Juvenile Dermatomyositis (JDM) is a rare autoimmune disorder that primarily affects muscles and skin. One of the severe complications associated with JDM is calcinosis, and treating this condition presents significant challenges. This study aimed to evaluate the efficacy and safety of local injection of infliximab into calcinosis lesions in patients with JDM. In this clinical trial, five patients diagnosed with JDM and calcinosis lesions were enrolled. The primary treatment consisted of weekly infliximab injections for 16 weeks, targeting all four sides of each lesion. Lesion dimensions, including length and width, were documented and monitored weekly. Before the intervention, patients underwent radiographic imaging. After the final injection in week 16, a follow-up radiographic assessment was performed. Data were analyzed using the Generalized Estimating Equation (GEE) method. The lesions’ size significantly decreased in both length and width during each visit. On average, the lesion length reduced by 2.66%, and the width shrank by 3.32% per visit. Based on radiographic findings, the average length and width of lesions at the initial visit were 12.09 ± 5.05 mm (range: 6.00-25.50 mm) and 6.35 ± 3.00 mm (range: 2.00–16.00 mm), respectively. The average length and width at the last visit were 5.59 ± 7.05 mm (range: 0–23.00 mm) and 3.41 ± 4.05 mm (range: 0–13.00 mm), respectively. No specific side effects related to the treatment were reported. The results suggest that the direct administration of infliximab into the calcinosis lesions of patients with JDM could be a safe and effective treatment approach. Name of the registry: The effect of infliximab injection into calcinosis lesions on patients with juvenile dermatomyositis (JDM), Trial registration number: IRCT20210808052107N1, Registration date: 2022-07-22, URL of trial registry record: https://en.irct.ir/trial/58329 .

中文翻译：

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青少年皮肌炎 (JDM) 患者钙质沉着病灶局部注射英夫利昔单抗：一项临床试验

青少年皮肌炎 (JDM) 是一种罕见的自身免疫性疾病，主要影响肌肉和皮肤。与 JDM 相关的严重并发症之一是钙质沉着，治疗这种疾病面临着巨大的挑战。本研究旨在评估 JDM 患者钙质沉着病灶局部注射英夫利昔单抗的有效性和安全性。在这项临床试验中，入组了 5 名诊断为 JDM 和钙质沉着病灶的患者。主要治疗包括每周注射英夫利昔单抗，持续 16 周，针对每个病变的所有四个侧面。每周记录和监测病变尺寸，包括长度和宽度。干预前，患者接受放射线成像。第 16 周最后一次注射后，进行了后续放射线评估。使用广义估计方程（GEE）方法分析数据。每次就诊期间，病变的长度和宽度均显着减小。平均每次就诊，病灶长度减少 2.66%，宽度缩小 3.32%。根据影像学检查结果，初次就诊时病灶的平均长度和宽度分别为 12.09 ± 5.05 mm（范围：6.00-25.50 mm）和 6.35 ± 3.00 mm（范围：2.00-16.00 mm）。上次就诊时的平均长度和宽度分别为 5.59 ± 7.05 mm（范围：0–23.00 mm）和 3.41 ± 4.05 mm（范围：0–13.00 mm）。没有报告与治疗相关的具体副作用。结果表明，将英夫利昔单抗直接注射到 JDM 患者的钙质沉着病灶中可能是一种安全有效的治疗方法。注册名称：英夫利昔单抗注射入钙质沉着病灶对青少年皮肌炎（JDM）患者的影响，试验注册号：IRCT20210808052107N1，注册日期：2022-07-22，试验注册记录网址：https://en.irct .ir/审判/58329 。