Intravitreal Therapies Pattern Of Use In Italy: A Real-World Evidence Study On Maculopathies

To investigate drug utilization and prescribing practices regarding intravitreal therapies for neovascular age-related macular degeneration (wAMD), retinal vein occlusions (RVO), diabetic macular edema (DME) and choroidal neovascularization (CNV) treatment, providing real-world evidence regarding their patterns of use, in the Italian clinical context. A study, based on data from pharmacy databases, was conducted in 6 Italian hospitals. Treatment-naïve wAMD, RVO, DME, and CNV patients’ eyes, who received an intravitreal injection from 01/01/2016 to 06/31/2017, were eligible for inclusion, and a 24-month follow-up was assumed. Information about the number of injections received and administered drugs were considered, for whom frequencies and descriptive statistics were assessed. 5,527 eyes were diagnosed for a maculopathy requiring intravitreal therapy. 33% received treatment up to 24 months. Focusing on wAMD, considering a single-year treatment (N=3,260;64%), eyes received on average 3.39±0.04(range:1-12), 3.54±0.06(range:1-8) and 3 injections with ranibizumab, aflibercept and pegaptanib respectively. Considering a two-year treatment (N=1,798;36%), wAMD eyes received on average 8.00±0.10(range:2-18) and 8.11±0.10(range:2-14) ranibizumab or aflibercept injections. Out of 1,210 DME eyes, 71% received a single-year treatment, with 3.02±0.02(range:1-8), 3.60±0.13(range:1-8), 1.43±0.05(range:1-5) ranibizumab, aflibercept and dexamethasone respectively. Within a 24-month timeframe (N=348; 29%), 8.05±0.23(range:1-17) ranibizumab, 8.12±0.24(range:3-14) aflibercept and 4.59±0.17(range:2-11) dexamethasone injections were administered. 560 RVO eyes received treatment within a 12-month period, with 3.31±0.11(range: 1-10), 3.24±0.15(range:1-9), 1.47±0.06(range:1-7) or 1.67±0.33(range:1-2) ranibizumab, aflibercept, dexamethasone or triamcinolone injections. Considering a two-year treatment (N=197), 8.67±0.29(range:3-15) ranibizumab, 8.51±0.27(range:2-15) aflibercept or 3.92±0.21(range:2-6) injections were performed. CNV eyes (N=300) were treated with ranibizumab and aflibercept drugs receiving 2.08±0.08(range:1-8) and 1.83±0.40(range:1-3) injections respectively considering a single-year treatment (N=244 eyes). 56 eyes treated for a 24-month time horizon, were administered with 5.52±0.36(range:1-6) ranibizumab injections. The study highlights differences between clinical practice and prescribing information, in terms of intravitreal injections frequency, suggesting the need to further analyze and describe reasons and related organizational factors and potential problems.