Biosimilars Versus Originators in Children With Juvenile Idiopathic Arthritis: A Real-World Experience.

IF 2.5 4区医学 Q2 HEALTH POLICY & SERVICES

Journal of Pediatric Health Care Pub Date : 2025-01-01 Epub Date: 2024-08-30 DOI:10.1016/j.pedhc.2024.08.003

Maria Francesca Gicchino, Giusy Capasso, Alessia Amodio, Emanuele Miraglia Del Giudice, Alma Nunzia Olivieri, Anna Di Sessa

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引用次数: 0

Abstract

Introduction: We aimed to evaluate the efficacy, safety, and immunogenicity profile of Etanercept (ETA) and Adalimumab (ADA) biosimilars (BIOs) compared to their originators in children with juvenile idiopathic arthritis (JIA).

Method: Eighty-one JIA children treated with ETA or ADA originators or BIOs were examined at baseline (T0) and after 3- (T1), 6- (T2), 12- (T3), and 24-(T4) months after starting treatment.

Results: Lower Juvenile Arthritis Disease Activity Score 10 (JADAS-10) scores were reported at T1, T2, T3, and T4 in JIA children treated with BIOs than originators (all p < 0.05). At T1 and T3, anti-drugs antibodies levels were lower in children receiving BIOs than originators (p = 0.04 and p = 0.0007, respectively), even after adjustments (both p < 0.05). Relapses were lower for BIOs compared to originators (p < 0.001). Safety profile was comparable between the groups (p > 0.05).

Discussion: A better overall profile of BIOs than originators was demonstrated in JIA children, but larger confirmatory studies are needed.

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生物仿制药与原研药在青少年特发性关节炎患儿中的应用：真实世界的经验。

简介我们旨在评估Etanercept (ETA)和Adalimumab (ADA)生物仿制药(BIOs)与原研药相比，在幼年特发性关节炎(JIA)患儿中的疗效、安全性和免疫原性概况：方法：对81名接受ETA或ADA原研药或BIO治疗的幼年特发性关节炎患儿进行了基线（T0）和开始治疗后3个月（T1）、6个月（T2）、12个月（T3）和24个月（T4）的检查：结果：在T1、T2、T3和T4，接受BIO治疗的JIA患儿的青少年关节炎疾病活动度评分10（JADAS-10）得分均低于原研药（P均<0.05）。在T1和T3，接受BIO治疗的患儿的抗药物抗体水平低于原研药（分别为p = 0.04和p = 0.0007），即使经过调整也是如此（均为p < 0.05）。与原研药相比，BIO 的复发率更低（p < 0.001）。两组的安全性相当（P > 0.05）：讨论：在JIA儿童中，BIOs的总体情况优于原研药，但还需要更大规模的确证研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Pediatric Health Care NURSING-PEDIATRICS

CiteScore

3.40

自引率

10.70%

发文量

140

审稿时长

24 days

期刊介绍： The Journal of Pediatric Health Care, the official journal of the National Association of Pediatric Nurse Practitioners, provides scholarly clinical information and research regarding primary, acute and specialty health care for children of newborn age through young adulthood within a family-centered context. The Journal disseminates multidisciplinary perspectives on evidence-based practice and emerging policy, advocacy and educational issues that are of importance to all healthcare professionals caring for children and their families.