Clinical Outcomes of Topical 0.1% Ciclosporin Cationic Emulsion Used on Label in Children with Vernal Keratoconjunctivitis,Ophthalmology and Therapy

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Clinical Outcomes of Topical 0.1% Ciclosporin Cationic Emulsion Used on Label in Children with Vernal Keratoconjunctivitis
Ophthalmology and Therapy ( IF 2.6 ) Pub Date : 2023-04-12 , DOI: 10.1007/s40123-023-00707-y
Giuseppe Giannaccare ₁ , Costanza Rossi ₁ , Massimiliano Borselli ₁ , Chiara Bonzano _{2,

3} , Giovanna Carnovale Scalzo ₁ , Massimo Nicolò _{2,

3} , Vincenzo Scorcia ₁ , Carlo Enrico Traverso _{2,

3} , Aldo Vagge _{2,

3}

Affiliation

Introduction

The purpose of this short article is to report the clinical outcomes of topical 0.1% ciclosporin cationic emulsion (CsA-CE) used on label in children with vernal keratoconjunctivitis (VKC).

Methods

In this prospective, non-comparative, observational study children affected by active severe VKC were treated for at least 12 months with topical 0.1% CsA-CE. The drug was instilled in both eyes 4 times daily. Data collected from medical charts for the baseline visit (T0) and 1-year follow-up visit (T1) included symptomatic score (0–15), clinical score (0–15), side effects, rescue therapy (need and total number of courses with 0.1% dexamethasone 4 times daily for 5 days), ocular complications and tolerability (visual analog scale [0–100]).

Results

Data from 25 children (20 boys, 5 girls; mean [± standard deviation] age 8.40 ± 2.54 years) were included in the study. Of the 25 patients, 23 (92%) used 0.1% CsA-CE eye drops as per label recommendations, including four patients who had prematurely stopped using topical galenic CsA due to side effects. Symptomatic and clinical scores decreased significantly after treatment, with the mean symptomatic score decreasing from 9.76 ± 1.27 at T0 to 3.80 ± 1.08 at T1, and the mean clinical score decreasing from 9.20 ± 1.32 at T0 to 3.44 ± 1.00 at T1; both P < 0.0001). Five patients (20%) required at least one course of rescue medication (mean 3.4 ± 4.8 courses/year). No patients experienced ocular complications during the study, and treatment tolerability was very high (mean score 89.40 ± 5.46).

Conclusion

Our findings confirm that topical CsA-CE is an effective on-label option for children with VKC in the real-life setting. In our pediatric patient population, CsA-CE provided good clinical outcomes with a limited need for rescue medication, and it was well tolerated by almost all patients, including those who were intolerant to galenic formulations.

中文翻译：

标签上使用局部 0.1% 环孢素阳离子乳剂治疗儿童春季角膜结膜炎的临床结果

介绍

这篇短文的目的是报告局部使用 0.1% 环孢素阳离子乳剂 (CsA-CE) 用于春季角膜结膜炎 (VKC) 儿童的临床结果。

方法

在这项前瞻性、非比较性、观察性研究中，受活动性严重 VKC 影响的儿童接受了至少 12 个月的局部 0.1% CsA-CE 治疗。每天将药物滴入双眼 4 次。从基线访问 (T0) 和 1 年随访访问 (T1) 的医疗图表中收集的数据包括症状评分 (0–15)、临床评分 (0–15)、副作用、挽救治疗（需要和总数0.1% 地塞米松每天 4 次，持续 5 天的疗程）、眼部并发症和耐受性（视觉模拟量表 [0–100]）。

结果

来自 25 名儿童（20 名男孩，5 名女孩；平均 [± 标准差] 年龄 8.40 ± 2.54 岁）的数据被纳入研究。在 25 名患者中，23 名 (92%) 根据标签建议使用 0.1% CsA-CE 滴眼液，其中包括四名因副作用而过早停止使用外用盖伦 CsA 的患者。治疗后症状和临床评分显着下降，平均症状评分从T0时的9.76±1.27下降到T1时的3.80±1.08，平均临床评分从T0时的9.20±1.32下降到T1时的3.44±1.00；P < 0.0001）。五名患者 (20%) 需要至少一个疗程的急救药物（平均 3.4 ± 4.8 个疗程/年）。研究期间没有患者出现眼部并发症，治疗耐受性非常高（平均得分 89.40 ± 5.46）。