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. 2025 Sep 8;9(4):rkaf094.
doi: 10.1093/rap/rkaf094. eCollection 2025.

Guselkumab effectiveness in real-world settings: observations from an Italian multicentre study

Andrea Becciolini  1 , Antonio Marchesoni  2 , Simone Parisi  3 , Alberto Lo Gullo  4 , Olga Addimanda  5 , Eleonora Celletti  6 , Luca Idolazzi  7 , Romina Andracco  8 , Marino Paroli  9 , Patrizia Del Medico  10 , Antonella Farina  11 , Palma Scolieri  12 , Aurora Ianniello  13 , Federica Lumetti  14 , Cecilia Giampietro  15 , Camilla Mazzanti  16 , Alessandra Bezzi  17 , Elisa Visalli  18 , Elena Bravi  19 , Alessandro Volpe  20 , Rosetta Vitetta  21 , Marta Priora  22 , Viviana Ravagnani  23 , Bernd Raffeiner  24 , Aldo Biagio Molica Colella  25 , Maddalena Larosa  26 , Francesco Girelli  27 , Veronica Franchina  28 , Giulio Ferrero  29 , Francesca Ometto  15 , Valeria Nucera  13 , Francesca Serale  22 , Rosalba Caccavale  9 , Mirco Magnani  5 , Natalia Mansueto  8 , Gianluca Smerilli  10 , Maria Chiara Ditto  3 , Riccardo Bixio  20 , Maria Cristina Focherini  17 , Fabio Mascella  17 , Myriam Di Penta  6 , Emanuela Sabatini  6 , Alessia Fiorenza  21 , Davide Murgia  21 , Guido Rovera  21 , Claudio Angrisani  16 , Massimiliano De Simone  16 , Giuditta Adorni  1 , Eleonora Di Donato  1 , Daniele Santilli  1 , Roberta Foti  18 , Ylenia Dal Bosco  18 , Francesco De Lucia  18 , Giorgio Amato  18 , Francesco Molica Colella  30 , Ilaria Platè  19 , Vincenzo Bruzzese  12 , Gerolamo Bianchi  26 , Simone Bernardi  27 , Antonio Marchetta  20 , Rosario Foti  18 , Gianluca Santoboni  16 , Dario Camellino  26 , Francesco Cipollone  6 , Enrico Fusaro  3 , Eugenio Arrigoni  19 , Gianluca Lucchini  1 , Gilda Sandri  31 , Dilia Giuggioli  31 , Massimo Reta  5 , Alarico Ariani  1
Affiliations

Guselkumab effectiveness in real-world settings: observations from an Italian multicentre study

Andrea Becciolini et al. Rheumatol Adv Pract. .

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.

Keywords: drug retention rate; guselkumab; psoriatic arthritis; real-world effectiveness.

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Figures

Figure 1.
Figure 1.
Kaplan–Meier estimates of the guselkumab retention rate over 24 months
Figure 2.
Figure 2.
Cox proportional hazards analysis of covariate factors associated with guselkumab treatment persistence over 24 months
See this image and copyright information in PMC

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