Real-World Experience with Lifitegrast Ophthalmic Solution (Xiidra®) in the US and Canada: Retrospective Study of Patient Characteristics, Treatment Patterns, and Clinical Effectiveness in 600 Patients with Dry Eye Disease

Abstract

Purpose This study evaluated real-world treatment of dry eye disease (DED) with lifitegrast. Patients and Methods Ophthalmologists and optometrists treating patients with DED were invited to participate through a healthcare provider (HCP)-based panel. HCPs completed a provider survey and contributed data toward a chart review for up to five qualifying patients with DED who initiated lifitegrast ophthalmic solution (index date) between 01/01/2017 (US) or 01/01/2018 (Canada) and 06/30/2019. Patient demographics, treatments, clinical characteristics, and outcomes (ie, severity, signs, symptoms) were collected for the 6-month pre-index period and up to 12-months post-index. Results For this study, 517 HCPs contributed 600 patient charts. Among 554 and 281 patients with follow-up at 6 and 12-months post-index, 512 (92.4%) and 238 (84.7%) patients had ongoing lifitegrast treatment, respectively. Other DED-related treatments were less frequently used post-index with lifitegrast vs pre-index: over-the-counter artificial tear use (45.2% vs 75.5%), topical corticosteroids (3.8% vs 18.8%), any cyclosporine (3.0% vs 20.5%). At 3-months (n=571) and 12-months (n=320) post-index vs pre-index, fewer patients had eye dryness (47 [8.2%] and 16 [5.0%] vs 525 [87.5%]), blurred vision (28 [4.9%] and 11 [3.4%] vs 346 [57.7%]), ocular burning/stinging (25 [4.4%] and 8 [2.5%] vs 336 [56.0%]), depression (8 [1.4%] and 9 [2.8%] vs 55 [9.2%]), fatigue (4 [0.7%] and 1 [0.3%] vs 82 [13.7%]), and headache (1 [0.2%] and 0 vs 19 [3.2%]). At 3 and 12-months post-index vs pre-index, average corneal staining score was numerically lower (2.7 and 2.0 vs 6.5), and average Schirmer score (10.6 and 10 vs 6.3) and tear film break-up time (7.3 and 8.0 vs 4.8) higher. Conclusion The majority of patients had ongoing lifitegrast treatment 6-months post-index with reduction in overall treatment burden. Improvement in DED signs and symptoms, including QoL impacts, was evident at 3 months and up to 12 months after lifitegrast initiation.

Reduction of Artificial Tears and Use of Adjunctive Dry Eye Therapies After Lifitegrast Treatment: Evidence from Clinical and Real-World Studies

“… 22 The RWE chart review study was an IRB-approved non-interventional, retrospective, longitudinal cohort study using patient charts from both the US and Canada that were obtained through a healthcare provider panel. 21 The study design and eligibility criteria for each study have been published previously. 21 , 22 Details of the IRBs of the SONATA and RWE studies are provided in Appendix 1 .…”

“… 22 The recently published US/Canada real-world evidence (RWE) chart review study demonstrated that the majority of patients receiving lifitegrast treatment had a considerable reduction in overall treatment burden and improvement in DED signs and symptoms 6 months after lifitegrast initiation. 21 …”

“…The aim of this report is to evaluate whether treatment with lifitegrast can provide sustained symptomatic relief such that patients become less reliant on the overall use and frequency of ATs. Patient data from SONATA 22 and the RWE chart review study 21 have been analyzed separately.…”

Current Advances in Mechanisms and Treatment of Dry Eye Disease: Toward Anti-inflammatory and Immunomodulatory Therapy and Traditional Chinese Medicine

“…Lifitegrast is structurally similar to ICAM-1 and acts as a competitive antagonist to block LFA-1 and ICAM-1 binding and hence reduce the release of inflammatory factors ( 145 ). Lifitegrast (5%) reduces dry eye scores and ocular discomfort with a good safety and tolerability profile ( 146 ). Experimental studies have shown that Lifitegrast can inhibit the levels of IL-1β, IFN-γ and IL-10, and can increase the number and spread of conjunctival goblet cells ( 147 ).…”

“…Experimental studies have shown that Lifitegrast can inhibit the levels of IL-1β, IFN-γ and IL-10, and can increase the number and spread of conjunctival goblet cells ( 147 ). It was approved by the FDA in 2016 to be a novel drug for the treatment of DED ( 146 ).…”