Maria Francesca Gicchino, Giusy Capasso, Alessia Amodio, Emanuele Miraglia Del Giudice, Alma Nunzia Olivieri, Anna Di Sessa
{"title":"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。","authors":"Maria Francesca Gicchino, Giusy Capasso, Alessia Amodio, Emanuele Miraglia Del Giudice, Alma Nunzia Olivieri, Anna Di Sessa","doi":"10.1016/j.pedhc.2024.08.003","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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).</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Discussion: </strong>A better overall profile of BIOs than originators was demonstrated in JIA children, but larger confirmatory studies are needed.</p>","PeriodicalId":50094,"journal":{"name":"Journal of Pediatric Health Care","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Biosimilars Versus Originators in Children With Juvenile Idiopathic Arthritis: A Real-World Experience.\",\"authors\":\"Maria Francesca Gicchino, Giusy Capasso, Alessia Amodio, Emanuele Miraglia Del Giudice, Alma Nunzia Olivieri, Anna Di Sessa\",\"doi\":\"10.1016/j.pedhc.2024.08.003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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).</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Discussion: </strong>A better overall profile of BIOs than originators was demonstrated in JIA children, but larger confirmatory studies are needed.</p>\",\"PeriodicalId\":50094,\"journal\":{\"name\":\"Journal of Pediatric Health Care\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2024-08-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Pediatric Health Care\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.pedhc.2024.08.003\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEALTH POLICY & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Pediatric Health Care","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.pedhc.2024.08.003","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEALTH POLICY & SERVICES","Score":null,"Total":0}
Biosimilars Versus Originators in Children With Juvenile Idiopathic Arthritis: A Real-World Experience.
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.
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.
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