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- W4379794351 abstract "Background Ixekizumab (IXE), an Interleukin (IL)-17A inhibitor (i), approved for the treatment (tx) of Psoriasis (Pso), psoriatic arthritis (PsA) and axSpA (rad/non rad) have limited real-world data. PRO-SPIRIT is the first large, prospective observational study for IXE in patients (pts) with PsA who start a new biologic/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD), with a primary endpoint of persistence at 24 months (M). Objectives To describe baseline (BL) characteristics of pts enrolled in PRO-SPIRIT. Methods PRO-SPIRIT enrolled pts December 2019-June 2022 in FR, ES, IT, DE, UK, and CA, who started a new b/tsDMARD, approved for PsA. Tx groups are; IXE, secukinumab (SEC), IL-12/-23i, IL-23i, tumor necrosis factor inhibitor (TNFi), Janus kinase inhibitors (JAKi), and Phosphodiesterase-4 inhibitor (PDE4i). Pts’ demographic, disease activity, and tx characteristics were recorded at BL, effectiveness outcomes and tx changes at 3, 6,12,18, and 24M. BL descriptive statistics are shown. Results The analysis included 1207 pts (2 pts with other tx not shown below). Most were female, had mean age 52.4yrs, poly/oligo-arthritis and enthesitis/dactylitis in similar proportions except for enthesitis in IL12/23i and IL-23i pts. Pts started on IXE had long disease duration (9.2yrs). Most had prior b/tsDMARDs (69.5%) and 38.7% had active PsO similar to SEC pts. For TNFi pts, mean disease duration was 6.5yrs, 30.8% had received prior b/tsDMARDs, and 30.4% had active PsO. IL-23i pts (n=57) were typified by long disease duration (8.7yrs), high proportions of PsO (50.9%)/nail PsO (50.9%) and prior b/tsDMARD use (78.9%). JAKi pts had long (9.2yrs) disease duration, 72.2% prior b/tsDMARDs experience, and 26.2% had active PsO. IXE and IL23i pts were more often treated on monotherapy. Conclusion In PRO-SPIRIT, pts starting IXE showed active PsA, with both joint and often skin involvement, and were mostly treated with monotherapy after failing several b/tsDMARDs. TNFis were often used as 1 st line therapy alongside csDMARDs. Table 1. Baseline Characteristics bDMARDs tsDMARDs Ixekizumab Secukinumab IL-12/23i IL-23i TNFi JAKi PDE4i N=344 N=169 N=36 N=57 N=441 N=126 N=32 Age 53.9±12.1 52.4±12.0 51.2±12.1 53.0±11.5 51.0±12.4 52.9±12.3 54.8±9.2 Female, n(%) 224(65.1) 106(62.7) 19(52.8) 34(59.6) 265(60.1) 82(65.1) 20(62.5) Yrs since PsA diagnosis 9.2±8.5 8.4±8.4 8.0±8.8 8.7±8.0 6.5±7.2 9.2±8.2 8.8±7.7 Prior b/tsDMARD, n(%) 239(69.5) 112(66.3) 26(72.2) 45(78.9) 136(30.8) 91(72.2) 6(18.8) Tx as monotherapy, n(%) 218(63.4) 102(60.4) 28(77.8) 40(70.2) 198(44.9) 67(53.2) 24(75.0) Tender Joint Count (0-68)* 8(0-60) 8(0-65) 6.5(0-32) 6.5(0-52) 7(0-65) 8(0-66) 4(0-47) Swollen Joint Count (0-66)* 3(0-35) 2(0-39) 2(0-24) 2(0-21) 3(0-31) 4(0-53) 2(0-17) Enthesitis, n(%) 142(41.3) 66 (39.1) 9(25.0) 33(57.9) 179(40.6) 55(43.7) 12(37.5) Dactylitis, n(%) 67(19.5) 38 (22.5) 6(16.7) 13(22.8) 85(19.3) 26(20.6) 5(15.6) BSA ≥3 n(%) 133(38.7) 62(36.7) 15(41.7) 29(50.9) 134(30.4) 33(26.2) 13(40.6) Nail PsO, n(%) 131(38.1) 64(37.9) 10(27.8) 29(50.9) 160(36.3) 43(34.1) 15(46.9) Physician Global assessment VAS 61.7±18.2 61.7±19.3 59.0±20.5 56.1±20.7 61.2±18.7 61.1±19.5 53.8±18.0 Patient Global Assessment VAS 60.7±21.2 61.0±22.3 55.3±25.1 63.9±22.7 57.7±23.2 61.4±22.2 53.2±23.5 Patient Assessment of (Joint) Pain VAS 62.9±21.5 63.2±22.6 53.5±27.4 62.8±22.1 59.7±23.6 62.8±24.0 55.5±25.1 Mean±SD, *Median(Range),unless stated b=biologic; BSA=body surface area; cs=conventional synthetic; DMARD=Disease Modifying Arthritis Rheumatic Drug; i=inhibitor; IL=interleukin; JAK=janus kinase; N=number of patients; PDE4=phosphodiesterase 4; PsO=psoriasis; TNF=tumor necrosis factor; ts=targeted synthetic; VAS = Visual Analog Scale Acknowledgements This study was funded by Eli Lilly and Company. Mr. Alan Ó Céilleachair, an employee of Eli Lilly and Company, provided scientific writing support for this submission. Disclosure of Interests Jacques Morel Speakers bureau: Biogen, Amgen, Bristol Myers Squib, Eli Lilly and Company, Novartis, Sanofi, MSD, Mylan, Fresenius Kabi, Roche, Union Chimique Belge, Janssen, Medac, and Nordic Pharma, Consultant of: Pfizer, AbbVie, Boerhinger Ingelheim, Galapagos, and GSK, Grant/research support from: Fresenius Kabi, Ennio Lubrano Speakers bureau: Abbvie, Janssen Cilag, Lilly, UCB, Pfizer, and Novartis, William Tillett Speakers bureau: AbbVie, Amgen, Eli Lilly and Company, GSK, Janssen, Novartis, Pfizer, and UCB., Consultant of: Abbvie, Amgen, Eli Lilly and Company, GSK, Janssen, Novartis, Ono Pharma, Pfizer, and UCB., Grant/research support from: Janssen, UCB, Pfizer, and Eli Lilly and Company., Rieke Alten Speakers bureau: AbbVie, BMS, Celltrion, Galapagos, Eli Lilly and Company, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, BMS, Celltrion, Galapagos, Eli Lilly and Company, Novartis, Pfizer, Roche, and UCB, Lars Erik Kristensen Speakers bureau: Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company, and Janssen, Consultant of: Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company, and Janssen, Grant/research support from: Pfizer, AbbVie, UCB, Gilead, Biogen, Novartis, Eli Lilly and Company, and Janssen, Vinod Chandran Consultant of: AbbVie, Eli Lilly, Novartis, Amgen, and Janssen, Grant/research support from: AbbVie, Tamas Treuer Shareholder of: Minor shareholder, Employee of: Eli Lilly and Company, Joanna Burke Employee of: Joanna Burke is contracted to Eli Lilly and Company, À Martínez-Ferrer Grant/research support from: Eli Lilly and Company, Thorsten Holzkaemper Shareholder of: Minor shareholder Eli Lilly and Company, Employee of: Eli Lilly and Company, Nicola Gullick Speakers bureau: AbbVie, Eli Lilly and Company, Janssen, Novartis, UCB, Consultant of: AbbVie, Janssen, Novartis, UCB, Grant/research support from: Astra Zeneca, AbbVie, Eli Lilly and Company, Izana, Novartis." @default.
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- W4379794351 date "2023-05-30" @default.
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- W4379794351 title "AB1115 STUDY DESIGN AND FULL BASELINE SAMPLE CHARACTERISTICS OF PATIENTS FROM THE 24-MONTH MULTINATIONAL PROSPECTIVE PSORIATIC ARTHRITIS OBSERVATIONAL STUDY OF PERSISTENCE OF TREATMENT (PRO-SPIRIT)" @default.
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