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Minerva Ophthalmology 2021 June-December;63(2-4):7-17

DOI: 10.23736/S2785-1265.22.01840-7


language: Italian

Adverse reactions of the Avastin®, Eylea® and Lucentis® intravitreal drugs: a real-world analysis

Edoardo PIEROBON 1 , Giulia PAPOTTI 2

1 School of Specialization in Hospital Pharmacy, University of Turin, Turin, Italy; 2 S.C. Farmacia Ospedaliera del P.O. Maria Vittoria, ASL Città di Torino, Turin, Italy

BACKGROUND: Age-related macular degeneration (AMD) and diabetic macular edema (EMD) are the two main causes of progressive vision loss and blindness in developed countries. In Italy are estimated 100,000 new cases of AMD a year, while the incidence of diabetic macular edema has dramatically increased in the last 40 years, involving over 60% of diabetics.
METHODS: Avastin® (Genentech Inc., San Francisco, CA, USA), Eylea® (Bayer, Leverkusen, Germany) and Lucentis® (Genentech Inc.) are the most commonly used drugs: the first is authorized in Law 648/96 while the other two are indicated in the RCP. They work by inhibiting the transduction of the VEGF-mediated signal, responsible for proliferation and neovascularization. The aim of the work was to compare the safety data collected in the pharmacovigilance phase. Data from the AIFA National Network, the European Network of EudraVigilance and the World Network headed by WHO were analyzed.
RESULTS: From the analysis of the worldwide database, it emerges that for Eylea® (Bayer) there are 28,994 reports, most of these are related to the site and methods of administration (30.1%). For Lucentis® (Genentech Inc.), 32,679 total reports were found, of which 27.2% involve the eye. The analysis of the European database also allows us to analyze the data relating to the severity of ADRs: for Eylea® (Bayer) there are 10,592 reports, of which 96.3% are serious and only 3.7% non-serious; 19,030 were found for Lucentis® (Genentech Inc.) and a similar percentage to Eylea® (Bayer) in terms of severity (96.6% serious and 3.4% non-serious). In Italy, the analysis of reports for Avastin® (Genentech Inc.), used off-label, recorded 73, of which 19 serious (26%) and 54 non-serious (74%); for Eylea® (Bayer) a total of 58 reports were extracted, of which 52 serious (89.7%) and 6 non-serious (10.3%); finally, for Lucentis® (Genentech Inc.) 84 total reports, of which 75 serious (89.3%) and 9 non-serious (10.7%). For the two drugs Eylea® (Bayer) and Lucentis® (Genentech Inc.) worldwide there is the same number of reports of adverse events concerning, in both cases, the ocular district and the site of intravitreal administration. The same situation is revived for the reports collected within the borders of the EU. The pharmacovigilance data extracted from the RNF for Avastin® (Genentech Inc.) are slightly in contrast with those of the other drugs, both nationally and abroad: almost all the reports, registered as not serious, concern the presumed lack of efficacy.
CONCLUSIONS: Therefore, it emerges that these therapies are well tolerated and almost overlapping in terms of safety: this is a fact that must certainly be taken into consideration in the light of a reallocation of the scarce economic resources with which the NHS today has to deal. Furthermore, the safety profile is superimposable in Italy and abroad.

KEY WORDS: Pharmacovigilance; Intravitreal injections; Macular degeneration

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