What is the best way to plan a 12-month clinical drug trial in JIA associated uveitis?

IF 3.7 3区医学 Q2 IMMUNOLOGY

Expert Review of Clinical Immunology Pub Date : 2026-05-08 DOI:10.1080/1744666X.2026.2659684

Ivan Foeldvari, Ameenat Solebo, Sheila T Angeles-Han, Agnes Galbo Brost, Joke de Boer, Jesus Díaz-Cascajosa, Mia Glerup, Helene Ingels, Jens Klotsche, Viera Koopman-Kalinina Ayuso, Ilaria Maccora, Stephanie Mata, Ellen Nordal, Nicolino Ruperto, Gabriele Simonini, Joost F Swart, Jan Titz, Charlotte L L I van Meerwij, Jordi Anton

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引用次数: 0

Abstract

Introduction: Juvenile idiopathic arthritis associated anterior uveitis (JIA-U) is the most common extraarticular manifestation of JIA. There are no published proposed criteria or outcome measures for a 12-month clinical trial for JIA-U.

Areas covered: Our expert group, the Multinational Interdisciplinary Working Group for Uveitis in Childhood (MIWGUC), reviewed the previous trials, the quality-of-life instruments, biomarkers, and the patient perspective. Based on an expert consensus, a proposal for a future clinical trial was developed, to provide a foundation for the standardization of outcome measures and trial design in JIA-U. By integrating clinical, imaging, biomarker, and patient-reported outcomes into a unified framework, we aim to accelerate evidence-based therapeutic development and improve long-term care for children affected by anterior uveitis.

Expert opinion: A key measure of primary outcome is the anterior chamber cell number, which has intra-observer and inter-observer variation. New techniques that are objective and decrease the variation of the assessment are emerging. Anterior Segmentation Optical Coherence Tomography (OCT) is an innovative imaging technology to assess the number of anterior chamber cells in OCT. The flare meter is an additional assessment, although not yet widely used.

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计划JIA相关性葡萄膜炎12个月临床药物试验的最佳方法是什么？

简介：幼年特发性关节炎相关性前葡萄膜炎（JIA- u）是JIA最常见的关节外表现。JIA-U的12个月临床试验没有公布的建议标准或结果测量。涵盖领域：我们的专家组，儿童葡萄膜炎多国跨学科工作组（MIWGUC），回顾了以前的试验，生活质量仪器，生物标志物和患者的观点。在专家共识的基础上，提出了未来临床试验的建议，为JIA-U的结果测量和试验设计的标准化提供了基础。通过将临床、影像学、生物标志物和患者报告的结果整合到一个统一的框架中，我们的目标是加速循证治疗的发展，并改善对受前葡萄膜炎影响的儿童的长期护理。专家意见：主要结果的一个关键指标是前房细胞数量，它在观察者内部和观察者之间都有变化。新技术是客观的，减少变化的评估正在出现。前切分光学相干断层扫描（OCT）是一种评估OCT前房细胞数量的创新成像技术，耀斑计是一种额外的评估方法，尽管尚未广泛使用。

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

Expert Review of Clinical Immunology IMMUNOLOGY-

CiteScore

7.60

自引率

2.30%

发文量

221

审稿时长

6-12 weeks

期刊介绍： Expert Review of Clinical Immunology (ISSN 1744-666X) provides expert analysis and commentary regarding the performance of new therapeutic and diagnostic modalities in clinical immunology. Members of the International Editorial Advisory Panel of Expert Review of Clinical Immunology are the forefront of their area of expertise. This panel works with our dedicated editorial team to identify the most important and topical review themes and the corresponding expert(s) most appropriate to provide commentary and analysis. All articles are subject to rigorous peer-review, and the finished reviews provide an essential contribution to decision-making in clinical immunology. Articles focus on the following key areas: • Therapeutic overviews of specific immunologic disorders highlighting optimal therapy and prospects for new medicines • Performance and benefits of newly approved therapeutic agents • New diagnostic approaches • Screening and patient stratification • Pharmacoeconomic studies • New therapeutic indications for existing therapies • Adverse effects, occurrence and reduction • Prospects for medicines in late-stage trials approaching regulatory approval • Novel treatment strategies • Epidemiological studies • Commentary and comparison of treatment guidelines Topics include infection and immunity, inflammation, host defense mechanisms, congenital and acquired immunodeficiencies, anaphylaxis and allergy, systemic immune diseases, organ-specific inflammatory diseases, transplantation immunology, endocrinology and diabetes, cancer immunology, neuroimmunology and hematological diseases.