Effectiveness of Etanercept Biosimilar Initiating for Etanercept-Naive Patients, Using Ultrasound, Clinical, and Biomarker Assessments in Outcomes of Real-World Therapy (ENPORT-NGSK Study): An Interventional, Multicenter, Open-Label, Single-Arm Clinical Trial.

ABSTRACT: Background/Objectives: This study aimed to investigate the effectiveness of etanercept biosimilar 1 under real-world clinical conditions in patients with rheumatoid arthritis (RA), using not only clinical evaluation but also musculoskeletal ultrasound (MSUS). Methods: This multicenter, interventional, open-label, single-arm clinical trial conducted a 24-week follow-up. Patients with RA with moderate to high disease activity received weekly subcutaneous injections of etanercept biosimilar 1 at 50 mg/dose for 24 weeks. The effectiveness was evaluated with clinical indices and MSUS. Results: Twenty-three patients were evaluated during the study period. The primary endpoint involves a change in the Global OMERACT-EULAR Synovitis Score by MSUS in bilateral second-fifth meta

SUBMITTER: Sumiyoshi R 

PROVIDER: S-EPMC11900585 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature