FRI0668 FIRST DATA OF THE TARDIS-RAREGISTRY, A NATIONWIDE BELGIAN BIOLOGIC REGISTRY
Authors: Diederik De Cock, Patrick Durez, Dirk Elewaut, Bernard Lauwerys, Rene Westhovens, Patrick Verschueren
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> The Tool for Administrative Reimbursement Drug Information Sharing (TARDIS) is an electronic platform combining data collection from patients with Rheumatoid Arthritis (RA) on biologic and synthetic targeted therapy, together with the submission of a request for reimbursement of this medication. <h3>Objectives</h3> To present the first data ever of the TARDIS-RA registry concerning the use of biologic and synthetic targeted therapy across Belgium. <h3>Methods</h3> The Belgian TARDIS-RA registry started in April 2015. All Belgian rheumatologist were obliged after a transition period to insert patient data via the online portal when prescribing. If data of a patient are entered for the first time, previous and current use of classical synthetic (cs), targeted synthetic (ts) and biologic (b) disease modifying antirheumatic drug (DMARD) therapies is registered. Afterwards, every next bDMARD or tsDMARD initiation, prolongation and discontinuation is registered electronically in the system. Other data captured are basic demographic information such as age, gender and disease duration and disease characteristics including ESR, CRP, joint counts, disease activity scores and HAQ. <h3>Results</h3> At 18/01/2019, information on 80 098 drug prescriptions in 13 614 patients was collected in the TARDIS-RA registry. Of these 80 098 drug prescriptions, 30 434 (38.0%) were csDMARDs and glucocorticoids, and 49 664 (62.0%) were bDMARD or tsDMARD prescriptions. This last category consisted of 30 380 (61.2%) tumour necrosis factor inhibitor (TNFi) bDMARDs, 17 104 (34.5%) non-TNFi bDMARDs and 2 170 (4.3%) tsDMARDs. Only 642 (2.3%) TNFi biosimilar prescriptions were registered. Fig1 shows the yearly evolution of bDMARD and tsDMARD prescription in Belgium from 2015 to 2018. At first registered interaction with the rheumatologist, the 13 614 patients had a median (IQR) age of 59 (50-68) years with a median (IQR) disease duration of 9 (4-16) years; 9 666 (73.4%) were female. The clinical characteristics showed a median (IQR) DAS28CRP of 3.6 (2.1-4.8) and a median (IQR) HAQ of 1.1 (0.6-1.8). Of patients at first time registration, 37.6% could be validated as being bionaïve and 62.5% as bioexperienced. <h3>Conclusion</h3> Approximately 70 000 individuals in Belgium are estimated to have a RA diagnosis. Corresponding to numbers of other western European countries, 20%-25% of them would be expected to receive ts/bDMARDs. This suggests that almost the entire Belgian RA population on biologic treatment is covered by TARDIS. The registration of initiation, prolongation and discontinuation of every ts/bDMARD since 2015 combined with the simultaneous collection of demographic and clinical data, will make the TARDIS-RA registry a useful and powerful tool for the long-term drug analyses in Belgian patients with RA. <h3>Disclosure of Interests</h3> Diederik De Cock: None declared, Patrick Durez Speakers bureau: Bristol-Myers Squibb, Eli Lilly, Sanofi, Celltrion, Dirk Elewaut: None declared, Bernard Lauwerys: None declared, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Patrick Verschueren Grant/research support from: Unrestricted Pfizer Grant for Early RA research