ABSTRACT
INTRODUCTION: Elderly residents of nursing homes (NHs) and long-term care units (LTCUs) have been shown to have a high risk of mortality and morbidity in cases of SARS-CoV-2 infection. The objective of this study was to examine the kinetics of neutralizing antibodies (NAbs) directed against the SARS-CoV-2 virus in residents of the NH and LTCU units of our University Hospital who were identified with positive serology after the first epidemic outbreak. MATERIALS AND METHODS: The participants included were sampled every three months for qualitative serological testing, as well as quantitative testing by neutralization tests using retroviral particles containing the S glycoprotein of SARS-CoV-2. Vaccination using the Comirnaty (Pfizer BNT162b2) vaccine begun before the last serological follow-up. RESULTS: The median NAb titer in June 2020 was 80 [40; 60] versus 40 [40; 160] three months later, showing a statistically significant decline (p < 0.007), but remained stable between the three- and six-month timepoints (p = 0.867). By nine months after vaccination, we observed a significant difference between vaccinated residents known to have positive serology before vaccination (SERO+, Vacc+) and those vaccinated without having previously shown COVID-19 seroconversion (SERO-, Vacc+), the latter group showing similar titers to the SERO+, Vacc- participants (p=0.166). The median antibody titer in SERO+, Vacc+ patients increased 15-fold following vaccination. DISCUSSION: Humoral immunity against SARS-CoV-2 appears to be persistent in elderly institutionalized patients, with a good post-vaccination response by residents who had already shown seroconversion but a notably diminished response by those who were seronegative before vaccination. To evaluate immunity in its entirety and elaborate a sound vaccination strategy, the cellular immune response via T cells specific to SARS-CoV-2 merits analysis, as this response is susceptible to being affected by immunosenescence.
Subject(s)
COVID-19 , SARS-CoV-2 , Aged , Antibodies, Neutralizing , BNT162 Vaccine , COVID-19 Vaccines , Humans , Kinetics , Long-Term CareABSTRACT
OBJECTIVES: The primary objective of the present study was to describe the characteristics of adverse drug reactions (ADRs) linked to self-medication that were notified to the French Pharmacovigilance Database (FPVD) during the COVID-19 outbreak in 2020 first wave. The secondary objective was to compare the characteristics of these ADRs in 2020 with those notified during the same calendar period a year previously. MATERIAL AND METHODS: We analyzed ADRs recorded in the FPVD between March 15th and May 31st, 2020 vs. the same dates in 2019. Only ADRs linked to self-medication were analyzed. Descriptive statistics were used to obtain an overview of the types and characteristics of these ADRs. RESULTS: Of 3114 ADRs notified to the FPVD during the COVID-19 period in 2020, 114 (3.7%) were linked to self-medication. The equivalent proportion in 2019 was 1.6% (113 out of 7097). Half of the ADRs notified in 2020 were "serious". The median age of affected patients was 30.5, and 22% of the ADRs concerned children. Of the 114 ADRs linked to self-medication, 107 (66%) were for prescription-only drugs. The three mostly frequently suspected ATC classes were analgesics, psycholeptics, and antibacterials for systemic use. The most frequent ADRs were general disorders, gastrointestinal disorders, and nervous system disorders. The main difference between the non-COVID-19 period and the COVID-19 period was the higher proportion of medication errors during the latter. CONCLUSION: The present study is the first to have reported on ADRs linked to self-medication and notified during a COVID-19 outbreak. Further studies of self-medication patterns and their consequences in a pandemic context are mandatory and effective information on medication use (including self-medication and its dangers) during a pandemic is essential.
Subject(s)
Adverse Drug Reaction Reporting Systems , COVID-19 , Drug-Related Side Effects and Adverse Reactions/epidemiology , Pandemics , Self Medication/adverse effects , Self Report , Accidents , Adolescent , Child , Child, Preschool , Drug Overdose/epidemiology , France , Humans , Medical Errors , PharmacovigilanceABSTRACT
Introduction Les immunosuppresseurs utilisés chez les greffés et les personnes atteintes de cancer sont associés à des formes sévères de COVID-19 et à une augmentation de la mortalité. Parmi les classes de médicaments antirhumatismaux modificateurs de la maladie (DMARDs), il est largement reconnu que les médicaments biologiques sont associés à une susceptibilité de réactivation virale et de formes sévères de grippe. L’objectif de cette étude est de déterminer s’il existe une disproportionnalité de notifications des cas de COVID-19 pour certaines classes de DMARDs utilisés au cours des rhumatismes inflammatoires chroniques (RIC). Patients et méthodes Une analyse–dite de cas-non cas–de la base de données de pharmacovigilance de l’Organisation Mondiale de la Santé (VigiBase®) a été réalisée entre le 1er janvier 2020 et le 10 juin 2020. La fréquence des notifications de COVID-19 concernant chaque classe de DMARDs identifiée a été comparée à celle des notifications de COVID-19 concernant tous les autres médicaments, et exprimée en termes de Reporting Odds Ratio (ROR) [intervalle de confiance à 95 %]. Des analyses stratifiées sur l’indication des DMARDs–donc le type de RIC–ont également été réalisées. Résultats Parmi les 980 446 notifications d’effets indésirables identifiés dans VigiBase® pendant la période d’étude, 398 concernaient des cas de COVID-19 chez des patients atteints de RIC traités par DMARD. Cent soixante-dix-sept (44,4 %) patients avaient une polyarthrite rhumatoïde (PR), 120 (30,2 %) une spondylarthrite ankylosante (SA), 93 (23,4 %) un rhumatisme psoriasique (RPs) et 8 (2,0 %) une arthrite juvénile idiopathique. La plupart des cas de COVID-19 ont été signalés sous anti-TNFα (84,2 %). Un signal de disproportionnalité significatif a été trouvé pour les anti-TNFα (ROR=8,31 [7,48–9,23]), en particulier au cours de la PR (ROR=2,96 [2,05–4,28]), de la SA (ROR=2,21 [1,24–3,95]) et du RPs (ROR=4,55 [2,65–7,80]). Un signal de disproportionnalité inverse a été trouvé avec le tocilizumab (ROR=0,12 [0,02–0,88]) et les inhibiteurs de Janus Kinase (JAK) (ROR=0,33 [0,19–0,58]) chez les patients atteints de PR. Discussion Nos résultats sont cohérents avec les données actuelles de la littérature concernant un profil de sécurité favorable des anti-IL-6 et des anti-JAK chez les patients atteints de PR [1]. Une étude récente a montré une association inverse significative entre l’utilisation des anti-TNFα et l’hospitalisation pour COVID-19 chez les patients atteints de RIC (OR=0,40, IC à 95 % [0,19–0,81]) [2]. Ainsi, l’utilisation d’anti-TNFα pourrait potentiellement favoriser la COVID-19, au même titre que d’autres infections virales, mais pourrait également réduire la gravité de la maladie en inhibant l’orage cytokinique. Conclusion Nos résultats suggèrent un profil de sécurité potentiel des anti-IL-6 et des JAK chez les patients atteints de PR. Il existe un signal de disproportionnalité important concernant les anti-TNFα.