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.

Keywords:

• symptoms
• signs
• severity
• QoL

Abbreviations

CI, confidence interval; CDEA, Canadian Dry Eye Assessment; DED, dry eye disease; DEQ-5, 5-Item Dry Eye Questionnaire; DEQS, Dry Eye-related Quality of Life Score; DESL, Dry Eye Severity Level; DEWS, Dry Eye Workshop Scale; eCRF, electronic case report form; EDS, Eye Dryness Score; HCP, healthcare provider; HIPAA, Health Insurance Portability and Accountability Act; IDEEL, Impact of Dry Eye on Everyday Life; NEIRB, New England Independent Review Board; NSAID, nonsteroidal anti-inflammatory drug; OSDI, Ocular Surface Disease Index; OTC, over-the-counter; QoL, quality of life; SD, standard deviation; SPEED, Standardized Patient Evaluation of Eye Dryness; TFBUT, tear film break-up time; US, United States.

Acknowledgments

This research was funded by Novartis Pharma AG, Basel, Switzerland. The authors would like to thank Dr. Mei Sheng Duh and Dr. Felicia Castriota from Analysis Group, Inc. for their contributions to this study.

Disclosure

Ms. Catherine Nguyen and Dr. Caroline Korves are employees of Analysis Group, Inc., a consulting company that has received funding from Novartis Pharma AG for this and other research. Ms. Annie Syntosi and Ms. Brigitte Sloesen are employees of Novartis Pharma AG. Dr. Mrudula B Glassberg and Dr. Arthur Chan are employees of Novartis Pharmaceuticals Corporation. Dr. John A Hovanesian, Dr. Kelly K Nichols, Dr. Mitchell Jackson and Dr. James Katz have been consultants to Novartis for this and other work. Dr. Kelly K Nichols reports personal fees from Bruder, Dompe, HanAll, Osmotica, Oyster Point, SightSciences, Alcon/Acquiom, Thea, Tarsus, and Topivert; personal fees, non-financial support from Kala; grants from Allergan, Tear Science, and NIH NEI, outside the submitted work. Dr. John A Hovanesian has received research grant support from Novartis. The authors report no other conflicts of interest in this work.