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. 2020 Jan 11:2020:7582763.
doi: 10.1155/2020/7582763. eCollection 2020.

How Have Intravitreal Anti-VEGF and Dexamethasone Implant Been Used in Italy? A Multiregional, Population-Based Study in the Years 2010-2016

Giulia Scondotto  1 , Janet Sultana  2 , Valentina Ientile  1 , Ylenia Ingrasciotta  2 , Andrea Fontana  3 , Massimiliano Copetti  3 , Eliana Mirabelli  2 , Costantino J Trombetta  2 , Carlo Rapisarda  4 , Michele Reibaldi  4 , Teresio Avitabile  4 , Antonio Longo  4 , Patricia Ibanez Toro  5 , Maria Vadalà  6 , Salvatore Cillino  7 , Gianni Virgili  8 , Rosa Gini  9 , Olivia Leoni  10 , Sebastiano Walter Pollina Addario  11 , Pasquale Cananzi  12 , Claudia La Cavera  12 , Maria Rosalia Puzo  5 , Giovambattista De Sarro  13 , Adele De Francesco  14 , Gianluca Trifirò  1   2
Affiliations

How Have Intravitreal Anti-VEGF and Dexamethasone Implant Been Used in Italy? A Multiregional, Population-Based Study in the Years 2010-2016

Giulia Scondotto et al. Biomed Res Int. .

Abstract

Purpose: To describe intravitreal anti-VEGF drug and dexamethasone use in four Italian regions.

Methods: Four regional claims databases were used to measure drug prevalence, compare dosing intervals to those recommended in the summary of product characteristics (SPC), and identify switchers. Bilateral treatment and diabetic macular edema (DME) coding algorithms were validated, linking claims with a sample of prospectively collected ophthalmological data.

Results: Overall, 41,836 patients received ≥1 study drug in 2010-2016 (4.8 per 10,000 persons). In 2016, anti-VEGF drug use ranged from 0.8 (Basilicata) to 5.7 (Lombardy) per 10,000 persons while intravitreal dexamethasone use ranged from 0.2 (Basilicata) to 1.4 (Lombardy) per 10,000 persons. Overall, 40,815 persons were incident users of study drugs. Among incident users with ≥1 year of follow-up (N = 30,745), 16.0% (N = 30,745), 16.0% (N = 30,745), 16.0% (.

Conclusion: Study drug use increased over time in Lombardy, Basilicata, Calabria, and Sicily, despite a large heterogeneity in prevalence of use across regions. Drug treatment appeared to be partly in line with SPC, suggesting that improvement in clinical practice may be needed to maximize drug benefits.

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Conflict of interest statement

Giulia Scondotto, Janet Sultana, Valentina Ientile, Ylenia Ingrasciotta, Andrea Fontana, Massimiliano Copetti, Eliana Mirabelli, Costantino J. Trombetta, Carlo Rapisarda, Teresio Avitabile, Antonio Longo, Patricia Ibanez Toro, Maria Vadalà, Salvatore Cillino, Gianni Virgili, Olivia Leoni, Sebastiano Walter Pollina Addario, Pasquale Cananzi, Claudia La Cavera, Maria Rosalia Puzo, Giovambattista De Sarro, Adele De Francesco have no conflicts of interest to declare. Gianluca Trifirò participated in advisory boards within the last five years on topics not related to this manuscript and organized by Sandoz, Hospira, Sanofi, Biogen, Ipsen, and Shire and is a consultant for Otsuka. He is the principal investigator of observational studies funded by several pharmaceutical companies (e.g., Amgen, AstraZeneca, Daiichi Sankyo, IBSA) to the University of Messina as well as scientific coordinator of the master's program “Pharmacovigilance, pharmacoepidemiology and pharmacoeconomics: real world data evaluations” at the University of Messina which receives unconditional funding from several pharmaceutical companies.

Figures

Figure 1
Figure 1
Identification of incident users of intravitreal anti-VEGF drugs or dexamethasone. Footnote: anti-VEGF: vascular endothelial growth factor; ID: Index Date (i.e., date of the first anti-VEGF or intravitreal dexamethasone dispensing during the study years). ∗Data availability ranged from 2010 to 2016 in Lombardy, from 2012 to 2015 in Calabria, and from 2012 to 2016 in Sicily and Basilicata. The crude numbers of inhabitants of each region used to calculate the mean yearly populations were based on official demographic data published by the Italian National Institute of Statistics
Figure 2
Figure 2
Yearly prevalence of use per 10,000 persons of intravitreal anti-VEGF or dexamethasone in the general population, grouped by region and calendar years (2010–2016). Error bars represent the Wilson score 95% confidence interval (with continuity correction) around prevalence estimates.
Figure 3
Figure 3
Distribution of the number of days between intravitreal anti-VEGF pharmacy claims among incident users, by drug dispensed at cohort entry. The solid line inside each box represents the median value whereas each circled dot represents the mean value.
Figure 4
Figure 4
Distribution of the number of days between intravitreal dexamethasone pharmacy claims among incident users. The solid line inside each box represents the median value whereas each circled dot represents the mean value.
Figure 5
Figure 5
Switching pattern among incident users with at least two pharmacy claims within the first year of treatment after cohort entry. Percentages are shown on the arrows.
See this image and copyright information in PMC

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