儿科非感染性葡萄膜炎参考药物与生物仿制药的比较。

Q3 Medicine International Ophthalmology Clinics Pub Date : 2024-10-01 Epub Date: 2024-10-29 DOI:10.1097/IIO.0000000000000530
Nita G Valikodath, Jay Rathinavelu, Jordan D Deaner, Mary Buckley, Dilraj S Grewal
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引用次数: 0

摘要

目标/目的:比较 TNF-α 抑制剂生物仿制药与参比药物在治疗小儿非感染性葡萄膜炎方面的疗效和成本:方法:纳入2013年1月1日至2023年6月1日期间接受参考药物或TNF-α抑制剂生物仿制药治疗的18岁或以下非感染性葡萄膜炎患者,这些患者均有活动性眼部炎症病史,并接受了至少1个月的眼科随访。结果:结果:19 名患者符合纳入标准。平均年龄为(9.3±4.0)岁,47.4%(9/19)为女性。在病程的任何时间点服用英夫利西单抗的患者(9 人)中,英夫利西单抗的平均服用时间为 3.6 年(42 个月)。在使用生物类似物英夫利西单抗的患者(10 人)中,平均用药时间为 0.82 年(9.8 个月)。英夫利昔单抗的平均复发年数为 0.22±0.3,生物类似物英夫利昔单抗的平均复发年数为 0.15±0.3。英夫利昔单抗(9例)的年平均费用为42298.97美元,英夫利昔单抗-Dyb(9例)为41141美元,英夫利昔单抗-axxq(1例)为40950美元。从阿达木单抗转为使用英夫利西单抗生物类似药的原因包括保险规定(100%)、疾病活动恶化(37.5%)或其他问题,如不合规(37.5%):结论:开始使用生物类似药的最常见原因是保险强制要求。与参考药物英夫利西单抗相比,使用生物类似物英夫利西单抗的儿童患者每年复发的次数较少,但与参考药物相比,他们使用生物类似物的时间较短,这可能会影响准确评估。与参考药物英夫利昔单抗相比,生物仿制药英夫利昔单抗的成本更低。
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Comparison of Reference and Biosimilar Medications for Pediatric Noninfectious Uveitis.

Objective/purpose: Compare outcomes and costs of TNF-alpha inhibitor biosimilars to reference medications in the treatment of pediatric NIU.

Methods: Patients 18 years old or below treated with reference or biosimilar TNF-alpha inhibitor for noninfectious uveitis and had a history of active ocular inflammation with at least 1 month of ophthalmology follow-up from January 1, 2013, to June 1, 2023, were included. Retrospective chart review was performed.

Results: Nineteen patients met the inclusion criteria. Mean age was 9.3±4.0 years, and 47.4% (9/19) were female. Of the patients who were on infliximab at any time point in their disease course (n=9), the mean duration on infliximab was 3.6 years (42 mo). Of the patients on biosimilar infliximab (n=10), the mean duration was 0.82 years (9.8 mo). Mean flares/year was 0.22±0.3 on infliximab and 0.15±0.3 on biosimilar infliximab. The average annual cost was $42,298.97 for infliximab (n =9), $41,141 for infliximab-dyyb (n=9), and $40,950 for infliximab-axxq (n=1). Reasons for switching to biosimilar infliximab from adalimumab included a combination of insurance mandate (100%), worsening disease activity (37.5%), or other issues such as noncompliance (37.5%).

Conclusions: The most common reason for biosimilar initiation was insurance mandate. Compared with the reference infliximab, pediatric patients had fewer number of flares per year on biosimilar infliximab, but they were also on the biosimilar for a shorter duration of time compared with the reference which may confound an accurate assessment. Biosimilar infliximab had a lower cost profile compared with reference infliximab.

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来源期刊
International Ophthalmology Clinics
International Ophthalmology Clinics Medicine-Ophthalmology
CiteScore
1.40
自引率
0.00%
发文量
94
期刊介绍: International Ophthalmology Clinics is a valuable resource for any medical professional seeking to stay informed and up-to-date regarding developments in this dynamic specialty. Each issue of this quarterly publication presents a comprehensive review of a single topic in a new or changing area of ophthalmology. The timely, tightly focused review articles found in this publication give ophthalmologists the opportunity to benefit from the knowledge of leading experts in this rapidly changing field.
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