Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in patients with juvenile dermatomyositis: a real-world multicentre study.

BACKGROUND: Concerns about the safety and efficacy of vaccines in patients with autoimmune diseases (AID) have led to contradictions and low vaccination coverage in this population, who are at a higher risk of infections, including by human papillomavirus (HPV). Although HPV vaccines have been recommended for immunocompromised patients, there is still a lack of data to support its use for AID patients, such as juvenile dermatomyositis (JDM) patients. The aim of this study was to assess the safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine in a cohort of JDM patients. METHODS: JDM patients aged from 9 to 20 years and healthy controls (HC) were enrolled to receive a 3-dose schedule of qHPV vaccine from March/2014 to March/2016. Study visits were performed before the first dose, 1 month after the second and third doses, and 6 months after the third dose. Participants completed a diary of possible adverse events for 14 days following each dose of vaccination (AEFV). Disease activity and current therapy were analyzed at each visit for JDM patients. In addition, serum samples from all participants were collected to test antibody concentrations against HPV16 and 18 at each visit. Participant recruitment was conducted in ten Brazilian centres. From 47 eligible JDM patients and 41 HC, 42 and 35, respectively, completed the 3-dose schedule of the vaccine, given that five JDM patients and two HC had received doses prior to their inclusion in the study. RESULTS: The AEFVs presented by the participants were mild and in general did not differ between JDM and HC groups. No severe AEFVs were related to the vaccination. Disease activity was stable, or even improved during the follow-up. One month after the third dose of the vaccine the JDM group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the HC group, who presented 100% for both serotypes (p = 1.000). Six months after the third dose the seropositivity for the patient group was 94% for both HPV types. CONCLUSIONS: The HPV vaccination in this cohort of JDM patients was safe and immunogenic. Since the seropositivity against HPV16 and 18 was very high after the 3-dose schedule, this regimen should be recommended for JDM patients. TRIAL REGISTRATION: Brazilian Clinical Trials Registry, number: RBR-9ypbtf . Registered 20 March 2018 - Retrospectively registered.

Interações medicamentosas em prescrições de idosos hipertensos: prevalência e significância clínica / Drug interactions in prescriptions for elderly hypertensive patients: prevalence and clinical significance / Interacciones medicamentosas en prescripciones de ancianos hipertensos: prevalencia y significado clínico

O objetivo deste estudo foi analisar a prevalência e significância clínica de interações medicamentosas identificadas nas prescrições de pacientes idosos hipertensos. Trata-se de um estudo descritivo, realizado na Unidade Básica de Saúde Dom Mielle da cidade de Ribeirão Preto, Estado de São Paulo, de julho a dezembro de 2011. As interações foram identificadas empregando o software Drug-Reax® da Micromedex e classificadas quanto à gravidade, documentação e tempo de início. Utilizou-se o software SAS®9.0 para análise estatística descritiva. Dos 40 pacientes do estudo, 65% eram mulheres e a mediana de idade foi 71 anos (DP=5,9). A média de medicamentos prescritos por paciente foi de 7,5 (DP=2,8). Todos apresentaram, no mínimo, uma interação medicamentosa. Do total de 169 interações identificadas, 17,1% eram graves. A ocorrência de interações medicamentosas foi elevada nos pacientes investigados. A equipe de saúde deve identificar as interações de significância clínica e implementar medidas para a sua prevenção e monitorização.

This study examined the prevalence and clinical significance of drug interactions identified in prescriptions of elderly hypertensive patients. This descriptive study was conducted at the Dom Mielle Primary Health Care Unit in Ribeirão Preto, São Paulo State, from July to December 2011. Interactions were identified using Drug-Reax® Micromedex software and classified by severity, time of onset and documentation. SAS®9.0 software was used for descriptive statistics. Of the 40 patients studied, 65.0% were women and the median age was 71.0 (SD = 5.9) years. The average number of drugs prescribed per patient was 7.5 (SD = 2.8); all patients had at least one drug interaction. Of the 169 interactions identified, 17.1% were severe. The occurrence of drug interactions was high in the patients studied. Healthcare teams must identify drug interactions of clinical significance and implement measures to prevent and monitor them.

El objetivo del estudio fue analizar la prevalencia y relevancia clínica de interacciones de drogas identificada sen las prescripciones de pacientes ancianos con hipertensión. Se trata de un estudio descriptivo, realizado en la Unidad Básica de Salud Dom Mielle en la ciudad de Ribeirão Preto, Estado de São Paulo –Brasil, de julio a diciembre de 2011. Las interacciones se identificaron usando el software Drug-Reax® Micromedex y clasificados por la gravedad, el tiempo de inicio y la documentación. Se utilizó el software SAS®9.0 para estadístico descriptivo. De los 40 pacientes estudiados, 65% eran mujeres y la edad mediana fue de 71,0 (SD=5,9) años. El número promedio de medicamentos prescritos por paciente fue de 7,5 (SD=2,8). Todos tenían, al menos, una interacción medicamentosa. Del total de 169 interacciones, 17,1% fueron graves. La aparición de las interacciones de drogas fue alta en los pacientes investigados. El equipo de salud debe identificar las interacciones farmacológicas de importancia clínica y aplicar medidas para su prevención y control.