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Switching patterns of biological drugs in patients with psoriasis and psoriatic arthritis: insight from the VALORE database network.
Spini, Andrea; Pellegrini, Giorgia; Ingrasciotta, Ylenia; L'Abbate, Luca; Bellitto, Chiara; Carollo, Massimo; Leoni, Olivia; Zanforlini, Martina; Ancona, Domenica; Stella, Paolo; Cavazzana, Anna; Scapin, Angela; Lopes, Sara; Belleudi, Valeria; Ledda, Stefano; Carta, Paolo; Rossi, Paola; Ejlli, Lucian; Sapigni, Ester; Puccini, Aurora; Spila Alegiani, Stefania; Massari, Marco; Guarneri, Claudio; Gisondi, Paolo; Trifirò, Gianluca.
Afiliación
  • Spini A; Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
  • Pellegrini G; Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
  • Ingrasciotta Y; Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
  • L'Abbate L; Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
  • Bellitto C; Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
  • Carollo M; Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
  • Leoni O; Lombardy Regional Centre of Pharmacovigilance and Regional Epidemiologic Observatory, Milan, Italy.
  • Zanforlini M; Azienda Regionale per l'Innovazione e gli Acquisti, S.p.A, Milan, Italy.
  • Ancona D; Centro Regionale di Farmacovigilanza Regione Puglia, Bari, Italy.
  • Stella P; Centro Regionale di Farmacovigilanza Regione Puglia, Bari, Italy.
  • Cavazzana A; Azienda Zero, Regione Veneto, Italy.
  • Scapin A; Azienda Zero, Regione Veneto, Italy.
  • Lopes S; Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
  • Belleudi V; Department of Epidemiology, Lazio Regional Health Service, Rome, Italy.
  • Ledda S; Regione Autonoma della Sardegna, Cagliari, Italy.
  • Carta P; Regione Autonoma della Sardegna, Cagliari, Italy.
  • Rossi P; Friuli-Venezia Giulia Regional Center of Pharmacovigilance, Trieste, Italy.
  • Ejlli L; Friuli-Venezia Giulia Regional Center of Pharmacovigilance, Trieste, Italy.
  • Sapigni E; Emilia-Romagna Regional Center of Pharmacovigilance, Bologna, Italy.
  • Puccini A; Emilia-Romagna Regional Center of Pharmacovigilance, Bologna, Italy.
  • Spila Alegiani S; Pharmacoepidemiology and Pharmacovigilance Unit, National Centre for Drug Research and Evaluation, Italian National Institute of Health (ISS), Rome, Italy.
  • Massari M; Pharmacoepidemiology and Pharmacovigilance Unit, National Centre for Drug Research and Evaluation, Italian National Institute of Health (ISS), Rome, Italy.
  • Guarneri C; University of Messina, AOU "G.Martino", Messina, Italy.
  • Gisondi P; Department of Medicine, University of Verona, Verona, Italy.
  • Trifirò G; Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
Expert Opin Biol Ther ; 24(5): 399-409, 2024 May.
Article en En | MEDLINE | ID: mdl-38767132
ABSTRACT

BACKGROUND:

Switch patterns among different biologics and from originators to biosimilars (and vice versa) can be complex in patients with psoriasis (PsO) and psoriatic arthritis (PsA).

OBJECTIVE:

The aim of this study was to describe switching patterns of biological drugs in PsO/PsA patients and to explore predictors of multiple switches and switch-back. RESEARCH DESIGN AND

METHODS:

A large-scale retrospective cohort study was conducted using the Italian VALORE database. Bio-naïve users treated for PsO/PsA during 2010-2022 were included. Time to switch/swap and predictors of multiple switches and switch-back were analyzed.

RESULTS:

Thirty-thousand seven hundred bio-naïve users were included. At 3 and 5 years of follow-up, patients with at least one switch/swap were 37.1% and 47.8%, respectively. The median time to first switch/swap was significantly shorter (p< 0.001) for TNF-α inhibitors (2,068 days) than anti-IL (2,780 days). At 1 year of follow-up patients starting with IL-23 switched/swapped biological therapy less frequently than those with anti-IL-12/23 and anti-IL-17 (4.9% vs. 8.7% and 9.4%, respectively). Patients starting with anti-IL-12/23 reported a significantly lower risk of multiple switches and switch-back (0.74, 95% CI, 0.67-0.83; 0.58, 95% CI, 0.44-0.77, respectively) than those with TNF-α inhibitors.

CONCLUSIONS:

Patients with PsO/PsA starting with TNF-α inhibitors switch/swap more rapidly and frequently than those with anti-IL, which are also associated with a reduced risk of multiple switches during follow-up.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Psoriasis / Productos Biológicos / Artritis Psoriásica / Bases de Datos Factuales / Sustitución de Medicamentos Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Expert Opin Biol Ther Asunto de la revista: BIOLOGIA / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Italia

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Psoriasis / Productos Biológicos / Artritis Psoriásica / Bases de Datos Factuales / Sustitución de Medicamentos Límite: Adult / Female / Humans / Male / Middle aged País/Región como asunto: Europa Idioma: En Revista: Expert Opin Biol Ther Asunto de la revista: BIOLOGIA / TERAPEUTICA Año: 2024 Tipo del documento: Article País de afiliación: Italia