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1.
ESMO Open ; 8(6): 102034, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37866029

ABSTRACT

BACKGROUND: In the phase III JAVELIN Renal 101 trial, first-line avelumab + axitinib improved progression-free survival (PFS) and objective response rate versus sunitinib in patients with advanced renal cell carcinoma across all International Metastatic RCC Database Consortium (IMDC) risk groups (favorable, intermediate, and poor); analyses of overall survival (OS) remain immature. Here, we report post hoc analyses of efficacy from the third interim analysis (data cut-off, April 2020) by the numbers of IMDC risk factors and target tumor sites at baseline. METHODS: Efficacy endpoints assessed were PFS, objective response, and best overall response per investigator assessment (RECIST v1.1) and OS. Best percentage change and percentage change from baseline in target tumor size over time during the study were also assessed. RESULTS: In patients with 0, 1, 2, 3, or 4-6 IMDC risk factors, hazard ratios [HRs; 95% confidence interval (CIs)] for OS with avelumab + axitinib versus sunitinib were 0.660 (0.356-1.223), 0.745 (0.524-1.059), 0.973 (0.668-1.417), 0.718 (0.414-1.248), and 0.443 (0.237-0.829), and HRs (95% CIs) for PFS were 0.706 (0.490-1.016), 0.709 (0.540-0.933), 0.711 (0.527-0.960), 0.501 (0.293-0.854), and 0.395 (0.214-0.727), respectively. In patients with 1, 2, 3, or ≥4 target tumor sites, HRs (95% CIs) for OS with avelumab + axitinib versus sunitinib were 0.912 (0.640-1.299), 0.715 (0.507-1.006), 0.679 (0.442-1.044), and 0.747 (0.346-1.615), and HRs (95% CIs) for PFS were 0.706 (0.548-0.911), 0.552 (0.422-0.723), 0.856 (0.589-1.244), and 0.662 (0.329-1.332), respectively. Across all subgroups, analyses of objective response rate and complete response rate favored avelumab + axitinib versus sunitinib, and a greater proportion of patients treated with avelumab + axitinib had tumor shrinkage. CONCLUSIONS: In post hoc analyses, first-line treatment with avelumab + axitinib was generally associated with efficacy benefits versus treatment with sunitinib in patients with advanced renal cell carcinoma across subgroups defined by different numbers of IMDC risk factors or target tumor sites.


Subject(s)
Antineoplastic Agents , Carcinoma, Renal Cell , Kidney Neoplasms , Humans , Carcinoma, Renal Cell/drug therapy , Carcinoma, Renal Cell/secondary , Axitinib/pharmacology , Axitinib/therapeutic use , Sunitinib/pharmacology , Sunitinib/therapeutic use , Antineoplastic Agents/therapeutic use , Follow-Up Studies , Kidney Neoplasms/drug therapy , Kidney Neoplasms/pathology , Risk Factors
2.
Eur Rev Med Pharmacol Sci ; 27(8): 3645-3663, 2023 04.
Article in English | MEDLINE | ID: mdl-37140315

ABSTRACT

Healthcare-associated infections are a serious threat in terms of morbidity and mortality for all patients receiving healthcare. The problem is aggravated by the increasingly widespread phenomenon of antibiotic resistance, with some microorganisms now resistant to all or almost all the currently available antibiotics. Nanomaterials are compounds used by many different industrial fields and they are currently studied for their intrinsic antimicrobial properties. To date, many researchers have considered using many different nanoparticles and nanomaterials to produce surfaces and medical devices with intrinsic antimicrobial features. Many compounds have shown very interesting and effective antimicrobial capacities and could be used, in the future, to manufacture new hospital surfaces and medical devices. However, many studies have to be carried out to evaluate the effective potential use of these compounds. The aim of this paper is to review the main literature regarding this topic, focusing on the main types of nanoparticles and nanomaterials studied for this purpose.


Subject(s)
Anti-Infective Agents , Cross Infection , Nanoparticles , Humans , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use
3.
ESMO Open ; 8(3): 101173, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37141847

ABSTRACT

BACKGROUND: We hypothesized that avelumab plus axitinib could improve clinical outcomes in patients with advanced non-small-cell lung cancer (NSCLC) or urothelial carcinoma (UC). PATIENTS AND METHODS: We enrolled previously treated patients with advanced or metastatic NSCLC, or untreated, cisplatin-ineligible patients with advanced or metastatic UC. Patients received avelumab 800 mg every 2 weeks (Q2W) and axitinib 5 mg orally two times daily. The primary endpoint was objective response rate (ORR). Immunohistochemistry was used to assess programmed death-ligand 1 (PD-L1) expression (SP263 assay) and the presence of CD8+ T cells (clone C8/144B). Tumor mutational burden (TMB) was assessed by whole-exome sequencing. RESULTS: A total of 61 patients were enrolled and treated (NSCLC, n = 41; UC, n = 20); 5 remained on treatment at data cut-off (26 February 2021). The confirmed ORR was 31.7% in the NSCLC cohort and 10.0% in the UC cohort (all partial responses). Antitumor activity was observed irrespective of PD-L1 expression. In exploratory subgroups, ORRs were higher in patients with higher (≥median) CD8+ T cells in the tumor. ORRs were higher in patients with lower TMB (

Subject(s)
Carcinoma, Non-Small-Cell Lung , Carcinoma, Transitional Cell , Lung Neoplasms , Urinary Bladder Neoplasms , Humans , Carcinoma, Non-Small-Cell Lung/drug therapy , Carcinoma, Non-Small-Cell Lung/pathology , Axitinib/pharmacology , Axitinib/therapeutic use , Cisplatin/pharmacology , Cisplatin/therapeutic use , Lung Neoplasms/drug therapy , Lung Neoplasms/pathology , Antibodies, Monoclonal/adverse effects
4.
ESMO Open ; 8(3): 101210, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37104931

ABSTRACT

BACKGROUND: We report updated data for avelumab plus axitinib versus sunitinib in patients with advanced renal cell carcinoma from the third interim analysis of the phase III JAVELIN Renal 101 trial. PATIENTS AND METHODS: Progression-free survival (PFS), objective response rate (ORR), and duration of response per investigator assessment (RECIST version 1.1) and overall survival (OS) were evaluated in the overall population and in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups; safety was also assessed. RESULTS: Overall, median OS [95% confidence interval (CI)] was not reached [42.2 months-not estimable (NE)] with avelumab plus axitinib versus 37.8 months (31.4-NE) with sunitinib [hazard ratio (HR) 0.79, 95% CI 0.643-0.969; one-sided P = 0.0116], and median PFS (95% CI) was 13.9 months (11.1-16.6 months) versus 8.5 months (8.2-9.7 months), respectively (HR 0.67, 95% CI 0.568-0.785; one-sided P < 0.0001). In patients with IMDC favorable-, intermediate-, poor-, or intermediate plus poor-risk disease, respectively, HRs (95% CI) for OS with avelumab plus axitinib versus sunitinib were 0.66 (0.356-1.223), 0.84 (0.649-1.084), 0.60 (0.399-0.912), and 0.79 (0.636-0.983), and HRs (95% CIs) for PFS were 0.71 (0.490-1.016), 0.71 (0.578-0.866), 0.45 (0.304-0.678), and 0.66 (0.550-0.787), respectively. ORRs, complete response rates, and durations of response favored avelumab plus axitinib overall and across all risk groups. In the avelumab plus axitinib arm, 81.1% had a grade ≥3 treatment-emergent adverse event (TEAE), and incidences of TEAEs and immune-related AEs were highest <6 months after randomization. CONCLUSIONS: Avelumab plus axitinib continues to show improved efficacy versus sunitinib and a tolerable safety profile overall and across IMDC risk groups. The OS trend favors avelumab plus axitinib versus sunitinib, but data remain immature; follow-up is ongoing. TRIAL REGISTRATION: ClinicalTrials.govNCT02684006; https://clinicaltrials.gov/ct2/show/NCT02684006.


Subject(s)
Antineoplastic Agents , Carcinoma, Renal Cell , Kidney Neoplasms , Humans , Carcinoma, Renal Cell/drug therapy , Carcinoma, Renal Cell/secondary , Sunitinib/pharmacology , Sunitinib/therapeutic use , Axitinib/pharmacology , Axitinib/therapeutic use , Antineoplastic Agents/therapeutic use , Follow-Up Studies , Kidney Neoplasms/drug therapy , Kidney Neoplasms/pathology
5.
ESMO Open ; 7(5): 100564, 2022 10.
Article in English | MEDLINE | ID: mdl-36037566

ABSTRACT

BACKGROUND: C-reactive protein (CRP) is an important prognostic and predictive factor in advanced renal cell carcinoma (aRCC). We report the association of CRP levels at baseline and early after treatment with efficacy of avelumab plus axitinib or sunitinib from the phase III JAVELIN Renal 101 trial. PATIENTS AND METHODS: Patients were categorized into normal (baseline CRP <10 mg/l), normalized (baseline CRP ≥10 mg/l and ≥1 CRP value decreased to <10 mg/l during 6-week treatment), and non-normalized (CRP ≥10 mg/l at baseline and during 6-week treatment) CRP groups. Progression-free survival and best overall response from the second interim analysis and overall survival (OS) from the third interim analysis were assessed. RESULTS: In the avelumab plus axitinib and sunitinib arms, respectively, 234, 51, and 108 patients and 232, 36, and 128 patients were categorized into normal, normalized, and non-normalized CRP groups. In respective CRP groups, objective response rates [95% confidence interval (CI)] were 56.0% (49.4% to 62.4%), 66.7% (52.1% to 79.2%), and 45.4% (35.8% to 55.2%) with avelumab plus axitinib and 30.6% (24.7% to 37.0%), 41.7% (25.5% to 59.2%), and 19.5% (13.1% to 27.5%) with sunitinib; complete response rates were 3.8%, 11.8%, and 0.9% and 3.0%, 0%, and 1.6%, respectively. Median progression-free survival (95% CI) was 15.2 months (12.5-21.0 months), not reached (NR) [11.1 months-not estimable (NE)], and 7.0 months (5.6-9.9 months) with avelumab plus axitinib and 11.2 months (8.4-13.9 months), 11.2 months (6.7-13.8 months), and 4.2 months (2.8-5.6 months) with sunitinib; median OS (95% CI) was NR (42.2 months-NE), NR (30.4 months-NE), and 23.0 months (18.4-33.1 months) and NR (39.0 months-NE), 39.8 months (21.7-NE), and 19.1 months (16.3-25.3 months), respectively. Multivariate analyses demonstrated that normalized or non-normalized CRP levels were independent factors for the prediction of objective response rate or OS, respectively, with avelumab plus axitinib. CONCLUSIONS: In patients with aRCC, CRP levels at baseline and early after treatment may predict efficacy with avelumab plus axitinib.


Subject(s)
Carcinoma, Renal Cell , Kidney Neoplasms , Humans , Antineoplastic Combined Chemotherapy Protocols , Axitinib/pharmacology , Axitinib/therapeutic use , C-Reactive Protein , Carcinoma, Renal Cell/drug therapy , Follow-Up Studies , Kidney Neoplasms/drug therapy , Kidney Neoplasms/pathology , Sunitinib/pharmacology , Sunitinib/therapeutic use
6.
Eur Rev Med Pharmacol Sci ; 26(7): 2610-2626, 2022 04.
Article in English | MEDLINE | ID: mdl-35442477

ABSTRACT

Pregnant women and their infants are at high risk to develop a severe COVID-19, with increased rates of hospitalisation to intensive care units, need for mechanical ventilation and mortality. Preterm birth, fetal vascular malperfusion, and premature rupture of membrane have been the most reported adverse pregnancy outcomes and these effects have been especially associated with the onset of the disease at early gestational age. The early expression of ACE2 and TMPRSS2 in human embryos has been proven, determining an increased susceptibility to SARS-CoV-2. Preterm infants born to women infected by SARS-CoV-2 have a higher risk of need for specialist neonatal care with prolonged hospitalization. Moreover, inflammation of developing embryos could cause long-term defects, regardless of vertical transmission of SARS-CoV-2. Due to Maternal Immune Activation (MIA), in utero inflammation is associated with neurodevelopmental, cognitive and psychiatric disorders in affected offspring. Despite risks that COVID-19 could induce in pregnancy, there are not many published data describing the safety and/or efficacy of COVID-19 vaccines in pregnant women, commonly not included in vaccine research. The evidence from the few pregnant women unintentionally enrolled in clinical trials and vaccinated suggests that COVID-19 vaccines, both based on mRNA and viral vectors, do not pose significant risks to the fetus or breastfeeding infants. Moreover, human studies using mRNA-based vaccines against Zika virus, influenza, and rabies have reported good safety and immunogenicity during pregnancy. In this review, we evaluate the role of COVID-19 in adverse pregnancy and neonatal outcomes and the need to vaccinate pregnant women.


Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Premature Birth , Zika Virus Infection , Zika Virus , COVID-19/prevention & control , COVID-19 Vaccines , Female , Humans , Infant, Newborn , Infant, Premature , Inflammation , Pregnancy , Pregnancy Complications, Infectious/prevention & control , Pregnancy Outcome , RNA, Messenger , SARS-CoV-2 , Vaccination
8.
ESMO Open ; 6(3): 100101, 2021 06.
Article in English | MEDLINE | ID: mdl-33901870

ABSTRACT

BACKGROUND: Among patients with advanced renal cell carcinoma (RCC), those with sarcomatoid histology (sRCC) have the poorest prognosis. This analysis assessed the efficacy of avelumab plus axitinib versus sunitinib in patients with treatment-naive advanced sRCC. METHODS: The randomized, open-label, multicenter, phase III JAVELIN Renal 101 trial (NCT02684006) enrolled patients with treatment-naive advanced RCC. Patients were randomized 1 : 1 to receive either avelumab plus axitinib or sunitinib following standard doses and schedules. Assessments in this post hoc analysis of patients with sRCC included efficacy (including progression-free survival) and biomarker analyses. RESULTS: A total of 108 patients had sarcomatoid histology and were included in this post hoc analysis; 47 patients in the avelumab plus axitinib arm and 61 in the sunitinib arm. Patients in the avelumab plus axitinib arm had improved progression-free survival [stratified hazard ratio, 0.57 (95% confidence interval, 0.325-1.003)] and a higher objective response rate (46.8% versus 21.3%; complete response in 4.3% versus 0%) versus those in the sunitinib arm. Correlative gene expression analyses of patients with sRCC showed enrichment of gene pathway scores for cancer-associated fibroblasts and regulatory T cells, CD274 and CD8A expression, and tumors with The Cancer Genome Atlas m3 classification. CONCLUSIONS: In this subgroup analysis of JAVELIN Renal 101, patients with sRCC in the avelumab plus axitinib arm had improved efficacy outcomes versus those in the sunitinib arm. Correlative analyses provide insight into this subtype of RCC and suggest that avelumab plus axitinib may increase the chance of overcoming the aggressive features of sRCC.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Axitinib , Carcinoma, Renal Cell , Kidney Neoplasms , Sunitinib , Antineoplastic Combined Chemotherapy Protocols , Axitinib/therapeutic use , Carcinoma, Renal Cell/drug therapy , Carcinoma, Renal Cell/genetics , Humans , Kidney Neoplasms/drug therapy , Kidney Neoplasms/genetics , Sunitinib/therapeutic use
9.
Environ Res ; 194: 110517, 2021 03.
Article in English | MEDLINE | ID: mdl-33271142

ABSTRACT

The Erice 56 Charter titled "Impact of the environment on the health: from theory to practice" was unanimously approved at the end of the 56th course of the "International School of Epidemiology and Preventive Medicine G. D'Alessandro" held from 3rd to November 7, 2019 in Erice - Sicily (Italy) and promoted by the Study Group of "Environment and Health" of the Italian Society of Hygiene, Preventive Medicine and Public Health. The course, that included lectures, open discussions and guided working groups, was aimed to provide a general training on epidemiological and toxicological aspects of the environmental health impact, to be used by public health professionals for risk assessment, without forgetting the risk communications. At the end of the course 12 key points were agreed among teachers and students: they underlined the need of specific training and research, in the perspective of "One Health" and "Global Health", also facing emerging scientific and methodological issues and focusing on communication towards stakeholders. This Discussion highlight the need to improve knowledge of Health and Environment topic in all sectors of health and environmental prevention and management.


Subject(s)
Environmental Health , Public Health , Global Health , Humans , Sicily
10.
Eur J Neurol ; 27(12): 2673-2675, 2020 12.
Article in English | MEDLINE | ID: mdl-32875645

ABSTRACT

Rituximab (RTX), a chimeric anti-CD20 monoclonal antibody, has demonstrated good efficacy as treatment in patients with resistant chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), but it is highly immunogenic due to its structure. Ocrelizumab (OCR) is a humanized anti-CD20 antibody, with higher tolerability and a lower immunogenic profile compared to RTX. We present a case of refractory CIDP effectively treated with OCR, switched from RTX after the development of anti-drug antibodies. A 25-year-old man was admitted to our clinic for the onset of distal upper and lower limb weakness and numbness, with electrodiagnostic criteria of CIDP. After several attempted standard CIDP treatments, RTX was introduced due to poor control of clinical relapses. Unfortunately, the patient developed a high anti-drug antibody titer after RTX infusion, with no control of disease. OCR was started as an off-label treatment, resulting in partial recovery from the last recurrence and achieving good prevention of new relapses with no adverse events. We suggest that OCR should be considered as another therapeutic option in refractory CIDP. In the literature, this is the first case of CIDP treated with OCR, demonstrating good efficacy for its anti-CD20 effect and better tolerability because of its lower immunogenicity.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Polyradiculoneuropathy, Chronic Inflammatory Demyelinating , Adult , Antibodies, Monoclonal , Humans , Male , Polyradiculoneuropathy, Chronic Inflammatory Demyelinating/drug therapy , Rituximab/therapeutic use
11.
Public Health ; 185: 394-399, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32758763

ABSTRACT

OBJECTIVES: In Italy, a recent irregular movement of people raised concerns among the host population on possible introduction of diseases that have long been controlled in the host countries. This study evaluates the health conditions of illegal immigrants landed on the north-eastern Sicilian territory, to provide information on the clinical and epidemiologic burden of infectious diseases among migrants and how the local population feel about these landings. STUDY DESIGN: The study design is a cross-sectional study. METHODS: The study considered all migrants landed illegally in the city of Messina, Sicily, between January 2014 and July 2018. Analysing the data of hospital admissions and disease notifications, we calculated the frequency of infectious diseases among migrant population. Furthermore, through a survey conducted by a well-known online newspaper, we analysed the perception that the local population has about the health risk represented by migrants. RESULTS: In the considered five-year period, 108 landings, for a total of 38,608 migrants occurred at the Messina port. The percentage of hospitalisation was rather low (3.5%), and it concerned mainly pregnant women. The notifications of infectious diseases were contained, with exception of scabies and tuberculosis. Finally, from the online survey, resulted that there is a large part of local population that considers migrants a potential danger to community health. CONCLUSIONS: Our data show that the presence of migrants should not have to date any impact on the health conditions of the resident population. However, monitoring over time the health of migrants and screening for infectious diseases as soon as possible after landing are advantageous for both migrants and host country.


Subject(s)
Communicable Diseases/epidemiology , Health Status , Transients and Migrants/statistics & numerical data , Adult , Child , Cross-Sectional Studies , Emigrants and Immigrants/statistics & numerical data , Female , Hospitalization/statistics & numerical data , Humans , Male , Middle Aged , Pregnancy , Sicily/epidemiology , Surveys and Questionnaires , Tuberculosis/epidemiology
12.
Mult Scler Relat Disord ; 43: 102186, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32450508

ABSTRACT

OBJECTIVES: Ocrelizumab (OCR) is a humanized monoclonal antibody targeting CD20 antigen exposed on B cells surface. Kinetic of B-cells repopulation after depletion therapy shows high intra and inter-individual variability. The aim of this study was to explore the influence of Body Mass Index (BMI) on kinetic of B-cell repopulation after treatment with OCR and on treatment response. METHODS: 108 Multiple Sclerosis (MS) patients were enrolled at the time of the first dose of OCR administration and prospectively evaluated. Clinical, instrumental activity and disability progression were analyzed. According to B cells count, patients were divided into two groups: with fast (FR) and with slow (SR) repopulation rate, respectively. RESULTS: Significant reduction of disease activity was observed in all patients and a stabilization of disease was obtained in progressive patients. Patients with FR had higher BMI compared to patients with a SR (p<0.001). Contrariwise no correlation between repopulation rate and treatment effectiveness was disclosed. CONCLUSIONS: In a real world setting we confirmed the effectiveness of OCR in relapsing remitting and progressive patients; patients with higher BMI had a FR. This suggests considering BMI for administration schedule although further investigations with longer follow up could improve treatment protocol and patient selection.


Subject(s)
Multiple Sclerosis, Relapsing-Remitting , Multiple Sclerosis , Antibodies, Monoclonal, Humanized , Antigens, CD20 , Body Mass Index , Humans , Immunologic Factors/therapeutic use , Kinetics , Multiple Sclerosis, Relapsing-Remitting/drug therapy
13.
Ann Oncol ; 31(8): 1030-1039, 2020 08.
Article in English | MEDLINE | ID: mdl-32339648

ABSTRACT

BACKGROUND: The phase 3 JAVELIN Renal 101 trial (NCT02684006) demonstrated significantly improved progression-free survival (PFS) with first-line avelumab plus axitinib versus sunitinib in advanced renal cell carcinoma (aRCC). We report updated efficacy data from the second interim analysis. PATIENTS AND METHODS: Treatment-naive patients with aRCC were randomized (1 : 1) to receive avelumab (10 mg/kg) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were PFS and overall survival (OS) among patients with programmed death ligand 1-positive (PD-L1+) tumors. Key secondary end points were OS and PFS in the overall population. RESULTS: Of 886 patients, 442 were randomized to the avelumab plus axitinib arm and 444 to the sunitinib arm; 270 and 290 had PD-L1+ tumors, respectively. After a minimum follow-up of 13 months (data cut-off 28 January 2019), PFS was significantly longer in the avelumab plus axitinib arm than in the sunitinib arm {PD-L1+ population: hazard ratio (HR) 0.62 [95% confidence interval (CI) 0.490-0.777]}; one-sided P < 0.0001; median 13.8 (95% CI 10.1-20.7) versus 7.0 months (95% CI 5.7-9.6); overall population: HR 0.69 (95% CI 0.574-0.825); one-sided P < 0.0001; median 13.3 (95% CI 11.1-15.3) versus 8.0 months (95% CI 6.7-9.8)]. OS data were immature [PD-L1+ population: HR 0.828 (95% CI 0.596-1.151); one-sided P = 0.1301; overall population: HR 0.796 (95% CI 0.616-1.027); one-sided P = 0.0392]. CONCLUSION: Among patients with previously untreated aRCC, treatment with avelumab plus axitinib continued to result in a statistically significant improvement in PFS versus sunitinib; OS data were still immature. CLINICAL TRIAL NUMBER: NCT02684006.


Subject(s)
Carcinoma, Renal Cell , Kidney Neoplasms , Antibodies, Monoclonal, Humanized , Axitinib , Carcinoma, Renal Cell/drug therapy , Humans , Kidney Neoplasms/drug therapy , Sunitinib/therapeutic use
14.
Mult Scler Relat Disord ; 38: 101518, 2020 Feb.
Article in English | MEDLINE | ID: mdl-31778927

ABSTRACT

BACKGROUND: Posterior fossa syndrome (PFS) is a rare manifestation of ponto-mesencephalic lesions frequently reported in post-surgical pediatric tumors, rarely described as a consequence of vascular, infective or inflammatory lesions. OBJECTIVE: The aim of this article is to report the clinical and neuroradiological characteristics of a patient with an acute PFS presentation as a relapse in relapsing-remitting MS, significantly responsive to Alemtuzumab treatment. CASE REPORT: 24-year-old patient affected by multiple sclerosis developed motor-cognitive and behavioral syndrome related to an extensive ponto-mesencephalic lesion under Fingolimod treatment. CONCLUSION: Our case highlights the significant and rapid effect of Alemtuzumab therapy on both cognitive and motor symptoms occurring during a MS relapse with atypical neuroradiological localization.


Subject(s)
Alemtuzumab/pharmacology , Behavioral Symptoms/etiology , Brain Diseases/etiology , Cognitive Dysfunction/etiology , Immunologic Factors/pharmacology , Multiple Sclerosis, Relapsing-Remitting/complications , Multiple Sclerosis, Relapsing-Remitting/drug therapy , Mutism/etiology , Adult , Alemtuzumab/administration & dosage , Behavioral Symptoms/drug therapy , Behavioral Symptoms/physiopathology , Brain Diseases/drug therapy , Brain Diseases/pathology , Brain Diseases/physiopathology , Brain Stem/pathology , Cognitive Dysfunction/drug therapy , Cognitive Dysfunction/physiopathology , Fingolimod Hydrochloride/administration & dosage , Humans , Immunologic Factors/administration & dosage , Magnetic Resonance Imaging , Mutism/drug therapy , Mutism/physiopathology , Recurrence , White Matter/pathology , Young Adult
15.
Eur Rev Med Pharmacol Sci ; 23(16): 7163-7182, 2019 Aug.
Article in English | MEDLINE | ID: mdl-31486519

ABSTRACT

Vaccinations are the most effective preventive methods against infectious diseases and represent one of the most relevant successes of medicine. Vaccine development is constantly evolving; therefore, the number of vaccine candidates is progressively increasing. However, most of new potential vaccines are characterized by a lower immunogenicity, with the inability to stimulate powerful and long-lasting immune responses. Hence, to get modern and effective vaccines, we need adjuvants and innovative delivery systems that increase their immunogenicity. The use of nanotechnology in vaccinology is providing the opportunity to contrast these difficulties and develop effective vaccines. Particularly, nanoparticles used as vehicles of vaccine components, are able to increase the host's immune responses and, due to their size, to reach specific cellular districts. To date, a certain number of nanovaccines has been approved for human health and many are studied in clinical or pre-clinical trials. There are several types of nanoparticles considered as possible delivers of vaccine antigens. These nanoparticles-based synthetic delivery systems, in the size range of 20-200 nm, protect antigen from degradation, enhance its presentation and facilitate its uptake by professional antigen-presenting cells. Virus-like particles, self-assembled proteins, micelles, liposomes, inorganic nanoparticles, and polymers are the most studied of these systems. In this review, we provide a general overview of different types, methods of synthesis, characterizations, properties and applications of nanoparticles in vaccine production.


Subject(s)
Drug Delivery Systems , Nanoparticles/chemistry , Vaccines/chemistry , Animals , Humans , Particle Size , Vaccines/chemical synthesis
16.
J Prev Med Hyg ; 60(2): E84-E92, 2019 Jun.
Article in English | MEDLINE | ID: mdl-31312737

ABSTRACT

INTRODUCTION: STIs are a serious public health problem. Worldwide, 500 million people a year acquire a STI, and young are the most affected. METHODS: This study was conducted administering an anonymous questionnaire to 1228 Sicilian students of high school and university. RESULTS: The students had variable understanding of STIs and their complications. The results demonstrate an extreme variability in the knowledge of STIs. Multiple linear regression showed that sexual health knowledge was associated with age and sexual orientation. CONCLUSIONS: Our results show that knowledge of STIs is poor and inadequate. This finding can put students at risk of STIs.


Subject(s)
Health Knowledge, Attitudes, Practice , Sexually Transmitted Diseases/psychology , Students/psychology , Unsafe Sex/statistics & numerical data , Adolescent , Adult , Age Factors , Female , Humans , Italy , Male , Schools , Sexual Behavior/psychology , Sexual Behavior/statistics & numerical data , Students/statistics & numerical data , Surveys and Questionnaires , Universities , Unsafe Sex/psychology , Young Adult
17.
Ann Ig ; 31(2 Supple 1): 54-64, 2019.
Article in English | MEDLINE | ID: mdl-30994164

ABSTRACT

The National Plan for Vaccine Prevention 2017-2019 has expanded the vaccination offer including new vaccines, enlarging the target population and introducing for the first time in Italy a life-course approach to vaccination. A "lifetime immunization schedule" is aimed to reduce the burden and the related costs of vaccine-preventable diseases through effective vaccination programs. However, to counteract the national steady downward trend in the uptake of vaccinations that caused a drop of the vaccination coverage below the 95% threshold to allow herd immunity, it was decided to make 10 vaccinations mandatory by the law 119/2017. In particular, in addition to already mandatory vaccinations against diphtheria, tetanus, hepatitis B and poliomyelitis, those against measles, mumps, rubella (MMR), varicella, pertussis and Haemophilus influenzae type b (Hib) were added to the list. According to the law, all unvaccinated children cannot attend preschool services until the age of 6 years and fines (from 100 to 500 Euros) are provided for parents. Moreover, this law provided, in its first application, a catch-up campaign for children up to the age of 16 years and the free-of-charge offer of all mandatory and recommended vaccines to each child not yet vaccinated according to the previous NPVP. The NPVP includes also several at risk categories, such as pregnant women, healthcare workers and subjects suffering from chronic diseases, to whom specific vaccinations, free of charge, are offered. The vaccinations of pregnant women have different purposes. In order to decrease the pertussis risk in newborns in the first months of life, a booster immunization of DTPa is recommended, at every pregnancy, between week 27th and 36th. Instead, the influenza vaccine administration to pregnant women during the second or third quarter is mainly aimed to avoid the risk of serious disease complications for both the mother and the fetus. Another group of at risk subjects included in the NPVP is that made up by healthcare workers. According to the plan, "an adequate immunization of the healthcare workers is essential for the prevention and control of infections (anti-hepatitis B, anti-influenza, anti-measles-mumps-rubella, anti-varicella, anti-pertussis)". Finally, almost all the vaccinations foreseen by the NPVP are offered free of charge to subjects suffering from specific diseases. These include cardiovascular, respiratory, hepatic, neoplastic, renal and metabolic disorders, in addition to immunosuppression that exposes them to an increased risk of contracting invasive infectious diseases.


Subject(s)
Health Personnel , Immunization Programs/legislation & jurisprudence , Immunization Schedule , Mandatory Programs/legislation & jurisprudence , National Health Programs/legislation & jurisprudence , Pregnant Women , Bacterial Infections/prevention & control , Humans , Immunity, Herd , Italy , Virus Diseases/prevention & control
18.
Eur Rev Med Pharmacol Sci ; 23(3): 1266-1278, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30779096

ABSTRACT

Healthcare-associated infections (HAIs) are one of the most relevant public health problems worldwide. The role of the hospital environment as a reservoir of pathogens causing HAIs is still debated. These pathogens are common in several hospital environments, where they are able to persist from hours to months and their circulation is favored by healthcare workers (HCWs). Hospital surfaces at close contact with patients such as bed bars and header, bedside table, taps, and handles in wards ("high-touched surfaces"), are considered easily contaminable and at risk to transfer pathogens to patients. However, some studies showed the possible role played by "non-classical" surfaces such as healthcare workers' (HCWs) mobile phones and personal computers as well as oxygen humidifiers and protective lead garments used in operating rooms. HCWs' hands play a fundamental role in patient-to-patient transmission by touching contaminated surfaces or patients during care activities. The aim of this review is to evaluate the role of the hospital environment in the transmission of nosocomial pathogens, focusing on single pathogens causing HAIs and the importance of hospital surfaces as reservoirs.


Subject(s)
Cross Infection/etiology , Disease Transmission, Infectious/prevention & control , Environmental Microbiology/standards , Hospitals/standards , Candida albicans/isolation & purification , Cross Infection/microbiology , Cross Infection/virology , Gram-Negative Bacteria/isolation & purification , Gram-Positive Bacteria/isolation & purification , Humans , Norovirus/isolation & purification
19.
Ann Ig ; 30(4 Supple 1): 23-27, 2018.
Article in English | MEDLINE | ID: mdl-30062376

ABSTRACT

The Herpes Zoster vaccine is strongly recommended by the World Health Organization to promote healthy aging by preventing the corresponding age- related disease, also named shingles. The disease is due to the endogenous reactivation of Varicella Zoster Virus, the causal agent of chickenpox, that becomes latent at the peripheral nervous system level. Here, owing to the host's cell-mediated immunity, it may be confined for several decades. However, the immune senescence allows the possibility of virus reactivation, causing the onset of neuropathic pain and skin rash that characterize the acute disease. Sometimes, the neuralgia becomes chronic causing postherpetic neuralgia that has a significant impact on the quality of patient life, analogously to the ophthalmic HZ, a particularly feared form of disease. Due to the causal relationship between decreasing immune defenses and virus reactivation with disease onset, the incidence of Herpes Zoster, in Italy now equal to 6.42 (95%CI: 5.93-6.95) cases per 1,000 people per year will increase steadily in the future due to the longevity rise of the population. Considering epidemiological impact, complications and sequelae in the short- and long-term, costs of clinical-therapeutical management of patients, and, above all, the poor effectiveness of available therapy the only effective intervention is vaccination of the elderly. Currently in the European Union, there is only one vaccine for Herpes Zoster prevention, formed by live attenuated OKA-Merck virus strain that is also used for paediatric vaccine. According to the Health Technology Assessment surveys, the intervention cost (based on "Quality Adjusted Life Years") is clearly below the discriminating threshold value to judge the feasibility and, as predicted by the Italian National Plan of Vaccinal Prevention 2017-2019, the vaccine is offered free to all subjects >65 years.


Subject(s)
Herpes Zoster Vaccine/administration & dosage , Herpes Zoster/prevention & control , Neuralgia, Postherpetic/prevention & control , Secondary Prevention , Skin Diseases, Viral/prevention & control , Age Factors , Aged , Aging/immunology , Exanthema/prevention & control , Exanthema/virology , Herpes Zoster/epidemiology , Herpes Zoster/virology , Humans , Immunocompromised Host , Italy/epidemiology , Quality-Adjusted Life Years , Skin Diseases, Viral/epidemiology , Skin Diseases, Viral/virology , Virus Activation
20.
J Prev Med Hyg ; 59(1): E8-E13, 2018 Mar.
Article in English | MEDLINE | ID: mdl-29938234

ABSTRACT

INTRODUCTION: Measles continues to be a major public health issue worldwide, with high morbidity and mortality rates. The disease remains endemic in 14 European countries, including Italy where, from 2013 to 2016, over 5,000 cases have been reported. In 2017, many Italian regions, including Sicily, have reported many cases of measles. In this study, we described the latest measles outbreak in the city of Messina, from 1st February to 31st August 2017. METHODS: We considered all reported measles cases that came to the "Public Health, Epidemiology and Preventive Medicine" Operative Unit of the Messina Provincial Health Agency Prevention Department, which receives all reported cases of measles in the Messina province. RESULTS: From 1st February to 31st August 2017, a total of 59 measles cases were reported, of which 44 were confirmed, nine were classified as possible, four were probable and two cases were discarded. Of the 57 possible, probable and confirmed cases, 31 (54%) were males and 26 (46%) were females. Moreover, 54 (95%) had not been previously vaccinated while the remaining cases had documented evidence of one (two cases) or two doses (one case). Genotype B3 was identified in 39/44 cases (88,6%) by the regional reference laboratory in Palermo. CONCLUSIONS: Despite the development of an effective vaccination, unfortunately measles continues to threaten the lives of millions of children worldwide each year. The suboptimal immunization level in Italy has led to an increase in the transmission of measles with detrimental effects on both public health and ongoing measles elimination efforts.


Subject(s)
Disease Outbreaks , Measles/epidemiology , Adolescent , Adult , Child , Child, Preschool , Databases, Factual , Female , Humans , Infant , Male , Measles/prevention & control , Sicily/epidemiology , Vaccination Coverage , Young Adult
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