Maxime Verhoeven

115 Effectiveness and safety of treat-to-target strategies over 5 years DISCUSSION This is the first long-term PTFU evaluating the effectiveness and safety of tight- controlled treat-to-target treatment strategies using a bDMARD from start of therapy in early DMARD- and GC-naïve RA patients up to 5 years. The high effectiveness during the trial period of 2 years was maintained in a real-world setting without differences between the treatment strategy groups over the 3-year PTFU period. This suggests that an early start of any tight-controlled treat-to-target treatment strategy is also effective on longer-term. The cumulative duration of SR over 5 years was significantly longer for the TCZ initiation strategy groups compared with the MTX initiation strategy group. For the TCZ+MTX initiation strategy group, the median SR duration was about 4 years (216 weeks), which may have an important positive impact on daily activities and quality of life. However, this effect may be biased as patients in the MTX initiation strategy group had a considerable delay in achieving remission compared with the TCZ initiation strategy groups. Including only the PTFU period, no differences for SR were found between the strategy groups, but the duration of SR was numerically longer in the TCZ initiation strategy groups. For future research, a cost effectiveness analysis is warranted to determine whether early initiation of TCZ is cost-effective over a period up to 5 years, compared with MTX initiation. During the trial, medication was tapered if the patients remained in SR. In the open label PTFU, the numbers of patients using a bDMARD remained numerically higher in the TCZ initiation strategy groups compared with the MTX initiation strategy group, and the number of patients using csDMARDs remained higher in the MTX initiation strategy group. This outcome and the long duration of SR as mentioned above suggest that bDMARD tapering is not yet widely applied in a real-world setting. The most frequently used bDMARD was TCZ in all strategy groups. Physicians were not completely familiar with the effects of TCZ tapering, probably therefore TCZ was tapered cautiously in the real-world setting during the follow-up phase. Our study also provides evidence for the safety over 5 years of the treatment strategies initiating TCZ, MTX or their combination in a step-up treat-to-target treatment strategy compared according to their randomized groups. The effectiveness and safety results are in line with those of other PTFU studies, with TCZ use, performed in established RA patients. 14–16 The limitations of this study include the non-protocolized follow-up, during the PTFU. However, this non-protocolized follow-up gives a realistic view of treatments in a daily practice setting. Not all patients who participated in the U-Act-Early trial could be included in the PTFU, but the sensitivity analysis suggests that results based on the patients with observed data is generalizable to the original U-Act-Early population. Another limitation is the number of missing radiographs at the end of the follow-up 6