Maxime Verhoeven

109 Effectiveness and safety of treat-to-target strategies over 5 years Baseline characteristics of the patients included in the PTFU were not statistically significantly different between the initial strategy groups at start of the U-Act-Early trial, Table 1. Additional information about patients (not) included in the PTFU is presented in Supplementary Table S1. Table 1 Baseline characteristics at start of U-Act-Early of patients included in the post-trial follow-up study (n=226).* TCZ+ MTX (n=75) TCZ (n=79) MTX (n=72) P-value Female, n (%) 47 (63) 61 (77) 48 (67) 0.13 RF +, n (%) 53 (71) 55 (71) 58 (82) 0.21 Anti CCP +, n (%) 51 (68) 54 (69) 56 (79) 0.28 RF- and/or anti-CCP+, n (%) 55 (73) 62 (79) 64 (89) 0.06 Caucasian, n (%) 71 (95) 77 (97) 71 (99) 0.47 Smoking status, n (%) - Never smoked - Quit smoking - Current smoking 29 (39) 21 (28) 25 (33) 34 (43) 24 (30) 21 (27) 28 (39) 25 (35) 19 (26) 0.81 Age (years), mean (SD) 53.8 (11.2) 55.5 (11.6) 53.7 (12.9) 0.63 Symptom duration (days), median (IQR) 27 (18 – 43) 25 (19 - 43) 28 (16 – 46) 0.96 DAS28, mean (SD) 5.1 (1.1) 5.3 (1.1) 5.0 (1.2) 0.33 HAQ, median (IQR) 1.3 (0.6 – 1.6) 1.3 (0.9 – 1.8) 1.0 (0.5 – 1.4) 0.17 SvdH score, median (IQR) 0 (0 - 0) 0 (0 - 2) 0 (0 - 1) 0.24 *according to their initial treatment strategy as randomized. TCZ+MTX= tocilizumab + methotrexate initiation strategy group; TCZ= tocilizumab + placebo-methotrexate initiation strategy group; MTX= methotrexate + placebo-tocilizumab initiation strategy group; RF= rheumatoid factor; += positive; anti-CCP= anti-cyclic citrullinated peptide antibodies; SD= standard deviation; IQR= interquartile range; DAS28= disease activity score assessing 28 joints; HAQ= health assessment questionnaire score; SvdH= Sharp van der Heijde score. The following results are based on data of the 226 patients who were included in the PTFU. DAS28 In line with the results of the U-Act-Early trial, the mean DAS28 over time was statistically significantly lower for the TCZ initiation strategy groups compared with the MTX initiation strategy group at year 1 and 2 of U-Act-Early. There were no statistically significant differences in average DAS28 over time between the initial treatment strategy groups during the 3-year PTFU period, neither over the total duration of 5 years, see Table 2 and Figure 2. 6