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. 2025 Sep;15(9):2423-2437.
doi: 10.1007/s13555-025-01476-1. Epub 2025 Jul 3.

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)

Mario Valenti #  1   2 , Luciano Ibba #  3   4 , Sara Di Giulio  3   4 , Paolo Dapavo  5 , Piergiorgio Malagoli  6 , Angelo V Marzano  7   8 , Francesco Loconsole  9 , Martina Burlando  10 , Anna Balato  11 , Valentina Dini  12 , Matteo Megna  13 , Giampiero Girolomoni  14 , Emanuele Trovato  15 , Claudia Lasagni  16 , Massimo Travaglini  17 , Claudio Guarneri  18 , Nicola Zerbinati  19 , Simone Ribero  5 , Francesca M Gaiani  6 , Carlo G Carrera  7 , Emanuele C Cozzani  10 , Eugenia V Di Brizzi  6 , Alessandra Michelucci  12 , Luca Potestio  13 , Martina Maurelli  14 , Martina Dragotto  15 , Luca Mastorino  5 , Eleonora Bongiovanni  5 , Francesco Messina  6 , Andrea Sechi  7 , Rossana Moroni  20 , Antonio Costanzo  3   4 , Alessandra Narcisi  3   4
Affiliations

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)

Mario Valenti et al. Dermatol Ther (Heidelb). 2025 Sep.

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.

Keywords: Anti-IL-23; Biologics; Guselkumab; Psoriasis; Psoriatic arthritis; Real-life.

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Conflict of interest statement

Declarations. Conflicts of Interest: Mario Valenti has been a consultant and/or speaker for Sanofi, Leo Pharma, Eli Lilly, Novartis, Janssen, AbbVie, and Boehringer Ingelheim. Luciano Ibba has been a consultant for Almirall. Paolo Dapavo has been a speaker for Novartis, AbbVie, Sanofi, UCB, Janssen, Eli Lilly, and Leo Pharma. Piergiorgio Malagoli has been a speaker for AbbVie, Eli Lilly, Novartis, Janssen-Cilag, Celgene, Leo Pharma, and Almirall. Angelo V. Marzano reports consultancy/advisory board disease-relevant honoraria from AbbVie, Amgen, Boehringer-Ingelheim, Bristol Myers Squibb, Incyte, Leopharma, Novartis, Pfizer, Sanofi, and UCB. Francesco Loconsole served on advisory boards and/or received honoraria for lectures from Abbvie, Janssen-Cilag, Novartis, Lilly, and Sanofi. Martina Burlando has acted as a speaker and consultant for AbbVie, Janssen, Amgen, Novartis, Eli Lilly, and UCB Pharma. Anna Balato has served as consultant and/or has received fees from Abbvie, Almirall, Amgen, BI, BMS, Eli-Lilly, Janssen, Leo-Pharma, Novartis, Pfizer, Sanofi, and UCB. Matteo Megna acted as a speaker or consultant for AbbVie, Eli Lilly, Janssen, Leo Pharma, and Novartis. Giampiero Girolomoni has received personal fees from AbbVie, Almirall, Amgen, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli-Lilly, Janssen-Cilag, Leo Pharma, Merck Serono, Novartis, Pfizer, Pierre Fabre, Samsung Bioepis, and Sanofi. Emanuele Trovato is involved in an intermittent project focused on consulting and/or advisory relationships and/or travel-congress support with Eli Lilly, Novartis, Janssen-Cilag, AbbVie, and Almirall. Claudia Lasagni declares a conflict of interest with AbbVie, Novartis, Eli Lilly, and Almirall. Claudio Guarneri has been a scientific consultant, speaker, and clinical study investigator for AbbVie, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, Sanofi, Almirall, and Leo Pharma. Simone Ribero has served as an advisory board member and/or consultant and has received fees and speaker’s honoraria or has participated in clinical studies for AbbVie, Almirall, Leo Pharma, Eli Lilly, Novartis, Pfizer, and Sanofi Genzyme. Francesca M. Gaiani acted as a speaker or consultant for Novartis, AbbVie, Eli Lilly, Celgene, Leo Pharma, and Almirall. Carlo G. Carrera has served as a board participant or speaker for Abbvie, Lilly, Janssen, Novartis, Celgene, Almirall, and Leopharma. Emanuele C. Cozzani acted as a speaker or consultant for Abbvie, Almirall, Eli Lilly, Leo-Pharma, and Novartis. Andrea Sechi has received honoraria from Novartis, DS Laboratories, Cantabria Labs Difa Cooper, and Eli Lilly. Rossana Moroni has been a consultant for Almirall. Antonio Costanzo has served as an advisory board member, consultant, and has received fees and speaker’s honoraria or has participated in clinical trials for AbbVie, Almirall, Biogen, Leo Pharma, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme, and UCB Pharma. Alessandra Narcisi has served on advisory boards, received honoraria for lectures, and received research grants from Almirall, AbbVie, Leo Pharma, Celgene, Eli Lilly, Janssen, Novartis, Sanofi Genzyme, Amgen, and Boehringer Ingelheim. Sara Di Giulio, Valentina Dini, Massimo Travaglini, Nicola Zerbinati, Eugenia V. Di Brizzi, Alessandra Michelucci, Luca Potestio, Martina Maurelli, Martina Dragotto, Luca Mastorino, Eleonora Bongiovanni, and Francesco Messina have no conflicts of interest to declare. Mario Valenti is an Editorial Board Member of Dermatology and Therapy. Mario Valenti was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Ethical Approval: Institutional review board approval was exempted, as the study protocol did not deviate from standard clinical practice. All patients received guselkumab, as per good clinical practice, in accordance with European guidelines. All included patients had provided written consent for retrospective study of data collected during routine clinical practice (demographics and clinical scores). The study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments. Data collection and handling complied with applicable laws, regulations, and guidance regarding patient protection, including patient privacy.

Figures

Fig. 1
Fig. 1
Effectiveness in terms of PASI 90 (a), PASI 100 (b), and absolute PASI ≤ 2 (c) in patients without PsA and with concomitant PsA treated with guselkumab throughout the study period. * p < 0.05 ** p < 0.01 *** p < 0.001; PsA psoriatic arthritis, PASI Psoriasis Area Severity Index
Fig. 2
Fig. 2
Kaplan–Meier curve of all-cause treatment discontinuation in patients with and without concomitant PsA treated with guselkumab up to 60 months. Data are presented as probability with 95% confidence intervals (CIs). PsA psoriatic arthritis
See this image and copyright information in PMC

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