16 0.03 0.34 0.22 2 TCZ+MTX vs. MTX TCZ vs. MTX TCZ+MTX vs. TCZ -0.38 -0.14 -0.24 -0.80 to 0.04 -0.55 to 0.28 -0.65 to 0.17 0.08 0.28 0.26 3 TCZ+MTX vs. MTX TCZ vs. MTX TCZ+MTX vs. TCZ 0.16 0.27 -0.11 -0.34 to 0.65 -0.22 to 0.76 -0.60 to 0.37 0.55 0.28 0.65