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...
An increased sensitivity of sonication compared to periprosthetic tissue cultures in the diagnosis of periprosthetic joint infection (PJI) of hip and knee arthroplasty has been reported. The goal of this study was to determine if there is also an added value of implant sonication in the diagnosis of PJI in total shoulder arthroplasty (TSA). A retrospective analysis of patients who underwent removal of their TSA combined with sonication of the implant for suspicion of PJI between April 2009 and August 2017 was performed. The diagnosis of PJI was based on the major criteria described by Parvizi. We calculated sensitivity, specificity, predictive values, likelihood ratios and diagnostic accuracy for sonication cultures in comparison with periprosthetic tissue cultures. Data from 41 patients were analysed. Standard synovial fluid cultures combined with intraoperative periprosthetic tissue cultures had a sensitivity of 95%, specificity of 95% and total accu- racy of 95%. Sonication cultures had a sensitivity of 91%, specificity of 68% and total accuracy of 80%. Six patients had negative standard cultures but positive sonication cultures. In patients with only one positive standard culture, the pathogen of the sonication culture corresponded to the pathogen of the positive soft tissue culture. We found a possible added value of sonication of TSA in the diagnosis of PJI in conjunction with standard intraoperative cultures. In some patients with suspicion of low-grade TSA infection, sonication could identify a possible causal microorganism despite negative standard cultures.
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