Sat0135 maintaining Remission in Patients With Established Rheumatoid Arthritis While Tapering Etanercept: An Insight in the Tapera Trial

Abstract

BackgroundEULAR 2016 recommendations for the management of Rheumatoid Arthritis (RA) suggest to consider tapering of biological Disease-Modifying Antirheumatic Drugs (bDMARDs) in patients in sustained remission. More insight on the effect of tapering strategies is needed in daily practice.ObjectivesTo investigate maintaining disease control after spacing dosages of etanercept 50mg from weekly to every other week (EOW) in a pragmatic randomized controlled trial (RCT).MethodsPatients with RA who were in remission according to the disease activity score 28 (DAS28) remission criteria for at least 6 months and treated with etanercept 50mg weekly for at least a year were included in the one-year non-blinded multicentre TapERA (Tapering Etanercept in RA) RCT (EudraCTnumber 2012-004631-22). Patients were 1:1 randomly assigned to continue etanercept 50mg weekly or to taper to 50mg EOW. Patients who lost remission (DAS28 C-Reactive Protein (CRP) ≥ 2.6) received nonsteroidal anti-inflammatory drugs and if needed were re-escalated to etanercept weekly. If remission was still not reached, treatment had to be adapted, at the discretion of the treating rheumatologist. The outcomes were proportion of patients in DAS28 remission at 6 and 12 months, proportion in sustained remission and proportion regaining remission after reintroducing weekly etanercept (intention to treat analysis). Missing components of DAS28 were imputed using expectation maximization.ResultsIn total, 69 patients (69.6% female) with a mean ± standard deviation (SD) age of 55.7 ± 11.3 years and a mean ± SD disease duration of 14.7 ± 8.0 years were included. The weekly and EOW group consisted of 35 and 34 patients respectively. At the month 6 visit 77.1% patients of the weekly and 76.5% of the EOW group were in remission (p=0.947) and 68.6% and 58.8% respectively maintained remission on every visit (p=0.400) (Table 1).Three (8.6%) patients of the weekly and 11 (32.4%) of the EOW group required a treatment adaptation, which was statistically significantly different (p=0.014). There was no difference between the weekly and EOW group in the mean ± SD DAS28 CRP at the first time of losing remission in patients flaring, namely 3.1 ± 0.6 and 3.1 ± 0.5 respectively (p=0.957).Eleven patients were re-escalated to a weekly treatment after a mean ± SD duration of 4.5 ± 3.1 months. Of these, 54.5% (6/11) regained remission after a mean ± SD duration of 4.7 ± 1.7 months. Of the 5 patients not regaining remission, 1 switched to a weekly regimen on the last trial visit, 1 required switching to another bDMARD and 3 patients had no additional treatment changes (mean ± SD DAS28 CRP at month 12: 3.4 ± 0.2). Two patients of the EOW group restarted weekly etanercept while still being in remission.ConclusionApproximately half of the EOW group was in sustained remission after 1 year and two thirds remained on their reassigned treatment. Furthermore, one in two patients were able to regain remission after reintroducing etanercept weekly. Therefore tapering of etanercept to EOW seems a f...

Evaluation of Disease Burden by (Separate) Patient-reported, Clinical, and Laboratory Factor Scores in Patients With Established Rheumatoid Arthritis: A Factor Analysis Replication

“…Detailed information on the trial was published previously. 3,4,5 The same analysis method was used as in the CareRA trial. Three hundred seventy-nine patients with early RA (< 1 yr) with a mean disease duration of 14.14 (SD 31.00) days and mean age of 53.91 (SD 12.98) years were included.…”