Access and Secondary Use of Data Collected In An Electronic Medical Chart: Results Of The Real World Roswitch Study

Secondary use of data to describe in real life the efficacy and the characteristics of Rheumatoid arthritis (RA) patients switching from Intravenous (IV) to Subcutaneous (SC) Tocilizumab (TCZ) formulation. RIC Nord de France, a French rheumatologist network, set up an electronic medical chart (eMC) to enhance communication and data sharing during RA patients’ course. Individual patient’s data fulfilling inclusion criteria were extracted from the eMC, and provided to Roche-Chugai for analyses. Patients switching or not from IV to SC TCZ between April 30th 2015 (date of available SC formulation) and January 15th 2016 were included. The Primary Efficacy Endpoint (PEE) was the proportion of patients remaining in their DAS28-ESR category remission/LDA or moving to an inferior DAS28-ESR category at 24 weeks (W24) and permanent discontinuation of TCZ before W24 was considered as failure. 263 patients were included, 30% switched from IV to SC TCZ. Baseline characteristics were: 77.6% females, mean BMI 27.46±6.40, and mean RA duration 15.11±9.38 years. Mean IV TCZ duration before inclusion was 35.2±24.3 months in switch and 24.7±22.1 months in non-switch patients. 51.1% of the switch patients were treated in monotherapy, 49.1% in the non-switch group. Mean DAS28-ESR were 2.23±1.16 in the switch and 3.07±1.70 in the non-switch patients. 79.3% of the switch patients were in DAS28-ESR category remission or LDA, and 20.7% in MDA. 53.8% of the non-switch patients were in DAS28-ESR category remission or LDA, 33.3% in MDA, and 12.9% in HDA. At W24, 73.9% (CI95% [63.4% - 82.7%]) of the switch patients, and 72% (CI95% [64.4% - 78.8%]) of the non-switch patients met the PEE. Electronic medical chart in RA is an efficient data source and enables to provide effective real world evidence.