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Article ; Online: Vaccine Hesitancy Among Religious Groups

Annie Kibongani Volet / Cristina Scavone / Daniel Catalán-Matamoros / Annalisa Capuano

Frontiers in Public Health, Vol

Reasons Underlying This Phenomenon and Communication Strategies to Rebuild Trust

2022 Volume 10

Keywords	vaccines ; hesitancy ; religion ; religious reasons ; communication strategies ; Public aspects of medicine ; RA1-1270
Language	English
Publishing date	2022-02-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Switching between Originators and Biosimilars in Dermatology

Maria Maddalena Nicoletti / Erminia Crisci / Ciro Pentella / Andrea Cantone / Donatella Ruggiero / Antonietta Anatriello / Cristina Scavone

Biologics, Vol 3, Iss 6, Pp 95-

A Systematic Review of Real-World Clinical Studies

2023 Volume 115

Abstract: Background. Although biosimilars have been increasingly used over recent years, some concerns about a potential loss of efficacy and altered safety profile when switching from an originator to a biosimilar still exist. Interchangeability can be a ... ...

Abstract	Background. Although biosimilars have been increasingly used over recent years, some concerns about a potential loss of efficacy and altered safety profile when switching from an originator to a biosimilar still exist. Interchangeability can be a challenge for dermatologists too. An extensive systematic review of published switching studies among originators and biosimilars was carried out in order to provide evidence regarding the effects derived from the switch in terms of efficacy and safety outcomes in real-life contexts. Results. Thirty-seven articles were included in this systematic review (14 studies related to adalimumab, 10 to etanercept, 12 to infliximab, and 1 each to adalimumab, etanercept, and infliximab). Studies were mainly carried out among European countries. Most of them were observational studies or register-based studies. The majority of studies enrolled patients diagnosed with psoriasis or psoriatic arthritis who underwent a single switch from the originator to the biosimilar. Overall, the studies’ results demonstrated that switching between adalimumab, etanercept, and infliximab originators and biosimilars is safe and effective in a real-life setting of patients with dermatological conditions. Only a few studies highlighted an increase in the risk of loss of efficacy as well as an increased rate of AEs, both of which were identified as the main causes of biosimilar discontinuation, probably associated with the well-known phenomenon of the nocebo effect. Conclusion. Switching from a biologic originator to its biosimilar is safe and effective. Only a few studies have evaluated the switch among biosimilars; thus, no firm conclusion can be drawn for this type of switch in terms of the efficacy and safety outcomes. Based on our results, we believe that biosimilars can be considered interchangeable with their reference products and that no additional switch studies are necessary to support switching among originators and biosimilars in clinical practice. However, the continuous monitoring of all ...
Keywords	biosimilar ; originator ; real-world studies ; switch ; systematic review ; Biology (General) ; QH301-705.5
Subject code	306
Language	English
Publishing date	2023-04-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Three Doses of COVID-19 Vaccines

Giorgia Teresa Maniscalco / Daniele Di Giulio Cesare / Valerio Liguori / Valentino Manzo / Elio Prestipino / Simona Salvatore / Maria Elena Di Battista / Ornella Moreggia / Antonio Rosario Ziello / Vincenzo Andreone / Cristina Scavone / Annalisa Capuano

Journal of Clinical Medicine, Vol 12, Iss 4236, p

A Retrospective Study Evaluating the Safety and the Immune Response in Patients with Multiple Sclerosis

2023 Volume 4236

Abstract: Since the beginning of the mass immunization of patients with multiple sclerosis (MS), many data on the efficacy and safety of COVID-19 vaccines have been produced. Considering that MS is an autoimmune disease and that some disease-modifying therapies ( ... ...

Abstract	Since the beginning of the mass immunization of patients with multiple sclerosis (MS), many data on the efficacy and safety of COVID-19 vaccines have been produced. Considering that MS is an autoimmune disease and that some disease-modifying therapies (DMTs) could decrease the antibody response against COVID-19 vaccines, we carried out this retrospective study with the aim to evaluate the safety of these vaccines in terms of AEFI occurrence and the antibody response after MS patients had received the third dose. Two hundred and ten patients (64.8% female; mean age: 46 years) received the third dose of the mRNA-based COVID-19 vaccine and were included in the study. Third doses were administered from October 2021 to January 2022. The majority of patients ( n = 193) were diagnosed with RRMS and EDSS values were ≤3.0 in 72.4% of them. DMTs most commonly used by included patients were interferon Beta 1-a, dimethyl fumarate, natalizumab and fingolimod. Overall, 160 patients (68.8% female) experienced 294 AEFIs, of which about 90% were classified as short-term, while 9.2% were classified as long-term. The most commonly reported following the booster dose were pain at the injection site, flu-like symptoms, headache, fever and fatigue. Regarding the immune response, consistently with literature data, we found that patients receiving ocrelizumab and fingolimod had lower IgG titer than patients receiving other DMTs.
Keywords	COVID-19 ; mRNA-based vaccine ; safety ; multiple sclerosis ; AEFI ; observational study ; Medicine ; R
Subject code	610
Language	English
Publishing date	2023-06-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: SARS-Cov-2 infection: Response of human immune system and possible implications for the rapid test and treatment

Cristina, Scavone / Concetta, Rafaniello / Francesco, Rossi / Annalisa, Capuano

Int Immunopharmacol

Abstract: The new coronavirus outbreak is an ongoing pandemic that is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The new coronavirus SARS-Cov-2 belongs to the subfamily of ß-coronaviruses and shares 79.5% of the genetic sequence of ... ...

Abstract	The new coronavirus outbreak is an ongoing pandemic that is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The new coronavirus SARS-Cov-2 belongs to the subfamily of ß-coronaviruses and shares 79.5% of the genetic sequence of SARS-CoV, the causative agent of the epidemic that started in 2002 and ended in 2004. Considering the clinical impact of the new outbreak, it is highly important to study the potential responses of the human immune system during the SARS-CoV-2 infection as well as the role of virus-specific T cells and by B-lymphocytes. Moreover, specific data on the production of IgG and IgM is crucial to allow the rapid identification of the infection. In this paper we also described the importance of sensitive and specific rapid test for SARS-CoV-2. Indeed, this test represents an important immunological tool aimed at identifying the precise phase of the infection in order to undertake a more appropriate pharmacological treatment. Lastly, we provided an overview of pharmacological treatments aimed to reduce inflammatory processes underlying the infection and the need for the discovery of a new vaccine against SARS-CoV-2.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #32311668
Database	COVID19

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Article ; Online: Anti-hypertensive drugs deprescribing

Salvatore Crisafulli / Nicoletta Luxi / Raffaele Coppini / Annalisa Capuano / Cristina Scavone / Alessia Zinzi / Simona Vecchi / Graziano Onder / Janet Sultana / Gianluca Trifirò

BMC Family Practice, Vol 22, Iss 1, Pp 1-

an updated systematic review of clinical trials

2021 Volume 11

Abstract: Abstract Background Polypharmacy is defined as the prescription of at least 5 different medicines for therapeutic or prophylactic effect and is a serious issue among elderly patients, who are frequently affected by multi-morbidity. Deprescribing is one ... ...

Abstract	Abstract Background Polypharmacy is defined as the prescription of at least 5 different medicines for therapeutic or prophylactic effect and is a serious issue among elderly patients, who are frequently affected by multi-morbidity. Deprescribing is one of the proposed approaches to reduce the number of administered drugs, by eliminating those that are inappropriately prescribed. The aim of this systematic review is to provide an updated and systematic assessment of the benefit-risk profile of deprescribing of anti-hypertensive drugs, which are among the most commonly used drugs. Methods MEDLINE, EMBASE and The Cochrane Library were searched for studies assessing the efficacy and safety of anti-hypertensive drugs deprescribing in the period between January, 12,016 and December, 312,019. The quality of randomized clinical trials (RCTs) was assessed using the GRADE approach for the evaluation of the main outcomes. The risk of bias assessment was carried out using the Cochrane risk-of-bias tool. Results Overall, two RCTs were identified. Despite summarized evidence was in favor of anti-hypertensive deprescribing, the overall risk of bias was rated as high for each RCT included. According to the GRADE approach, the overall quality of the RCTs included was moderate regarding the following outcomes: systolic blood pressure < 150 mmHg after 12 weeks of follow-up, quality of life, frailty and cardiovascular risk. Conclusions This updated systematic review of the efficacy and safety of anti-hypertensive treatment deprescribing found two recently published RCTs, in addition to the previous guideline of the National Institute for Health and Care Excellence (NICE). Evidence points towards non-inferiority of anti-hypertensive deprescribing as compared to treatment continuation, despite the quality of published studies is not high. High quality experimental studies are urgently needed to further assess the effect of deprescribing for this drug class in specific categories of patients.
Keywords	Deprescribing ; Ant-hypertensive drugs ; Multimorbidity ; Polypharmacy ; Medicine (General) ; R5-920
Subject code	610
Language	English
Publishing date	2021-10-01T00:00:00Z
Publisher	BMC
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Renin-Angiotensin System and Coronavirus Disease 2019

Annamaria Mascolo / Cristina Scavone / Concetta Rafaniello / Carmen Ferrajolo / Giorgio Racagni / Liberato Berrino / Giuseppe Paolisso / Francesco Rossi / Annalisa Capuano

Frontiers in Cardiovascular Medicine, Vol

A Narrative Review

2020 Volume 7

Abstract: Although clinical manifestations of the 2019 novel coronavirus disease pandemic (COVID-19), caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), are mainly respiratory symptoms, patients can also develop severe cardiovascular ...

Abstract	Although clinical manifestations of the 2019 novel coronavirus disease pandemic (COVID-19), caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), are mainly respiratory symptoms, patients can also develop severe cardiovascular damage. Therefore, understanding the damage caused by SARS-COV-2 to the cardiovascular system and the underlying mechanisms is fundamental. The cardiovascular damage may be related to the imbalance of the renin-angiotensin-system (RAS) as this virus binds the Angiotensin-Converting-Enzyme 2 (ACE2), expressed on the lung alveolar epithelial cells, to enter into cells. Virus internalization may cause a downregulation of ACE2 on host cell surface that could lead to a local increased level of angiotensin II (AII) and a reduced level of angiotensin 1-7 (A1-7). An imbalance between these angiotensins may be responsible for the lung and heart damage. Pharmacological strategies that interfere with the viral attachment to ACE2 (umifenovir and hydroxychloroquine/chloroquine) or that modulate the RAS (analogous of A1-7 and ACE2, losartan) are in clinical development for COVID-19. The use of RAS inhibitors has also become a matter of public concern as these drugs may increase the mRNA expression and levels of ACE2 and impact the virulence and transmission of SARS-COV-2. Data on the effect of RAS inhibitors on ACE2 mRNA expression are scarce. Scientific societies expressed their opinion on continuing the therapy with RAS inhibitors in patients with COVID-19 and underlying cardiovascular diseases. In conclusion, RAS may play a role in SARS-COV-2-induced cardiac and pulmonary damage. Further studies are needed to better understand the role of RAS in COVID-19 and to guide decision on the use of RAS inhibitors.
Keywords	COVID-19 ; renin-angiotensin system ; SARS-COV-2 ; heart damage ; pulmonary damage ; RAS inhibitors ; Diseases of the circulatory (Cardiovascular) system ; RC666-701 ; covid19
Subject code	610
Language	English
Publishing date	2020-08-01T00:00:00Z
Publisher	Frontiers Media S.A.
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Cardiac Events Potentially Associated to Remdesivir

Concetta Rafaniello / Carmen Ferrajolo / Maria Giuseppa Sullo / Mario Gaio / Alessia Zinzi / Cristina Scavone / Francesca Gargano / Enrico Coscioni / Francesco Rossi / Annalisa Capuano

Pharmaceuticals, Vol 14, Iss 611, p

An Analysis from the European Spontaneous Adverse Event Reporting System

2021 Volume 611

Abstract: Remdesivir was recommended for hospitalized patients with COVID-19. As already reported in the Summary of Product Characteristics, most of remdesivir’s safety concerns are hepatoxicity and nephrotoxicity related. However, some cases have raised concerns ... ...

Abstract	Remdesivir was recommended for hospitalized patients with COVID-19. As already reported in the Summary of Product Characteristics, most of remdesivir’s safety concerns are hepatoxicity and nephrotoxicity related. However, some cases have raised concerns regarding the potential cardiac events associated with remdesivir; therefore, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency requested to investigate all available data. Therefore, we analyzed all Individual Case Safety Reports (ICSRs) collected in the EudraVigilance database focusing on cardiac adverse events. From April to December 2020, 1375 ICSRs related to remdesivir were retrieved from EudraVigilance, of which 863 (62.8%) were related to male and (43.3%) adult patients. A total of 82.2% of all AEs (N = 2604) was serious and one third of the total ICSRs (N = 416, 30.3%) had a fatal outcome. The most frequently reported events referred to hepatic/hepatobiliary disorders (19.4%,), renal and urinary disorders (11.1%) and cardiac events (8.4%). Among 221 cardiac ICSRs, 69 reported fatal outcomes. Other drugs for cardiovascular disorders were reported as suspected/concomitant together with remdesivir in 166 ICSRs (75.1%), 62 of which were fatal. Moreover, the mean time to overall cardiac event was 3.3 days (±2.2). Finally, disproportionality analysis showed a two-fold increased risk of reporting a cardiac adverse event associated with remdesivir compared to both hydroxychloroquine and azithromycin. This study showed that remdesivir could be associated to risk of cardiac events, suggesting a potential safety signal which has not been completely evaluated yet. Further studies are needed to confirm these findings.
Keywords	remdesivir ; cardiac events ; safety monitoring ; Medicine ; R ; Pharmacy and materia medica ; RS1-441
Subject code	616
Language	English
Publishing date	2021-06-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Evaluación saturométrica y polisomnográfica de prematuros con y sin displasia broncopulmonar

Cristina Scavone / Daniel Lorenzo / Isabel Moreira / Lilian Chiappella / Alexandra Criado / Lilian Sastre

Revista de la Sociedad Boliviana de Pediatría, Vol 53, Iss 1, Pp 47-

2014 Volume 53

Abstract: Objetivo: determinar la necesidad de oxígeno suplementario en diferentes estados de comportamiento en una población de recién nacidos prematuros. Pacientes y método: este es un estudio prospectivo, descriptivo, longitudinal. Recién nacidos prematuros ... ...

Abstract	Objetivo: determinar la necesidad de oxígeno suplementario en diferentes estados de comportamiento en una población de recién nacidos prematuros. Pacientes y método: este es un estudio prospectivo, descriptivo, longitudinal. Recién nacidos prematuros consecutivos cumplieron con los criterios de inclusión: edad gestacional 32 semanas y/o peso al nacer 1.500 g. Se estudiaron 105 prematuros con o sin DBP a las 36 semanas de edad gestacional. Las oximetrías se realizaron a las 36 semanas de edad gestacional. Resultados: el grupo de BPD presentó menor edad gestacional, peso al nacer, perímetro craneal y el número de controles médicos durante el embarazo que en el grupo sin DBP. Los principales hallazgos fueron las caídas de saturación durante el sueño y en algunos casos durante la alimentación. Discusión: las diferencias en las variables clínicas entre ambos grupos se han reportado en diferentes estudios. A pesar de que oximetrías patológicas son más frecuentes en los pacientes con DBP, algunos prematuros sin DBP también mostraron resultados anormales. Conclusión: los beneficios reales de medir la saturación de oxigeno a las 36 semanas de edad gestacional se reflejan en una mejor gestión del aporte de oxigeno suplementario en los prematuros con y sin DBP. Igualmente la estimulación de las funciones de la oro-faringe conducen a una mejor oxigenación durante la alimentación. Ambos hechos tienden a optimizar el crecimiento y desarrollo de estas poblaciones.
Keywords	Oximetría ; Displasia Broncopulmonar ; Recién Nacido ; Prematuro ; Medicine ; R ; Pediatrics ; RJ1-570
Publishing date	2014-01-01T00:00:00Z
Publisher	Sociedad Boliviana de Pediatría
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Preliminary Results of the FASM Study, an On-Going Italian Active Pharmacovigilance Project

Giorgia Teresa Maniscalco / Vincenzo Brescia Morra / Ciro Florio / Giacomo Lus / Gioacchino Tedeschi / Maddalena Cianfrani / Renato Docimo / Stefania Miniello / Felice Romano / Leonardo Sinisi / Daniele L. A. Spitaleri / Giuseppe Longo / Ugo Trama / Maria Triassi / FASM Group / Cristina Scavone / Annalisa Capuano

Pharmaceuticals, Vol 13, Iss 466, p

2020 Volume 466

Abstract: Background and aim: Disease-modifying therapies (DMTs) used in multiple sclerosis (MS) have distinct safety profiles. In this paper, we report preliminary results of an on-going pharmacovigilance project (the FASM study). Results: Neurologists working at ...

Abstract	Background and aim: Disease-modifying therapies (DMTs) used in multiple sclerosis (MS) have distinct safety profiles. In this paper, we report preliminary results of an on-going pharmacovigilance project (the FASM study). Results: Neurologists working at involved multiple sclerosis centers collected 272 Individual Case Safety Reports (ICSRs). Adverse drug reactions (ADRs) mainly occurred in adult patients and in a higher percentage of women compared to men. No difference was found in ADRs distribution by seriousness. The outcome was reported as favorable in 61% of ICSRs. Out of 272 ICSRs, almost 53% reported dimethyl fumarate, fingolimod and IFN beta 1a as suspected. These medications were commonly associated to the occurrence of ADRs related hematological, gastrointestinal, general, infective or cancer disorders. The median time to event (days) was 177 for dimethyl fumarate, 1058 for fingolimod and 413 for IFN beta 1a. The median time to event for the remaining suspected drugs was 226. Conclusion: We believe that our results, together with those that will be presented at the end of the study, may bring new knowledge concerning the safety profile of DMTs and their proper use. This will provide the opportunity to draw new recommendations both for neurologists and patients.
Keywords	multiple sclerosis ; disease-modifying therapies ; safety ; adverse drugs reactions ; FASM study ; pharmacovigilance project ; Medicine ; R ; Pharmacy and materia medica ; RS1-441
Subject code	616
Language	English
Publishing date	2020-12-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Meningitis y encefalitis víricas en Uruguay. Relevamiento mediante técnicas de reacción en cadena de polimerasa aplicadas al líquido cefalorraquídeo de los grupos herpes, enterovirus y arbovirus como principales agentes etiológicos

Ronald Salamano / Cristina Scavone / Mariana Baz / Andrea Rey / Gabriel González / Abayubá Perna / Pablo Cardinal / Sara Lewin / Juan Arbiza / Dora Ruchanski

Revista Médica del Uruguay, Vol 25, Iss

2009 Volume 4

Abstract: Introducción: en nuestro país no existen trabajos sistemáticos relativos a la incidencia de virus que provoquen encefalitis y meningitis. Sí existen trabajos realizados en las décadas de 1960 y 1970 sobre seroprevalencia de arbovirus y poliovirus. ... ...

Abstract	Introducción: en nuestro país no existen trabajos sistemáticos relativos a la incidencia de virus que provoquen encefalitis y meningitis. Sí existen trabajos realizados en las décadas de 1960 y 1970 sobre seroprevalencia de arbovirus y poliovirus. Mediante la técnica de reacción en cadena de polimerasa (PCR) aplicada al líquido cefalorraquídeo (LCR) hoy es posible realizar en un breve lapso de tiempo un diagnóstico de certeza sobre diversos agentes virales responsables de estas neurovirosis. Material y métodos: se exploró la incidencia de virus de la familia herpes, enterovirus y grupo arbovirus mediante técnicas de PCR aplicadas al LCR en pacientes VIH negativos. Resultados: este trabajo presenta a 59 pacientes VIH negativos que padecieron encefalitis y meningitis de presumible etiología viral. Estos agentes son los responsables de la mayor cantidad de meningitis y encefalitis que suceden en nuestro continente. Conclusiones: el diagnóstico virológico final es posible realizarlo en más de la mitad de los casos presentados, predominando virus de la familia herpes tanto en niños como en adultos, no siendo despreciable la incidencia de enterovirus. No se detectó en este trabajo la presencia de arbovirus.
Keywords	ENCEFALITIS VIRAL ; MENINGITIS VIRAL ; REACCIÓN EN CADENA DE LA POLIMERASA ; Medicine ; R ; Medicine (General) ; R5-920
Language	Spanish
Publishing date	2009-12-01T00:00:00Z
Publisher	Sindicato Médico del Uruguay
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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