6 and 12-month Drug Retention Rates and Treatment Outcomes in 941 Patients with Axial Spondyloarthritis Treated with Secukinumab in Routine Clinical Practice in 12 European Countries in the EuroSpA Research Collaboration Network

Brigitte Michelsen¹, Johan Askling ², Catalin Codreanu ³, Herman Mann ⁴, Anne Gitte Loft ⁵, Manuel Pombo-Suarez ⁶, Ziga Rotar ⁷, Tore Kvien ⁸, Maria José Santos ⁹, Anna Mari Hokkanen ¹⁰, Florenzo Iannone ¹¹, Bjorn Gudbjornsson ¹², Fatos Onen ¹³, Lennart Jacobsson ¹⁴, Ruxandra IONESCU ¹⁵, Karel Pavelka ⁴, Carlos Sánchez-Piedra ¹⁶, Matija Tomsic ¹⁷, Joe Sexton ¹⁸, Helena Santos ¹⁹, Jenny Österlund ²⁰, Alberto Cauli ²¹, Arni Jon Geirsson ²², Servet Akar ²³, Adrian Ciurea ²⁴, Gareth Jones ²⁵, Irene van der Horst-Bruinsma ²⁶, Cecilie Heegaard Brahe ²⁷, Stylianos Georgiadis ²⁸, Lykke Midtbøll Ørnbjerg ²⁷, Mikkel Østergaard ²⁹ and Merete Lund Hetland ³⁰, ¹Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet Glostrup, Denmark/ Hospital of Southern Norway Trust, Kristiansand, Norway/ Diakonhjemmet Hospital, Oslo, Norway, Oslo, Norway, ²Karolinska Institutet, Stockholm, Sweden, ³Center of Rheumatic Diseases, University of Medicine and Pharmacy, Bucharest, Romania., Bucharest, Romania, ⁴Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Prague, Czech Republic, Prague 2, Czech Republic, ⁵Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark, Århus, Denmark, ⁶Unit Research, Spanish Society of Rheumatology, Madrid, Spain, ⁷UMC LJUBLJANA, DPT. OF RHEUMATOLOGY, LJUBLJANA, Slovenia, ⁸Diakonhjemmet Hospital, Dept. of Rheumatology / University of Oslo, Faculty of Medicine, Oslo, Norway, ⁹Rheumatology department, Hospital Garcia de Orta, Almada, Portugal, ¹⁰Helsinki University Hospital, Helsinki, Finland, ¹¹Department of Emergency and Transplantation , Rheumatology Unit, University Hospital of Bari, Bari, Italy., Bari, Italy, ¹²Centre for Rheumatology Research, Landspitali and Faculty of Medicine, University of Iceland, Reykjavik, Iceland, ¹³Dokuz Eylul University School of Medicine, Division of Rheumatology, İzmir, Turkey, ¹⁴Dept of Rheumatology and Inflammation Research, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden,, Gothenburg, Sweden, ¹⁵SPITALUL CLINIC SFANTA MARIA, Bucharest, ¹⁶Research Unit, Spanish Society of Rheumatology, Madrid, Spain, ¹⁷Department of Rheumatology, University Medical Center Ljubljana, Slovenia, Ljubljana, Slovenia, ¹⁸Diakonhjemmet Hospital, Dept. of Rheumatology, Oslo, Norway, ¹⁹Instituto Português de Reumatologia (IPR), Lisbon, Portugal, ²⁰ROB-FIN registry, Helsinki University and Helsinki University Hospital, Helsinki, Finland, ²¹Universitá di Cagliari, Cagliari, Italy, ²²Centre for Rheumatology Research, University Hospital and Faculty of Medicine, Reykjavik, Iceland, ²³Izmir Katip Celebi University, Faculty of Medicine, Division of Rheumatology, İzmir, Turkey, ²⁴University Hospital Zürich, Zürich, Switzerland, ²⁵University of Aberdeen, Aberdeen, United Kingdom, ²⁶Amsterdam University Medical Center, Amsterdam, Netherlands, ²⁷Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet Glostrup, Denmark, Copenhagen, Denmark, ²⁸DANBIO registry and Copenhagen Center for Arthritis Research, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, ²⁹Copenhagen Center for Arthritis Research, University of Copenhagen, Copenhagen, Denmark, ³⁰DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: axial spondyloarthritis, Biologic agents, observation and registries, remission

Session Information

Date: Monday, November 11, 2019

Title: 4M096: Spondyloarthritis Including Psoriatic Arthritis – Clinical III: Miscellaneous (1818–1823)

Session Type: ACR Abstract Session

Session Time: 2:30PM-4:00PM

Background/Purpose: Secukinumab is a fully human IgG1 monoclonal antibody targeting interleukin-17A. There is a lack of real-life evidence on secukinumab retention rates and treatment outcomes in axial spondyloarthritis (axSpA) patients. Hence, the aim of this study was to determine the 6- and 12-month secukinumab retention rates as well as the crude and LUNDEX corrected proportions of patients in remission after 6 and 12 months of treatment in Europe. This was assessed overall as well as stratified by prior biologic disease-modifying anti-rheumatic drug (bDMARD)/targeted synthetic (ts)DMARD use.

Methods: Data from axSpA patients treated with secukinumab in routine care from 12 countries in the European Spondyloarthritis (EuroSpA) Research Collaboration Network were pooled. Time from treatment initiation to data cut was ≥ 12 months regardless of treatment durations and cover start date between May 2015 and April 2018. The following outcomes were calculated: Proportions of patients achieving Bath Ankylosing Spondylitis Disease Activity Score (BASDAI) < 2 / BASDAI < 4 and Ankylosing Spondylitis Disease Activity Score (ASDAS) < 1.3/ ASDAS < 2.1 at 6 and 12 months, including with LUNDEX1 adjustments. Group comparisons between b/tsDMARD naïve and 1 or ≥2 prior b/tsDMARD users were performed with ANOVA, Kruskal-Wallis or Chi-square test or with Kaplan-Meier analyses with log rank test, as appropriate.

Results: A total of 941 axSpA patients were included, thereof 6 who started treatment in 2015, 215 in 2016, 573 in 2017 and 147 in 2018. Overall 6/12-month secukinumab retention rate was 82%/73% and higher in b/tsDMARD naïve compared to non-naïve patients (table, figure). After 6/12 months treatment BASDAI < 4 was achieved by 51%/62%, BASDAI < 2 by 24%/34%, ASDAS < 2.1 by 23/33% and ASDAS < 1.3 by 8%/14% of the patients. b/tsDMARD naïve patients compared with patients treated with 1 prior or 2 or more prior b/tsDMARDs had shorter time since diagnosis, higher baseline disease activity and a higher proportion were men. Overall, LUNDEX adjusted 6 and 12 months’ responses were achieved more often in b/tsDMARD naive patients than in patients who had received 1 or 2 or more previous b/tsDMARDs (table).

Conclusion: This study of >900 patients in 12 European countries provided real-world data on the effectiveness of secukinumab in patients with axSpA, adding evidence to existing RCTs. A majority of the patients were treated with 2 or more previous b/tsDMARDs and had long disease duration. Overall retention rate was 82%/73% at 6/12 months, respectively, with higher retention rates for b/tsDMARD naïve compared with patients treated with 1 or 2 or more previous b/tsDMARDs. Overall, a higher proportion of bionaïve than previous b/tsDMARD users achieved remission regardless of remission criteria.

References: ¹Kristensen et al. Arthritis Rheum 2006, 54(2):600-606

Figure. Pooled 12-month secukinumab retention rates for axSpA patients in EuroSpA stratified by previous b/tsDMARD treatment -log rank test; p<0.001-.

Disclosure: B. Michelsen, Novartis, 2, 5; J. Askling, AbbVie, 2, BMS, 2, Lilly, 2, MSD, 2, Pfizer, 2, Roche, 2, Samsung Bioepis, 2, UCB, 2; C. Codreanu, AbbVie, 5, 8, Egis, 5, 8, Eli-Lilly, 5, 8, Ewopharma, 5, 8, Mylan, 5, 8, Novartis/Sandoz, 5, 8, Pfizer, 5, 8, Roche, 5, 8, UCB, 5, 8; H. Mann, None; A. Loft, None; M. Pombo-Suarez, None; Z. Rotar, AbbVie, 9, Amgen, 5, 8, Eli-Lilly, 9, MSD, 5, Novartis, 9, Pfizer, 9, Sanofi, 5; T. Kvien, AbbVie, 2, 8, Biogen, 5, 8, Biogen, Egis, Eli Lilly, Hikma, Mylan, Novartis/Sandoz, Oktal, Hospira/Pfizer, Sanofi and UCB, 5, BMS, 8, Celltrion, 8, Egis, 5, 8, Eli Lilly, 5, 8, Hikma, 5, 8, Hospira/Pfizer, 2, 5, 8, MSD, 2, 8, Mylan, 5, 8, Novartis, 8, Novartis/Sandoz, 5, 8, Oktal, 5, 8, Orion Pharma, 8, Roche, 2, 8, Sandoz, 8, Sanofi, 5, 8, UCB, 5, 8; M. Santos, AbbVie, 8, Biogen, 8, Novartis, 8, Pfizer, 8, Roche, 8; A. Hokkanen, None; F. Iannone, AbbVie, 5, 8, BMS, 5, 8, Janssen, 5, 8, lilly, 5, 8, Lilly, 5, 8, MSD, 2, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Roche, 5, 8, Sanofi, 5, 8, UCB, 5, 8; B. Gudbjornsson, Actavis, 8, Amgen, 8, Novartis, 8, Pfizer, 8; F. Onen, Tofacitinib (Pfizer), 8; L. Jacobsson, None; R. IONESCU, Abbvie, 5, 8, Amgen, 5, 8, Alpha Sigma, 5, 8, BMS, 5, 8, Ewopharma, 5, 8, Lilly, 5, 8, Mylan, 5, 8, Novartis, 5, 8, MSD, 5, 8, Pfizer, 5, 8, UCB, 5, 8, Roche, 5, 8, Sandoz, 5, 8; K. Pavelka, AbbVie, 8, Abbvie, 5, 8, Amgen, 5, 8, BMS, 8, Egis, 5, 8, Lilly, 5, 8, MSD, 8, Novartis, 5, 8, Pfizer, 5, 8, Roche, 5, 8, UCB, 8; C. Sánchez-Piedra, None; M. Tomsic, None; J. Sexton, None; H. Santos, AbbVie, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Janssen-Cilag, 5, 8, Eli-Lilly, 5; J. Österlund, None; A. Cauli, None; A. Geirsson, None; S. Akar, Abbvie, 2, 5, Amgen, 2, 5, MSD, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, 8, Roche, 2, 5, UCB, 2, 5; A. Ciurea, AbbVie, 5, Celgene, 5, Eli Lilly, 5, Janssen-Cilag, 5, MSD, 5, Novartis, 5, Pfizer, 5, UCB, 5; G. Jones, Celgene, 2; I. van der Horst-Bruinsma, AbbVie, 2, 5, 8, Bristol Myers-Squibb, 2, 5, 8, MSD, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, UCB Pharma, 2, 5, 8; C. Heegaard Brahe, Novartis, 2; S. Georgiadis, Novartis, 2; L. Midtbøll Ørnbjerg, Novartis, 2; M. Østergaard, AbbVie, 2, 8, 9, Abbvie, 2, 5, 8, Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, UCB, 5, 8, Abbvie, BMS, Boehringer-Ingelheim, Celgene, Eli-Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, Pfizer, Regeneron, Roche, and UCB, 5, 8, Abbvie, Celgene, Centocor, Merck, and Novartis, 2, Abbvie, Celgene, Centocor, Merck, Novartis, 2, BMS, 2, 5, 8, 9, Boehringer Ingelheim, 5, 8, Boehringer-Ingelheim, 2, 8, Boehringer-ingelheim, 9, Celgene, 2, 5, 8, Centocor, 2, Eli Lilly, 5, 8, 9, Eli Lilly and Company, 5, 8, Eli-Lilly, 2, 8, Hospira, 2, 5, 8, Janssen, 2, 5, 8, 9, Merck, 2, 5, 8, 9, Novartis, 2, 5, 8, Novo, 2, 5, 8, Novo Nordisk, 5, 8, Orion, 2, 5, 8, Pfizer, 2, 5, 8, 9, Regeneron, 2, 5, 8, Roche, 2, 5, 8, roche, 9, Sandoz, 2, 8, Sanofi, 2, 8, UCB, 2, 5, 8; M. Lund Hetland, Abbvie, 2, AbbVie, 2, Biogen, 2, BMS, 2, CellTrion, 2, 9, MSD, 2, Novartis, 2, Orion, 2, Pfizer, 2, Samsung, 2, UCB, 2.

To cite this abstract in AMA style:

Michelsen B, Askling J, Codreanu C, Mann H, Loft A, Pombo-Suarez M, Rotar Z, Kvien T, Santos M, Hokkanen A, Iannone F, Gudbjornsson B, Onen F, Jacobsson L, IONESCU R, Pavelka K, Sánchez-Piedra C, Tomsic M, Sexton J, Santos H, Österlund J, Cauli A, Geirsson A, Akar S, Ciurea A, Jones G, van der Horst-Bruinsma I, Heegaard Brahe C, Georgiadis S, Midtbøll Ørnbjerg L, Østergaard M, Lund Hetland M. 6 and 12-month Drug Retention Rates and Treatment Outcomes in 941 Patients with Axial Spondyloarthritis Treated with Secukinumab in Routine Clinical Practice in 12 European Countries in the EuroSpA Research Collaboration Network [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/6-and-12-month-drug-retention-rates-and-treatment-outcomes-in-941-patients-with-axial-spondyloarthritis-treated-with-secukinumab-in-routine-clinical-practice-in-12-european-countries-in-the-eurospa-re/. Accessed .

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