Clinical and radiographic outcomes at 2years and the effect of tocilizumab discontinuation following sustained remission in the second and third year of the ACT-RAY study

ObjectiveTo assess the efficacy and safety of tocilizumab (TCZ) plus methotrexate/placebo (MTX/PBO) over 2years and the course of disease activity in patients who discontinued TCZ due to sustained remission.MethodsACT-RAY was a double-blind 3-year trial. Patients with active rheumatoid arthritis despite MTX were randomised to add TCZ to ongoing MTX (add-on strategy) or switch to TCZ plus PBO (switch strategy). Using a treat-to-target approach, open-label conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), other than MTX, were added from week 24 if Disease Activity Score in 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) >3.2. Between weeks 52 and 104, patients in sustained clinical remission (DAS28-ESR 3upper limit of normal were more frequent in add-on (14.3%) versus switch patients (5.4%).ConclusionsTreat-to-target strategies could be successfully implemented with TCZ to achieve sustained remission, after which TCZ was stopped. Biologic-free remission was maintained for about 3months, but most patients eventually flared. TCZ restart led to rapid improvement.Trial registration numberNCT00810199.