FRI0103 BENEFIT STUDY: A PAN-EUROPEAN OBSERVATIONAL STUDY TO EVALUATE REAL-WORLD EFFECTIVENESS OF SB4 FOLLOWING TRANSITION FROM ORIGINATOR ETANERCEPT (ETN) IN PATIENTS WITH RHEUMATOID ARTHRITIS (RA) OR AXIAL SPONDYLOARTHRITIS (AXSPA)
Authors: Klaus Krueger, Carlo Selmi, Alain Cantagrel, Abad Hernández, Ulrich Freudensprung, Mourad Farouk Rezk, Janet Addison
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background:</h3> Having demonstrated bioequivalence and similar efficacy, safety and immunogenicity as the originator, SB4 is approved in the EU as an ETN biosimilar. There is limited evidence on outcomes of transition from originator to biosimilar in a multi-country real-world setting. <h3>Objectives:</h3> To provide real-world evidence on outcomes of transition from ETN to SB4 in routine clinical practice at EU sites. <h3>Methods:</h3> Eligible patients had RA or axSpA and had initiated SB4 in routine clinical practice following a minimum of 6 months treatment with a stable dose of originator ETN, at clinics in France, Germany, Italy, and Spain. Data were captured from patient records prospectively and/or retrospectively for 6 months following transition. Outcome measures include clinical characteristics, disease scores (DAS-28 for RA, BASDAI for axSpA) and clinical management. <h3>Results:</h3> Analysis of 533 eligible patients (347 RA, 186 axSpA) demonstrated no clinically significant difference in disease score from baseline to 6 months post-transition; mean individual change was 0.0 (95% CI -0.1, 0.1) and 0.0 (95% CI -0.3, 0.2) at 6 months post-transition in RA and axSpA subjects respectively. Regarding dose regimen, 73.5% and 63.4% of RA and axSpA subjects transitioned from ETN 50mg QW to SB4 50mg QW; by 6 months post-transition, 73.5% and 63.4% of subjects were receiving SB4 50mg QW. <h3>Conclusion:</h3> Patients with stable RA or axSpA who transitioned from originator ETN to SB4 maintained clinical response at 6 months post-transition. Most patients transitioned to the same dose regimen of biosimilar as they had received for the originator, remaining largely unchanged at 6 months, supporting ease and effectiveness of transition. Biogen International GmbH sponsored and funded this study. <h3> Disclosure of Interests: </h3> Klaus Krueger: None declared, Carlo Selmi Grant/research support from: Abbvie, Janssen, MSD, Novartis, Pfizer, Consultant for: Abbvie, Alfa-Sigma, Biogen, BMS, Celgene, Eli-Lilly, GSK, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, YCB, Speakers bureau: Abbvie, Alfa-Sigma, Biogen, BMS, Celgene, Eli-Lilly, GSK, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, YCB, Alain Cantagrel Grant/research support from: Abbvie, Chugai, MSD, Pfizer, UCB, Consultant for: BMS, Chugai, Janssen, Lilly France, Médac, MSD France, Novartis, Pfizer, Roche, Sandoz, Sanofi Aventis, UCB, Speakers bureau: Abbvie, Biogen, BMS, Celgene, Chugai, Janssen, Lilly France, MSD France, Nordic-Pharma, Novartis, Pfizer, Roche, Sanofi, UCB, Abad Hernández: None declared, Ulrich Freudensprung Shareholder of: Biogen, Employee of: Biogen, Mourad Farouk Rezk Shareholder of: Biogen, Employee of: Biogen, Janet Addison Shareholder of: Biogen, Employee of: Biogen