Long-term persistence with guselkumab: a 5-year multicenter retrospective study across 14 dermatology centers in Italy

Nicoletta  Bernardini; Giacomo Caldarola; Antonio Giovanni Richetta; Maria Esposito; Federica Trovato; Paolo Amerio; Edvige Morea; Claudio Bonifati; Dario Graceffa; Pier Luigi Bruni; Domenico Giordano; Severino Persechino; Annamaria Mazzotta; Gaia Moretta; Gianluca Pagnanelli; Sabatino Pallotta; Jasmine Anedda; Cristina Mugheddu; Emanuele Miraglia; Vincenzo Panasiti; Elisa Molinelli; Oriana Simonetti; Maria Concetta Fargnoli; Ketty Peris; Giovanni Pellacani; Concetta Potenza; Annunziata Dattola

doi:10.5826/dpc.1504a6646

Long-term persistence with guselkumab: a 5-year multicenter retrospective study across 14 dermatology centers in Italy

Authors

Nicoletta Bernardini Dermatology Unit, A. Fiorini Hospital, Sapienza University of Rome – Polo Pontino, Terracina, Italy
Giacomo Caldarola Department of Abdominal and Endocrine-Metabolic Medical and Surgical Sciences, Policlinico Gemelli, Rome, Italy
Antonio Giovanni Richetta Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Policlinico Umberto I, Rome, Italy
Maria Esposito Unit of General and Oncologic Dermatology, San Salvatore Hospital, L’Aquila, Italy
Federica Trovato Dermatology Clinic, Sapienza University of Rome, Rome, Italy
Paolo Amerio Dermatology Unit, Local Health Authority ASL2 Abruzzo, Chieti, Italy
Edvige Morea Dermatology Unit, Local Health Authority ASL2 Abruzzo, Chieti, Italy
Claudio Bonifati Clinical Dermatology – Psoriasis Center, San Gallicano Dermatological Institute (IRCCS), Rome, Italy
Dario Graceffa IFO-San Gallicano Hospital, Rome,
Pier Luigi Bruni Dermatology Clinic, Terni, Italy
Domenico Giordano Sant'Andrea Hospital, Rome, Italy
Severino Persechino Department of Neurosciences, Mental Health and Sensory Organs (NESMOS), Sapienza University of Rome, Rome, Italy
Annamaria Mazzotta Dermatology Unit, San Camillo Forlanini Hospital, Rome, Italy
Gaia Moretta IDI-IRCCS, Luigi Maria Monti Foundation, Rome, Italy
Gianluca Pagnanelli IDI-IRCCS, Luigi Maria Monti Foundation, Rome,
Sabatino Pallotta IDI-IRCCS, Luigi Maria Monti Foundation, Rome, Italy
Jasmine Anedda Department of Medical Sciences and Public Health, Dermatology Clinic, University of Cagliari, Cagliari, Italy
Cristina Mugheddu Department of Medical Sciences and Public Health, Dermatology Clinic, University of Cagliari, Cagliari, Italy
Emanuele Miraglia San Sebastiano Hospital, Frascati, Italy
Vincenzo Panasiti Dermatology Unit, Campus Bio-Medico University Hospital, Rome, Italy
Elisa Molinelli Dermatology Clinic, Azienda Ospedaliero-Universitaria Ospedali Riuniti, Ancona, Italy
Oriana Simonetti Dermatology Clinic, Azienda Ospedaliero-Universitaria Ospedali Riuniti, Ancona, Italy
Maria Concetta Fargnoli Unit of General and Oncologic Dermatology, San Salvatore Hospital, L’Aquila, Italy
Ketty Peris Department of Abdominal and Endocrine-Metabolic Medical and Surgical Sciences, Policlinico Gemelli, Rome, Italy
Giovanni Pellacani Department of Clinical Internal, Anesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Rome, Italy
Concetta Potenza Dermatology Unit – Polo Pontino, Sapienza University of Rome, Rome, Italy
Annunziata Dattola Dermatology Clinic, Sapienza University of Rome, Rome, Italy

Keywords:

• Psoriasis, • Guselkumab, • Drug survival, • Real-world evidence, • Biologic therapy

Abstract

Introduction: Psoriasis is a chronic systemic inflammatory disease that requires long-term treatment strategies to maintain sustained disease control. Treatment persistence is an important real-world indicator of therapeutic effectiveness and tolerability. Guselkumab, an IL-23 inhibitor, has shown favorable persistence in several studies, but extended long-term data remain limited.

Objectives: To assess 3- and 5-year drug survival rates of guselkumab in patients with moderate-to-severe plaque psoriasis and to examine the relationship between persistence and clinical variables such as PASI, BMI, prior biologic exposure, and involvement of difficult-to-treat areas.

Methods: This was a multicenter retrospective observational study conducted across 14 dermatology centers in Italy. Adult patients with moderate-to-severe plaque psoriasis who started guselkumab were included. Data collected included demographics, clinical history, disease severity, comorbidities, and treatment details. Drug survival was analyzed using Kaplan–Meier curves and Cox proportional hazards models.

Results: A total of 247 patients were included. At three years, 80.2% of patients remained on guselkumab, and at five years, 72.8% continued treatment. Persistence was not significantly influenced by BMI, PASI, or age. However, prior biologics exposure was associated with a higher risk of discontinuation (hazard ratio (HR): 1.84; P=0.0208), especially in those previously treated with IL-17 inhibitors (HR:2.14; P=0.0150). The involvement of difficult-to-treat areas did not significantly affect persistence, although a trend toward reduced discontinuation was observed in patients with genital involvement (P=0.0539).

Conclusions: Guselkumab demonstrated high long-term persistence in real-world clinical practice. Drug survival remained consistently high across various subgroups, with prior IL-17 inhibitor exposure being the main predictor of decreased persistence.

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