THU0649 Mandatory choice of first bdmard in denmark – an opportunity to study real-life effectiveness? results from the danbio registry
Authors: KL Grøn, B Glintborg, M Nørgaard, F Mehnert, M Østergaard, L Dreyer, NS Krogh, ML Hetland
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> In Denmark, biological treatments (bDMARDs) are tax paid. Since year 2013, The Danish Council for the Use of Expensive Hospital Medicines (RADS) has issued recommendations with annual updates regarding RA patients (pts) initiating biological treatment, dictating a mandatory choice of the cheapest bDMARD (1). Furthermore, the percentage of pts expected to be treated according to the RADS recommendation per year is stated. For pts treated with concomitant methotrexate (MTX) recommendations on first line, first choice bDMARD were: Jan 1th 2013-June 30th 2014: certolizumab pegol (in 80% of pts); July 1th 2014 - June 30th 2015: abatacept (80%); July 1th 2015-June 30th 2016: biosimilar infliximab (CT-P13) (50%). The nationwide Danish DANBIO registry collect data prospectively and covers &gt;90% of adults with rheumatological diseases treated with bDMARDs in routine care (2). <h3>Objectives</h3> To characterize Danish RA pts initiating first line, first choice treatment with a bDMARD in combination with MTX in the three RADS periods and to explore the degree of compliance to RADS recommendations. Furthermore, to investigate differences in baseline characteristics between those pts who were compliant to RADS guidelines and those who were not. <h3>Methods</h3> For each of the three RADS9 periods bio-naive pts with RA were identified in DANBIO and compliance to RADS recommendations was assessed. Baseline characteristics of those who started first choice bDMARD treatment according to RADS were compared with those who started another biologic instead. Comorbidities and previous hospitalized infections were identified in the Danish National Patient Registry. Comorbidities from Charlson Comorbidity Index were summarized except category number 7, connective tissue disease. <h3>Results</h3> For all three RADS periods, age, gender, functional status and disease activity were typical for pts with RA. Age was median: 57 years, range 18–88 years and disease duration: 3 years, range 0–54 years. 16–22% of pts had ≥1 comorbidity and 7–9% had ≥1 hospitalized infection the previous year. In each of the three RADS periods, 71%, 66% and 60% of pts followed the RADS recommendations, respectively (Table). The table shows differences between those who started first choice bDMARD treatment according to RADS, and those who did not. Overall, pts who complied to RADS had higher DAS28 and patient VAS global. Characteristics of pts who followed RADS recommendations in the three periods appeared similar. <h3>Conclusions</h3> In this nationwide study of &gt;600 RA pts, pts9 clinical characteristics were more heterogeneous than in clinical trials, reflecting routine care. Overall, compliance to recommendations was good. Thus, the national guidelines in Denmark with mandatory choice of the first biological drug may provide an interesting opportunity to study effectiveness of bDMARDs in routine care. This highlights observational studies as a valuable supplement to RCTs. <h3>References</h3> The Danish Council for the Use of Expensive Hospital medicines (RADS), http://www.regioner.dk/media/28308/radsfolder-engelsk.pdf. Hetland ML. Rehumatology 2011;50:69–77. <h3>Disclosure of Interest</h3> K. Grøn Grant/research support from: BMS, B. Glintborg Grant/research support from: Abbvie, M. Nørgaard Grant/research support from: Department of Clinical Epidemiology is involved in studies with funding from various companies as research grants to (and administered by) Aarhus University, Denmark, F. Mehnert Grant/research support from: Department of Clinical Epidemiology is involved in studies with funding from various companies as research grants to (and administered by) Aarhus University, Denmark, M. Østergaard Grant/research support from: Consultation fees from: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Centocor, GSK, Hospira, Janssen, Merck, Mundipharma, Novartis, Novo, Orion, Pfizer, Regeneron, Schering-Plough, Roche, Takeda, UCB, and Wyeth; Research support and grants from: Abbvie, BMS, Janssen and Merck, L. Dreyer Grant/research support from: MSC, UCB, Janssen Pharmaceutical, N. Krogh: None declared, M. Hetland Grant/research support from: Abbvie, BMS, MSD, Orion, Novartis, UCB, Pfizer