Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUSTM Study
Received 16 December 2019
Accepted for publication 29 April 2020
Published 2 June 2020 Volume 2020:14 Pages 1473—1481
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 4
Editor who approved publication: Dr Scott Fraser
Anita M Leys,1,2 Eva Ramboer,3 Mérédis Favreau,3 Kris Denhaerynck,4,5 Karen MacDonald,4 Ivo Abraham,4,6– 8 Heidi Brié3
1Department of Ophthalmology, Universitair Ziekenhuis Gasthuisberg, KULeuven, Leuven, Belgium; 2Oogartsen, Alken, Belgium; 3Novartis Pharma, Vilvoorde, Belgium; 4Matrix45, Tucson, AZ, USA; 5Department of Public Health, University of Basel, Basel, Switzerland; 6Center for Health Outcomes and Pharmacoeconomic Research, University of Arizona, Tucson, AZ, USA; 7Department of Pharmacy Practice and Science, College of Pharmacy, University of Arizona, Tucson, AZ, USA; 8Department of Family and Community Medicine, College of Medicine – Tucson, University of Arizona, Tucson, AZ, USA
Correspondence: Heidi Brié
N.V. Novartis Pharma S.A., Medialaan 40, Vilvoorde B-1800, Belgium
Purpose: To evaluate long-term, real-world treatment patterns and outcomes of ranibizumab 0.5 mg for neovascular age-related macular degeneration (nAMD) in a Belgian cohort.
Patients and Methods: This Belgian (BE) cohort of the 5-year global observational LUMINOUS study included 229 patients with nAMD. Outcomes included visual acuity (VA), central retinal thickness (CRT) and safety.
Results: The mean age was 79.5± 7.7 years. The majority of patients (67.7%) were female and all patients were Caucasian. Most patients previously received ranibizumab with only 17.5% of patients being treatment-naïve. The injection frequency declined over time irrespective of prior treatment status (p< 0.0001), with treatment-naïve eyes receiving a mean of 4.2± 2.9 yearly injections and prior-ranibizumab eyes 3.6± 2.7. Regression analysis confirmed first-year VA increases for treatment-naïve eyes (p=0.002) followed by a slight decrease of − 1.8 letters per year. For prior-ranibizumab eyes, the visual changes over 1 year were statistically non-significant (p=0.90) but declined slightly after year one (p< 0.0001). Anatomically, the CRT of treatment-naïve eyes decreased over time from baseline (p< 0.0001), whereas the CRT of prior-ranibizumab eyes remained stable (p=0.43). No new safety findings were identified.
Conclusion: LUMINOUS-BE reconfirms the well-characterized benefit-risk profile of ranibizumab for nAMD treatment. The observed low injection frequency reflects a need for more rigorous treatment in real-world settings.
Clinical Trial Registration: NCT01318941.
Keywords: ranibizumab, effectiveness, safety, treatment patterns, neovascular age-related macular degeneration, Belgium
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