Guselkumab effectiveness in real-world settings: observations from an Italian multicentre study.
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Becciolini Andrea, Marchesoni Antonio, Parisi Simone, Lo Gullo Alberto, Addimanda Olga, Celletti Eleonora, Idolazzi Luca, Andracco Romina, Paroli Marino, Del Medico Patrizia, Farina Antonella, Scolieri Palma, Ianniello Aurora, Lumetti Federica, Giampietro Cecilia, Mazzanti Camilla, Bezzi Alessandra, Visalli Elisa, Bravi Elena, Volpe Alessandro, Vitetta Rosetta, Priora Marta, Ravagnani Viviana, Raffeiner Bernd, Molica Colella Aldo Biagio, Larosa Maddalena, Girelli Francesco, Franchina Veronica, Ferrero Giulio, Ometto Francesca, Nucera Valeria, Serale Francesca, Caccavale Rosalba, Magnani Mirco, Mansueto Natalia, Smerilli Gianluca, Ditto Maria Chiara, Bixio Riccardo, Focherini Maria Cristina, Mascella Fabio, Di Penta Myriam, Sabatini Emanuela, Fiorenza Alessia, Murgia Davide, Rovera Guido, Angrisani Claudio, De Simone Massimiliano, Adorni Giuditta, Di Donato Eleonora, Santilli Daniele, Foti Roberta, Dal Bosco Ylenia, De Lucia Francesco, Amato Giorgio, Molica Colella Francesco, Platè Ilaria, Bruzzese Vincenzo, Bianchi Gerolamo, Bernardi Simone, Marchetta Antonio, Foti Rosario, Santoboni Gianluca, Camellino Dario, Cipollone Francesco, Fusaro Enrico, Arrigoni Eugenio, Lucchini Gianluca, Sandri Gilda, Giuggioli Dilia, Reta Massimo, Ariani Alarico
Аннотация
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.