Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study.

ABSTRACT:

Background

Golimumab is a safe and effective treatment for patients with rheumatoid arthritis. Biosimilars to the reference product (RP; Simponi^®) may make treatment more accessible.

Objectives

The aim of this study was to assess the efficacy of AVT05, a golimumab biosimilar, and RP, each used in combination with methotrexate, in participants with moderate-to-severe rheumatoid arthritis.

Methods

This was a 52-week, randomized, double-blind, two-arm, parallel-group, active-controlled study. Participants were randomized 1:1 to receive AVT05 (n = 251) or RP (n = 251), 50 mg subcutaneously once every 4 weeks to Week 12 inclusive. Randomization was stratified by the baseline Disease Activity Score-28 for Rheumatoid Arthritis using C-Reactive Protein (DAS28-CRP)

SUBMITTER: Luque M 

PROVIDER: S-EPMC12790503 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature