In COVID-19, the inflammatory cytokine-release syndrome is associated with the progression of the disease. Itolizumab is a monoclonal antibody that recognizes human CD6 expressed in activated T cells. The antibody has shown to be safe and efficacious in the treatment of moderate to severe psoriasis. Its effect is associated with the reduction of pro-inflammatory cytokines release, including IFN-γ, IL-6 and TNF-α. Here, we report the outcome of three severe and critically ill COVID-19 patients treated with itolizumab as part of an expanded access protocol. Itolizumab was able to reduce IL-6 concentrations in all the patients. Two of the three patients showed respiratory and radiological improvement and were fully recovered. We hypothesize this anti-inflammatory therapy in addition to antiviral and anticoagulant therapy could reduce COVID-19 associated morbidity and mortality.
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In COVID-19, a percentage of patients develop severe disease, with high mortality, since has been necessary to study its characteristics to stop the progression of the disease. A retrospective study was carried out in a cohort of 150 adult patients attended at Manuel Fajardo Hospital in Villa Clara, Cuba, from March to June 2020. Demographic, clinical, laboratory, gasometric and radiological variables measured at hospital admission were analyzed, defining two groups of patients according to clinical evolution: severe and non-severe. For the comparison of the groups a bivariate analysis was performed, with the objective of determining those variables with a significant association to severity. Of the total number of patients, 26 (17.3%) evolved to severity and 124 (83.7%) evolved satisfactorily. Severe patients were characterized by advanced age (mean: 83 years) and comorbidities; the most significant being hypertension, diabetes mellitus, heart disease, chronic kidney disease and cancer (p< 0.0001). Polypnea and diarrhea were the clinical manifestations with the highest association with severity (p<0.0001), followed by fever (p=0.0157). The quick SOFA prognostic scale proved to be a useful instrument to evaluate patients at admission. Laboratory variables: neutrophils, lymphocytes, neutrophil/lymphocyte ratio, hemoglobin and lactate dehydrogenase were the most associated with severity (p<0.0001). Leukocytes, lactate, D-dimer, C-reactive protein, glycemia and calcium also showed significant results (p<0.05). Of the gasometric variables, arterial oxygen pressure and saturation were the most significantly associated with severity; as well as the presence of pulmonary infiltrates or consolidation in the chest X-ray (p<0.0001). The study allowed us to identify variables at hospital admission associated with progression to severe forms of the disease.
La COVID-19 puede progresar a formas severas de la enfermedad con una elevada mortalidad, por lo que ha sido necesario identificar factores predictivos que permitan estratificar el riesgo en los enfermos. Se realizó un estudio retrospectivo analítico en una cohorte de 150 pacientes del hospital Manuel Fajardo de Villa Clara, Cuba, en el periodo de marzo a junio de 2020. Con la información obtenida se construyó un índice pronóstico de severidad mediante un modelo de regresión logística binaria multivariada, en el que se expresó la probabilidad de que el paciente evolucionara hacia la severidad en función del conjunto de variables que fueron identificadas como predictoras del evento de salud de interés. Para el resumen de los datos y la aplicación de las pruebas de hipótesis se utilizó el software R versión 4.0.2. Con los resultados finales se elaboró un índice pronostico a través de una ecuación matemática en la cual se sustenta el modelo. Para facilitar su interpretación se construyó el nomograma de predicción, que constituyó la salida principal de este estudio. Las variables con mayor poder predictivo, que definitivamente quedaron en el modelo y con las cuales se construyó el nomograma fueron: edad (p=0.049), hipertensión arterial (p=0.013), índice neutrófilos/linfocitos (p=0.004), deshidrogenasa láctica (p=0.039) y saturación arterial de oxígeno (p=0.044). El resultado del estadígrafo del test de Hosmer-Lemeshow fue p= 0.976 y la capacidad discriminatoria dada por el área bajo la curva ROC (receiver operating characteristic curve) fue igual a 0.988 (AUC: 0.9882, 95% CI: 0.9756-1). El punto de corte óptimo fue 0. 099.Se concluye que nuestro nomograma constituye un instrumento de gran utilidad para identificar precozmente los pacientes con riesgo de progresar a formas severas de COVID-19. De esta manera, facilita una mejor estratificación y adecuación de tratamientos oportunos, capaces de frenar la progresión de la enfermedad.
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