Myocarditis due to COVID-19 in a pediatric patient

Current knowledge about the COVID-19 pandemic is still limited, especially in the pediatric age group. So far, children are considered to be a minimally affected population;however, physicians from different parts of the world have recognized a new pediatric multi-systemic inflammatory syndrome, that provokes a multiple organ dysfunction, from which the heart is not exempted. The direct action of the virus on myocardial cells, as well as the cytokines storm -triggered by the infection- are responsible for the myocarditis developed in these patients. In this article a case with criteria of myocarditis associated with COVID-19 is described. Achieving an early diagnosis ofmyocarditis secondary to SARS-CoV-2 infection in the current epidemiological context allows a correct and timely therapeutic approach, avoiding the torpid evolution and fatal outcome of this disease, as well as other long-term complications.

Direct bilirubin and the neutrophil-to-monocyte ratio timely predict intensive care unit admission in patients with severe acute respiratory syndrome coronavirus-2 infection (COVID-19)

Objective: Intensive care units (ICUs) collapsed under the global wave of coronavirus disease 2019 (COVID-19). Thus, we designed a clinical decision-making model that can help predict at hospital admission what patients with COVID-19 are at higher risk of requiring critical care. Method(s): This was a cross-sectional study in 119 patients that met hospitalization criteria for COVID-19 including less than 30 breaths per minute, peripheral oxygen saturation < 93%, and/or >= 50% lung involvement on imaging. Depending on the need for critical care, patients were retrospectively assigned to ICU and non-ICU groups. Demographic, clinical, and laboratory parameters were collected at admission and analyzed by classification and regression tree (CRT). Result(s): Forty-five patients were admitted to ICU and 80% of them were men older than 57.13 +/- 12.80 years on average. The leading comorbidity in ICU patients was hypertension. The CRT revealed that direct bilirubin (DB) > 0.315 mg/dl together with the neutrophil-to-monocyte ratio (NMR) > 15.90 predicted up to correctly in 92% of the patients the requirement of intensive care management, with sensitivity of 93.2%. Preexisting comorbidities did not influence on the tree growing. Conclusion(s): At hospital admission, DB and NMR can help identify nine in 10 patients with COVID-19 at higher risk of ICU admission.Copyright © 2022 Sociedad Medica del Hospital General de Mexico.

Liver biomarkers for prognosis in COVID-19

The novel coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).Mortality attributable to COVID-19 remains considerably high, with case fatality rates as high as 8-11%. Early medical intervention in patients who are seriously and critically ill with COVID-19 reduces fatal outcomes. Thus, there is an urgent need to identify biomarkers that could help clinicians determine which patients with SARS-CoV-2 infection are at a higher risk of developing the most adverse outcomes, which include intensive care unit (ICU) admission, invasive ventilation, and death. In COVID-19 patients experiencing the most severe form of the disease, tests of liver function are frequently abnormal and liver enzymes are found to be elevated. For this reason, we examine the most promising liver biomarkers for COVID-19 prognosis in an effort to help clinicians predict the risk of ARDS, ICU admission, and death at hospital admission. In patients meeting hospitalization criteria for COVID-19, serum albumin < 36 g/L is an independent risk factor for ICU admission, with an AUC of 0.989, whereas lactate dehydrogenase (LDH) values > 365 U/L accurately predict death with an AUC of 0.943.The clinical scores COVID-GRAM and SOFA that include measures of liver function such as albumin, LDH, and total bilirubin are also good predictors of pneumonia development, ICU admission, and death, with AUC values ranging from 0.88 to 0.978.Thus, serum albumin and LDH, together with clinical risk scores such as COVID-GRAM and SOFA, are the most accurate biomarkers in the prognosis of COVID-19.Copyright © 2021 Sociedad Medica del Hospital General de Mexico. Published by Permanyer.

Bradyarrhythmias in patients with SARS- CoV- 2 infection: Report of two cases

Several cardiovascular diseases and arrhythmogenic events have been associated with COVID-19 due to SARS-COV-2 infection, a topic of current global interest. Bradyarrhythmias are less frequent than other types of arrhythmia. We present a patient at 27 weeks of pregnancy, who on the fourth day of infection presented asymptomatic transient sinus pauses that did not require treatment ( sinus bradycardia of 41 beats per minute, pauses of two seconds and junctional escape rhythm). She was diagnosed as possible atrial myopathy with third degree sinoatrial block, sinus arrest or atrial quiescence, primary sinoatrial node dysfunction due to myocarditis ( edema and inflammation of the conduction system). She continued under follow-up, since after the infection was overcome arrhythmical events may recur. The second patient, 39 years old, presented bradyarrhythmia on the ninth day of infection, transient absence of P waves and junctional atrioventricular and idioventricular escape rhythms, as well as atrioventricular dissociation. No specific treatment was required.

Evaluation of the Prevalence of Psychological Disturbances in Patients with Immune-Mediated Rheumatic Diseases and Covid-19 Infection in an Ambulatory Service

Objectives: COVID-19 is an acute respiratory infection caused by the new coronavirus that has spread around the world, becoming an international public health emergency. Studies have shown a high prevalence of psychiatric symptoms such as depression, anxiety and post-traumatic stress disorder in patients after the infection, a situation that can be evenmore pronounced in patients with chronic diseases such as Immune-mediated rheumatic diseases (IRMD). The aim of this study is to evaluate the psychological impact of the COVID-19 infection and pandemic on patients with IRMD as well as to describe the epidemiological profile of the selected population. Method(s): A longitudinal cohort observational study was carried out with a comparison group, based on the analysis of data from patients of Project Reumacov, organized by de Brazilian Society of Rheumatology, in Manaus/ Amazonas. Data regarding the psychological impact was obtained through the application of DASS-21 forms, which evaluated levels of depression, anxiety and stress. Possible answers were divided into four categories according to the frequency of the symptoms presented, such as Not applicable;Present for a short time;Present for a significant amount of time or Present most of the time. Result(s): In total, 283 patients were included in the study. The mean age was 44 years and the majority of the patients were female. The most frequent diagnosis was systemic lupus erythematosus, followed by rheumatoid arthritis. Of the patients included, 270 answered the DASS-21 questionnaire, being 152 in the Case group (patients with COVID-19) and 118 in the Control group (patients without COVID-19). There was a significant statistic correlation between high levels of depression, anxiety and stress and the presence of COVID-19 related symptoms. Conclusion(s): Our study demonstrated that high levels of stress, depression and anxiety were associated to the coronavirus infection. It is, however, difficult to determine whether this scenario is a result of a physiological response to the infection or a consequence of the social context of a pandemic. This knowledge may contribute to a better understanding of COVID-19 infection and its repercussions as well as to highlight the necessity of a multidisciplinary approach aimed at the mental health of patients with rheumatic diseases.

Association between Covid-19 and Fatigue in Patients with Immune-Mediated Rheumatic Diseases in an Outpatient Service

Objectives: Patients with immune-mediated rheumatic diseases (IMRD) constitute an important subgroup of immunosuppressed patients at risk of developing severe infections. Since coronavirus 19 infection (COVID-19) is an international public health emergency, it is necessary to observe the relationship between this viral infection and the development or intensification of the clinical course of IMRD and the persistence of new associated symptoms. The aim of this study is to trace this population's epidemiological profile and evaluate the frequency of chronic fatigue syndrome in patients with IMRD and COVID-19 compared to uninfected patients. Method(s): This is a descriptive cross-sectional observational study with a comparison group. The sociodemographic, clinical, and FACIT-F Fatigue Scale data were from patients with IMRD of Project Reumacov, organized by the Brazilian Society of Rheumatology, locally inManaus/Amazonas. The statistical analysis was performed through the inferential method to demonstrate the prevalence. Result(s): 268 patients were evaluated, those who had contact with COVID-19 had fatigue according with the fatigue assessment scale compared to unexposed patients. There was a statistically significant correlation between fatigue post-COVID-19 infection in the patients studied. Conclusion(s): Clinically relevant fatigue was a prevalent and commonly reported symptom in the post-COVID-19 period in the evaluated population. These data should direct attention to the reported manifestations as they affect the functioning of individuals' socioeconomic and health well-being throughout the pandemic period and beyond.

Experiencia En Vida Real De La Eficacia, Seguridad Y Datos Farmacocineticos Del Cambio De Infliximab Intravenoso a Subcutaneo En Pacientes Con Enfermedad Inflamatoria Intestinal Inactiva. Resultados Del Registro Eneida

Poster con relevancia para la practica clinica Introduccion: Recientemente, se ha aprobado una formulacion subcutanea de infliximab biosimilar (CT-P13) (IFX- SC, dosis 120 mg) para la enfermedad inflamatoria intestinal (EII). Objetivos: Evaluar la eficacia, seguridad, farmacocinetica y experiencia de los pacientes tras el cambio a IFX-SC estando en remision clinica con tratamiento intravenoso. Metodos: Estudio multicentrico, descriptivo y observacional que incluyo a pacientes con enfermedad de Crohn (EC) y colitis ulcerosa (CU) que iban a ser cambiados de la via iv (IFX-IV) a la subcutanea (IFX-SC) a partir de datos obtenidos del registro ENEIDA (base de datos nacional, de recogida prospectiva por el Grupo Espanol de Trabajo en EII-GETECCU). Todos los pacientes estaban en remision clinica y biologica al menos 24 semanas antes del cambio. Se recogieron datos demograficos y de la enfermedad, actividad clinica (mediante indice de Harvey-Bradshaw para la EC e indice de mayo para la CU), datos analiticos (proteina C reactiva [PCR] y calprotectina fecal [CF]), asi como niveles valle al inicio, a las 12 y a las 24 semanas. Resultados: Se incluyeron 155 pacientes: 54 CU (35%) y 91 (65%) EC;44% mujeres;edad 45,5 anos (32-55). La indicacion del IFX-IV fue principalmente por enfermedad activa (72%) y perianal (7%), tratados durante 32 meses [14-56]. Pre- cambio, 78 (50,3%) recibian IFX-IV cada 8 semanas, 77 (49,7%) dosis intensificada. La mitad llevaban tratamiento inmunomodulador concomitante. El IFX-SC se cambio por mejorar adherencia durante la pandemia de COVID-19 (60%), para aumentar niveles (15%) o a peticion del paciente (25%). Permanecieron con dosis estandar 140 pacientes (90%), 8 (5%) requirieron intensificacion (120 mg semanal 4 y 240 mg cada 2 semanas 4) y en 7 (4,5%) se hizo una desescalada exitosa (120 mg cada 3 semanas en 4 y 120 mg cada 4 semanas en 3). Los indices clinicos, los niveles de PCR y la FC se mantuvieron sin cambios. Los niveles de IFXSC aumentaron significativamente de 4,5 μg/dl [2,6-9,2] basal a 14 μg/dl [9,5-16,2] a las 12 semanas y 13,2 μg/dl [10,4-19,7] a las 24 semanas. Ningun factor analizado (inmunosupresor concomitante, indice de masa corporal, localizacion de la enfermedad) se asocio con el aumento de niveles valle. Durante el seguimiento, suspendieron tratamiento inmunosupresor 16 de 78 (20,5%). Se registraron acontecimientos adversos en 9 pacientes (5,8%) y hubo 4 (2,6%) hospitalizaciones y 4 (2,6%) cirugias (1 de ellas perianal). Suspendieron tratamiento 9 pacientes (5,8%): 1 fracaso primario, 2 perdida de respuesta, 4 acontecimientos adversos, 1 voluntariamente y 1 cirugia. Conclusiones: El cambio de IFX IV a IFX SC mantiene la remision clinica de forma segura en la EII, ofrece mayores niveles de farmaco y una buena aceptacion por parte de los pacientes. El significado de los niveles mas altos con IFX-SC requiere una mayor exploracion.Copyright © 2023 Elsevier Espana, S.L.U. Todos los derechos reservados.

Diagnosis by levels of organizational flexibility. Case study: Meat Company of Camaguey

The study of organizational flexibility in companies, as well as its dimensions, is an increasingly recurrent and relevant topic in business sustainability, whatever its size or nature, given the need to adapt to changes. The COVID19 pandemic was a filter between flexible and non-flexible companies, unable to reinvent themselves. This paper presents a study dedicated to understanding organizational flexibility by levels, using a meat products company as a case study. From there, the objective is planted: to evaluate the level of organizational flexibility as a capacity to adapt to changes in the environment. The evaluation is carried out through the contextualization and application of a methodological instrument, finding that it is viable, resulting in the assessment of flexibility at a medium level.

Sources for the Study of the Social Consequences of Covid-19. A Review of the Surveys Conducted in Spain (2020-2021)

The changes caused by the COVID-19 crisis have received a great deal of attention in social research. However, their volume is such that many of the surveys have gone unnoticed, remaining underutilised to this day. This paper presents a review of the different specific social surveys on COVID-19 carried out by public institutions in Spain, with a twofold objective. On the one hand, to serve as a reference tool for researchers who wish to undertake research work on the pandemic using secondary data. On the other, to reflect on the meta-analysis of the characteristics and evolution of the surveys produced. Our results show that the production of information follows a course similar to that of the disease itself, with each wave also triggering a period of high data production. At the same time, there was also an evolution of topics and blocks of questions, which initially focused on aspects of everyday life, then on impacts on the economy and society, then on political management and finally, with the onset of vaccination, on health issues.

Interactions detected with the use of nirmatrelvir/ritonavir in a tertiary hospital

Background and ImportanceThe incorporation of nirmatrelvir/ritonavir into the therapeutic arsenal for the treatment of SARS-CoV2 infection has made it necessary for Pharmacy departments to activate circuits and tools that allow us to adequately review the potential multiple interactions that ritonavir can produce.Aim and ObjectivesTo describe the interactions detected since the beginning of the use of nirmatrelvir/ritonavir in a tertiary hospital.Material and MethodsAll patients who received nirmatrelvir/ritonavir from April to the end of August 2022 were included. The patient‘s usual treatment was consulted in the electronic prescription system of the region of Madrid, as well as an interview with the patient, and the medical history was consulted when deemed necessary. For the detection of interactions, the ‘COVID-19 Drug Interactions' platform of the University of Liverpool was used and Farmaweb, an application of the Madrid Health Service, was used to validate the dispensing of medication. If there are any interacciones the pharmacist notifies the prescribing physician, as well as the necessary adjustments, these treatment modifications are also explained to the patient when the medication is given to them. An Excel table was used to record whether the patient had any interaction and, if there were any, the drugs were recorded.ResultsDuring the study period, these drugs were dispensed to a total of 81 patients, and interactions with the patient‘s usual medication were detected in 61.73% (50 patients). 18 patients had one interaction, 21 patients had 2 interactions, 6 patients had 3, 4 patients had 4 and one patient had 5 potential interactions. The most commonly detected interaction was with atorvastatin (19) followed by metamizole (11), simvastatin (7), amlodipine (6) and tramadol (4).Conclusion and RelevanceThe percentage of patients with interactions is very high, and it is very important to review the usual treatment as well as an interview with the patient to identify whether the patient is taking other unregistered medication that could interact.This has highlighted the importance of interdisciplinary collaboration between the medical team (mainly in the emergency department, where most of these drugs have been prescribed) and the pharmacy team to ensure the correct use of this drug.References and/or AcknowledgementsConflict of InterestNo conflict of interest

Oxidative stress in diverse clinical conditions of SARS-CoV-2 Cuban hospitalized patients

Context: COVID-19 related to SARS-CoV-2 infection generates inflammation with increased reactive oxygen species production. Drug treatment and others factors could influence systemic oxidative stress during pathogenic insult. Aims: To determine the redox status in COVID-19 patients with different clinical conditions and explore the relationship between redox and hematological hemochemical variables. Methods: In this comparative longitudinal study, blood samples were drawn from 160 individuals divided into four groups: COVID-19 asymptomatic, COVID-19 symptomatic (low and moderate symptoms), COVID-19 convalescent, and presumable healthy subjects. Demographic, redox, hematological, and hemochemical indices were assessed. Statistical analyses compared the median values of each variable and explored individual, simultaneous indices, and multivariate alteration. Results: Relative to the healthy group, acute COVID-19, and convalescent groups had significant differences in global damage indices and antioxidant status (p<0.05). The convalescent group showed significantly higher damage (malondialdehyde, advanced oxidation protein products, nitric oxide) and lower antioxidant enzymatic activities and glutathione concentration compared to other groups (p<0.05). Global modification of redox indices showed that more than 80% of studied individuals in acute conditions had simultaneous detrimental differences compared to a healthy status. The discriminant analysis permitted obtaining two canonical functions (p< 0.05) that reflect 98% of redox variables with 95% of variances with successful case classifications. Conclusions: These results corroborate that oxidative stress occurred in different COVID-19 and post-acute conditions with different molecular alterations of redox indices. Redox diagnosis should be considered in early diagnosis and treatment of infection, which would be worthwhile to conduct a more comprehensive study and management of disease evolution. © 2023 Journal of Pharmacy & Pharmacognosy Research.

Home-based educational care in times of pandemic. A technological challenge for the Hospital and Home Education Care Team in the Region of Murcia

The way of understanding education has changed as a result of the health emergency caused by COVID-19. The education system has faced a new challenge of adaptation and transformation of our educational reality. The aim of this article is to present the strategies that the Educational Home Care Service (SAED) has offered. To this end, this organisation has developed an avant-garde methodology that has taken the form of a platform where a student-friendly environment and resources have been recreated to provide a basic scaffolding for teaching activity. A series of online platforms were selected with which the SAED team of professionals optimised their telematic teachinglearning process. This research highlights the attention received by students with special educational needs. The results reflect on this review of education in an exceptional context in which educational and interactive material has served to stimulate different types of learners in an exceptional situation. © GTE-Educational Technology Group, University of the Balearic Islands. All Rights Reserved.

Feasibility, Safety and Efficacy of a Combined Supervised Physical Exercise and Nutritional Program in a Selected Population of Luminal Metastatic Breast Cancer Patients: Oncare01 Pilot Study

Background: Supervised exercise programs (SEP) have demonstrated an improvement in quality of life (QoL), cardiovascular health, treatment tolerance and disease outcomes in early breast cancer patients. In metastatic breast cancer (MBC), previous data suggest SEP are safe but no impact on QoL and a low adherence to programs were shown. These studies included a heterogenous population in terms of type of treatments received, numbers of previous lines or comorbidities. From our perspective, MBC profile that could benefit most from SEP needs to be explored. Thus, we conducted a pilot study to assess adherence, safety and impact on QoL of a combined SEP and nutritional program (NP) in a selected population of MBC of patients treated with cyclin-dependent kinase 4/6 inhibitors (iCDK 4/6). Method(s): This is a prospective, single center, single arm pilot study. SEP consisted in a 12-week intervention with twice a week in-person resistance exercise session. Patients also completed weekly aerobic exercise goals in self-managed sessions monitored with activity trackers. SEP was conducted by registered Physical Activity and Sports Science instructors that followed American College of Sports Medicine guidelines. In addition, participants had an initial nutritional assessment and personalized counselling by a qualified nutritionist. Adherence to treatment, biological variables and QoL assessments (FACIT-Fatigue and QLQ-C30 questionnaires) were collected at baseline (B) and week-12 (w12). Primary endpoint was global adherence (>=70% of attended sessions relative to scheduled sessions). Secondary endpoints included safety, changes in biological variables and QoL. Paired samples t-tests (Wilcoxon) were used to assess biological changes and QoL. Result(s): Patients (n=26) were recruited from October 2020 to November 2021. Median age was 47,5 years (45-55);84,6% of patients were ECOG 0. 42,3% of patients were receiving Abemaciclib;34,6% Ribociclib and 23,1% Palbociclib in first (73,1%) or second (26,9%) line treatment. Patients had bone (69,2%);visceral metastasis (57,7%) or both (30,8%). 2 patients did not start the intervention and additional 7 patients discontinued the program prematurely, the majority of them due to COVID-related concerns. Considering all patients who at least attended one session, global adherence was 66% (39-77,5%) and 45,8% of patients achieved an adherence of >= 70%. Patients reported an improvement in QoL [B global QLQ-C30 66,6 (50-75), w12 75 (66,6-83,3);p 0,0121] and fatigue [B FACIT-Fatigue 37 (30-44), w12 42 (38-48);p 0,0017]. Sit-to-stand repetitions in 30-second period also improved [(B 15 (12-17), 19 (15-23);p 0,0002]. Same benefits were seen in patients with adherence >= 70%. No statistically significant changes were seen in body fat or muscular composition and handgrip scores. Importantly, no safety issues related to study intervention were reported. Conclusion(s): Even though the study was conducted during COVID-19 pandemic, global adherence was 66%. For the first time in MBC, SEP and NP combined program demonstrated to be safe and improved QoL in patients with first or second line MBC treated with iCDK4/6. Further research is needed to identify strategies that improve QoL in MBC.

Clinical impact of the use of glucocorticoids for the treatment of COVID-19 in intermediate respiratory care units

Background and ImportanceDuring the pandemic, patients admitted to intermediate respiratory care units (IRCU) received non-invasive respiratory support and pharmacological treatment, mainly glucocorticoids (GC). Dexamethasone is the only one that has shown reducing mortality;however, there are no comparative efficacy studies between the different GC.Aim and ObjectivesTo determine the possible influence of the type and dose of GC on the patients' evolution with SARS-CoV-2 pneumonia admitted to the IRCU during the first and second wave of the pandemic.Material and MethodsDescriptive, observational and retrospective study of patients with SARS-CoV-2 infection admitted to the IRCU in a tertiary care hospital since March until December 2020. Demographic variables, comorbidities, GC therapy received and final resolution (improvement, transfer to ICU, or death) were analysed. The data were obtained from the clinical history and the electronic prescription.Results135 patients (62.5% men) were included with a mean age of 67.00 (SD:13.16) years. 69.31% of them had overweight and 29.41% respiratory pathologies.89.63% of the patients admitted to the IRCU received treatment with GC, within them, 89 received treatment with a single GC, 27 received the combination of two and only 3 patients received three GC. 64 GC-treated patients improved, receiving a mean prednisone equivalent dose of 65.43 (SD:88.77) mg daily for a mean of 13.40 (SD:7.02) days.The 19 patients transferred to the ICU received a mean dose of 89.18 (SD:71.81) mg daily for 6,00 (SD: 5.19) days. The 38 patients who died in IRCU treated with GC received a mean dose of 114.18 (SD: 90.39) mg daily for a mean of 8.92 (SD: 6.17) days.The most used GC or combinations were: dexamethasone (76 patients), dexamethasone and prednisone (13 patients), methylprednisolone (11 patients), dexamethasone and methylprednisolone (8 patients), and methylprednisolone and prednisone (5 patients). 100% of patients treated with dexamethasone and prednisone improved, followed by dexamethasone and methylprednisolone (62.5%) and methylprednisolone and prednisone (60%). 27.27% of the patients treated with methylprednisolone alone improved, with 63.64% dying.Conclusion and RelevanceMost of the patients admitted to the IRCU with coronavirus received GC and the results suggest some improvement in those who received lower doses of GC for longer periods.The GC combination was associated with a higher rate of improvement, especially with dexamethasone and prednisone. Treatment with methylprednisolone alone had the highest death rate.References and/or AcknowledgementsConflict of InterestNo conflict of interest.

Covid-19 and NETs

Introduction: Neutrophil extracellular traps (NETs) have recently been linked to an important role in the pathogenesis of Covid-19. Method(s): Prospective observational study of 91 hospitalized patients. We studied longitudinally the viral phase, early inflammatory and late, and the 4 most specific components of NETs: cell free-DNA (cfDNA), MPO-DNA and NE-DNA complexes and citrullinated Histone 3 (citH3). Result(s): We observed elevated levels vs controls of MPO-DNA and NE-DNA complexes and cfDNA at admission and in the 3 phases of the disease. CitH3 was elevated from the early inflammatory phase onwards. There was a significant correlation in survivors (r=0.798) and in all severity degrees between MPO and NE and between cfDNA and H3 cit (r=0.3), but not in the rest of combinations among the 4, nor in dead patients. We did not observe any correlation in any group between MPO or NE with citH3. There was an increase of only cfDNA levels in more severe patients. The area under the ROC curve for critical severity and mortality was high for cfDNA (0.7327 and 0.7482) and much poorer for the other 3 NETs markers. Conclusion(s): -We found evidence of neutrophil activation of NETs components in Covid-19, during the 3 phases of the disease, but without a clear relationship with severity and mortality. -cfDNA was related to severity and mortality, and its sources appeared to be more related to tissue damage than to NETs -The best correlation between them was MPO-NE, and these more neutrophil-specific markers reflect probably better NET formation. NETs role has maybe been overestimated using other less specific markers.

Real-life experience of the efficacy, safety and pharmacokinetic data of switching from intravenous to subcutaneous infliximab in inactive inflammatory bowel disease patients. Results from the ENEIDA registry

Background: Recently, a subcutaneous formulation of biosimilar infliximab (CT-P13) (SC-IFX) has been approved for inflammatory bowel disease (IBD). The aims of this study were to evaluate efficacy, safety, pharmacokinetics and patient experience following a switching to SC-IFX in patients who are in clinical remission on IV-IFX maintenance treatment. Method(s): Multicentre, descriptive, and observational study including Crohn's disease (CD) and ulcerative colitis (UC) patients who were going to be changed from IV-IFX to SC-IFX on the ENEIDA registry (a large, prospectively maintained database of the Spanish Working Group in IBD-GETECCU). All patients were on clinical and biological remission at least 24 weeks before changing. Demographic and disease data, clinical activity (Harvey-Bradshaw index for CD and mayo index for UC), analytical data (C reactive protein (CRP) and fecal calprotectin (FC), as well as trough levels were collected at baseline, at 12 and 24 weeks. Result(s): One hundred and fifty-five patients were included: 54 UC (35%) and 91 (65%) CD;44% women and 56% men;age 45.5 years (32-55). IV-IFX was mainly administered due to active disease (72%) and perianal disease (7%) and during 32 months [range 14-56]. Preswitch, 78 (50.3%) were on 8-weekly dosing of IV-IFX, 77 (49.7%) were with intensification dose and the half (50.3%) were on concomitant immunomodulatory therapy. SC-IFX was mainly switching by COVID-19 pandemic (60%), to increase through levels (15%) or patient request (25%). The majority of patients (140, 90%) remained with standard dose, 8 (5%) required dose intensification (120 mg weekly in 4 and 240 mg every 2 weeks in 4) and 7 (4.5%) had successful de-escalation (120 mg every 3 weeks in 4 and 120 mg every 4 weeks in 3). Clinical indices, CRP levels and FC remained unchanged (Figure). Median SC-IFX levels significantly increased from baseline of 4.5 mug/ dl [range 2.6-9.2] to 14 mug/dl [range 9.5-16.2] at week 12 and 13.2 mug/ dl [range 10.4-19.7] at week 24. No factors (immunossupresor, body mass index, disease location) were associated with the increase of IFX trough levels. During 24 weeks of follow-up, 16 of the 78 patients (20.5%) stopped immunosuppressant treatment. The adverse events were recorded in 9 patients (5.8%), 4 (2.6%) were hospitalized and 4 (2.6%) had surgery (one of them for perianal disease). Nine patients (5.8%) stopped SC-IFX (1 primary failure, 2 loss of response, 4 adverse events, 1 voluntarily, and 1 surgery). Conclusion(s): The switch from IV to SC IFX maintains clinical remission safely in IBD patients, offers higher drug levels and a good patient acceptance. However, the significance of higher drug levels with SC-IFX requires further exploration.

[Translated article] Has the COVID-19 lockdown influenced the mortality of hip fracture? Analysis of one-year mortality.

INTRODUCTION AND OBJECTIVES: The main objective of this study is to analyse the one-year mortality in patients with intracapsular hip fracture who were admitted during severe social confinement in the first months of the COVID-19 lockdown and compare it with previous years. MATERIAL AND METHODS: Retrospective observational study in which a cohort from March 14 to June 21, 2020 (pandemic group, n=62) was compared with a control cohort on the same dates in the years 2017, 2018 and 2019 (control group, n=172). Thirty-day-mortality and one-year-mortality, orthopaedic complications, ASA grade, comorbidities, diagnosis and treatment, time to surgery and mean stay were measured. RESULTS: No significant differences were found in 30-day mortality (p=0.156; 9.7% compared to 4.7%) or in one-year mortality (p=0.47) between the pandemic group (21%) and the control one (16.9%). A decrease in surgical delay and mean stay was observed in the pandemic group, although without statistical significance. CONCLUSION: The State of Alarm modified the distribution of the type of hip fracture with a predominance of intracapsular fracture. Maintaining the same hospital management as prior to the pandemic period made it possible not to increase 30-day mortality and one-year mortality in patients with intracapsular hip fracture.

Differences between Forms of Intra-and Extra-Domiciliary Contagion in Three Epidemic Outbreaks of COVID-19 in Santiago de Cuba.

Introduction: In the transmission of COVID-19 in Santiago de Cuba province, three epidemic outbreaks were observed between 2020 and 2021. Objective(s): To identify the differences between intra-and extra-domiciliary infections in three epidemic outbreaks of COVID-19 in Santiago de Cuba between March 2020 and May 2021. Method(s): A cross-sectional descriptive study of COVID-19 cases in the territory and period above mentioned was carried out, using the usual bivariate techniques of statistics and implicative statistical analysis, to a sample of 6408 cass that was chosen by simple random sampling from the database of confirmed cases. Result(s): Extra-domiciliary contagion was significantly higher than intra-domiciliary contagion without differences by sex, but according to age groups and municipalities within and between both groups. The predominance of older adults in intra-domiciliary contagion and of young adults in extra-domiciliary contagion was significant. Symptomatic patients prevailed in the intra-domiciliary;and, the asymptomatic, in the extra-domiciliary, without significant differences between both forms. Children under 20 years of age, older adults, asymptomatic and Mella municipality were the characteristics that were associated with intra-domiciliary contagion, while, with the extra-domiciliary were related symptomatic young adults. Conclusion(s): The forms of intra-and extra-domiciliary contagion were modulated according to the behavior of the people and the isolation of each age group. Extra-domiciliary predominated in intermediate ages of life, as an expression of the behavior mediated by their economic responsibility at home, while extreme ages, who remained at home to comply with isolation measures, were more prone to intra-domiciliary contagion. Copyright © 2022, Editorial Ciencias Medicas. All rights reserved.