Intravenous tocilizumab in the management of rheumatoid arthritis: Clinical practice findings from a 6-month international, multicentre, observational study in Central America and the Caribbean / El tocilizumab intravenoso en el tratamiento de la artritis reumatoide: resultados de la práctica clínica de un estudio internacional, multicéntrico y observacional de 6 meses de duración en América Central y el Caribe

ABSTRACT Tocilizumab (TCZ), an 1interieukin-6 receptor-α Inhibitor, is Indicated in patients with moderate to severe rheumatoid arthritis with inadequate response to disease modifying drugs. ACT UP is a multinational project co11ecting information from severa1 post-marketing TCZ studies. Aim: To determine the proportion of patients in the routine clinical care setting receiving intravenous TCZ after 6 months treatment. Identification of TCZ treatment patterns, efficacy, and safety were also recorded. Method: This prospective non-interventional 6-month study, collected real-world information from 169 Central American and Caribbean patients. No interventional procedures or additional visits outside routine clinical care practice were performed. Statistical analysis was essentially descriptive. Results: Adherence rate was 74.0%, with 97% of patients receiving TCZ as first biological therapy line and there were no deviations from the local label. Almost 85% of patients started with combination therapy, and the majority remained under this scheme throughout the study. A significant decrease in disease activity assessments and acute phase reactants values were detected during TCZ treatment. The percentage of patients that achieved improvement according to the different levels of the American College of Rheumatology (ACR) increased during the study, and relevant enhancements in quality of life were also accomplished. Adverse events (AEs) occurred in 35 patients, with metabolic and nutritional disorders being the most common. Serious AEs were reported in 3% of patients, and special interest AEs occurred in 6 patients. Conclusion: Treatment adherence was mainly determined by follow-up and compliance with the administration schedule. Efficacy analysis showed better results than those reported in international literature. The incidence of AEs was also lower than in previously published data.

RESUMEN El tocilizumab (TCZ) está indicado en la artritis reumatoide moderada a severa, principalmente en respuestas inadecuadas a fármacos convencionales. ACT UP es un proyecto multinacional que recopila información relacionada con varios estudios de poscomercialización. Objetivo: Determinar la proporción de pacientes en la atención clínica de rutina que continúan en tratamiento con TCZ intravenoso después de 6 meses. Se llevó a cabo la identificación de patrones de administración, eficacia y seguridad. Método: Este estudio observacional prospectivo recopiló información de la vida real de 169 pacientes de América Central y el Caribe. No se hicieron intervenciones ni visitas adicionales fuera de la práctica clínica habitual. El análisis estadístico fue esencialmente descriptivo. Resultados: La tasa de adherencia al tratamiento fue del 74,0%, el 97% de los pacientes reci bieron TCZ como primera línea biológica y no existieron desviaciones en las indicaciones de administración según el inserto local. Aproximadamente el 85% de los pacientes inició TCZ como terapia combinada, y la mayoría permaneció bajo este esquema. Se evidenció una dis minución en la actividad de la enfermedad y un aumento en el porcentaje de pacientes que lograron respuesta según los diferentes grados del Colegio Americano de Reumatología. En 35 pacientes se presentaron eventos adversos (EA), siendo los relacionados con metabolismo y nutrición los más comunes. Se informaron EA graves en el 3% de los pacientes y de interés especial en 6 casos. Conclusión: El seguimiento de los pacientes y el cumplimiento del programa fueron los prin cipales determinantes en la adherencia. El análisis de eficacia mostró mejores resultados que los reportados previamente y la incidencia de EA fue menor que en otros estudios.

Metastatic non-small cell lung cancer in Brazil: treatment heterogeneity in routine clinical practice

ABSTRACT: Lung cancer is one of the main causes of cancer related deaths. Approximately three quarters of these tumors are non-small cell carcinomas. When diagnosed the majority of patients show the disease locally advanced or metastatic. The chemotherapy is the chosen therapy for patients with advanced lung cancer. The majority of published studies with chemotherapy are performed in academic centers under a strict control of research protocols. PURPOSE: The aim of this study is to evaluate the usual management of metastatic NSCLC patients outside of a clinical trial setting in three different oncologic centers in Brazil. METHODS: This is a retrospective study of patients with metastatic non-small cell lung cancer admitted for treatment in three different Cancer Centers in Brazil. 564 patients from Brazilian public heath system and private/health insurance system were considered for the present study. RESULTS: Among 564 patients in this study, 335 (59.4 percent) received chemotherapy. For all patients, 47 different regimens of chemotherapy were identified. The median follow-up time was eight months and the overall median survival of all patient population submitted to chemotherapy was 9.7 months. DISCUSSION: There was a great heterogeneity in the regimens of drugs to treat metastatic NSCLC patients. The overall survival was significantly better for patients treated with first line chemotherapy compared to patients that only received best supportive care. Results of prospective randomized clinical trials should be carefully analyzed before transferred to the daily clinical practice.

INTRODUÇÃO: O câncer de pulmão é uma das principais causas de morte relacionadas ao câncer. Aproximadamente três quartos destes tumores são carcinoma não pequenas células. Ao diagnóstico, a maioria dos pacientes se apresenta com doença avançada localmente ou metastática. A quimioterapia é o tratamento de escolha para pacientes com câncer de pulmão em estadiamento avançado. A maioria dos estudos publicados com quimioterapia é realizada em centros acadêmicos sob controle rígido de protocolos de pesquisa. OBJETIVO: O objetivo deste estudo é avaliar os resultados do tratamento rotineiro de pacientes com carcinoma de pulmão não pequenas células metastático, fora de protocolos de pesquisa clínica em três centros oncológicos brasileiros. MÉTODO: Trata-se de um estudo retrospectivo de pacientes com câncer de pulmão não pequenas células metastático, admitidos para tratamento em três diferentes centros oncológicos no Brasil. Foram avaliados 564 pacientes neste estudo provenientes do sistema de saúde público e privado. RESULTADOS: Dentre os 564 pacientes deste estudo, 335 (59,4 por cento) receberam quimioterapia. Considerando todos os pacientes, foram identificados 47 esquemas diferentes de quimioterapia. O tempo médio de seguimento foi de oito meses e a sobrevida global mediana de todos os pacientes submetidos à quimioterapia foi de 9,7 meses. DISCUSSÃO: Havia uma grande heterogeneidade de esquemas de drogas para o tratamento de pacientes com câncer de pulmão não pequenas células metastático. A sobrevida global foi significativamente melhor para pacientes tratados com quimioterapia de primeira linha comparado com pacientes que receberam somente tratamento de suporte clínico. Resultados de estudos clínicos prospectivos randomizados deverão ser cuidadosamente analisados antes de serem transferidos para a prática clínica diária.