Maxime Verhoeven

104 Chapter 6 ABSTRACT Objective U-Act-Early was a 2-year, randomized placebo controlled, double-blind trial, in which DMARD-naïve early RA patients were treated to the target of sustained remission (SR). The 2 strategies initiating tocilizumab (TCZ), with and without methotrexate (MTX), were more effective than the strategy initiating MTX. The aim of the current study was to determine longer-term effectiveness in daily clinical practice. Methods At the end of U-Act-Early, patients were included in a 3-year post-trial follow-up (PTFU), in which treatment was according to standard care and data was collected every 3 months during the first year and every 6 months thereafter. Primary end point was DAS28 over time. Mixed effects models were used to compare effectiveness between initial strategy groups, correcting for relevant confounders. Between the groups as randomized, proportions of patients were tested for DMARD use, SR and radiographic progression of joint damage. Results Of patients starting U-Act-Early, 226/317 (71%) participated in the PTFU. Over the total 5 years, mean DAS28 was similar between groups (p>0.20). During U-Act-Early, bDMARD use decreased in both TCZ initiation groups and increased in the MTX initiation group, but during follow-up this trend did not continue. SR was achieved at least once in 99% of patients. Of the 226 patients, only 30% had any radiographic progression over 5 years, without significant differences between the groups. Conclusion Although on short-term the strategies initiating TCZ yielded the most clinical benefit, on longer-term differences in important clinical outcomes between the strategies disappeared, probably due to continuation of the treat-to-target principle.