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Real-world evidence of biologic treatments in psoriatic arthritis in Italy: results of the CHRONOS (EffeCtiveness of biologic treatments for psoriatic artHRitis in Italy: an ObservatioNal lOngitudinal Study of real-life clinical practice) observational longitudinal study

BACKGROUND: Biologics have demonstrated efficacy in PsA in randomized clinical trials. More evidence is needed on their effectiveness under real clinical practice conditions. The aim of the present work is to provide real-world evidence of the effectiveness of biologics for PsA in the daily clinical...

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Autores principales: Colombo, Delia, Frassi, Micol, Pagano Mariano, Giusy, Fusaro, Enrico, Lomater, Claudia, Del Medico, Patrizia, Iannone, Florenzo, Foti, Rosario, Limonta, Massimiliano, Marchesoni, Antonio, Raffeiner, Bernd, Viapiana, Ombretta, Grassi, Walter, Grembiale, Rosa Daniela, Guggino, Giuliana, Mazzone, Antonino, Tirri, Enrico, Perricone, Roberto, Sarzi Puttini, Pier Carlo, De Vita, Salvatore, Conti, Fabrizio, Ori, Alessandra, Simoni, Lucia, Fiocchi, Martina, Orsenigo, Roberto, Zagni, Emanuela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9464489/
https://www.ncbi.nlm.nih.gov/pubmed/36089612
http://dx.doi.org/10.1186/s41927-022-00284-w
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author Colombo, Delia
Frassi, Micol
Pagano Mariano, Giusy
Fusaro, Enrico
Lomater, Claudia
Del Medico, Patrizia
Iannone, Florenzo
Foti, Rosario
Limonta, Massimiliano
Marchesoni, Antonio
Raffeiner, Bernd
Viapiana, Ombretta
Grassi, Walter
Grembiale, Rosa Daniela
Guggino, Giuliana
Mazzone, Antonino
Tirri, Enrico
Perricone, Roberto
Sarzi Puttini, Pier Carlo
De Vita, Salvatore
Conti, Fabrizio
Ori, Alessandra
Simoni, Lucia
Fiocchi, Martina
Orsenigo, Roberto
Zagni, Emanuela
author_facet Colombo, Delia
Frassi, Micol
Pagano Mariano, Giusy
Fusaro, Enrico
Lomater, Claudia
Del Medico, Patrizia
Iannone, Florenzo
Foti, Rosario
Limonta, Massimiliano
Marchesoni, Antonio
Raffeiner, Bernd
Viapiana, Ombretta
Grassi, Walter
Grembiale, Rosa Daniela
Guggino, Giuliana
Mazzone, Antonino
Tirri, Enrico
Perricone, Roberto
Sarzi Puttini, Pier Carlo
De Vita, Salvatore
Conti, Fabrizio
Ori, Alessandra
Simoni, Lucia
Fiocchi, Martina
Orsenigo, Roberto
Zagni, Emanuela
author_sort Colombo, Delia
collection PubMed
description BACKGROUND: Biologics have demonstrated efficacy in PsA in randomized clinical trials. More evidence is needed on their effectiveness under real clinical practice conditions. The aim of the present work is to provide real-world evidence of the effectiveness of biologics for PsA in the daily clinical practice. METHODS: CHRONOS was a multicenter, non-interventional, cohort study conducted in 20 Italian hospital rheumatology clinics. RESULTS: 399 patients were eligible (56.9% females, mean (SD) age: 52.4 (11.6) years). The mean (SD) duration of PsA and psoriasis was 7.2 (6.9) and 15.3 (12.2) years, respectively. The mean (SD) duration of the biologic treatment under analysis was 18.6 (6.5) months. The most frequently prescribed biologic was secukinumab (40.4%), followed by adalimumab (17.8%) and etanercept (16.5%). The proportion of overall responders according to EULAR DAS28 criteria was 71.8% (95% CI: 66.7–76.8%) out of 308 patients at 6 months and 68.0% (95% CI: 62.7–73.3%) out of 297 patients at 1 year. Overall, ACR20/50/70 responses at 6 months were 41.2% (80/194), 29.4% (57/194), 17.1% (34/199) and at 1-year were 34.9% (66/189), 26.7% (51/191), 18.4% (36/196), respectively. Secondary outcome measures improved rapidly already at 6 months: mean (SD) PASI, available for 87 patients, decreased from 3.2 (5.1) to 0.6 (1.3), the proportion of patients with dactylitis from 23.6% (35/148) to 3.5% (5/142) and those with enthesitis from 33.3% (49/147) to 9.0% (12/133). CONCLUSIONS: The CHRONOS study provides real-world evidence of the effectiveness of biologics in PsA in the Italian rheumatological practice, confirming the efficacy reported in RCTs across various outcome measures. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s41927-022-00284-w.
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spelling pubmed-94644892022-09-12 Real-world evidence of biologic treatments in psoriatic arthritis in Italy: results of the CHRONOS (EffeCtiveness of biologic treatments for psoriatic artHRitis in Italy: an ObservatioNal lOngitudinal Study of real-life clinical practice) observational longitudinal study Colombo, Delia Frassi, Micol Pagano Mariano, Giusy Fusaro, Enrico Lomater, Claudia Del Medico, Patrizia Iannone, Florenzo Foti, Rosario Limonta, Massimiliano Marchesoni, Antonio Raffeiner, Bernd Viapiana, Ombretta Grassi, Walter Grembiale, Rosa Daniela Guggino, Giuliana Mazzone, Antonino Tirri, Enrico Perricone, Roberto Sarzi Puttini, Pier Carlo De Vita, Salvatore Conti, Fabrizio Ori, Alessandra Simoni, Lucia Fiocchi, Martina Orsenigo, Roberto Zagni, Emanuela BMC Rheumatol Research BACKGROUND: Biologics have demonstrated efficacy in PsA in randomized clinical trials. More evidence is needed on their effectiveness under real clinical practice conditions. The aim of the present work is to provide real-world evidence of the effectiveness of biologics for PsA in the daily clinical practice. METHODS: CHRONOS was a multicenter, non-interventional, cohort study conducted in 20 Italian hospital rheumatology clinics. RESULTS: 399 patients were eligible (56.9% females, mean (SD) age: 52.4 (11.6) years). The mean (SD) duration of PsA and psoriasis was 7.2 (6.9) and 15.3 (12.2) years, respectively. The mean (SD) duration of the biologic treatment under analysis was 18.6 (6.5) months. The most frequently prescribed biologic was secukinumab (40.4%), followed by adalimumab (17.8%) and etanercept (16.5%). The proportion of overall responders according to EULAR DAS28 criteria was 71.8% (95% CI: 66.7–76.8%) out of 308 patients at 6 months and 68.0% (95% CI: 62.7–73.3%) out of 297 patients at 1 year. Overall, ACR20/50/70 responses at 6 months were 41.2% (80/194), 29.4% (57/194), 17.1% (34/199) and at 1-year were 34.9% (66/189), 26.7% (51/191), 18.4% (36/196), respectively. Secondary outcome measures improved rapidly already at 6 months: mean (SD) PASI, available for 87 patients, decreased from 3.2 (5.1) to 0.6 (1.3), the proportion of patients with dactylitis from 23.6% (35/148) to 3.5% (5/142) and those with enthesitis from 33.3% (49/147) to 9.0% (12/133). CONCLUSIONS: The CHRONOS study provides real-world evidence of the effectiveness of biologics in PsA in the Italian rheumatological practice, confirming the efficacy reported in RCTs across various outcome measures. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s41927-022-00284-w. BioMed Central 2022-09-12 /pmc/articles/PMC9464489/ /pubmed/36089612 http://dx.doi.org/10.1186/s41927-022-00284-w Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Colombo, Delia
Frassi, Micol
Pagano Mariano, Giusy
Fusaro, Enrico
Lomater, Claudia
Del Medico, Patrizia
Iannone, Florenzo
Foti, Rosario
Limonta, Massimiliano
Marchesoni, Antonio
Raffeiner, Bernd
Viapiana, Ombretta
Grassi, Walter
Grembiale, Rosa Daniela
Guggino, Giuliana
Mazzone, Antonino
Tirri, Enrico
Perricone, Roberto
Sarzi Puttini, Pier Carlo
De Vita, Salvatore
Conti, Fabrizio
Ori, Alessandra
Simoni, Lucia
Fiocchi, Martina
Orsenigo, Roberto
Zagni, Emanuela
Real-world evidence of biologic treatments in psoriatic arthritis in Italy: results of the CHRONOS (EffeCtiveness of biologic treatments for psoriatic artHRitis in Italy: an ObservatioNal lOngitudinal Study of real-life clinical practice) observational longitudinal study
title Real-world evidence of biologic treatments in psoriatic arthritis in Italy: results of the CHRONOS (EffeCtiveness of biologic treatments for psoriatic artHRitis in Italy: an ObservatioNal lOngitudinal Study of real-life clinical practice) observational longitudinal study
title_full Real-world evidence of biologic treatments in psoriatic arthritis in Italy: results of the CHRONOS (EffeCtiveness of biologic treatments for psoriatic artHRitis in Italy: an ObservatioNal lOngitudinal Study of real-life clinical practice) observational longitudinal study
title_fullStr Real-world evidence of biologic treatments in psoriatic arthritis in Italy: results of the CHRONOS (EffeCtiveness of biologic treatments for psoriatic artHRitis in Italy: an ObservatioNal lOngitudinal Study of real-life clinical practice) observational longitudinal study
title_full_unstemmed Real-world evidence of biologic treatments in psoriatic arthritis in Italy: results of the CHRONOS (EffeCtiveness of biologic treatments for psoriatic artHRitis in Italy: an ObservatioNal lOngitudinal Study of real-life clinical practice) observational longitudinal study
title_short Real-world evidence of biologic treatments in psoriatic arthritis in Italy: results of the CHRONOS (EffeCtiveness of biologic treatments for psoriatic artHRitis in Italy: an ObservatioNal lOngitudinal Study of real-life clinical practice) observational longitudinal study
title_sort real-world evidence of biologic treatments in psoriatic arthritis in italy: results of the chronos (effectiveness of biologic treatments for psoriatic arthritis in italy: an observational longitudinal study of real-life clinical practice) observational longitudinal study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9464489/
https://www.ncbi.nlm.nih.gov/pubmed/36089612
http://dx.doi.org/10.1186/s41927-022-00284-w
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