A Randomised, Double-Blind Trial to Compare the Efficacy, Safety, and Immunogenicity of the Biosimilar Ustekinumab FYB202 with Reference Ustekinumab in Patients with Moderate-to-Severe Plaque Psoriasis.

ABSTRACT:

Introduction

Biosimilars allow more patients access to affordable treatment options and help reduce the financial burden on healthcare systems. This multicentre trial compared the efficacy, safety, and immunogenicity of the approved biosimilar ustekinumab FYB202 with reference ustekinumab.

Methods

Eligible patients were ≥ 18 years old with stable moderate-to-severe plaque psoriasis for ≥ 6 months and inadequate treatment response to or intolerance of ≥ 1 previous systemic treatment. Patients were randomised (1:1) to double-blind treatment with FYB202 or reference ustekinumab; patients in the reference group who achieved Psoriasis Area and Severity Index (PASI) 75 percent improvement at week 28 were re-randomised to FYB202 or reference product. The primary efficacy endpoint w

SUBMITTER: Papp K 

PROVIDER: S-EPMC12006271 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature