Characteristics and Treatment Patterns of Patients with Diabetic Macular Edema Non-Responsive to Anti-Vascular Endothelial Growth Factor Treatment in Ontario, Canada

Abstract

Sohel Somani,1 Keyvan Koushan,2 Bijal Shah-Manek,3 Daniel Mercer,4 Thula Kanagenthiran,5 Changgeng Zhao,5 Ali Alobaidi5 1Department of Ophthalmology and Vision Sciences, University of Toronto and Uptown Eye Specialists, Brampton, Canada; 2Toronto Retina Institute, Toronto, Canada; 3Health Economics and Outcomes Research, Noesis Healthcare Technologies, Inc., Redwood City, CA, USA; 4Genesis Research, Hoboken, NJ, USA; 5Allergan, an AbbVie Company, Irvine, CA, USACorrespondence: Sohel Somani, Email [email protected]: To understand the demographics, clinical characteristics, treatment patterns, visual and anatomic responses of patients with diabetic macular edema (DME) initially treated with anti-vascular endothelial growth factor (anti-VEGF) agents in the real-world clinical setting.Patients and Methods: This retrospective cohort study used electronic health records to identify consecutively presenting patients with DME who received their first documented anti-VEGF injection (index injection) on or after 1 October 2015 and before 30 September 2016 (index period) at 4 clinical sites in Ontario, Canada. Patients receiving anti-VEGF injections in the study eye were followed for ≥ 18 months. After the first 3 monthly injections, patients were classified as “responder” (≥ 20% reduction in central retinal thickness [CRT] from index date) or “nonresponder” (< 20% reduction in CRT) to anti-VEGF treatment.Results: At 12 months, change from baseline (CFB) in best visual acuity (BVA) of responders (n = 30) was mean (SD) 12.8 (13.00) letters; CFB in nonresponders (n = 56) was 3.2 (16.3) letters. Sensitivity analyses stratified by initial BVA were supportive. Mean (SD) change in CRT (μm) was − 160.4 (111.4) in responders and − 62.2 (98.6) in nonresponders. While changes in anti-VEGF therapy were lower in responders versus nonresponders (10.0% vs 23.2%), mean number of injections was similar (8.3 in each cohort).Conclusion: Despite receiving a substantial number of injections and requiring changes in therapy more frequently, nonresponders showed a lack of clinically meaningful change in BVA and CRT. Nonresponders could be identified after 3 anti-VEGF injections. There remains an unmet need for treatment options in patients with DME who show a nonresponse after 3 months of anti-VEGF treatment.Keywords: real-world evidence, diabetic macular edema, drug therapy, anti-vascular endothelial growth factor, visual acuity

Keywords

• real-world evidence
• diabetic macular edema
• drug therapy
• anti-vascular endothelial growth factor
• visual acuity