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Publications

Journal Article Ppublish

PubMed: 40608253 DOI: 10.1007/s13555-025-01476-1

Guselkumab Retention, Effectiveness, and Safety in Psoriasis: A 260-Week Real-World Multicenter Retrospective Study Exploring the Role of Concomitant PsA-IL PSO (Italian Landscape Psoriasis).

Dermatol Ther (Heidelb) 15(9):2423-2437

Authors: Mario Valenti, Luciano Ibba, Sara Di Giulio, Paolo Dapavo, Piergiorgio Malagoli, Angelo V Marzano, Francesco Loconsole, Martina Burlando, Anna Balato, Valentina Dini, Matteo Megna, Giampiero Girolomoni, Emanuele Trovato, Claudia Lasagni, Massimo Travaglini, Claudio Guarneri, Nicola Zerbinati, Simone Ribero, Francesca M Gaiani, Carlo G Carrera, Emanuele C Cozzani, Eugenia V Di Brizzi, Alessandra Michelucci, Luca Potestio, Martina Maurelli, Martina Dragotto, Luca Mastorino, Eleonora Bongiovanni, Francesco Messina, Andrea Sechi, Rossana Moroni, Antonio Costanzo, Alessandra Narcisi

Affiliations

  • Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
  • Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
  • Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
  • Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
  • Dermatologic Clinic, Department of Clinical Medicine, University of Turin, Turin, Italy.
  • Department of Dermatology, Dermatology Unit Azienda Ospedaliera San Donato Milanese, Milan, Italy.
  • Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
  • Department of Pathophysiology and Transplantation, Università Degli Studi di Milano, Milan, Italy.
  • Department of Dermatology, University of Bari, Piazza Umberto I, 1, 70121, Bari, Italy.
  • Department of Dermatology, Dipartimento di Scienze della Salute (DISSal), University of Genoa, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
  • Dermatology Unit, University of Campania L. Vanvitelli, Naples, Italy.
  • Department of Dermatology, University of Pisa, Pisa, Italy.
  • Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
  • Department of Medicine, Section of Dermatology, University of Verona, Verona, Italy.
  • Unit of Dermatology, Department of Medical, Surgical and Neurological Sciences, University of Siena, Siena, Italy.
  • Dermatological Clinic, Department of Specialized Medicine, University of Modena, Modena, Italy.
  • U.O.S.D. Dermatologica-Centro per la Cura della Psoriasi, Ospedale Perrino, Brindisi, Italy.
  • Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
  • Dermatology Unit, Department of Medicine and Surgery, University of Insubria, Varese, Italy.
  • Rome, Italy.

Abstract

INTRODUCTION

Guselkumab is a monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, approved for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis (PsA). While patients with psoriasis often achieve high clinical response rates (Psoriasis Area and Severity Index [PASI] 90 and PASI 100), the presence of PsA may influence long-term outcomes. We conducted a 260-week, multicenter, retrospective study to compare the effectiveness, safety, and drug survival of guselkumab in patients with and without concomitant PsA.

METHODS

A total of 1765 patients were enrolled, including 352 with a concomitant diagnosis of PsA and 1413 with isolated skin involvement. All patients were treated with guselkumab following the approved dosing schedule for moderate-to-severe plaque psoriasis for at least 1 year. Treatment effectiveness was evaluated in terms of PASI 90, PASI 100, and absolute PASI ≤ 2 at weeks 16, 28, 52, 104, 156, 204, and 260. Guselkumab drug survival was assessed using the Kaplan-Meier method at the same time points. The safety profile was evaluated by analyzing adverse events recorded in medical charts at each follow-up visit.

RESULTS

Throughout the study period, response rates remained comparable between the two cohorts of patients, with a significant difference at 2 years of follow-up in terms of PASI 90 (80.51% versus 74.02%). Drug survival overall remained stable and similar, with 79.5% (95% confidence interval (CI) 76.9-81.9) of patients without PsA and 78.5% (95% CI 72.9-83.1) of patients with PsA still receiving guselkumab treatment after 5 years.

CONCLUSIONS

Our results confirm the long-term effectiveness, persistence, and favorable safety profile of guselkumab in patients with moderate-to-severe psoriasis, regardless of the presence of concomitant PsA.

MeSH

Safety, Pharmaceutical Preparations, Retrospective Studies, Therapeutics, Retention, Psychology, Psoriasis