ABSTRACT
BACKGROUND: Severe pediatric allergic asthma (SPAA) induces a huge economic burden in terms of direct, indirect, and intangible costs. The use of omalizumab for the treatment of these patients has produced a significant improvement in several clinical outcomes, but at the same time, the cost for the management of the disease has also increased. The aim of this report was to evaluate whether the use of omalizumab is cost-effective. METHODS: A sample of 426 children with SPAA from the ANCHORS (Asthma iN CHildren: Omalizumab in Real-life in Spain) study was used to calculate the incremental cost-effectiveness ratio (ICER) for the avoidance of moderate-to-severe exacerbations (MSE) and also for the improvement in childhood Asthma Control Test (c-ACT) or the Asthma Control Questionnaire (ACQ5). We retrospectively collected data on health encounters and drug consumption before and up to 6 years after the beginning of the treatment with omalizumab. RESULTS: The ICER per avoided MSE was 2107 after 1 year, and it consistently decreased to 656 in those followed up to 6 years. Similarly, the ICER for the minimally important difference in control tests showed a decrease from 2059 to 380 per each 0.5 points of improvement in ACQ5 and from 3141 to 2322 per each 3 points improvement in c-ACT, at years 1 and 6, respectively. CONCLUSION: The use of OMZ is a cost-effective option for most children with uncontrolled SPAA, especially those who have frequent exacerbations; the costs are progressively reduced in successive years of treatment.
Subject(s)
Anti-Asthmatic Agents , Asthma , Humans , Child , Omalizumab/therapeutic use , Cost-Benefit Analysis , Anti-Asthmatic Agents/therapeutic use , Spain , Retrospective Studies , Asthma/therapy , Treatment Outcome , Quality of LifeABSTRACT
BACKGROUND: Various studies have assessed omalizumab outcomes in the clinical practice setting but follow-up and/or number of patients included were limited. We aim to describe the long-term outcomes of pediatric patients with severe persistent allergic asthma receiving omalizumab in the largest real-life cohort reported to date. METHODS: ANCHORS was a multicenter, observational, retrospective cohort study conducted in 25 Pediatric Allergy and Pulmonology units in Spain. We collected data of patients < 18 years and initiating omalizumab between 2006 and 2018, from the year prior to omalizumab initiation to discontinuation or last available follow-up. The primary outcome was the evolution of the annual number of moderate-to-severe exacerbations compared with the baseline period. RESULTS: Of the 484 patients included, 101 (20.9%) reached 6 years of treatment. The mean ± standard deviation number of exacerbations decreased during the first year of treatment (7.9 ± 6.6 to 1.1 ± 2.0, P < .001) and remained likewise for up to 6 years. The other clinical parameters assessed also improved significantly during the first year and stabilized or continued to improve thereafter. The percentage of patients experiencing adverse events was consistently low, and the main reason for discontinuation was good disease evolution. CONCLUSION: In this large, long-term, observational study, moderate-to-severe exacerbations decreased significantly from the first year of treatment with omalizumab. The beneficial effect was maintained in the long term, along with a good safety profile. Our results position omalizumab as an effective long-term treatment in pediatric patients with severe persistent allergic asthma.
Subject(s)
Anti-Asthmatic Agents/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Asthma , Omalizumab/therapeutic use , Anti-Asthmatic Agents/adverse effects , Antibodies, Monoclonal, Humanized/adverse effects , Asthma/drug therapy , Child , Humans , Omalizumab/adverse effects , Retrospective Studies , Treatment OutcomeABSTRACT
INTRODUCCIÓN: Los antimicrobianos son uno de los agentes terapéuticos más empleados en niños. Se estima que entre el 30 y el 50% de las prescripciones son inadecuadas. En este escenario, el análisis de la prescripción aporta información importante para la implementación de medidas de mejora en este campo. OBJETIVOS: Evaluar la adecuación de la prescripción de antimicrobianos en población pediátrica en un servicio de urgencias. MÉTODOS: Estudio observacional, descriptivo y transversal en población menor de 14 años atendida en las urgencias hospitalarias de un hospital comarcal durante el año 2013. Se seleccionó una muestra aleatoria de 630 pacientes (intervalo de confianza: 99%; error alfa: 5%). Se analizó el grado de adecuación del tratamiento antimicrobiano comparando nuestra práctica clínica con las recomendaciones de una guía de tratamiento antimicrobiano basada en la mejor evidencia disponible diseñada especialmente para este estudio. RESULTADOS: Se prescribió antimicrobiano al 16,5% de los pacientes (n=104). El tratamiento fue considerado inadecuuado en el 51,9% de los pacientes (n = 54). Se prescribió tratamiento innecesario en el 40,7%, la elección del antimicrobiano fue incorrecta en el 35,2% y la posología en el 24,1%. Las principales enfermedades en las que se produjo la prescripción inadecuada fueron: otitis media aguda, episodio de sibilancias, fiebre sin foco, faringoamigdalitis aguda y neumonía adquirida en la comunidad. CONCLUSIÓN: Hasta en la mitad de los pacientes la prescripción de antimicrobianos puede ser inadecuada. Estos resultados ponen de manifiesto la importancia de introducir un programa de optimización de antimicrobianos para reducir su uso innecesario
INTRODUCTION: Antibiotics represent one of the most widely prescribed therapeutic agents in children. It has been estimated that 30-50% of antibiotic prescriptions for this population are inappropriate. In this scenario, analysis of prescription data provides an invaluable source of information as a basis for implementing strategies for improvement in this field. OBJECTIVE: To assess the appropriateness of antibiotic prescriptions in a paediatric population at an emergency department. METHODS: An observational, descriptive, and cross-sectional study was conducted on patients under 14 years who attended the emergency department during 2013. A random sample of 630 patients was selected (confidence level 99%, accuracy 5%). To assess the suitability of antibiotic prescriptions, the clinical practice was compared with an evidence-based guideline especially designed for this study. RESULTS: Antibiotics were prescribed to 16.5% patients (n = 104). Antibiotic treatment was inappropriate in 51.9% patients (n = 54). Unnecessary treatment was indicated in 40.7%, with wrong antibiotics chosen in 35.2%, and the posology was incorrect in 24.1% of them. The most frequent diseases with incorrectly prescribed antibiotics were: acute otitis media, episodes of wheezing, fever of unknown origin, acute pharyngo-tonsillitis, and community-acquired pneumonia. CONCLUSION: Antibiotic prescribing seems to be inappropriate in up to half of the patients. These data reinforce the need to develop a paediatric antimicrobial stewardship program to decrease the unnecessary use of antimicrobial agents
Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Child , Anti-Bacterial Agents/therapeutic use , Drug Prescriptions/standards , Inappropriate Prescribing/statistics & numerical data , Cross-Sectional Studies , Emergency Medical Services , Emergency Service, HospitalABSTRACT
INTRODUCTION: Antibiotics represent one of the most widely prescribed therapeutic agents in children. It has been estimated that 30-50% of antibiotic prescriptions for this population are inappropriate. In this scenario, analysis of prescription data provides an invaluable source of information as a basis for implementing strategies for improvement in this field. OBJECTIVE: To assess the appropriateness of antibiotic prescriptions in a paediatric population at an emergency department. METHODS: An observational, descriptive, and cross-sectional study was conducted on patients under 14 years who attended the emergency department during 2013. A random sample of 630 patients was selected (confidence level 99%, accuracy 5%). To assess the suitability of antibiotic prescriptions, the clinical practice was compared with an evidence-based guideline especially designed for this study. RESULTS: Antibiotics were prescribed to 16.5% patients (n=104). Antibiotic treatment was inappropriate in 51.9% patients (n=54). Unnecessary treatment was indicated in 40.7%, with wrong antibiotics chosen in 35.2%, and the posology was incorrect in 24.1% of them. The most frequent diseases with incorrectly prescribed antibiotics were: acute otitis media, episodes of wheezing, fever of unknown origin, acute pharyngo-tonsillitis, and community-acquired pneumonia. CONCLUSION: Antibiotic prescribing seems to be inappropriate in up to half of the patients. These data reinforce the need to develop a paediatric antimicrobial stewardship program to decrease the unnecessary use of antimicrobial agents.
