FRI0404 POOLED 6-MONTH TREATMENT OUTCOMES AND DRUG RETENTION RATES IN 1556 PATIENTS WITH AXIAL SPONDYLOARTHRITIS TREATED WITH SECUKINUMAB IN ROUTINE CLINICAL PRACTICE IN 12 EUROPEAN COUNTRIES IN THE EUROSPA RESEARCH COLLABORATION
Authors: Brigitte Michelsen, Cecilie Heegaard Brahe, Johan Askling, Catalin Codreanu, Adrian Ciurea, Anne Gitte Loft, Heřman Mann, Manuel Pombo-Suarez, Fatos Onen, Joe Sexton, Ziga Rotar, Maria Jose Santos, Kari Eklund, Björn Gudbjornsson, Florenzo Iannone, Daniela DI Giuseppe, Ruxandra Ionescu, Michael Nissen, Karel Pavelka, Carlos Sánchez-Piedra, Servet Akar, Eirik Kristianslund, Matija Tomsic, Helena Santos, Nina Trokovic, Arni Jon Geirsson, Ennio Giulio Favalli, Irene van der Horst-Bruinsma, Gary Macfarlane, Lise Hyldstrup, Niels Steen Krogh, Mikkel Ǿstergaard, Merete L. Hetland
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> There is a lack of real-life data on secukinumab exposure, treatment outcomes and retention rates in axial spondyloarthritis (axSpA) patients. <h3>Objectives</h3> Primary objective: To assess the proportion of axSpA patients in BASDAI low disease activity (&lt;4) and ASDAS inactive disease (&lt;1.3) after 6 months of secukinumab treatment across Europe. Secondary objectives: To compare baseline characteristics, crude and LUNDEX adjusted 6-month BASDAI &lt;4 and ASDAS &lt;1.3 rates, retention rates and median time to secukinumab withdrawal (due to loss of efficacy/adverse events) between biologic DMARD (bDMARD) naïve and non-naïve patients, as well as across the participating registries. <h3>Methods</h3> Data from axSpA patients treated with secukinumab in routine care from 12 countries in the European Spondyloarthritis Research Collaboration (EuroSpA) were pooled. Time from treatment initiation to data cut was &gt;= 6 months. Group comparisons were performed with independent t-test, Mann-Whitney U-test, ANOVA, Kruskal-Wallis and Chi-square test, as appropriate. Kaplan-Meier analyses with log rank test were performed for comparison of secukinumab drug survival. <h3>Results</h3> A total of 1556 axSpA patients were included. Overall 6-month BASDAI&lt;4 was achieved by 49% and ASDAS&lt;1.3 by 9% of the patients. bDMARD naïve compared with non-naïve secukinumab starters had shorter disease duration, higher baseline disease activity, a higher proportion were men and a higher proportion achieved crude and LUNDEX adjusted 6-month BASDAI&lt;4 but not ASDAS&lt;1.3 (table). Drug retention was higher for bDMARD naïve compared with non-naïve patients (figure 1a). Baseline characteristics and disease activity (data not shown) as well as drug retention differed in-between the European registries (figure 1b). <h3>Conclusion</h3> This study of &gt;1500 patients in 12 European countries provides real-world data on the effectiveness of secukinumab in patients with axSpA, adding evidence to existing RCTs. A majority of the patients was previous bDMARD users and had long disease duration. BASDAI &lt;4 was achieved by 49% of the patients and ASDAS &lt;1.3 by 9% at 6 months. Overall retention rate was 83% at 6 months, with significant differences across the registries and higher retention rates for bDMARD naïve compared with non-naïve axSpA patients. <h3>Acknowledgement</h3> Novartis Pharma AG and IQVIA for supporting the EuroSpA collaboration <h3>Disclosure of Interests</h3> Brigitte Michelsen Grant/research support from: Unrestricted grant: Novartis, Consultant for: Novartis, UCB, Cecilie Heegaard Brahe Grant/research support from: Unrestricted grant: Novartis, Johan Askling Grant/research support from: Karolinska Institutet (JA) has or has had research agreements with the following pharmaceutical companies, mainly in the context of the ATRIS national safety monitoring programme for rheumatology biologicals: Abbvie, BMS, MSD, Eli Lilly, Pfizer, Roche, Samsung Bioepis, and UCB., Consultant for: Karolinska Institutet has received remuneration for JA participating in ad boards arranged by Lilly, Novartis, and Pfizer., Catalin Codreanu: None declared, Adrian Ciurea Consultant for: AbbVie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Janssen-Cilag, MSD, Eli Lilly, Novartis, Pfizer, UCB, Anne Gitte Loft: None declared, Heřman Mann Consultant for: Pfizer, Eli Lilly, Sanofi, Speakers bureau: AbbVie, Roche, Pfizer, MSD, Eli Lilly, Sanofi, Manuel Pombo-Suarez: None declared, Fatos Onen: None declared, Joe Sexton: None declared, Ziga Rotar: None declared, Maria Jose Santos: None declared, Kari Eklund: None declared, Björn Gudbjornsson: None declared, Florenzo Iannone Consultant for: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Speakers bureau: F Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Novartis, Lilly, UCB outside this work, Daniela Di Giuseppe: None declared, Ruxandra Ionescu: None declared, Michael Nissen Consultant for: AbbVie, Lilly, Novartis, and Pfizer, Karel Pavelka: None declared, Carlos Sánchez-Piedra: None declared, Servet Akar Grant/research support from: MSD, Abbvie, Roche, UCB, Novartis, Pfizer, Amgen, Consultant for: MSD, Abbvie, Roche, UCB, Novartis, Pfizer, Amgen, Speakers bureau: Pfizer, Eirik kristianslund: None declared, Matija Tomsic: None declared, Helena Santos: None declared, Nina Trokovic: None declared, Arni Jon Geirsson: None declared, Ennio Giulio Favalli: None declared, Irene van der Horst-Bruinsma Grant/research support from: MSD, Pfizer, AbbVie, Consultant for: Abbvie, UCB, MSD, Novartis, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Gary Macfarlane Grant/research support from: Have received research grants (not current) from Abbvie and Pfizer. Have received research grants (not current) from the British Society for Rheumatology, who received the funds from Abbive, Pfizer and UCB. Have received research grant (current) from the British Society for Rheumatology, who received the funds from Celgene., Lise Hyldstrup: None declared, Niels Steen Krogh: None declared, Mikkel Ǿstergaard Grant/research support from: Abbvie, Celgene, Centocor, Merck, Novartis, Consultant for: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Speakers bureau: Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen, Pfizer, Consultant for: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck, Samsung Bioepis