Real-life Effectiveness and Safety of Guselkumab in Moderate-to-Severe Plaque Psoriasis: A 104-Week Retrospective Single-Center Study

August 2024 | Volume 23 | Issue 8 | 632 | Copyright © August 2024


Published online July 17, 2024

doi:10.36849/JDD.7486R1

Luigi Gargiulo MDa,b, Luciano Ibba MDa,b, Andrea Cortese MDa,b, Francesco Toso MDa,b, Carlo A. Vignoli MDa,b, Giovanni Fiorillo MDa,b, Francesco Piscazzi MDa,b, Mario Valenti MDa,b, Antonio Costanzo MDa,b, Alessandra Narcisi MD PhDb

aDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy
bDermatology Unit, IRCCS Humanitas Research Hospital, Rozzano (MI), Italy

Abstract
Background: Guselkumab is a monoclonal antibody approved for treating moderate-to-severe plaque psoriasis. Long-term data on the effectiveness and safety of guselkumab in a real-world setting are still limited.
Materials and Methods: We conducted a 104-week monocentric retrospective study on 102 psoriasis patients, all treated with guselkumab for at least 16 weeks. At each visit, we used the Psoriasis Area and Severity Index (PASI): effectiveness endpoints were the percentages of patients achieving 75%/90%/100% (PASI 75/90/100) improvement in PASI compared with baseline. The Kaplan-Meier curve was used to assess the drug survival.
Results: At week 16, PASI 90 and PASI 100 were achieved by 49.02% and 32.35% of patients. At week 52, PASI 90 and PASI 100 were achieved by 71.58% and 55.79% of patients. After 2 years, PASI 90 and PASI 100 were achieved by 79.63% and 61.11% of patients. Obese and overweight patients had comparable PASI 90 and PASI 100 responses throughout the study. At week 104, no significant differences were observed between bio-naïve and bio-experienced patients regarding all effectiveness endpoints. No significant safety signals were reported in our study. After 24 months, 91.57% of our cohort was still on treatment with guselkumab.
Conclusion: Our findings, although limited by the study's retrospective nature, confirm that guselkumab is a safe and effective therapeutic option for a "real-life" cohort of patients with psoriasis.

J Drugs Dermatol. 2024;23(8):632-639.  doi:10.36849/JDD.7486R1

INTRODUCTION

Psoriasis is a chronic inflammatory disorder affecting up to 2% to 4% of the general population worldwide.1 The treatment of moderate-to-severe psoriasis includes systemic disease-modifying antirheumatic drugs (DMARDs), such as cyclosporin, methotrexate, and acitretin. Biological drugs are the treatment of choice when there is a contraindication or an incomplete/inadequate response to conventional DMARDs.2,3 Biologics are engineered monoclonal antibodies that block specific cytokines or receptors critical to psoriatic inflammation.4

Guselkumab is the first human IgG1λ monoclonal antibody that inhibits IL-23 selectively,5 and it has been evaluated in 3 phase 3 clinical trials (VOYAGE1, VOYAGE2, and NAVIGATE), showing superior efficacy compared with placebo, adalimumab, and ustekinumab.6-8 Some real-life experiences have also been published, with results in line with those observed in clinical trials.

The study reported here is a monocentric retrospective real-world experience including 102 patients, all followed for at least 16 weeks. Out of this cohort, 95 completed 52 weeks of treatment, while 54 of them reached at least 2 years of follow-up.

MATERIALS AND METHODS

We conducted a non-interventional retrospective single-center study by analyzing our psoriasis database records between 2019 and 2022. One hundred and two patients were included, and all received at least 16 weeks of treatment. Patient eligibility for guselkumab treatment was assessed following the Italian adaptation of EuroGuiDerm guidelines.3 Before starting guselkumab, all patients underwent screening for tuberculosis, HIV, and viral hepatitis.3 Each patient received guselkumab 100 mg at week 0 and week 4, and then every 8 weeks, according to the summary of product characteristics.9
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