Safety outcomes in 2132 Danish patients with inflammatory arthritis treated with biosimilar infliximab (GP1111) in routine care.

ABSTRACT:

Background

Biosimilar biologic disease-modifying antirheumatic drugs (bDMARDs) are increasingly used in clinical practice; however, real-world evidence regarding safety outcomes is currently limited. Denmark has rapidly implemented biosimilars through nationwide mandatory switches, introducing infliximab biosimilars CT-P13 in 2015 and GP1111 in 2019.

Objectives

To investigate the incidence of serious safety outcomes among Danish real-world arthritis patients (including biosimilar-to-biosimilar switchers) during the first year of infliximab biosimilar GP1111 treatment.

Methods

Patients with rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis initiating GP1111 during April 1, 2019-April 1, 2022 were identified in the nationwide DANBIO registry. Comorbi

SUBMITTER: Nabi H 

PROVIDER: S-EPMC12739103 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature