THU0398 DRUG RETENTION RATES AND TREATMENT OUTCOMES IN 1860 AXIAL SPONDYLOARTHRITIS PATIENTS TREATED WITH SECUKINUMAB IN ROUTINE CLINICAL PRACTICE IN 13 EUROPEAN COUNTRIES IN THE EUROSPA RESEARCH COLLABORATION NETWORK
Authors: B. Michelsen, U. Lindström, C. Codreanu, A. Ciurea, J. Zavada, A. G. Loft, M. Pombo-Suarez, F. Onen, T. K. Kvien, Z. Rotar, M. J. Santos, F. Iannone, A. M. Hokkanen, B. Gudbjornsson, J. Askling, R. Ionescu, M. Nissen, K. Pavelka, C. Sánchez-Piedra, S. Akar, J. Sexton, M. Tomsic, H. Santos, M. Sebastiani, J. Osterlund, A. J. Geirsson, G. T. Jones, I. Van der Horst-Bruinsma, S. Georgiadis, C. H. Brahe, L. Midtbøll Ørnbjerg, M. L. Hetland, M. Ǿstergaard
Journal: Annals of the Rheumatic Diseases (2020)

Background: To determine the real-life 6- and 12-month secukinumab effectiveness in Europe overall, as well as stratified by prior biologic disease-modifying anti-rheumatic drug (bDMARD)/targeted synthetic (ts)DMARD use. Objectives: Real-life data from axSpA patients treated with secukinumab from 13 countries in the European Spondyloarthritis (EuroSpA) Research Collaboration Network were pooled. We calculated proportions of patients achieving Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) &lt;2/&lt;4 and Ankylosing Spondylitis Disease Activity Score (ASDAS) &lt;1.3/&lt;2.1 at 6 and 12 months, including with LUNDEX adjustments (crude value adjusted for drug retention). Retention rates were compared between b/tsDMARD naïve, 1 prior and ≥2 prior b/tsDMARD users with Kaplan-Meier analyses with log rank test and disease states by Chi-square test. Methods: A total of 1860 axSpA patients were included (Table 1). Overall 6/12-month secukinumab retention rates were 82%/72% and higher in bionaïve patients (Table 2, Figure). Significant differences in retention rates in-between the registries were found. Inactive disease/low-disease-activity (LDA) were achieved more often in bionaïve patients (Table 2). Table 1 All patients (n=1860 ) b/tsDMARD naïve (n=414 ) 1 prior b/tsDMARD (n=448 ) ≥2 prior b/tsDMARDs (n=998 ) Age (years), mean (SD ) 47 (12) 45 (12) 47 (12) 48 (12) Men, % 57% 68% 58% 49% Years since diagnosis, mean (SD ) 10 (9) 8 (9) 10 (9) 11 (9) Current smokers, % 25 % 27% 25% 23% Patient’s global (0-100), median (IQR ) 70 (50-81) 80 (60-90) 64 (50-80) 70 (50-82) Physician’s global (0-100), median (IQR ) 45 (25-63) 64 (43-78) 45 (22-60) 40 (20-58) C reactive protein (mg/L), median (IQR ) 8 (3-25) 15 (5-31) 7 (3-25) 6 (2-22) Erythrocyte sedimentation rate (mm/h), median (IQR ) 22 (9-44) 30 (14-44) 24 (8-45) 18 (8-42) Pain (0-100), median (IQR ) 70 (50-81) 80 (65-90) 65 (49-80) 70 (50-80) BASDAI, median (IQR ) 6.2 (4.6-7.6) 6.8 (5.2-8.0) 5.9 (4.2-7.2) 6.1 (4.4-7.6) BASFI, median (IQR ) 5.5 (3.2-7.3) 6.1 (3.2-7.6) 4.8 (2.8-6.8) 5.5 (3.3-7.2) ASDAS, median (IQR ) 3.6 (2.9-4.3) 4.2 (3.5-4.8) 3.5 (2.7-4.2) 3.5 (2.8-4.2) Table 2 Months All patients (n=1860) b/tsDMARD naïve (n=414) 1 prior b/tsDMARD (n=448) ≥2 prior b/tsDMARDs (n=998) p-value* Secukinumab retention rate, % (95%CI) 6 82% (80-84%) 90% (87-93%) 83% (79-86%) 78% (76-81%) 0.001 12 72% (69-74%) 84% (81-88%) 73% (69-78%) 66% (63-69%) &lt;0.001 BASDAI &lt;2, % Crude 6 26 37 35 18 &lt;0.001 LUNDEX adjusted 21 34 28 13 &lt;0.001 Crude 12 25 41 29 18 &lt;0.001 LUNDEX adjusted 16 31 18 11 &lt;0.001 BASDAI &lt;4, % Crude 6 51 71 60 40 &lt;0.001 LUNDEX adjusted 40 65 47 30 &lt;0.001 Crude 12 51 76 56 39 &lt;0.001 LUNDEX adjusted 32 57 36 23 &lt;0.001 ASDAS &lt;1.3, % Crude 6 9 13 13 6 0.001 LUNDEX adjusted 7 12 11 5 &lt;0.001 Crude 12 11 18 15 7 0.002 LUNDEX adjusted 7 13 9 4 0.002 ASDAS &lt;2.1, % Crude 6 24 32 26 20 0.002 LUNDEX adjusted 19 29 21 15 &lt;0.001 Crude 12 27 44 27 21 &lt;0.001 LUNDEX adjusted 17 33 17 12 &lt;0.001 *Comparisons between b/tsDMARD naïve, 1 prior and ≥2 prior b/tsDMARD users were performed with Kaplan-Meier with log-rank test or Chi-Square test, as appropriate Conclusion: In this real-life study of 1860 patients with axSpA in 13 European countries secukinumab retention was high and significantly higher for bionaïve patients. Overall, a higher proportion of bionaïve than previous b/tsDMARD users achieved inactive disease/LDA. Figure Acknowledgments: Novartis and IQVIA for supporting the EuroSpA RCN Disclosure of Interests: Brigitte Michelsen Grant/research support from: Research support from Novartis, Consultant of: Consulting fees Novartis, Ulf Lindström: None declared, Catalin Codreanu Consultant of: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Speakers bureau: Speaker and consulting fees from AbbVie, Accord Healthcare, Alfasigma, Egis, Eli Lilly, Ewopharma, Genesis, Mylan, Novartis, Pfizer, Roche, Sandoz, UCB, Adrian Ciurea Consultant of: Consulting and/or speaking fees from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Merck Sharp &amp; Dohme, Novartis and Pfizer., Jakub Zavada Speakers bureau: Abbvie, UCB, Sanofi, Elli-Lilly, Novartis, Zentiva, Accord, Anne Gitte Loft Grant/research support from: Novartis, Consultant of: AbbVie, MSD, Novartis, Pfizer and UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer and UCB, Manuel Pombo-Suarez Consultant of: Janssen, Lilly, MSD and Sanofi., Speakers bureau: Janssen, Lilly, MSD and Sanofi., Fatos Onen: None declared, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Ziga Rotar Consultant of: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Speakers bureau: Speaker and consulting fees from Abbvie, Amgen, Biogen, Eli Lilly, Medis, MSD, Novartis, Pfizer, Roche, Sanofi., Maria Jose Santos Speakers bureau: Novartis and Pfizer, Florenzo Iannone Consultant of: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Speakers bureau: Speaker and consulting fees from AbbVie, Eli Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, MSD, Anna-Mari Hokkanen: None declared, Björn Gudbjornsson Speakers bureau: Novartis and Amgen, Johan Askling Grant/research support from: JA acts or has acted as PI for agreements between Karolinska Institutet and the following entities, mainly in the context of the ARTIS national safety monitoring programme of immunomodulators in rheumatology: Abbvie, BMS, Eli Lilly, Merck, MSD, Pfizer, Roche, Samsung Bioepis, Sanofi, and UCB Pharma, Ruxandra Ionescu Consultant of: Consulting fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, Speakers bureau: Consulting and speaker fees from Abbvie, Eli-Lilly, Novartis, Pfizer, Roche, Sandoz, Michael Nissen Grant/research support from: Abbvie, Consultant of: Novartis, Lilly, Abbvie, Celgene and Pfizer, Speakers bureau: Novartis, Lilly, Abbvie, Celgene and Pfizer, Karel Pavelka Consultant of: Abbvie, MSD, BMS, Egis, Roche, UCB, Medac, Pfizer, Biogen, Speakers bureau: Abbvie, MSD, BMS, Egis, Roche, UCB, Medac, Pfizer, Biogen, Carlos Sánchez-Piedra: None declared, Servet Akar: None declared, Joe Sexton: None declared, Matija Tomsic: None declared, Helena Santos Speakers bureau: AbbVie, Eli-Lilly, Janssen, Pfizer, Novartis, Marco Sebastiani: None declared, Jenny Osterlund: None declared, Arni Jon Geirsson: None declared, Gareth T. Jones Grant/research support from: Pfizer, AbbVie, UCB, Celgene and GSK., Irene van der Horst-Bruinsma Grant/research support from: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Consultant of: AbbVie, Novartis, Eli Lilly, Bristol-Myers Squibb, MSD, Pfizer, UCB Pharma, Stylianos Georgiadis Grant/research support from: Novartis, Cecilie Heegaard Brahe Grant/research support from: Novartis, Lykke Midtbøll Ørnbjerg Grant/research support from: Novartis, Merete L. Hetland Grant/research support from: BMS, MSD, AbbVie, Roche, Novartis, Biogen and Pfizer, Consultant of: Eli Lilly, Speakers bureau: Orion Pharma, Biogen, Pfizer, CellTrion, Merck and Samsung Bioepis, Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB