Patients with Persistent Mild Psoriasis after Treatment with Ustekinumab Achieved Greater Improvements in Skin Clearance and Patient-reported Outcomes after Switching to Guselkumab in the Phase 3 NAVIGATE Trial.


Journal

Acta dermato-venereologica
ISSN: 1651-2057
Titre abrégé: Acta Derm Venereol
Pays: Sweden
ID NLM: 0370310

Informations de publication

Date de publication:
05 Sep 2024
Historique:
received: 24 06 2024
accepted: 14 08 2024
medline: 5 9 2024
pubmed: 5 9 2024
entrez: 5 9 2024
Statut: epublish

Résumé

Mild psoriasis may be burdensome; if symptoms are inadequately controlled, switching therapy may be warranted. In the Phase 3 NAVIGATE trial, patients with moderate-to-severe plaque psoriasis received ustekinumab for 16 weeks. Patients with inadequate response (Investigator's Global Assessment [IGA] ≥ 2) were randomized to switch to guselkumab or continue ustekinumab. This post-hoc analysis evaluated the patient subgroup with residual mild psoriasis (IGA = 2) after initial ustekinumab therapy. Outcomes assessed included the Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), and Psoriasis Symptoms and Signs Diary (PSSD). Initially, 871 patients received ustekinumab. At Week 16, 161 randomized patients had residual mild psoriasis (IGA = 2). Among guselkumab- vs ustekinumab-treated patients at Week 28, 59.0% vs 27.7% achieved PASI 90, and 50.0% vs 21.0% achieved DLQI 0/1. Mean changes from baseline in PSSD score were -44 vs -28 and -50 vs -32, respectively, with thresholds of -40 considered clinically meaningful. Mean changes in PSSD itch score were -4.6 vs -2.9, with reductions ≥ 4.0 considered clinically meaningful. Treatment differences were maintained/increased through Week 52. Among patients with residual mild psoriasis after 16 weeks of ustekinumab, those switching to guselkumab had greater improvements in skin clearance, health-related quality of life, and patient-reported symptoms and signs than those continuing ustekinumab.

Identifiants

pubmed: 39233617
doi: 10.2340/actadv.v104.41053
doi:

Substances chimiques

Ustekinumab FU77B4U5Z0
guselkumab 089658A12D
Antibodies, Monoclonal, Humanized 0
Dermatologic Agents 0

Types de publication

Journal Article Clinical Trial, Phase III Randomized Controlled Trial Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

adv41053

Auteurs

Enzo Errichetti (E)

University Hospital "Santa Maria della Misericordia," Udine, Italy. enzoerri@yahoo.it.

Peter Wolf (P)

Department of Dermatology, Medical University of Graz, Graz, Austria.

Saakshi Khattri (S)

Mount Sinai Doctors, New York, NY, USA.

Patricia Gorecki (P)

Janssen-Cilag Ltd, High Wycombe, UK.

Megan Miller (M)

Janssen Research and Development, LLC, Spring House, PA, USA.

Jingzhi Jiang (J)

Janssen Research and Development, LLC, Spring House, PA, USA.

Chenglong Han (C)

Janssen Global Services, LLC, Malvern, PA, USA.

Brian Kirby (B)

St. Vincent's University Hospital and Charles Institute of Dermatology, University College Dublin, Ireland.

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Classifications MeSH