OTX-101滴眼液、环孢素滴眼乳剂和利替格斯特滴眼液治疗干眼病的真实治疗模式：回顾性分析,BMC Ophthalmology

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OTX-101滴眼液、环孢素滴眼乳剂和利替格斯特滴眼液治疗干眼病的真实治疗模式：回顾性分析
BMC Ophthalmology ( IF 1.7 ) Pub Date : 2023-11-02 , DOI: 10.1186/s12886-023-03174-y
Paul Karpecki ₁ , Victoria Barghout ₂ , Brad Schenkel ₃ , Lynn Huynh ₄ , Anamika Khanal ₄ , Brittany Mitchell ₃ , Mihran Yenikomshian ₄ , Enrico Zanardo ₅ , Cynthia Matossian ₆

Affiliation

干眼病 (DED) 是一种以泪膜稳态丧失为特征的疾病，会导致眼表炎症和损伤。DED 的发病率随着年龄的增长而增加。环孢素眼用溶液 0.09%（CEQUA®；OTX-101）、环孢素眼用乳剂 0.05%（Restasis®；CsA）和 lifitegrast 滴眼液 5%（Xiidra®；LFT）是适用于 DED 的抗炎药。该分析比较了接受 OTX-101、CsA 或 LFT 治疗的 DED 患者的治疗模式。这项现实世界的回顾性纵向队列研究利用了 2019 年 7 月至 2021 年 6 月的 Symphony Health Integrated Dataverse 索赔。数据集包括所有 OTX-101 索赔患者以及按 2:1 比例随机选择 OTX-101 的 CsA 或 LFT 索赔患者。根据指标治疗将患者分为 3 组。索引日期是首次治疗索赔的日期，随访期是从索引日期到临床活动或数据可用性结束的日期。分别评估 OTX-101 与 CsA 和 OTX-101 与 LFT 的治疗中断时间 (TTD)、中断概率和治疗持续性。根据年龄和既往 DED 治疗情况进行亚组分析。Kaplan-Meier 分析和对数秩检验用于检查 TTD。逻辑模型评估了指标治疗与停药之间的关联。报告了未经调整和调整的比值比、95% 置信区间和 P 值，基于 P 值 < 0.05 具有统计显着相关性。总体而言，7102 名患者（OTX-101 n = 1846；CsA n = 2248；LFT n = 3008）符合资格。接受 OTX-101 治疗的患者的中位 TTD 为 354 天，而接受 CsA 治疗的患者为 241 天，接受 LFT 治疗的患者为 269 天。对数秩检验表明，与 CsA 治疗组相比，OTX-101 组患者的 TTD 显着更长 (P = 0.033)。接受 CsA 治疗的患者比接受 OTX-101 治疗的患者停止治疗的可能性高出 35%；OTX-101 和 LFT 组的停药率相似。360 天后，接受 OTX-101 的患者中有 49.8% 仍在接受治疗，而接受 CsA 的患者为 39.4%（P = 0.036），接受 LFT 的患者为 44.0%（P = 0.854）。与接受 CsA 的患者相比，接受 OTX-101 的患者接受治疗的时间明显更长，并且中断治疗的可能性也显着降低。老年患者服用 OTX-101 的时间明显长于 CsA。这些发现凸显了接受这些抗炎药物治疗的 DED 患者的治疗模式差异。

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Real-world treatment patterns of OTX-101 ophthalmic solution, cyclosporine ophthalmic emulsion, and lifitegrast ophthalmic solution in patients with dry eye disease: a retrospective analysis

Dry eye disease (DED) is a disorder characterized by loss of tear film homeostasis that causes ocular surface inflammation and damage. The incidence of DED increases with age. Cyclosporine ophthalmic solution 0.09% (CEQUA®; OTX-101), cyclosporine ophthalmic emulsion 0.05% (Restasis®; CsA), and lifitegrast ophthalmic solution 5% (Xiidra®; LFT) are anti-inflammatory agents indicated for DED. This analysis compared treatment patterns in patients with DED receiving OTX-101, CsA, or LFT. This real-world, retrospective, longitudinal cohort study utilized Symphony Health Integrated Dataverse claims from July 2019 to June 2021. The dataset included all patients with OTX-101 claims and patients with CsA or LFT claims randomly selected 2:1 to OTX-101. Patients were sorted into 3 cohorts based on index treatment. Index date was that of first treatment claim, and follow-up period was from index date to end of clinical activity or data availability. Time to treatment discontinuation (TTD), probability of discontinuation, and treatment persistence were assessed for OTX-101 vs. CsA, then OTX-101 vs. LFT. Subgroup analysis was performed based on age and prior DED treatment. Kaplan-Meier analysis and log-rank test were used to examine TTD. A logistic model evaluated association between index treatment and discontinuation. Unadjusted and adjusted odds ratios, 95% confidence intervals, and P-values were reported, with statistically significant associations based on P-values < 0.05. Overall, 7102 patients (OTX-101 n = 1846; CsA n = 2248; LFT n = 3008) were eligible. Median TTD was 354 days for patients receiving OTX-101 vs. 241 days for CsA and 269 days for LFT. Log-rank test indicated TTD was significantly longer for patients on OTX-101 vs. CsA (P = 0.033). Patients on CsA were 35% more likely to discontinue treatment than patients on OTX-101; OTX-101 and LFT groups had similar discontinuation rates. After 360 days, 49.8% of patients receiving OTX-101 remained on treatment vs. 39.4% of patients on CsA (P = 0.036) and 44.0% of patients on LFT (P = 0.854). Patients receiving OTX-101 remained on treatment significantly longer and were significantly less likely to discontinue treatment than patients on CsA. Older patients remained on OTX-101 significantly longer than CsA. These findings highlight treatment pattern differences in patients with DED receiving these anti-inflammatory agents.

更新日期：2023-11-02

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