Maxime Verhoeven

122 Chapter 6 Supplementary Table S3 (continued) Number of patients (%) achieving sDFR at least once 14 (38) 9 (23) 8 (21) 0.20 1 Cumulative duration of sDFR in weeks, median (IQR) 136 (101-163) 102 (33-132) 85 (62-152) 0.24 2 Median (IQR) [min to max] change in SvdH scores over 5 years TCZ+ MTX (n=37) TCZ (n=39) MTX (n=38) Strategy comparisons; p-value 3 Total SvdH score 0 (0-2) [-2 to 15] 0 (0-1) [-2 to 9] 0 (0-2) [0 to 10] TCZ+MTX vs. MTX; 0.97 TCZ vs. MTX; 0.08 TCZ+MTX vs. TCZ; 0.31 Erosion score 0 (0-2) [0 to 9] 0 (0-0) [-2 to 6] 0 (0-1) [0 to 5] TCZ+MTX vs. MTX; 0.52 TCZ vs. MTX; 0.12 TCZ+MTX vs. TCZ; 0.23 JSN score 0 (0-0) [-2 to 8] 0 (0-0) [-1 to 9] 0 (0-1) [0 to 6] TCZ+MTX vs. MTX; 0.14 TCZ vs. MTX; 0.19 TCZ+MTX vs. TCZ; 0.97 Mean difference in HAQ scores between initial treatment strategy groups over 5 years # Period Strategy comparisons Mean difference 95%CI of mean difference Over 5 years TCZ+MTX vs. MTX TCZ vs. MTX TCZ+MTX vs. TCZ - 0.15 0.04 - 0.19 - 0.36 to 0.54 - 0.16 to 0.25 - 0.40 to 0.01 The treatment strategy groups are according to the initial randomization at start of U-Act-Early. All analyses were corrected for centre. Outcomes are based onmixedmodel analyses with random intercept for repeated measurements, and fixed effects for treatment arm, visit-week, interaction visit-week*treatment arm. 1 = Cochran-Mantel-Haenszel test, 2 = linear regression, 3 = van Elteren test, # = no statistically significant differences between the groups, non-severe RA= baseline DAS28≤5.1. TCZ+MTX= tocilizumab + methotrexate initiation strategy group; TCZ= tocilizumab + placebo-methotrexate initiation strategy group; MTX= methotrexate + placebo-tocilizumab initiation strategy group; 95%CI= 95 percent confidence interval; SR= sustained remission; IQR= interquartile range; sDFR= sustained drug free remission; min= minimum; max= maximum; SvdH= Sharp van der Heijde score; JSN= joint space narrowing. Supplementary Table S4 shows the number of patients using any medication for RA during the post-trial follow-up. The use of GCs and csDMARDs were most frequently used in the MTX initiation strategy group, where the bDMARDs were most frequently used in the TCZ initiation strategy groups. According to the protocol, GC was not permitted during U-Act-Early. During the post-trial follow-up, the median dosage of GC, in those patients that used oral GC, was somewhat higher in the TCZ+MTX initiation strategy group. However, no relevant difference between the groups could be observed, and proportions of patients using GCs were higher in the MTX initiation strategy group, see Supplementary Figure S2. GC injections were given in 17% of patients of the TCZ+MTX and TCZ groups, and in 12% of patients of the MTX group.