Introduction: Efgartigimod and ravulizumab, both approved for treating acetylcholine receptor auto-antibody-positive (AChR-Ab+) generalized myasthenia gravis (gMG), have not been directly compared. This paper assessed comparative effects of efgartigimod vs. ravulizumab for treating adults with AChR-Ab+ gMG using indirect treatment comparison methods.
View Article and Find Full Text PDFIntroduction: For patients with generalized myasthenia gravis (gMG), the association between symptom severity, often measured with the Myasthenia Gravis Activities of Daily Living (MG-ADL) instrument, and utility values is unknown.
Methods: Data was analyzed from the phase 3 ADAPT trial, which included adult patients with gMG randomly assigned to treatment with efgartigimod + conventional therapy (EFG + CT) or placebo + CT (PBO + CT). MG-ADL total symptom scores and the EQ-5D-5L, a measure of health-related quality of life (HRQoL), were collected biweekly up to 26 weeks.
The most serious complication in the treatment of hemophilia A (HA) is the development of factor (F)VIII inhibitors or antidrug antibodies (ADA) occurring in 25-35% of patients with severe HA. The immunological mechanisms underlying the development of ADA against FVIII products have not been completely understood yet. Immunological danger signals associated with events such as infection or surgery have been suggested to play a critical role.
View Article and Find Full Text PDFThis research aimed to compare the relative efficacy of avapritinib versus midostaurin for patients with advanced systemic mastocytosis. A systematic literature review was performed to identify relevant evidence. Unanchored matching-adjusted indirect comparisons were conducted for overall survival (OS), overall response rate (ORR) and complete remission (CR).
View Article and Find Full Text PDFObjectives: Despite extensive efforts to monitor the diffusion of COVID-19, the actual wave of infection is worldwide characterized by the presence of emerging SARS-CoV-2 variants. The present study aims to describe the presence of yet undiscovered SARS-CoV-2 variants in Italy.
Methods: Next Generation Sequencing was performed on 16 respiratory samples from occasionally employed within the Bangladeshi community present in Ostia and Fiumicino towns.
Background: Identifying healthcare workers (HCW) who have less awareness and knowledge on antibiotic use and resistance represents a challenge for public health, since it might help the development of novel educational and training initiatives tailored on specific subgroups of professionals. This work aims to compare knowledge, attitudes and behaviors on antibiotic use and resistance across different groups of Italian HCW.
Methods: We used data from the multi-country and multi-professional survey launched by the European Centre for Disease Prevention and Control between 28 January to 4 March 2019 to assess knowledge, attitude and behaviors of HCW on antibiotics, antibiotic use and resistance.
Background: Avapritinib, a potent inhibitor of KIT and platelet-derived growth factor receptor A (PDGFRA) tyrosine kinases, has demonstrated unprecedented clinical activity in PDGFRA D842V-mutant gastrointestinal stromal tumors (GIST).
Methods: This retrospective analysis compared efficacy of avapritinib in patients enrolled in the NAVIGATOR phase 1 trial (NCT02508532) with the efficacy of other tyrosine kinase inhibitors (TKIs) in patients with unresectable/metastatic PDGFRA D842V-mutant GIST enrolled in a retrospective natural history study (Study 1002). The primary endpoint was overall survival (OS) from the start of reference treatment (avapritinib for NAVIGATOR patients or first-line TKI for treatment of unresectable/metastatic GIST for Study 1002 patients); the secondary endpoint was progression-free survival (PFS).
Glob Reg Health Technol Assess
March 2021
Objectives: Using the case study of patisiran and inotersen, we conducted a narrative comparative analysis of the health technology assessment (HTA) agency appraisals of these two first-in-class transthyretin gene silencers, which represent exceptional advances in the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis, a rare and multisystemic disease. Despite the impact of each product on the treatment landscape, the majority of HTAs are only considered standard of care as a comparator, resulting in a void of information and limited comprehension of the clinical and pharmacoeconomic differences between the two treatments.
Methods: A search was conducted internationally for HTA reports, and only instances where assessment decisions for both treatments were publicly available were included in the present analysis.
Introduction: Despite continuing efforts, compliance rates and knowledge of best practices in hand hygiene remain disappointing. Recognizing that conventional educational tools seem out of touch with young people and that the med and messages contents need refreshing, the Italian Study Group of Hospital Hygiene of the Italian Society of Hygiene, Preventive Medicine and Public Health devised a novel approach to promote the creation of innovative educational tools for improving knowledge of, and compliance with, hand hygiene rules among healthcare and medical students.
Methods: A contest in creating educational material on hand hygiene practices involved university students of nursing and medicine, and of other healthcare degrees.
TB is still a major public health problem and a threat to global health security. In Italy, TB control is consistent with the WHO global strategy, in which the role of prevention and, within it, contacts tracing and their management are emphasized. In this work, a protocol for the correct and homogeneous management of TB cases, at local level, is described in all its phases, from reporting to contacts management.
View Article and Find Full Text PDFIn Tuscany, Italy, New Delhi metallo-beta-lactamase-producing carbapenem-resistant Enterobacterales (NDM-CRE) have increased since November 2018. Between November 2018 and October 2019, 1,645 samples were NDM-CRE-positive: 1,270 (77.2%) cases of intestinal carriage, 129 (7.
View Article and Find Full Text PDFDespite evidence supporting the effectiveness of best practices in infection prevention and management, many healthcare workers fail to implement them and evidence-based practices tend to be underused in routine practice. Prevention and management of infections across the surgical pathway should always focus on collaboration among all healthcare workers sharing knowledge of best practices. To clarify key issues in the prevention and management of infections across the surgical pathway, a multidisciplinary task force of experts convened in Ancona, Italy, on May 31, 2019, for a national meeting.
View Article and Find Full Text PDFAim: In patients with chronic kidney disease (CKD), hyperkalaemia (HK) (potassium level ≥ 5.0 mEq/L) is associated with poor clinical outcomes. This study provides novel insights by comparing management costs of CKD patients with normokalaemia vs those with persistent HK regularly followed in renal clinics in Italy.
View Article and Find Full Text PDFIntroduction: In the WHO European Region, endemic transmission of measles and rubella had been interrupted by 37 and 42 of the 53 member states (MSs), respectively, by 2018. Sixteen MSs are still endemic for measles, 11 for rubella and nine for both diseases, the latter including Italy. Elimination is documented by each country's National Verification Committee (NVC) through an annual status update (ASU).
View Article and Find Full Text PDFItaly introduced a national law extending the number of compulsory vaccines from four to 10 in July 2017. The implementation placed a further burden on immunisation centres as they were required to cover the increased demand of vaccination by the parents of unvaccinated children. Vaccine coverage (VC) estimated 6 months and 1 year later, at 24 and 30 months (same birth cohort), had increased for all vaccines.
View Article and Find Full Text PDFBackground And Objectives: Third-line treatment options for patients with chronic-phase chronic myeloid leukemia include tyrosine kinase inhibitors and allogeneic hematopoietic stem cell transplantation (alloHSCT). The objective of this study was to develop a Markov model with a lifetime time horizon to assess the cost effectiveness of ponatinib for third-line chronic-phase chronic myeloid leukemia vs. second-generation tyrosine kinase inhibitors (dasatinib, nilotinib, bosutinib) or alloHSCT from the public healthcare system perspective in Germany, Sweden, and Canada.
View Article and Find Full Text PDFESCULAPIO Project, funded by the Centre for Disease Prevention and Control (CCM) of the Italian Ministry of Health, for the program 2013, aims at increasing awareness on vaccine preventable infectious diseases (VPID) and vaccination in different targets of population and at spreading the culture of prevention by the development of information/training interventions on VPID. In Tuscany Region (Central Italy), educational courses on VPID in high schools were organized and students were stimulated to prepare informative materials on VPID for lower grade school pupils. Educational games for school pupils were realized in Liguria Region (Northern Italy) with the aim to increase awareness and knowledge of vaccination among primary school children, their families, and teachers.
View Article and Find Full Text PDFBackground: Also in Italy, a flourishing evidence confirms the recent spread of vaccine hesitancy movements resulting in approximately 4-7% of the paediatric population not immunised every year against polio and approximately 9-15% against measles in the last few years. The aim of this paper is to describe the reasons of polio and measles missed vaccination in Italy, in the period 2015-2017, and to analyse any potential effect of the 2017 mandatory vaccination law.
Methods: Number of missed vaccinations in children younger than 24 months, stratified by reason, were collected separately for measles and polio with a regional level of detail.
Background: The World Health Organization estimated that 90% of the infected people need to be diagnosed and 80% need to be treated to reach the aim of hepatitis C virus (HCV) elimination by 2030. For this reason, all possible strategies to detect and treat HCV-infected people need to be carefully evaluated to implement the best one.
Aim: To review and synthesise the economic evaluations of HCV screening programs conducted in the era of direct-acting antiviral agents regimens.
Although most countries in the WHO European Region were verified in 2017 as having interrupted endemic measles transmission, nine countries were still endemic. Among these, Italy accounted for the second highest number of measles cases reported in Europe in 2017. The elimination of measles is verified at national level by each country's National Verification Committee (NVC) through the production of an Annual Status Update (ASU).
View Article and Find Full Text PDFIn 2015 an increased incidence of invasive meningococcal disease due to serogroup-C (MenC) occurred in Tuscany, Italy. This led the Regional Health Authority of Tuscany to implement a reactive immunisation campaign and to launch an epidemiological field investigation aiming to address targeted immunisation interventions. In 2011-14, 10 MenC cases had been reported compared with 62 cases in 2015-16.
View Article and Find Full Text PDFObjective: Comparing the benefit-risk profiles of ponatinib vs. bosutinib in third-line (3L) treatment of chronic phase chronic myeloid leukemia (CP-CML) is challenging because their pivotal trials lacked comparator arms. To characterize the overall benefit-risk profile in 3L CP-CML patients treated with bosutinib vs.
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