First-line biologic therapy with tumor necrosis factor inhibitors for psoriatic arthritis: a prospective observational study

ABSTRACT BACKGROUND: Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects multiple joints. It is associated with psoriasis and treated with synthetic and biologic drugs. OBJECTIVE: The objective of this study was to assess the outcomes of patients who received biologic therapy with tumor necrosis factor (TNF) inhibitors in terms of effectiveness, safety, functionality, and quality of life. DESIGN AND SETTING: A prospective observational study was performed at a single center in Belo Horizonte, Brazil. METHODS: Patients with PsA who received their first TNF inhibitor treatment were followed up for 12 months. Disease activity was measured using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Clinical Disease Activity Index (CDAI). Functionality was measured using the Health Questionnaire Assessment (HAQ), and quality of life was evaluated using the European Quality of Life Five Dimensions (EQ-5D). Multiple linear regression was used to identify predictors of the clinical response at 12 months. RESULTS: A total of 143 patients treated with adalimumab or etanercept were evaluated. Most of the clinical measures were significantly improved at 12 months. However, 31%-51% of the patients did not achieve good clinical control. No differences were observed between adalimumab and etanercept, except for poor functionality at 12 months among patients treated with etanercept. The main predictors of a worse clinical response were female sex, etanercept use, poor functionality, or lower quality of life at baseline. The main adverse reactions were alopecia, headache, injection site reaction, sinusitis, flu, dyslipidemia, and infections. CONCLUSION: TNF inhibitor therapy was effective and safe. However, despite improvements in clinical measures, most patients did not achieve satisfactory control of the disease.

Biological therapy in psoriatic arthritis patients with and without previous biologic experience / Terapia biológica em pacientes com artrite psoriásica com e sem experiência prévia no uso de medicamentos biológicos

Objective: this study evaluated the biological therapy effects on disease activity, functionality, quality of life, drug survival, and safety of patients with psoriatic arthritis naïve and experienced in biological therapy. Methods: a one-year prospective observational study was performed. The outcomes assessed were drug survival, disease activity, functionality, quality of life, and safety. Multiple linear regression was used to assess predictive factors for clinical re-sponse. Results: a total of 205 patients were included, 155 of whom were biologic naïve and 50 biologic experienced. Drug survival rate was greater for naïve patients than experienced patients at 6 months, but not at 12 months. Drug survival rates were 71.5% for naïve patients and 70.0% for experienced patients at 12 months. All clinical parameters improved for both biologic naïve and experienced patients. At 12 months, 63% of naïve patients and 52% of expe-rienced patients had an improvement in their quality of life. Besides, 48% of naïve patients and 42% of experienced patients had an improvement in functionality. The axial disease improved in 67% of naïve individuals and 56% of experienced patients. Good control of peripheral disease was achieved by 49% of naïve patients and 44% of experi-enced patients. Female sex, use of etanercept or infliximab, and lower functionality or quality of life at baseline were the main predictors of poor clinical response. Conclusion: Patients' health improved after starting biological therapy. In general, biologic experienced patients had more adverse reactions and lesser effectiveness (AU)

Objetivo: avaliar os efeitos da terapia biológica sobre a atividade da doença, funcionalidade, qualidade de vida, per-sistência no tratamento e segurança em pacientes com artrite psoriásica sem experiência e com experiência prévia em terapia biológica. Métodos: um estudo observacional prospectivo de um ano foi realizado. Os desfechos avaliados foram a persistência no tratamento, atividade da doença, funcionalidade, qualidade de vida e segurança. Um modelo de regressão linear múltipla foi utilizado para avaliar os fatores preditores de resposta clínica. Resultados: foram incluídos 205 pacientes, dos quais 155 não tinham e 50 tinham experiência prévia com medicamentos biológicos. As taxas de persistência no tratamento foram maiores para pacientes sem experiência prévia em comparação aos experientes em seis meses de acompanhamento, mas não em 12 meses. As taxas de persistência no tratamento foram 71,5% em pa-cientes sem experiência prévia e 70% em pacientes com experiência prévia em 12 meses. Todos os desfechos clínicos avaliados melhoraram em ambos os grupos de pacientes. Aos 12 meses, 63% dos pacientes sem experiência prévia e 52% dos pacientes com experiência prévia apresentaram melhora na qualidade de vida. Além disso, 48% dos pacientes sem experiência prévia e 42% dos pacientes com experiência prévia apresentaram melhora na funcionalidade. A do-ença axial melhorou em 67% dos pacientes sem experiência prévia e em 56% dos pacientes com experiência prévia. Um bom controle da doença articular periférica foi observado em 49% dos pacientes sem experiência prévia e em 44% dos pacientes com experiência prévia. Os principais fatores preditores de pior resposta clínica foram sexo feminino, uso de etanercepte ou infliximabe, bem como pior funcionalidade e qualidade de vida no início do estudo. Conclusão:a saúde dos pacientes melhorou após o início do tratamento com os medicamentos biológicos. Em geral, pacientes com experiência prévia com medicamentos biológicos apresentaram mais reações adversas e menor efetividade (AU)

Access to high-cost medications for psoriatic arthritis in the National Health System in Brazil: the long path up to dispensation

Abstract Background: Pharmaceutical Assistance (PA) is a dynamic and multidisciplinary process that aims to supply health systems, programs or services with quality medicines, enabling access and health care, in an efficient and timely manner. The objective of the study was to evaluate the profile of administrative processes for the treatment of PsA, identify the time elapsed in the flow of processes and its associated factors. Methods: A cross-sectional study of medication requests for the treatment of PsA was carried out between November 2014 and December 2016. Linear regression was used to verify the factors associated with time to delivery. Results: A total of 218 cases containing 250 drugs were analyzed. The median time between the medical appointment and the first dispensation was 66 days (interquartile range, 44-90). The State proceedings, which includes requesting the drug until the authorization of treatment, was the stage that most contributed to the total time spent. The factors associated with the longer time to delivery of medications were prescriptions coming from clinics and specialty centers, from dermatologists, non-authorized processes and non-persistent patients in the treatment in 12 months. Conclusion: The median time to receive medicines for the PsA treatment in Belo Horizonte health region after a medical prescription was higher than 2 months. The time between the solicitation of the medicines and the authorization of the treatment in the SUS (State administrative procedure) was the main component of the total time spent.

Uso de medicamentos e fatores associados à polifarmácia em indivíduos com diabetes mellitus em Minas Gerais, Brasil / Drug utilization and factors associated with polypharmacy in individuals with diabetes mellitus in Minas Gerais, Brazil

Resumo O objetivo deste estudo foi avaliar o uso de medicamentos, a prevalência e os fatores associados à polifarmácia em pacientes com diabetes mellitus (DM) em Minas Gerais. Realizou-se um estudo transversal com descrição dos medicamentos em uso e análise da associação entre características sociodemográficas e clínicas com polifarmácia, por meio de regressão logística. Dos 2619 entrevistados, 56,5% estavam em polifarmácia. Medicamentos para DM, agentes no sistema renina-angiotensina e diuréticos foram os mais usados. Fatores como envelhecimento, presença de comorbidades e maior acesso aos serviços de saúde foram associados à polifarmácia. Observou-se elevada prevalência de polifarmácia, o que requer um cuidado adequado e melhor qualidade do uso de medicamentos para essa população.

Abstract The objective of this study was to evaluate the use of drugs and the factors associated with polypharmacy in patients with diabetes mellitus (DM) in Minas Gerais. Descriptive analysis of drugs in use and logistic regression to estimate the association between socio-demographic and clinical characteristics with polypharmacy were performed. Of the 2619 respondents, 56.5% were in polypharmacy. Drugs for DM, agent in renin-angiotensin system, and diuretics are the most frequently used. Factors such as age, comorbidities and increased access to health services were associated with polypharmacy. It was observed high prevalence of polypharmacy, which requires a suitable care and better quality of drug use in this population.

Perfil dos usuários com doenças reumáticas e fatores associados à qualidade de vida no sistema único de saúde, Brasil / Profile of users with rheumatic diseases and factors associated with the quality of life in the National Health System, Brazi

INTRODUÇÃO: Doenças reumáticas (DR) compreendem algumas das doenças mais antigas e incapacitantes da prática clínica, acarretando um considerável impacto na vida dos acometidos. OBJETIVOS: Traçar o perfil dos usuários do SUS com DR e identificar os fatores associados à qualidade de vida (QV) no Sistema Único de Saúde (SUS) do Brasil. MÉTODOS: Por meio da Pesquisa Nacional Sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM), os usuários do SUS com DR foram identificados. Realizou-se análise descritiva das variáveis sociodemográficas e clínicas. QV foi avaliada pelo EuroQol 5 dimensions (Eq-5D), sendo os fatores associados à ela identificados por regressão linear multivariada. RESULTADOS: Dentre os entrevistados, 1632 (19,1%) tinham DR, sendo a maior parte mulheres (81,6%), com mais de 40 anos (90,9%), casados ou em união estável (63,1%), pertencentes à classe econômica C (55,6%) e sem plano de saúde (87,7%). Além disso, 60% apresentavam três doenças crônicas, 92,2% utilizavam medicamentos, 49,5% avaliavam seu estado de saúde como nem ruim e nem bom. O escore médio de QV foi 0,660. Os fatores associados à pior QV foram ter idade entre 40 e 59 anos, residir na região Sul, relatar AVC e/ou depressão, estar em uso de cinco medicamentos ou mais, realizar dieta para perder peso e declarar estado de saúde ruim ou muito ruim. CONCLUSÃO: Compreender a perspectiva do usuário com DR ajuda o profissional de saúde a atingir o paciente de forma eficiente nas suas orientações, na forma de abordagem e nas ações educativas.(AU)

Introduction: Rheumatic diseases (RD) comprise one of the oldest and most disabling diseases in clinical practice, with a considerable impact on the lives of those affected. Objectives: To outline the profile of SUS users with DR and to identify associated factors with quality of life (QoL) in the Brazilian Unified Health System (SUS). Methods: Through the National Survey on Access, Use and Promotion of Rational Use of Medicines (PNAUM), SUSs users with RD were identified. A descriptive analysis of sociodemographic and clinical variables was performed. QoL was evaluated by EuroQol 5 dimensions (Eq-5D), and factors associated with it were identified by multivariate linear regression. Results: Among interviewees, 1632 (19.1%) had RD, with the majority of women (81.6%), over 40 years old (90.9%), married or in a stable union (63.1%), belonging to economy class C (55.6%) and without health insurance (87.7%). In addition, 60% had three chronic diseases, 92.2% used medicines, 49.5% evaluated their health status as neither bad nor good. The mean QoL score was 0.660. Factors associated with worse QoL were between 40 and 59 years of age, living in the southern region, reporting stroke and/or depression, being in use of five medications or more, performing a diet to lose weight and declaring poor or very poor health. Conclusion: Understanding the perspective of the user with RD helps the health professional to reach the patient in an efficient way in his orientations, in the form of approach and in the educational actions. (AU)