RESUMO
OBJECTIVE: Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint destruction. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. This post hoc analysis assessed the safety of tofacitinib in Latin American (LA) patients with RA versus the Rest of World (RoW) population. METHODS: Data were pooled from 14 clinical studies of tofacitinib: six Phase 2, six Phase 3 and two long-term extension studies. Incidence rates (IRs; patients with events/100 patient-years of treatment exposure) were calculated for safety events of special interest combined across tofacitinib doses. 95% confidence intervals (CI) for IRs were calculated using the maximum likelihood method. Descriptive comparisons were made between LA and RoW (excluding LA) populations. RESULTS: This analysis included data from 984 LA patients and 4687 RoW patients. IRs for safety events of special interest were generally similar between LA and RoW populations, with overlapping 95% CIs. IRs for discontinuation due to adverse events, serious infections, tuberculosis, all herpes zoster (HZ), serious HZ, malignancies (excluding non-melanoma skin cancer) and major adverse cardiovascular events were numerically lower for LA versus RoW patients; IR for mortality was numerically higher. No lymphoma was reported in the LA population versus eight cases in the RoW population. Exposure (extent and length) was lower in the LA population (2148.33 patient-years [mean = 2.18 years]) versus RoW (10515.68 patient-years [mean = 2.24 years]). CONCLUSION: This analysis of pooled data from clinical studies of tofacitinib in patients with RA demonstrates that tofacitinib has a consistent safety profile across LA and RoW patient populations.
Assuntos
Artrite Reumatoide , Piperidinas , Pirimidinas , Pirróis , Adulto , Idoso , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Ensaios Clínicos como Assunto , Relação Dose-Resposta a Droga , Monitoramento de Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Incidência , Inibidores de Janus Quinases/administração & dosagem , Inibidores de Janus Quinases/efeitos adversos , América Latina/epidemiologia , Efeitos Adversos de Longa Duração/epidemiologia , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Piperidinas/administração & dosagem , Piperidinas/efeitos adversos , Pirimidinas/administração & dosagem , Pirimidinas/efeitos adversos , Pirróis/administração & dosagem , Pirróis/efeitos adversos , Resultado do TratamentoRESUMO
Introducción: El objetivo principal fue comparar la actividad clínico-quirúrgica de nuestro Servicio de Ortopedia y Traumatología antes de la instauración del plan de contingencia frente a la pandemia de la COVID-19 y durante este, un aspecto relevante para establecer antecedentes que permitan guiar nuestro desempeño ante la segunda ola de casos y futuras contingencias semejantes. materiales y métodos: Estudio analítico observacional longitudinal ambispectivo de los pacientes atendidos en el Servicio de Ortopedia y Traumatología de un hospital del sistema público de la Ciudad Autónoma de Buenos Aires, durante el plan de contingencia frente a la pandemia de la COVID-19. Como variable de resultado primaria se valoró el número total de cirugías realizadas durante el período de estudio. Resultados: La pandemia se asoció con menos cirugías totales (p = 0,002), de Guardia (p = 0,000) y de Planta (p = 0,002). Las cirugías totales se redujeron un 81,5%. Las cirugías de urgencia representaron el 97%, diferencia significativa con el período fuera de la pandemia (p = 0,080). Además, el promedio de cirugías por día quirúrgico disponible fue significativamente menor (p = 0,000). Conclusiones: Creemos que la atención de la enfermedad ortopédica y el trauma musculoesquelético, adaptada a las obligaciones indicadas por el plan nacional y regional de contingencia frente a la pandemia, fue notoriamente menor que nuestro desempeño habitual. Si bien respondimos adecuadamente a las urgencias de nuestra especialidad queda pendiente la posibilidad de estratificar y considerar tipos de pacientes con cuadros pasibles de ser tratados, en forma gradual, durante la pandemia. Nivel de Evidencia: IV
Introduction: Our aim was to compare our activity in the Orthopedics and Traumatology service during the first wave of the COVID-19 pandemic. materials and methods: Ambispective longitudinal observational analytical study of patients treated in the Orthopedics and Traumatology Service of a public health hospital of Buenos Aires during the first wave of the COVID-19 pandemic. The primary outcome variable was the total number of surgeries performed during the study period. Results: The pandemic was associated with fewer total surgeries (p = 0.002), emergency department surgeries (p = 0.000) and elective surgeries (p = 0.002). Total surgeries were reduced by 81.5%. Emergency surgeries accounted for 97%, a significant difference with the non-pandemic period (p = 0.080). Additionally, the average number of surgeries per available surgical day was significantly lower (p = 0.000). Conclusions: We believe that, under the regulations indicated by the national and regional pandemic contingency plan, the care of orthopedic pathology and musculoskeletal trauma was notoriously lower than our usual performance. Although we responded adequately to the emergencies of our specialty, the possibility of stratifying and considering types of patients with conditions that could be treated gradually during the pandemic remains pending. Level of Evidence: IV
Assuntos
Ortopedia/organização & administração , Ortopedia/estatística & dados numéricos , Pandemias , COVID-19RESUMO
La Artritis Reumatoide (AR) tiene adversas consecuencias en la salud su diagnóstico temprano y manejo óptimo requiere recomendaciones basadas en evidencia de alta calidad adaptadas a cada sistema de salud. Objetivo: Proveer recomendaciones clínicas basadas en evidencia para el diagnóstico y manejo inicial de la AR. Material y Métodos: Se conformó un grupo elaborador de la guía (GEG) que incluyó médicos especialistas y metodólogos. El GEG formuló 10 preguntas clínicas a ser respondidas por la presente GPC. Se realizaron búsquedas sistemáticas de la evidencia publicada en PubMed y CENTRAL entre diciembre 2017 a julio 2019 (revisiones sistemáticas y cuando fue considerado pertinente estudios primarios). Se seleccionó la evidencia de mayor calidad para responder cada una de las preguntas clínicas planteadas. La certeza de la evidencia fue evaluada usando la metodología Grading of Recommendations Assessment, Development, and Evaluation (GRADE) y en reuniones de trabajo periódicas, el GEG usó dicha metodología para revisar la evidencia y formular las recomendaciones, los puntos de buena práctica clínica y los flujogramas. Finalmente, la GPC fue aprobada con Resolución N° 132 IETSI ESSALUD 2019. Resultados: La presente GPC abordó 10 preguntas clínicas, divididas en dos temas: diagnóstico y manejo. En base a dichas preguntas se formularon 16 recomendaciones (5 fuertes y 11 condicionales), 45 puntos de buena práctica clínica, y 3 flujogramas. Conclusión: El presente artículo resume la metodología y las conclusiones basadas en evidencias de la GPC para el diagnóstico y manejo inicial de la AR en EsSalud.
Rheumatoid arthritis (RA) has adverse health consequences its early diagnosis and optimal management requires high quality evidence-based recommendations tailored to each health system. Objective: To provide evidence-based clinical recommendations for the diagnosis and initial management of RA. Material and Methods: A guideline development group (GDG) was formed that included medical specialists and methodologists. The GEG formulated 10 clinical questions to be answered by this CPG. Systematic searches of the evidence published in PubMed and CENTRAL were performed between December 2017 and July 2019 (systematic reviews and -when considered relevant- primary studies). The highest quality evidence was selected to answer each of the clinical questions posed. The certainty of the evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, and in periodic working meetings, the GEG used this methodology to review the evidence and formulate the recommendations, good clinical practice points, and flowcharts. Finally, the CPG was approved by Resolution No. 132 - IETSI - ESSALUD - 2019. Results: This CPG addressed 10 clinical questions, divided into two topics: diagnosis and management. Based on these questions, 16 recommendations (5 strong and 11 conditional), 45 points of good clinical practice, and 3 flowcharts were formulated. Conclusion: This article summarizes the methodology and evidence-based conclusions of the CPG for the diagnosis and initial management of RA in EsSalud.