Single-Centre Real-Life Experience of Guselkumab in Patients with Moderate-to-Severe Plaque Psoriasis

August 2022 | Volume 21 | Issue 8 | 864 | Copyright © August 2022


Published online July 19, 2022

Dario Antonio Marletta MD, Giulia Murgia MD, Angelo Cattaneo MD, Carlo Giovanni Carrera MD, Angelo Valerio Marzano PhD

Unit of Dermatology, Ca’ Granda Foundation and Institute for Research and Care, Maggiore Polyclinic Hospital, Milan, Italy
Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy

Abstract
The efficacy of guselkumab has been demonstrated in randomized controlled trials, but real-life data are still missing. This study presents a single-center real-life experience in treating moderate-to-severe plaque psoriasis with guselkumab, underlying the efficacy and safety of this biological agent. Primary efficacy endpoint was the percentage of patients reaching psoriasis area and severity index (PASI) 90 response at week 28. The cohort included 79 patients of mean age 51 ± 15 years. Mean duration of guselkumab treatment was 16,5 ± 7.5 months. All 79 patients completed at least 28 weeks of treatment.

At week 28, 73 (92%) patients reached PASI 50 or higher, 65 (82%) achieved PASI 75 or higher, 54 (68%) achieved PASI 90 or higher, and 35 (44%) reached PASI 100. Very similar percentages were found at week 44 and at the end of the study period.

No significant adverse effects were reported. This study confirms that guselkumab is an effective and safe biologic agent capable of maintaining long-lasting clinical response efficacy in real-world clinical practice, although at slightly lower levels than in clinical trials.

J Drugs Dermatol. 2022;21(8):864-866. doi:10.36849/JDD.6962

INTRODUCTION

Psoriasis is a common, chronic inflammatory disease, affecting approximately 2% to 3% of the population over 20 years of age.1,2 This condition is a systemic disease that often causes immune dysregulation and significantly affects people’s quality of life and well-being.

The etiology of this disease is complex, but most theories describe, amongst other factors, cytokine disbalance due mainly to IL-23 with IL-17 as effector cytokine. The abnormal immune response leads to various effects such as keratinocyte proliferation, immune activation, and altered differentiation, as well as local and systemic inflammation.2,3 Psoriasis can present with different types of skin manifestation: plaque psoriasis being the most common. Moderate-to-severe psoriasis can be treated with more traditional approaches, including phototherapy, retinoids, methotrexate, and cyclosporine.4 These therapies often result in minimal response, with some cases of intolerance or adverse effects (AEs). Biologic therapies generally result in higher levels of response and are well tolerated with fewer drug-related AEs than traditional therapies.6 Guselkumab (Tremfya; CNTO 1959, Janssen Biotech, Inc., PA, USA) is a selective IL-23 antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adults. It was approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2017.5,7 Guselkumab is a fully human monoclonal antibody that selectively targets and binds to IL-23, a key cytokine in psoriasis pathogenesis, named interleukin-23 (IL-23).7

In this study we present our single-center real-life experience in treating moderate-to-severe plaque psoriasis with guselkumab, underscoring the efficacy and safety of this biological agent.

MATERIALS AND METHODS

A retrospective cohort study design was used. The electronic database of the Dermatology Department in Milan was searched for patients treated with guselkumab for moderate-to-severe psoriasis since 2019. Data were collected from the clinic's electronic registry. The primary efficacy endpoint was psoriasis area and severity index (PASI) 90 response at week