Abstract
Abstract Background/Aims The Psoriatic Arthritis Observational Study of Persistence of Treatment (PRO-SPIRIT) is the first large-sample, multinational, prospective, observational study to provide real-world evidence for ixekizumab (IXE) in patients with psoriatic arthritis (PsA) who start a new biologic/targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD), with a primary end point of persistence at 24 months. Aims: To describe baseline characteristics of PRO-SPIRIT patients initiating or switching to IXE, secukinumab (SEC) or a tumour necrosis factor inhibitor (TNFi) in Canada (CA), France (FR), Germany (DE), Italy (IT), Spain (ES) and the United Kingdom (UK). Methods PRO-SPIRIT enrolled adults diagnosed with PsA (≥6 months) between December 2019 and June 2022 to be initiated or switched to a new b/tsDMARD, locally approved for the management of PsA. Baseline characteristics, including patient demographics, therapy and disease activity measures, are described here by country for patients initiating IXE, SEC (both IL-17A inhibitors) or a TNFi (adalimumab, etanercept, infliximab or biosimilar) only. Results This analysis included 943 patients (Table 1). The overall proportion of patients with BMI ≥30 mg/kg2 was highest in CA (67.2%) and lowest in IT (24.5%); across countries, higher proportions of patients initiating an IL-17A vs a TNFi had BMI ≥30 mg/kg2 (except IXE groups in IT, ES and UK). Higher proportions of patients initiating an IL-17A vs a TNFi were diagnosed with PsA ≥3 years before baseline (except SEC groups in DE and ES). The highest proportions of b/tsDMARD-naïve patients were observed in the TNFi groups in all countries (range 46.2% [CA] to 81.9% [UK]). Patients in the IL-17A groups were more likely to be on monotherapy than patients in the TNFi groups (except in FR). There were no clear trends in baseline disease activity for patients initiating IL-17As or TNFis, although country-specific differences were observed. Conclusion The PRO-SPIRIT baseline characteristics described offer important insights into country-specific patient demographics and treatment patterns when initiating or switching to a new b/tsDMARD in a real-world setting. Between-country variations observed in PRO-SPIRIT baseline characteristics may be due to differences in healthcare systems and/or the evolution of treatment options for patients with PsA in each country. Disclosure N. Gullick: Consultancies; AbbVie,Novartis, UCB. Honoraria; AbbVie, Eli Lilly, Janssen, Novartis, UCB. Grants/research support; AbbVie, Astra Zeneca, Eli Lilly, Novartis. M. Sheesh: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. C. Laedermann: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. M. Ngantcha: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. B. Gittens: Corporate appointments; Eli Lilly and Company. K. Ng: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. W. Tillett: Consultancies; Abbvie, Amgen, Eli Lilly and Company, GSK, Janssen, Novartis, Ono Pharma, Pfizer, UCB. Member of speakers’ bureau; AbbVie, Amgen, Eli Lilly and Company, GSK, Janssen, Novartis, Pfizer, UCB. Grants/research support; Janssen, UCB, Pfizer, Eli Lilly and Company. J. Morel: Consultancies; Pfizer, AbbVie, Boerhinger Ingelheim, Galapagos, GSK. Member of speakers’ bureau; Biogen, Amgen, Bristol Myers Squib, Eli Lilly and Company, Novartis, Sanofi, MSD, Mylan, Fresenius Kabi, Roche, Union Chimique Belge, Janssen, Medac, Nordic Pharma. Grants/research support; Fresenius Kabi. E. Lubrano: Member of speakers’ bureau; Abbvie, Janssen Cilag, Lilly, UCB, Pfizer, Novartis. R. Alten: Consultancies; AbbVie, BMS, Celltrion, Galapagos, Eli Lilly and Company, Novartis, Pfizer, Roche, UC. Member of speakers’ bureau; AbbVie, BMS, Celltrion, Galapagos, Eli Lilly and Company, Novartis, Pfizer, Roche, UCB. L. Kristensen: Consultancies; Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company, Janssen. Member of speakers’ bureau; Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company, Janssen. Grants/research support; Pfizer, Abb- Vie, UCB, Gilead, Biogen, Novartis, Eli Lilly and Company, Janssen. V. Chandran: Consultancies; AbbVie, Eli Lilly, Novartis, Amgen, Janssen. Grants/research support; AbbVie. A. Martinez-Ferrer: Grants/research support; Eli Lilly and Company. B. Kirkham: Consultancies; Abbvie, Eli Lilly and Company, Galapagos, Novartis. Member of speakers’ bureau; Abbvie, Eli Lilly and Company, Galapagos, Janssen, Novartis, Pfizer, UCB. Grants/research support; Eli Lilly and Company, Novartis.
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