Secukinumab effectiveness in 1134 patients with psoriatic arthritis treated in routine clinical practice in 11 European countries in the EuroSpA research collaboration network

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Abstract Number: 1557

Secukinumab Eﬀ ectiveness in 1134 Patients with Psoriatic Arthritis

Treated in Routine Clinical Practice in 11 European Countries in the

EuroSpA Research Collaboration Network

Brigitte  Michelsen , 1 _{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 _,1 _{Copenhagen 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, 2 _{Clinical Epidemiology Division,}

Dept of Medicine Solna, Karolinska Institutet,, Stockholm, Sweden, 3

Department of Rheumatology, Aarhus University

Hospital, Aarhus, Denmark, Århus, Denmark, 4 _{Unit Research, Spanish Society of Rheumatology, Madrid, Spain,}

5

Institute of Rheumatology, Department of Rheumatology, 1st Faculty of Medicine, Prague, Czech Republic, Prague

2, Czech Republic, 6 _{UMC LJUBLJANA, DPT. OF RHEUMATOLOGY, LJUBLJANA, Slovenia,}7 _{Department of Emergency and}

Transplantation , Rheumatology Unit, University Hospital of Bari, Bari, Italy., Bari, Italy, 8 _{Diakonhjemmet Hospital,}

Dept. of Rheumatology / University of Oslo, Faculty of Medicine, Oslo, Norway, 9 _{Rheumatology department, Hospital}

Garcia de Orta, Almada, Portugal, 10 _{ROB- FIN registry, Department of Medicine, Helsinki University and University}

Hospital, Helsinki, Finland, 11 _{Centre for Rheumatology Research, Landspitali and Faculty of Medicine, University}

of Iceland, Reykjavik, Iceland, 12 _{Center of Rheumatic Diseases, University of Medicine and Pharmacy, Bucharest,}

Romania., Bucharest, Romania, 13 _{Division of Rheumatology, Selcuk University School of Medicine, Konya, Turkey,}

Konya, Turkey, 14 _{Karolinska Institutet, Stockholm, Sweden,}15 _{Research Unit, Spanish Society of Rheumatology, Madrid,}

Spain, 16 _{Department of Rheumatology, University Medical Center Ljubljana, Slovenia, Ljubljana, Slovenia,}17 _Sapienza

University of Rome, Rome, Italy, 18 _{Diakonhjemmet Hospital, Dept. of Rheumatology, Oslo, Norway,}19 _Instituto

Português de Reumatologia (IPR), Lisbon, Portugal, 20 _{Helsinki University Central Hospital, Helsinki, Finland,}21 _{Faculty of}

Medicine, University of Iceland, Reykjavik, Iceland, 22 _{SPITALUL CLINIC SFANTA MARIA, Bucharest,}23 _{Uludağ University,}

Bursa, Turkey, 24 _{University Hospital Geneva, Geneva, Switzerland,}25 _{University of Aberdeen, Aberdeen, United}

Kingdom, 26 _{Amsterdam University Medical Center, Amsterdam, Netherlands,}27 _{DANBIO registry and Copenhagen}

Center for Arthritis Research, Centre for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark,

28 _{Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet Glostrup,}

Denmark, Copenhagen, Denmark, 29 _{DANBIO and Copenhagen Center for Arthritis Research}COPECARE _{, Center for}

Rheumatology and Spine Diseases, Centre of Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark,

30 _{Copenhagen Center for Arthritis Research, University of Copenhagen, Copenhagen, Denmark}

SESSION INFORMATION

Session Date: Monday, November 11, 2019

Session 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 ar-thritis (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 LUNDEX 1 _{adjusted Disease Activity Score with 28 joints and CRP (DAS28CRP) and Disease Activity index for}

Prnted by [Selcuk Unverstes - 193.255.247.064 - /do/epdf/10.1002/art.41

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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.

Table

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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 signi cantly higher in b/tsDMARD naïve compared with non- naïve patients after 12, but not 6 months (table,  gure). 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 dis-ease 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 signi cantly 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

1. Kristensen et al. Arthritis Rheum 2006, 54(2):600- 606. 2 . _{Michelsen et al. Ann Rheum Dis 2018;77:1736- 1741.}

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, P zer, 9, Sano , 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, P zer, 5, 8, Roche, 5, 8, Sano , 5, 8, UCB, 5, 8; T. Kvien , AbbVie, 2, 8, Biogen, 5, 8, Biogen, Egis, Eli Lilly, Hikma, Mylan, Novartis/Sandoz, Oktal, Hospira/P zer, Sano and UCB, 5, BMS, 8, Celltrion, 8, Egis, 5, 8, Eli Lilly, 5, 8, Hikma, 5, 8, Hospira/P zer, 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, Sano , 5, 8, UCB, 5, 8; M. Santos , AbbVie, 8, Biogen, 8, Novartis, 8, P zer, 8, Roche, 8; K. Eklund , None; B. Gudbjornsson , Actavis, 8, Amgen, 8, Novartis, 8, P zer, 8; C. Codreanu , AbbVie, 5, 8, Egis, 5, 8, Eli- Lilly, 5, 8, Ewopharma, 5, 8, Mylan, 5, 8, Novartis/Sandoz, 5, 8, P zer, 5, 8, Roche, 5, 8, UCB, 5, 8; S. Yılmaz , None; J. Askling , AbbVie, 2, BMS, 2, Lilly, 2, MSD, 2, P zer, 2, Roche, 2, Samsung Bioepis, 2, UCB, 2; C. Sánchez-Piedra , None; K. Pavelka , AbbVie, 8, Abbvie, Figure. Pooled 12-month secukinumab retention rates for PsA patients in EuroSpA strati ed by b/tsDMARD naive patients, patients treated with 1 prior b/tsDMARD or 2 or more prior b/tsDMARDs (log rank test; p<0.001).

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5, 8, Amgen, 5, 8, BMS, 8, Egis, 5, 8, Lilly, 5, 8, MSD, 8, Novartis, 5, 8, P zer, 5, 8, Roche, 5, 8, UCB, 8; M. Tomsic , None; F. Conti , None; J. Sexton , None; H. Santos , AbbVie, 5, 8, Novartis, 5, 8, P zer, 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, P zer, 5, 8, UCB, 5, 8, Roche, 5, 8, Sandoz, 5, 8; Y. Pehlivan , None; M. Nissen , Abbvie, Celgene, Lilly, MSD, Novartis, P zer, 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, P zer, 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, P zer, 2, Sam-sung, 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, P zer, Regeneron, Roche, UCB, 5, 8, Abbvie, BMS, Boehringer- Ingelheim, Celgene, Eli- Lilly, Hospira, Janssen, Merck, Novartis, Novo, Orion, P zer, 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, P zer, 2, 5, 8, 9, Regeneron, 2, 5, 8, Roche, 2, 5, 8, roche, 9, Sandoz, 2, 8, Sano , 2, 8, UCB, 2, 5, 8.

Abstract Number: 1558

Should Lupus Podocytopathy Be a Subclass in Class I and Class II Lupus

Nephritis?

Whitney  Bembry , 1 _{Dasha  Lopez ,}2 _{Christopher  Mesa ,}3 _{Nirupa  Patel ,}3 _{and Myriam  Guevara}4 _,1 _{Tulane University School}

of Medicine, New Orleans, LA, 2 _{Baton Rouge General Hospital, Baton Rouge, LA,}3 _{Louisiana State University School of}

Medicine, New Orleans, LA, 4 _{Louisiana State University School of Medicine, New Orleans}

SESSION INFORMATION

Session Date: Monday, November 11, 2019

Session Title: SLE – Clinical Poster II: Comorbidities

Session Type: Poster Session (Monday)

Session Time: 9:00AM–11:00AM

Background/Purpose : Evidence of podocyte effacement on electron microscopy and signi cant proteinuria in a systemic lupus erythematosus (SLE) patient with biopsy proven minimal mesangial (MM), mesangial proliferation (MsP) and focal segmental glomerulosclerosis (FSGS) is the de ning quality of lupus podocytopathy (LP). Our objec-tive is to recognize the prevalence of LP and signi cant proteinuria in SLE patients with biopsy proven class I, class II and/or FSGS.

Methods : In this single center retrospective study, two independent reviewers evaluated records from 96 hospi-talized patients admitted with ICD- 10 codes corresponding to a diagnosis of glomerular disease and/or tubulo- interstitial nephropathy in SLE from 2015 to 2018.

Results : The prevalence of LP in our cohort was 8.33% (Table 1). Seventy-  ve percent of our cohort were females and of African descent. Class II lupus nephritis (LN) was the most common pathological diagnosis (50% of patients); followed by class I LN (37.5%), and one case of FSGS (12.5%). Five patients presented with signi cant proteinuria (62.5%). Majority of the patients had active disease, presenting with low C3 levels (62.5%). Most patients received corticosteroids (CS), either pulse dose steroids or high dose prednisone being the most common mode (62.5%); four