Maxime Verhoeven

110 Chapter 6 Table 2 Effectiveness outcomes over 5 years, results based on data of patients included in the post-trial follow-up, n=226. Mean difference in DAS28 between initial treatment strategy groups over 5 years and at the end of every year # Period Strategy comparison Mean difference 95%CI of mean difference Over 5 years TCZ+MTX vs. MTX TCZ vs. MTX TCZ+MTX vs. TCZ - 0.11 - 0.12 0.00 - 0.32 to 0.10 - 0.32 to 0.09 - 0.20 to 0.21 1 TCZ+MTX vs. MTX TCZ vs. MTX TCZ+MTX vs. TCZ - 0.75 - 0.65 - 0.10 - 0.89 to - 0.61 - 0.79 to - 0.51 - 0.23 to 0.04 2 TCZ+MTX vs. MTX TCZ vs. MTX TCZ+MTX vs. TCZ - 0.63 - 0.55 - 0.08 - 0.77 to - 0.49 - 0.69 to - 0.40 - 0.23 to 0.06 3 TCZ+MTX vs. MTX TCZ vs. MTX TCZ+MTX vs. TCZ 0.07 0.09 - 0.02 - 0.19 to 0.33 - 0.17 to 0.34 - 0.27 to 0.24 4 TCZ+MTX vs. MTX TCZ vs. MTX TCZ+MTX vs. TCZ 0.09 0.10 - 0.01 - 0.17 to 0.35 - 0.16 to 0.36 - 0.27 to 0.24 5 TCZ+MTX vs. MTX TCZ vs. MTX TCZ+MTX vs. TCZ 0.11 0.12 - 0.01 - 0.16 to 0.37 - 0.14 to 0.38 - 0.27 to 0.25 Sustained (drug free) remission over 5 years TCZ+ MTX (n=75) TCZ (n=79) MTX (n=72) P-value Number of patients (%) achieving SR at least once 75 (100) 77 (98) 72 (100) 0.15 1 Cumulative duration of SR in weeks, median (IQR) 216 (152-251) 190 (135-240) 172 (129-202) <0.01 2 Number of patients (%) achieving sDFR at least once 26 (35) 19 (26) 14 (19) 0.10 1 Cumulative duration of sDFR in weeks, median (IQR) 119 (76-157) 107 (53-157) 83 (37-146) 0.27 2 Median (IQR) [min to max] change in SvdH scores over 5 years TCZ+MTX (n=75) TCZ (n=79) MTX (n=72) Strategy comparisons; p-value 3 Total SvdH score 0 (0-1) [-2 to 15] 0 (0-1) [-2 to 30] 0 (0-2) [0 to 35] TCZ+MTX vs. MTX; 0.41 TCZ vs. MTX; 0.05 TCZ+MTX vs. TCZ; 0.67 Erosion score 0 (0-0) [0 to 9] 0 (0-1) [-2 to 17] 0 (0-1) [0 to 35] TCZ+MTX vs. MTX; 0.62 TCZ vs. MTX; 0.80 TCZ+MTX vs. TCZ; 0.62 JSN score 0 (0-0) [-2 to 8] 0 (0-0) [-1 to 13] 0 (0-1) [0 to 6] TCZ+MTX vs. MTX; 0.03 TCZ vs. MTX; 0.11 TCZ+MTX vs. TCZ; 0.31