THU0569 A randomised, double-blind, parallel study to compare rates of remission (INACTIVE DISEASE) in patients with jia on mtx treatment alone versus a combination of mtx and etanercept
Authors: E. Alexeeva, T. Dvoryakovskaya, R. Denisova, I. Nikishina, E. Zholobova, V. Malievskiy, G. Santalova, E. Stadler, L. Balykova, Y. Spivakovskiy, I. Becker, G. Horneff
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Remission is the major goal of treatment of juvenile idiopathic arthritis(JIA). Advances in treatment options allowed achievement of remission to come into reach. Timing for initiating intensive treatment in a treat to target approach to early reach remission is still a debate. <h3>Objectives</h3> Multi-centre, double-blind, randomised study in polyarticular JIA patients (pts) receiving either Etanercept+Methotrexate (cohort 1) or Placebo +Methotrexate (cohort 2) for 24 weeks followed by 24 week open label phase. Escape to open-label ETN and MTX for pts not achieving paedACR30 at week 12 or not achieving inactive disease at week 24. <h3>Results</h3> 35 pts were randomised to cohort 1 and 33 to cohort 2. Baseline demographic and clinical characteristics were comparable between the groups except mean tender joint count, physician assessment of global disease activity and JADAS10 which all were higher in cohort 1. At week 12, 12 pts randomised to cohort 2 did not reach paedACR30. At week 24, further 10 pts of cohort 2 not reaching inactive disease escaped to ETA and MTX. 5 pts of cohort 1 and 4 pts of cohort 2 dropped out. At week 12, significantly more pts on ETA and MTX (33 (94%)/27 (79%)) than on PLC and MTX (17 (52%)/15 (47%) reached paedACR30/50 (p&lt;0.001/0.01). At week 24, inactive disease was reached by 10 pts on ETA and MTX vs. 6 on PLC and MTX. Inactive disease at week 48 was achieved by 5 pts of cohort 2 on MTX alone while 22 patients (67%) escaped to open label ETA and MTX. 15 (43%) pts of cohort 1 and 16 (49%) of cohort 2 reached inactive disease at week 48. At week 48, paedACR30/50/70/90 was reached by 100%/97%/97%/77% in cohort 1 compared to (97%/93%/93%/73%) in cohort 2. The number of visits with inactive disease in cohort 1 (87 (24%)) was comparable to that of cohort 2 (79 (21%)) while the number of visits with no active joint was significantly higher in cohort 1 (178(48%) vs. 146 (39%); OR 1.45 (1.08–1.94); p=0.012). 44 (74/100 y) adverse events (AE) were noted leading to discontinuation in 6 patients. 3 serious AE occurred, two first uveitis events and one diagnosis of dermatomyositis, all in the placebo group. No new safety signal arised from our observation. <h3>Conclusions</h3> Early combination of ETA and MTX proved to be highly effective with a high rate of patients reaching high paediatric ACR response and 50% reaching inactive disease. Pre-defined targets to treat to, paediatric ACR30 at week12, defining minimal response or inactive disease at week 24/48 were more often reached upon ETA and MTX than with MTX alone. Compared to immediate intense antirheumatic combination treatment with ETA and MTX, a comparable rate of patients on targeted therapy reached the final endpoint of inactive disease at week 48 but numbers of visits with active arthritis were higher in patients receiving delayed combination therapy. <h3>Reference</h3> [1] Wallace CA, et al. Arthritis Care Res2011;63:929–36. <h3>Acknowledgements</h3> The study was sponsored by an unrestricted grant by Pfizer, Russia <h3>Disclosure of Interest</h3> None declared