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Safety Profile of Biological Intravenous Therapy in a Rheumatoid Arthritis Patients Cohort. Clinical Nursing Monitoring (Sebiol Study).

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Title: Safety Profile of Biological Intravenous Therapy in a Rheumatoid Arthritis Patients Cohort. Clinical Nursing Monitoring (Sebiol Study).
Alternate Title: Perfil de seguridad de las terapias biológicas intravenosas en una cohorte de pacientes con artritis reumatoide. Monitorización clínica por enfermería (estudio Sebiol).
Authors: Corominas, Hèctor1 vancor@yahoo.com, Sánchez-Eslava, Lucinda2, García, Guadalupe3, Padró, Isabel4, Aimarich, Cristina5, Gonzàlez, Joana2, Franco, Maria3, Mur, Emilia3, Sanchez, Silvia4, Roldán, Glòria6, Iniesta, Silvia4, Sesma, Montse5, Martín, Josefina7, Rodriguez, Mari Carmen6, Capellan, Maria Rosa8, Gosálvez, Coral9, Garcia-Diaz, Silvia1, Sáez, Encarnación9, Luna, Yolanda8, Plana, Pilar10
Source: Reumatología Clínica. mar/abr2013, Vol. 9 Issue 2, p80-84. 5p.
Subjects: INTRAVENOUS therapy, RHEUMATOID arthritis, PATIENT monitoring, DRUG administration, ADVERSE health care events, RHEUMATOID arthritis treatment, MEDICAL registries, SAFETY, PATIENTS
Abstract (English): Introduction: The biologics used in the management of rheumatoid arthritis (RA) in recent years have comprehensively permitted to understand their security, as shown in registries such as BIOBADASER. The present manuscript represents an observational cohort study to describe the safety perinfusional profile of those intravenous treatments. Objectives: To confirm the safety profile of biological therapies in routine clinical practice, after the administration of intravenous drugs and 24 h post-administration. Material and methods: We evaluated a cross-sectional cohort of 114 patients with RA (according to the American College of Rheumatology ACR criteria), attending within one month in 2009 the nursing clinics of day care hospital of 12 Catalonian hospitals. All patients were treated with intravenous biological agents. We recorded the age, sex, current and previous drug treatments. We also collected data about previous vaccination and premedication received and any adverse event occurring at the time of drug administration or within 24 h. If an adverse event occurred, it was categorized by MedDRAv1 1.0 International Dictionary, and categorized in terms of intensity (mild, moderate, severe), relationship to drug administration according to Karch and Lasagna algorithm (unrelated, unlikely, possible, probable, definite) and the further measures taken. Results: 111 patients met the inclusion criteria, with a mean age of 56.06 years (SD: 12.12), 90 of them women (81.1%) and mean time since diagnosis of the disease of 11.97 years (SD: 7.95). 24 patients (21.6%) had a history of allergy. 12 adverse events were observed in 7 patients, 9 of which at the time of administration and 3 in 24 h after. There were no serious adverse events and only one of the adverse events (AEs) was rated as moderate (urticaria). The remaining AEs were mild. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): Introducción: El uso de biológicos ha permitido conocer de manera exhaustiva su seguridad gracias a registros como BIOBADASER. El presente trabajo permite, con un estudio observacional de cohortes, describir el perfil de seguridad perinfusional de dichos tratamientos por vía intravenosa. Objetivos: Conocer el perfil de seguridad en la práctica clínica, tras la administración de biológicos por vía intravenosa y durante las 24 h posteriores. Material y métodos: Cohorte transversal de 114 pacientes con AR tratados con agentes biológicos (criterios ACR) durante un mes de 2009 por enfermería de hospital de día de 12 centros hospitalarios catalanes. Se analizaron la edad, el sexo, los tratamientos actuales y previos, los datos de vacunación previa y la premedicación. Se registró también cualquier acontecimiento adverso (AA) durante la administración o en las 24 h posteriores. Se clasificó según el diccionario internacional MedDRAv1 1.0 y se describieron la intensidad (leve, moderada, severa), la relación con la administración del fármaco según el algoritmo de Karch y Lasagna (no relacionada, improbable, posible, probable, definitiva) y las medidas emprendidas. El análisis estadístico se realizó mediante SPSS 18.0. Resultados: Ciento once con criterios de inclusión (edad media ± desviación estándar 56,06 ±12,12 años), 90 mujeres (81,1%) y evolución de 11,97 ± 7.95 años; 24 pacientes (21,6%) con antecedentes de alergia. Se observaron 12 AA en 7 pacientes, 9 de ellos durante la administración y 3 en las 24 h posteriores. No hubo ningún acontecimiento adverso grave y uno de los AA se calificó de intensidad moderada (urticaria). El resto de los AA fueron de intensidad leve. [ABSTRACT FROM AUTHOR]
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Database: MedicLatina
Description
Abstract:Introduction: The biologics used in the management of rheumatoid arthritis (RA) in recent years have comprehensively permitted to understand their security, as shown in registries such as BIOBADASER. The present manuscript represents an observational cohort study to describe the safety perinfusional profile of those intravenous treatments. Objectives: To confirm the safety profile of biological therapies in routine clinical practice, after the administration of intravenous drugs and 24 h post-administration. Material and methods: We evaluated a cross-sectional cohort of 114 patients with RA (according to the American College of Rheumatology ACR criteria), attending within one month in 2009 the nursing clinics of day care hospital of 12 Catalonian hospitals. All patients were treated with intravenous biological agents. We recorded the age, sex, current and previous drug treatments. We also collected data about previous vaccination and premedication received and any adverse event occurring at the time of drug administration or within 24 h. If an adverse event occurred, it was categorized by MedDRAv1 1.0 International Dictionary, and categorized in terms of intensity (mild, moderate, severe), relationship to drug administration according to Karch and Lasagna algorithm (unrelated, unlikely, possible, probable, definite) and the further measures taken. Results: 111 patients met the inclusion criteria, with a mean age of 56.06 years (SD: 12.12), 90 of them women (81.1%) and mean time since diagnosis of the disease of 11.97 years (SD: 7.95). 24 patients (21.6%) had a history of allergy. 12 adverse events were observed in 7 patients, 9 of which at the time of administration and 3 in 24 h after. There were no serious adverse events and only one of the adverse events (AEs) was rated as moderate (urticaria). The remaining AEs were mild. [ABSTRACT FROM AUTHOR]
ISSN:1699258X
DOI:10.1016/j.reuma.2012.06.001