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Abstract Number: 1557

Secukinumab Effectiveness in 1134 Patients with Psoriatic Arthritis Treated in Routine Clinical Practice in 11 European Countries in the EuroSpA Research Collaboration Network

Brigitte Michelsen1, Daniela DiGuiseppe 2, Anne Gitte Loft 3, Manuel Pombo-Suarez 4, Herman Mann 5, Ziga Rotar 6, Florenzo Iannone 7, Tore Kvien 8, Maria José Santos 9, Kari K. Eklund 10, Bjorn Gudbjornsson 11, Catalin Codreanu 12, Sema Yılmaz 13, Johan Askling 14, Carlos Sánchez-Piedra 15, Karel Pavelka 5, Matija Tomsic 16, Fabrizio Conti 17, Joe Sexton 18, Helena Santos 19, Nina Trokovic 20, Thorvardur J Love 21, Ruxandra IONESCU 22, Yavuz Pehlivan 23, Michael J. Nissen 24, Gary Macfarlane 25, Irene van der Horst-Bruinsma 26, Stylianos Georgiadis 27, Lykke Midtbøll Ørnbjerg 28, Cecilie Heegaard Brahe 28, Merete Lund Hetland 29 and Mikkel Østergaard 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, 2Clinical Epidemiology Division, Dept of Medicine Solna, Karolinska Institutet,, Stockholm, Sweden, 3Department of Rheumatology, Aarhus University Hospital, Aarhus, Denmark, Århus, Denmark, 4Unit Research, Spanish Society of Rheumatology, Madrid, Spain, 5Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Prague, Czech Republic, Prague 2, Czech Republic, 6UMC LJUBLJANA, DPT. OF RHEUMATOLOGY, LJUBLJANA, Slovenia, 7Department of Emergency and Transplantation , Rheumatology Unit, University Hospital of Bari, Bari, Italy., Bari, Italy, 8Diakonhjemmet Hospital, Dept. of Rheumatology / University of Oslo, Faculty of Medicine, Oslo, Norway, 9Rheumatology department, Hospital Garcia de Orta, Almada, Portugal, 10ROB-FIN registry, Department of Medicine, Helsinki University and University Hospital, Helsinki, Finland, 11Centre for Rheumatology Research, Landspitali and Faculty of Medicine, University of Iceland, Reykjavik, Iceland, 12Center of Rheumatic Diseases, University of Medicine and Pharmacy, Bucharest, Romania., Bucharest, Romania, 13Division of Rheumatology, Selcuk University School of Medicine, Konya, Turkey, Konya, Turkey, 14Karolinska Institutet, Stockholm, Sweden, 15Research Unit, Spanish Society of Rheumatology, Madrid, Spain, 16Department of Rheumatology, University Medical Center Ljubljana, Slovenia, Ljubljana, Slovenia, 17Sapienza University of Rome, Rome, Italy, 18Diakonhjemmet Hospital, Dept. of Rheumatology, Oslo, Norway, 19Instituto Português de Reumatologia (IPR), Lisbon, Portugal, 20Helsinki University Central Hospital, Helsinki, Finland, 21Faculty of Medicine, University of Iceland, Reykjavik, Iceland, 22SPITALUL CLINIC SFANTA MARIA, Bucharest, 23Uludağ University, Bursa, Turkey, 24University Hospital Geneva, Geneva, Switzerland, 25University of Aberdeen, Aberdeen, United Kingdom, 26Amsterdam University Medical Center, Amsterdam, Netherlands, 27DANBIO registry and Copenhagen Center for Arthritis Research, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, 28Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet Glostrup, Denmark, Copenhagen, Denmark, 29DANBIO and Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark, 30Copenhagen Center for Arthritis Research, University of Copenhagen, Copenhagen, Denmark

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: observation and registries, Psoriatic arthritis, remission, treatment

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Session Information

Date: Monday, November 11, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Secukinumab represents a relatively new approach to treating patients with psoriatic arthritis (PsA) and has shown promising results in RCTs. However, there is a lack of real-life evidence on secukinumab effectiveness. 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 and low disease activity (LDA) at 6 and 12 months after treatment initiation based on observational registries in Europe. This was assessed overall as well as by prior biologic disease-modifying anti-rheumatic drug (bDMARD)/targeted synthetic (ts)DMARD use.

Methods: Data from PsA patients treated with secukinumab in routine care from 11 countries in the European Spondyloarthritis (EuroSpA) Research Collaboration Network were pooled. Time from treatment initiation to data cut was ≥ 12 months regardless of treatment duration and cover start date between May 2015 and April 2018. Crude and LUNDEX1 adjusted Disease Activity Score with 28 joints and CRP (DAS28CRP) and Disease Activity index for PSoriatic Arthritis with 28 joints (DAPSA28) 2 remission and LDA rates were calculated. Group comparisons between b/tsDMARD naïve, and 1 or 2 or more 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 1134 PsA patients were included, thereof 21 patients who started treatment in year 2015, 375 in 2016, 623 in 2017 and 115 in 2018. Overall 6/12-month secukinumab retention rate was 85%/74% and significantly higher in b/tsDMARD naïve compared with non-naïve patients after 12, but not 6 months (table, figure). Overall 6- and 12-month DAS28< 2.6/DAPSA28≤4 was achieved by 33%/12% and 55%/18% of the patients, respectively and 6- and 12-month DAS28/DAPSA28 LDA by 52%/34% and 73%/49%, respectively. B/tsDMARD naïve patients compared with patients treated with 1 or 2 or more previous b/tsDMARDs had shorter time since diagnosis, higher baseline disease activity, a higher proportion were men and a higher proportion achieved LUNDEX adjusted 6-month remission.

Conclusion: This study of >1100 patients in 11 European countries provided real-world data on the effectiveness of secukinumab in patients with PsA, adding evidence to existing RCTs. A majority of the patients were treated with 2 or more previous b/tsDMARDs, were female and had long disease duration. Overall retention rate was 85%/74% at 6/12 months, respectively, with significantly higher retention rates for b/tsDMARD naïve compared with patients treated with 1 or 2 or more previous b/tsDMARDs after 12, but not 6 months. 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. 2Michelsen et al. Ann Rheum Dis 2018;77:1736-1741.

Table

Figure. Pooled 12-month secukinumab retention rates for PsA patients in EuroSpA stratified by b/tsDMARD naïve patients, patients treated with 1 prior b/tsDMARD or 2 or more prior b/tsDMARDs -log rank test; p<0.001-.


Disclosure: B. Michelsen, Novartis, 2, 5; D. DiGuiseppe, None; A. Loft, None; M. Pombo-Suarez, None; H. Mann, None; Z. Rotar, AbbVie, 9, Amgen, 5, 8, Eli-Lilly, 9, MSD, 5, Novartis, 9, Pfizer, 9, Sanofi, 5; 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; 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; K. Eklund, None; B. Gudbjornsson, Actavis, 8, Amgen, 8, Novartis, 8, Pfizer, 8; 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; S. Yılmaz, None; J. Askling, AbbVie, 2, BMS, 2, Lilly, 2, MSD, 2, Pfizer, 2, Roche, 2, Samsung Bioepis, 2, UCB, 2; C. Sánchez-Piedra, None; 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; M. Tomsic, None; F. Conti, None; J. Sexton, None; H. Santos, AbbVie, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, Janssen-Cilag, 5, 8, Eli-Lilly, 5; N. Trokovic, None; T. Love, 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; Y. Pehlivan, None; M. Nissen, Abbvie, Celgene, Lilly, MSD, Novartis, Pfizer, 5, 8; G. Macfarlane, 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; S. Georgiadis, Novartis, 2; L. Midtbøll Ørnbjerg, Novartis, 2; C. Heegaard Brahe, Novartis, 2; 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; 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.

To cite this abstract in AMA style:

Michelsen B, DiGuiseppe D, Loft A, Pombo-Suarez M, Mann H, Rotar Z, Iannone F, Kvien T, Santos M, Eklund K, Gudbjornsson B, Codreanu C, Yılmaz S, Askling J, Sánchez-Piedra C, Pavelka K, Tomsic M, Conti F, Sexton J, Santos H, Trokovic N, Love T, IONESCU R, Pehlivan Y, Nissen M, Macfarlane G, van der Horst-Bruinsma I, Georgiadis S, Midtbøll Ørnbjerg L, Heegaard Brahe C, Lund Hetland M, Østergaard M. Secukinumab Effectiveness in 1134 Patients with Psoriatic Arthritis Treated in Routine Clinical Practice in 11 European Countries in the EuroSpA Research Collaboration Network [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/secukinumab-effectiveness-in-1134-patients-with-psoriatic-arthritis-treated-in-routine-clinical-practice-in-11-european-countries-in-the-eurospa-research-collaboration-network/. Accessed .
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