Purpose To report the real-world experience of using topical ciclosporin, Ikervis, in the management of ocular surface inflammatory diseases (OSIDs). Methods This was a retrospective study of patients treated with Ikervis for OSIDs at the Queen’s Medical Centre, Nottingham, between 2016 and 2019. Relevant data, including demographics, indications, clinical parameters, outcomes and adverse events, were collected and analysed for patients who had completed at least 6 months follow-up. For analytic purpose, clinical outcome was categorised as ‘successful’ (resolved or stable disease), ‘active disease’ and ‘drug intolerance’. Results 463 patients were included; mean age was 51.1±21.6 years, with a 59.0% female predominance. Mean follow-up was 14.6±9.2 months. The most common diagnosis was dry eye disease (DED; 322, 69.5%), followed by allergic eye disease (AED; 53, 11.4%) and ocular mucous membrane pemphigoid/Steven-Johnson syndrome (OMMP/SJS; 38, 8.2%). Successful treatment was achieved in 343 (74.1%) patients, with 44 (9.5%) requiring additional treatment and 76 (16.4%) reporting drug intolerance. The efficacy of Ikervis was highest in DED (264, 82.0%), followed by OMMP/SJS (25, 65.8%) and post-keratoplasty (7, 50.0%; p<0.001). Logistic regression analysis demonstrated age <70 years (p=0.007), AED (p=0.002) and OMMP/SJS (p=0.001) as significant predictive factors for Ikervis intolerance. AED and post-keratoplasty were 8.16 times (95% CI, 2.78 to 23.99) and 13.98 times (95% CI, 4.22 to 46.28), respectively, more likely to require additional treatment compared with DED. Conclusions Ikervis is a useful steroid-sparing topical treatment for managing OSIDs in the real-world setting. Preparations with improved tolerability are needed to benefit a larger number of patients. All relevant data have been provided in this manuscript.

中文翻译：

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使用 0.1% 环孢素 A 治疗眼表炎性疾病的真实经验

目的 报告使用外用环孢素 Ikervis 治疗眼表炎性疾病 (OSID) 的真实经验。方法 这是一项对 2016 年至 2019 年间在诺丁汉女王医疗中心接受 Ikervis 治疗 OSID 的患者的回顾性研究。收集并分析了相关数据，包括人口统计学、适应症、临床参数、结果和不良事件。完成至少6个月的随访。出于分析目的，临床结果被归类为“成功”（已解决或稳定的疾病）、“活动性疾病”和“药物不耐受”。结果共纳入463例患者；平均年龄为 51.1±21.6 岁，女性占 59.0%。平均随访时间为 14.6±9.2 个月。最常见的诊断是干眼症 (DED; 322, 69.5%), 其次是过敏性眼病（AED；53, 11.4%）和眼粘膜类天疱疮/Steven-Johnson 综合征（OMMP/SJS；38, 8.2%）。343 名 (74.1%) 患者获得成功治疗，其中 44 名 (9.5%) 需要额外治疗，76 名 (16.4%) 报告药物不耐受。Ikervis 在 DED 中的疗效最高 (264, 82.0%)，其次是 OMMP/SJS (25, 65.8%) 和角膜移植术后 (7, 50.0%; p<0.001)。Logistic 回归分析表明年龄 <70 岁 (p=0.007)、AED (p=0.002) 和 OMMP/SJS (p=0.001) 是 Ikervis 不耐受的重要预测因素。与 DED 相比，AED 和角膜移植术后分别为 8.16 倍（95% CI，2.78 至 23.99）和 13.98 倍（95% CI，4.22 至 46.28），更可能需要额外治疗。结论 Ikervis 是一种有用的节省类固醇的局部治疗，用于在现实世界环境中管理 OSID。需要具有改善耐受性的制剂以使更多患者受益。本手稿中提供了所有相关数据。