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Purpose: Diabetic macular edema (DME) is a leading cause of vision loss and blindness. The aim of this study was to evaluate the economic benefits of introducing additional alternative technologies (Dexamethasone intravitreal implant – DEX – and Aflibercept injections), compared with the historical scenario of Ranibizumab intravitreal injections. Methods: A 3‐year budget impact model was developed, taking into consideration the perspective of the Lombardy Region Healthcare Service (LRHS). Total administration costs (real‐life data retrieved from clinical practice at three Departments of Ophthalmology) as well as costs related to the management of potential adverse events (information collected from the literature) were analysed. Results: Over a 36‐month horizon, the results showed that a higher consumption of DEX could lead to significant economic savings for the Regional Healthcare Service, ranging from a minimum of −4.35% (if DEX were used only in the second‐line of treatment) to a maximum of −12.97% (if DEX were used in both the first‐line and second‐line), including the potential impact of adverse events. Therapy costs with Aflibercept and Ranibizumab were similar. Conclusions: This study demonstrates that concentrating all eligible patients within the Ranibizumab regimen is unlikely to represent a cost‐effective strategy. Indeed, significant economic advantages would be achieved by introducing the other licensed alternatives, Dexamethasone implant and Aflibercept, thus optimising DME Italian healthcare expenditure. The results demonstrate DEX as an advantageous technological alternative for the target population affected by DME, both as a first‐ and second‐line treatment option, reducing the economic burden of the pathology for the Regional/National Health Service. [ABSTRACT FROM AUTHOR]

INTRODUCTION:Health Technology Assessment (HTA) aims at providing decision makers with relevant data, matching different perspectives, with an evidence-based approach. The most common framework used is the European Network for Health Technology Assessment (EUnetHTA) Core Model (1): HTA may be further supported by a Multi-Criteria Decision Analysis (MCDA) (2,3), leading to a final quantitative synthesis, facilitating the appraisal phase.This project presents a multi-dimensional comparison of the technologies available for the treatment of diabetic macular edema (Ranibizumab, Aflibercept, Dexamethasone implant and off-label Bevacizumab), comparing three Italian Regions: Lombardy, Liguria and Veneto.METHODS:The nine EUnetHTA dimensions were first prioritized by seventeen multidisciplinary evaluators. Thereafter a further nine professionals attributed a 3-level rating score (from “1” not performant, to “3” most performant) to each dimension and sub-dimension, after carefully assessing the three HTA reports. In conclusion, the investigation of statistically significant differences between the attributed scores of the evaluators was conducted, using a multi-variate analysis.RESULTS:No statistically significant differences were reported in the prioritization of each dimension, except for the equity (more important in Liguria and in Lombardy) and the economic financial dimensions (more relevant in Veneto and in Lombardy).Notwithstanding the evaluators’ different professional titles, job roles, center size, and various Regional contexts, they attributed similar scores to the HTA dimensions during the appraisal phase (even though conducted in different years, in 2015 and 2016). This finding demonstrates the robustness of both the evaluations and the final MCDA results: i) no statistically inter-regional significant differences emerged regarding Ranibizumab and Aflibercept (p-value >.05); ii) no statistically significant inter-regional differences emerged regarding Dexamethasone, except for the assessments in the clinical dimensions (p-value = .026), since in Lombardy Region the evaluation was carried out earlier in the technology's life-cycle.CONCLUSIONS:Dexamethasone was consistently attributed a higher total score, considering the final normalised weight derived from the MCDA approach (p-value =.001). [ABSTRACT FROM PUBLISHER]

Introduction: Some hemodialysis patients are reluctant to undergo COVID-19 vaccination for the fear of developing adverse events (AEs). The aim of this study was to verify the safety of the mRNA-1273 vaccine in hemodialysis patients. Methods: We conducted a retrospective analysis of in-center hemodialysis patients who underwent mRNA-1273 vaccine from March 1st to April 30th, 2021. All AEs occurring after the first and the second doses were collected and classified as local or systemic. Results: Overall, 126 patients on chronic maintenance dialysis without a prior COVID-19 diagnosis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54,7-76) years and 53.6% of patients were aged ≥65 years. During the observational period of 68 (IQR, 66-70) days, AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were: injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%), nausea/vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%). The rates of local AEs were similar after the first and second doses (P=0.8), whereas systemic AEs occurred more frequently after the second dose (P=0.001). Fever (P=0.03), fatigue (P=0.02) and nausea/vomiting (P=0.03) were significantly more frequent after the second dose of the vaccine. There were no age-related differences in the rate of AEs. Overall, vaccine-related AEs in hemodialysis patients seem to be lower than in the general population. Conclusion: The RNA-1273 vaccine was associated with the development of transient AEs after the first and second doses in patients on chronic maintenance hemodialysis. They were mostly local, whereas systemic AEs were more prevalent after the second dose. Overall, all AEs lasted for a few days, without any apparent sequelae., (Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.)

Background: Kidney transplant (KT) recipients with COVID-19 are at high risk of poor outcomes due to the high burden of comorbidities and immunosuppression. The effects of immunosuppressive therapy (IST) reduction are unclear in patients with COVID-19. Methods: A retrospective study on 45 KT recipients followed at the University Hospital of Modena (Italy) who tested positive for COVID-19 by RT-PCR analysis. Results: The median age was 56.1 years (interquartile range,[IQR] 47.3-61.1), with a predominance of males (64.4%). Kidney transplantation vintage was 10.1 (2.7-16) years, and 55.6 % of patients were on triple IST before COVID-19. Early immunosuppression minimization occurred in 27 (60%) patients (reduced-dose IST group) and included antimetabolite (88.8%) and calcineurin inhibitor withdrawal (22.2%). After SARS-CoV-2 infection, 88.9% of patients became symptomatic and 42.2% required hospitalization. One patient experienced irreversible graft failure. There were no differences in serum creatinine level and proteinuria in non-hospitalized patients before and post-COVID-19, whereas hospitalized patients experienced better kidney function after hospital discharge (P=0.019). Overall mortality was 17.8%. without differences between full- and reduced-dose IST. Risk factors for death were age (odds ratio [OR]: 1.19; 95%CI: 1.01-1.39), and duration of kidney transplant (OR: 1.17; 95%CI: 1.01-1.35). One KT recipient developed IgA glomerulonephritis and two ones experienced symptomatic COVID-19 after primary infection and SARS-CoV-2 mRNA vaccine, respectively. Conclusions: Despite the reduction of immunosuppression, COVID-19 affected the survival of KT recipients. Age of patients and time elapsed from kidney transplantation were independent predictors of death . Early kidney function was favorable in most survivors after COVID-19., (Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.)

Background and Aim: The urgency of having rapidly safe and efficient COVID-19 vaccines called for the need to shorten trial phases, reduce sample sizes, and speed-up the approval process by the regulatory Agencies. In light of this, monitoring adverse effects (AEFI) (both immediate and at medium-long term) become of great importance. Aim of this cross-sectional study was to explore the associations between several factors and risk of immediate AEFI., Methods: Data come from the electronic dataset developed ad hoc to record demographic data, anamnesis and data related to immunization, set-up in the mass vaccination site in Novegro (Milan). Novegro mass vaccination site was one of the mass vaccinations sites with the highest flow in Lombardy Region, with a maximum capacity of 5,000 vaccinations/day. The center opened in April 2021 and closed the 1st of August 2021. A multivariable logistic regression model was used. Odds ratios adjusted (aOR) for age and sex are presented. Statistical significance was set at p<0.05. Analyses were conducting using STATA., Results: Among the total of 314,671 subjects vaccinated, 0.5% developed an immediate AEFI, on average 17.0 ± 0.43 minutes after the administration. The three most frequent AEFI recorded were vagal response (30%), anxiety reaction (24%) and dizziness (21%). AEFI were more frequently observed among women [aOR= 2.24 (95%CI= 2.00 - 2.50)], and those with at least one previous disease [aOR= 1.47 (95%CI= 1.22-1.76)]., Conclusions: In conclusion, AEFI were less likely to occur for increasing age and after the second dose. Results from this large, complete and representative sample population regarding enrich the interesting scientific debate on potential adverse events following COVID-19 immunization.