ABSTRACT
OBJECTIVES: to describe the epidemiology of SARS-CoV-2 infection in relation with the use of nasal swabs in the immigrant population in Italy, using data from the COVID-19 national surveillance system and to verify if a difference is present comparing natives and immigrant. DESIGN: descriptive study based on longitudinal health-administrative data. SETTING AND PAR TICIPAN TS: general population of six Italian Regions (Piedmont, Lombardy, Veneto, Emilia-Romagna, Tuscany, Lazio) covering about 55% of the resident population and 72% of foreigners' population. MAIN OUTCOME MEASURES: regional rates of access to at least a nasal swab, separately by country of origin. RESULTS: across all the periods, a lower rate in the foreigners' group was observed, with the only exception of the period May-June 2021. Considering separately High Migratory Pressure Countries (HMPCs) and Highly Developed Countries (HDCs), a higher proportion of nasal swabs performed in people coming from HDC with respect to HMPCs and natives was noticed. This observation is consistent in males and females. CONCLUSIONS: during the first wave of the pandemic, Italians have had a higher proportion of nasal swabs compared to migrants across all Regions. This difference disappeared in the following periods, probably due to a major availability of diagnostic tests.
ABSTRACT
Introduction: In Lombardy and Piedmont (Northern Italy, about 14 million people) the GRESIF pharmacovigilance network project, aimed to collect, assess, treat and prevent severe systemic drug reactions was activated in 2021, supported by the Italian Medicines Agency (AIFA). GRESIF involves regional and hospital pharmacovigilance centers, and several hospital wards: burn, dermatology, allergology, internal medicine, infectivology and intensive care departments. The registry collects in the National Pharmacovigilance Network all reports of suspected adverse drug reactions (ADRs) concerning Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), Drug reaction with eosinophilia and systemic symptoms (DRESS) and Acute Generalized Exanthematous Pustulosis (AGEP). Objective(s): The specific objectives of the study are to early detect severe systemic ADRs, evaluate their incidence, morbidity and mortality rates, focus on new generation drugs such as RNA antivirals and oncological drugs, implement and optimize guidelines, manage long-term sequelae by follow-up and create a consultable web-based database. Method(s): We have drawn up the guidelines [1,2], through a multidisciplinary approach in order to improve the management of very complex patients even in facilities that are not habitually involved in the treatment of these pathologies. This document aims to support professionals in standardizing diagnostic criteria and methods of therapeutic approach. It's useful to inform the general practitioner about responsible drugs and give some information about risk /benefit on the riexposure. Result(s): In 2021, 27 cases of SJS/TEN, 18 cases of DRESS and no cases of AGEP were collected. There is a female prevalence (25 cases out 44);the age range is from 20 to 93 years. The median age of patients in Lombardy and in Piedmont is respectively 55 and 66 for females, 47 and 63 for males. The total mortality for cases of SJS/ TEN is about 19% and for DRESS we have no deaths. More frequent suspected drugs are antibiotics, followed by allopurinol and anticonvulsants. Noteworthy is the presence of 4 cases of severe ADR related to anti Covid19 RNA vaccines. In all cases, according to the guidelines, the timely discontinuation of the responsible drug was fundamental as the general management. Furthermore we started a study for the HLA typing of these patients. We enrolled 18 cases and the results showed that 6 patients who received allopurinol were all positive to HLA <= 58:01. Conclusion(s): Despite being extremely rare but serious reactions, the absolute need to implement shared diagnostic and therapeutic protocols to be applied promptly is highlighted, in order to reduce both patient mortality and long-term sequelae.
ABSTRACT
Introduction: In Lombardy and Piedmont (Northern Italy, about 14 million people) the GRESIF pharmacovigilance network project, aimed to collect, assess, treat and prevent severe systemic drug reactions was activated in 2021, supported by the Italian Medicines Agency (AIFA). GRESIF involves regional and hospital pharmacovigilance centers, and several hospital wards: burn, dermatology, allergology, internal medicine, infectivology and intensive care departments. The registry collects in the National Pharmacovigilance Network all reports of suspected adverse drug reactions (ADRs) concerning Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), Drug reaction with eosinophilia and systemic symptoms (DRESS) and Acute Generalized Exanthematous Pustulosis (AGEP). Objective: The specific objectives of the study are to early detect severe systemic ADRs, evaluate their incidence, morbidity and mortality rates, focus on new generation drugs such as RNA antivirals and oncological drugs, implement and optimize guidelines, manage long-term sequelae by follow-up and create a consultable web-based database. Methods: We have drawn up the guidelines [1,2], through a multidisciplinary approach in order to improve the management of very complex patients even in facilities that are not habitually involved in the treatment of these pathologies. This document aims to support professionals in standardizing diagnostic criteria and methods of therapeutic approach. Its useful to inform the general practitioner about responsible drugs and give some information about risk /benefit on the riexposure. Results: In 2021, 27 cases of SJS/TEN, 18 cases of DRESS and no cases of AGEP were collected. There is a female prevalence (25 cases out 44);the age range is from 20 to 93 years. The median age of patients in Lombardy and in Piedmont is respectively 55 and 66 for females, 47 and 63 for males. The total mortality for cases of SJS/ TEN is about 19% and for DRESS we have no deaths. More frequent suspected drugs are antibiotics, followed by allopurinol and anticonvulsants. Noteworthy is the presence of 4 cases of severe ADR related to anti Covid19 RNA vaccines. In all cases, according to the guidelines, the timely discontinuation of the responsible drug was fundamental as the general management. Furthermore we started a study for the HLA typing of these patients. We enrolled 18 cases and the results showed that 6 patients who received allopurinol were all positive to HLA B 58:01. Conclusion: Despite being extremely rare but serious reactions, the absolute need to implement shared diagnostic and therapeutic protocols to be applied promptly is highlighted, in order to reduce both patient mortality and long-term sequelae.
ABSTRACT
Objective: Chloroquine (CLQ)/hydroxychloroquine (HCQ) are two of the most studied drugs for the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. There are very limited data on the effect of treatment of patients affected by rheumatic diseases with HCQ/CLQ and other conventional disease-modifying anti-rheumatic drugs (cDMARDs) on COVID-19. The aim of this study is to investigate the hypothesis that treatment of rheumatic diseases with hydroxychloroquine (HCQ)/chloroquine (CLQ) as compared to other conventional disease-modifying anti-rheumatic drugs (cDMARDs) might decrease the COVID-19-related risk of hospitalization and mortality. Methods: This large-scale case-control study nested within a cohort of cDMARD users was conducted in the Lombardy, Veneto, Tuscany and Lazio regions and Reggio Emilia (Emilia Romagna) Local Health Unit, covering a total of 25.1 million inhabitants. Claims databases were linked to loco-regional COVID-19 surveillance registries from the same catchment area through unique fully-anonymized patient identifiers. Risk of COVID-19-related outcomes was estimated as odds ratios (ORs) along with 95% confidence intervals (CIs), using a multivariate conditional logistic regression analysis, by comparing HCQ/CLQ vs methotrexate (primary comparator) and other cDMARDs (secondary comparator). In addition, the same risk for HCQ/CLQ, methotrexate and other cDMARDs separately vs nonuse of these drugs as well as for presence of rheumatic diseases vs. absence in a non-nested population was investigated. Results: From the cohort of cDMARD users, 1275 cases who were hospitalized due to COVID-19 were identified and matched to 12,734 controls. When compared to recent use of methotrexate, no statistically significant association between recent HCQ/CLQ monotherapy with COVID-19 hospitalization (OR 0.83 [95% CI, 0.69 to 1.00]) or mortality (OR 1.19 [95% CI, 0.85 to 1.67]) was observed. A statistically significant lower risk was found when comparing recent use of HCQ/CLQ to treatment with other cDMARDs and glucocorticoids concomitantly. In the sensitivity analysis in the non-nested population, HCQ/CLQ was not associated with COVID-19 hospitalization as compared with non-use, whereas a mild statistically significant increased risk for recent use of both methotrexate as monotherapy (OR 1.19 [95% CI, 1.05 to 1.34]) or other cDMARDs (OR 1.21 [95% CI, 1.08 to 1.36]) vs non-use was found. Finally, the presence of rheumatoid arthritis or systemic lupus erythematosus was not associated with COVID-19 hospitalization (OR 0.98 [95% CI, 0.89 to 1.07]) or mortality (OR 0.88 [95% CI, 0.74 to 1.05]). Conclusion: Prior exposure to HCQ/CLQ in rheumatic patients was not associated with a protective effect against COVID-19-related hospitalization and mortality. On the contrary, an increased risk in patients receiving other cDMARDs was observed when compared to non-use, especially in those patients concomitantly treated with glucocorticoids. This is likely attributable to a synergistic immunosuppressive effect, leading to increased risk of severe SARS-CoV-2 infection.