Andrea Becciolini, Antonio Marchesoni, Simone Parisi, Alberto Lo Gullo, Olga Addimanda, Eleonora Celletti, Luca Idolazzi, Romina Andracco, Marino Paroli, Patrizia Del Medico, Antonella Farina, Palma Scolieri, Aurora Ianniello, Federica Lumetti, Cecilia Giampietro, Camilla Mazzanti, Alessandra Bezzi, Elisa Visalli, Elena Bravi, Alessandro Volpe, Rosetta Vitetta, Marta Priora, Viviana Ravagnani, Bernd Raffeiner, Aldo Biagio Molica Colella, Maddalena Larosa, Francesco Girelli, Veronica Franchina, Giulio Ferrero, Francesca Ometto, Valeria Nucera, Francesca Serale, Rosalba Caccavale, Mirco Magnani, Natalia Mansueto, Gianluca Smerilli, Maria Chiara Ditto, Riccardo Bixio, Maria Cristina Focherini, Fabio Mascella, Myriam Di Penta, Emanuela Sabatini, Alessia Fiorenza, Davide Murgia, Guido Rovera, Claudio Angrisani, Massimiliano De Simone, Giuditta Adorni, Eleonora Di Donato, Daniele Santilli, Roberta Foti, Ylenia Dal Bosco, Francesco De Lucia, Giorgio Amato, Francesco Molica Colella, Ilaria Platè, Vincenzo Bruzzese, Gerolamo Bianchi, Simone Bernardi, Antonio Marchetta, Rosario Foti, Gianluca Santoboni, Dario Camellino, Francesco Cipollone, Enrico Fusaro, Eugenio Arrigoni, Gianluca Lucchini, Gilda Sandri, Dilia Giuggioli, Massimo Reta, Alarico Ariani
{"title":"Guselkumab effectiveness in real-world settings: observations from an Italian multicentre study.","authors":"Andrea Becciolini, Antonio Marchesoni, Simone Parisi, Alberto Lo Gullo, Olga Addimanda, Eleonora Celletti, Luca Idolazzi, Romina Andracco, Marino Paroli, Patrizia Del Medico, Antonella Farina, Palma Scolieri, Aurora Ianniello, Federica Lumetti, Cecilia Giampietro, Camilla Mazzanti, Alessandra Bezzi, Elisa Visalli, Elena Bravi, Alessandro Volpe, Rosetta Vitetta, Marta Priora, Viviana Ravagnani, Bernd Raffeiner, Aldo Biagio Molica Colella, Maddalena Larosa, Francesco Girelli, Veronica Franchina, Giulio Ferrero, Francesca Ometto, Valeria Nucera, Francesca Serale, Rosalba Caccavale, Mirco Magnani, Natalia Mansueto, Gianluca Smerilli, Maria Chiara Ditto, Riccardo Bixio, Maria Cristina Focherini, Fabio Mascella, Myriam Di Penta, Emanuela Sabatini, Alessia Fiorenza, Davide Murgia, Guido Rovera, Claudio Angrisani, Massimiliano De Simone, Giuditta Adorni, Eleonora Di Donato, Daniele Santilli, Roberta Foti, Ylenia Dal Bosco, Francesco De Lucia, Giorgio Amato, Francesco Molica Colella, Ilaria Platè, Vincenzo Bruzzese, Gerolamo Bianchi, Simone Bernardi, Antonio Marchetta, Rosario Foti, Gianluca Santoboni, Dario Camellino, Francesco Cipollone, Enrico Fusaro, Eugenio Arrigoni, Gianluca Lucchini, Gilda Sandri, Dilia Giuggioli, Massimo Reta, Alarico Ariani","doi":"10.1093/rap/rkaf094","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>Guselkumab is a biologic disease-modifying antirheumatic drug (bDMARD) with proven efficacy for psoriatic arthritis (PsA) in randomized controlled trials. Evidence of its effectiveness from clinical practice remains limited. We evaluated the real-world effectiveness of guselkumab for PsA (primary objective) and identified factors influencing clinical outcomes.</p><p><strong>Methods: </strong>This retrospective, observational, multicentre study enrolled consecutive patients with PsA prescribed guselkumab for joint involvement at 26 Italian rheumatology referral centres. Baseline data included patient history, PsA subtype, treatment history and disease activity. Treatment effectiveness was assessed with Kaplan-Meier curves; Cox proportional hazards analysis identified factors associated with treatment persistence.</p><p><strong>Results: </strong>The study included 278 patients (median age: 57 years [interquartile range, IQR: 50-63]; 64.4% female); median observation 10.7 months (IQR: 5.3-15.9; total: 3332.6 patient-months). Retention rates at 6, 12 and 24 months were 90.4%, 80.0% and 67.8%, respectively. Reasons for discontinuation included primary inefficacy (48% of 54 cases), secondary inefficacy (41%) and skin/mucosal intolerance (4%). Statistically significant factors (<i>P </i>< 0.05) influencing treatment persistence included sex, smoking, concurrent conventional synthetic DMARDs (csDMARDs), corticosteroid use, year of prescription and axial or enthesitic involvement.</p><p><strong>Conclusions: </strong>Approximately two-thirds of PsA patients treated with guselkumab remained on therapy after 2 years. Adverse events motivated <10% of discontinuations. Effectiveness was higher in patients with enthesitic or axial PsA and in those without concurrent corticosteroids or csDMARDs, confirming the effectiveness and safety of guselkumab as an optimal choice for monotherapy, particularly in PsA patients with enthesitis, with or without joint impairment, and/or axial involvement.</p>","PeriodicalId":21350,"journal":{"name":"Rheumatology Advances in Practice","volume":"9 4","pages":"rkaf094"},"PeriodicalIF":2.1000,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12448697/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Rheumatology Advances in Practice","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/rap/rkaf094","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Objectives: Guselkumab is a biologic disease-modifying antirheumatic drug (bDMARD) with proven efficacy for psoriatic arthritis (PsA) in randomized controlled trials. Evidence of its effectiveness from clinical practice remains limited. We evaluated the real-world effectiveness of guselkumab for PsA (primary objective) and identified factors influencing clinical outcomes.
Methods: This retrospective, observational, multicentre study enrolled consecutive patients with PsA prescribed guselkumab for joint involvement at 26 Italian rheumatology referral centres. Baseline data included patient history, PsA subtype, treatment history and disease activity. Treatment effectiveness was assessed with Kaplan-Meier curves; Cox proportional hazards analysis identified factors associated with treatment persistence.
Results: The study included 278 patients (median age: 57 years [interquartile range, IQR: 50-63]; 64.4% female); median observation 10.7 months (IQR: 5.3-15.9; total: 3332.6 patient-months). Retention rates at 6, 12 and 24 months were 90.4%, 80.0% and 67.8%, respectively. Reasons for discontinuation included primary inefficacy (48% of 54 cases), secondary inefficacy (41%) and skin/mucosal intolerance (4%). Statistically significant factors (P < 0.05) influencing treatment persistence included sex, smoking, concurrent conventional synthetic DMARDs (csDMARDs), corticosteroid use, year of prescription and axial or enthesitic involvement.
Conclusions: Approximately two-thirds of PsA patients treated with guselkumab remained on therapy after 2 years. Adverse events motivated <10% of discontinuations. Effectiveness was higher in patients with enthesitic or axial PsA and in those without concurrent corticosteroids or csDMARDs, confirming the effectiveness and safety of guselkumab as an optimal choice for monotherapy, particularly in PsA patients with enthesitis, with or without joint impairment, and/or axial involvement.
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