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

被引:5
作者
Karpecki, Paul [1 ]
Barghout, Victoria [2 ]
Schenkel, Brad [3 ]
Huynh, Lynn [4 ]
Khanal, Anamika [4 ]
Mitchell, Brittany [3 ]
Yenikomshian, Mihran [4 ]
Zanardo, Enrico [5 ]
Matossian, Cynthia [6 ]
机构
[1] Univ Pikeville, Kentucky Coll Optometry, Kentucky Eye Inst, Lexington, KY 41501 USA
[2] VEB HealthCare, Morristown, NJ USA
[3] Sun Pharmaceut Ind Inc, Princeton, NJ USA
[4] Anal Grp Inc, Boston, MA USA
[5] Anal Grp Inc, Denver, CO USA
[6] CM Associates LLC, New Hope, PA USA
关键词
Cyclosporine A; Discontinuation; Keratoconjunctivitis sicca; Persistence; SOLUTION; 5.0-PERCENT; EFFICACY; PLACEBO; SAFETY; MANAGEMENT; MODERATE; THERAPY;
D O I
10.1186/s12886-023-03174-y
中图分类号
R77 [眼科学];
学科分类号
100212 ;
摘要
Background 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 (R); OTX-101), cyclosporine ophthalmic emulsion 0.05% (Restasis (R); CsA), and lifitegrast ophthalmic solution 5% (Xiidra (R); LFT) are anti-inflammatory agents indicated for DED. This analysis compared treatment patterns in patients with DED receiving OTX-101, CsA, or LFT.Methods 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.Results 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).Conclusions 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.
引用
收藏
页数:12
相关论文
共 25 条
[1]  
[Anonymous], 2022, CEQUA (cyclosporine ophthalmic solution) Full Prescribing Information
[2]  
[Anonymous], 2017, Restasis (cyclosporine ophthalmic emulsion) Full Prescribing Information
[3]  
[Anonymous], 2020, Xiidra (lifitegrast ophthalmic solution) Full Prescribing Information
[4]   TFOS DEWS II pathophysiology report [J].
Bron, Anthony J. ;
de Paiva, Cintia S. ;
Chauhan, Sunil K. ;
Bonini, Stefano ;
Gabison, Eric E. ;
Jain, Sandeep ;
Knop, Erich ;
Markoulli, Maria ;
Ogawa, Yoko ;
Perez, Victor ;
Uchino, Yuichi ;
Yokoi, Norihiko ;
Zoukhri, Driss ;
Sullivan, David A. .
OCULAR SURFACE, 2017, 15 (03) :438-510
[5]   TFOS DEWS II Report Executive Summary [J].
Craig, Jennifer P. ;
Nelson, J. Daniel ;
Azar, Dimitri T. ;
Belmonte, Carlos ;
Bron, Anthony J. ;
Chauhan, Sunil K. ;
de Paiva, Cintia S. ;
Gomes, Jose A. P. ;
Hammitt, Katherine M. ;
Jones, Lyndon ;
Nichols, Jason J. ;
Nichols, Kelly K. ;
Novack, Gary D. ;
Stapleton, Fiona J. ;
Willcox, Mark D. P. ;
Wolffsohn, James S. ;
Sullivan, David A. .
OCULAR SURFACE, 2017, 15 (04) :802-812
[6]   TFOS DEWS II Definition and Classification Report [J].
Craig, Jennifer P. ;
Nichols, Kelly K. ;
Akpek, Esen K. ;
Caffery, Barbara ;
Dua, Harminder S. ;
Joo, Choun-Ki ;
Liu, Zuguo ;
Nelson, J. Daniel ;
Nichols, Jason J. ;
Tsubota, Kazuo ;
Stapleton, Fiona .
OCULAR SURFACE, 2017, 15 (03) :276-283
[7]   Estimated Prevalence and Incidence of Dry Eye Disease Based on Coding Analysis of a Large, All-age United States Health Care System [J].
Dana, Reza ;
Bradley, John L. ;
Guerin, Annie ;
Pivneva, Irina ;
Stillman, Ipek Ozer ;
Evans, Amber M. ;
Schaumberg, Debra A. .
AMERICAN JOURNAL OF OPHTHALMOLOGY, 2019, 202 :47-54
[8]   Practical guidance for the use of cyclosporine ophthalmic solutions in the management of dry eye disease [J].
de Oliveira, Rodrigo Carlos ;
Wilson, Steven E. .
CLINICAL OPHTHALMOLOGY, 2019, 13 :1115-1122
[9]   A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease [J].
Goldberg, Damien F. ;
Malhotra, Ranjan P. ;
Schechter, Barry A. ;
Justice, Angela ;
Weiss, Sidney L. ;
Sheppard, John D. .
OPHTHALMOLOGY, 2019, 126 (09) :1230-1237
[10]   Lifitegrast for the Treatment of Dry Eye Disease Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3) [J].
Holland, Edward J. ;
Luchs, Jodi ;
Karpecki, Paul M. ;
Nichols, Kelly K. ;
Jackson, Mitchell A. ;
Sall, Kenneth ;
Tauber, Joseph ;
Roy, Monica ;
Raychaudhuri, Aparna ;
Shojaei, Amir .
OPHTHALMOLOGY, 2017, 124 (01) :53-60