Efficacy of etanercept biosimilar switching from etanercept reference product, using ultrasound and clinical data in outcomes of real world therapy (ESCORT-NGSK Study)

抄録

This study aimed to investigate in detail the efficacy of switching from etanercept reference product (RP) to etanercept biosimilar in patients with rheumatoid arthritis (RA) under real-world clinical conditions using clinical indices and musculoskeletal ultrasound (MSUS). This interventional, multicenter, open-label, single-arm clinical trial involved 24- or 52-week follow-up. This study enrolled patients with RA who had been treated with etanercept-RP for ≥ 24 weeks, achieved clinical low disease activity (LDA) or remission, and switched from etanercept-RP to etanercept biosimilar. This study included 20 patients. Of the 17 patients, 16 (94.1%; 95% confidence interval [CI]: 71.3–99.9) remained in LDA/remission on DAS28-ESR at 24 weeks. The dose of 50 mg/week was reduced to 25 mg/week at 24 weeks, and LDA/remission was sustained until 52 weeks in 9 (81.8%, 95% CI: 48.2–97.7] of 11 participants. DAS28-ESR, DAS28-CRP, SDAI, and CDAI scores showed no apparent worsening. The median total PD score remained 0. The switch from etanercept-RP to etanercept biosimilar and subsequent dose reduction demonstrated favorable outcomes, including MSUS evaluation.