Treatment of psoriatic arthritis with anti-TNF agents: a systematic review and meta-analysis of efficacy, effectiveness and safety.

We did a systematic review and meta-analysis on the efficacy and safety of the anti-TNF drugs adalimumab, etanercept, golimumab and infliximab used in psoriatic arthritis (PsA) adult treatment. Additionally, we present results of anti-TNF use in real life settings. We searched Embase, Medline, Cochrane Central and LILACS, from inception to 11/08/2013, for studies comparing anti-TNFs with each other or with controls. We included nine randomized controlled trials and six observational studies. ACR20, ACR50, PsARC and PASI75 responses were achieved by more users of anti-TNF than control after up to 24 weeks of treatment. More participants who used etanercept and infliximab achieved ACR70. After all patients originally randomized to anti-TNF or placebo had used anti-TNF for at least 24 weeks, we observed difference only with regard to ACR70 response. Radiographic end points were achieved by more patients in anti-TNF group, and they seem to be time dependent-the longer patients use the drug the better the results. Etanercept and infliximab had worse results on application site reactions, but in general anti-TNF drugs in the regimens studied were as safe as control/placebo. There seems to be no difference in efficacy and effectiveness among anti-TNFs, but superiority head-to-head studies are still needed. Meanwhile, other factors should be taken into account in the choice of medication, such as costs and patient convenience.

Survival Analysis of COPD Patients in a 13-Year Nationwide Cohort Study of the Brazilian National Health System.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) has an appreciable socioeconomical impact in low- and middle-income countries, but most epidemiological data originate from high-income countries. For this reason, it is especially important to understand survival and factors associated with survival in COPD patients in these countries. OBJECTIVE: To assess survival of COPD patients in Brazil, to identify risk factors associated with overall survival, including treatment options funded by the Brazilian National Health System (SUS). METHODOLOGY: We built a retrospective cohort study of patients dispensed COPD treatment in SUS, from 2003 to 2015 using a National Database created from the record linkage of administrative databases. We further matched patients 1:1 based on sex, age and year of entry to assess the effect of the medicines on patient survival. We used the Kaplan-Meier method to estimate overall survival of patients, and Cox's model of proportional risks to assess risk factors. RESULT: Thirty seven thousand and nine hundred and thirty eight patients were included. Patient's survival rates at 1 and 10 years were 97.6% (CI 95% 97.4-97.8) and 83.1% (CI 95% 81.9-84.3), respectively. The multivariate analysis showed that male patients, over 65 years old and underweight had an increased risk of death. Therapeutic regimens containing a bronchodilator in a free dose along with a fixed-dose combination of corticosteroid and bronchodilator seem to be a protective factor when compared to other regimens. CONCLUSION: Our findings contribute to the knowledge of COPD patients' profile, survival rate and related risk factors, providing new evidence that supports the debate about pharmacological therapy and healthcare of these patients.

Decentralisation of leprosy control activities in the municipality of Betim, Minas Gerais State, Brazil.

OBJECTIVES: The present study aims at evaluating the decentralisation of the leprosy control activities in the municipality of Betim, Minas Gerais, Brazil. DESIGN: A quantitative study was undertaken using data from SINAN (Sistema Nacional de Agravos de Notificação) and patient records. The study included 435 new cases registered and living in Betim. The pre (1995-2000) and post (2001-2005) decentralisation periods were compared using the chi-square test. Besides this, units which already had leprosy control activities were compared to those which implemented them from 2001 on. RESULTS: There was a decrease in the percentage of cases diagnosed with deformities after decentralisation, as well as an increase in the number of cases detected through self-reporting. More patients were notified closer to home after decentralisation. The selected indicators did not show any difference between the quality of assistance regarding prevention of disabilities when comparing health units which already had leprosy activities to those which implemented them from 2001 onwards. CONCLUSIONS: Decentralisation, in Betim, did not lead to an increase in the number of cases, but led to earlier diagnosis and patients being treated closer to their homes. The study did not show evidence of decrease in the quality of care after decentralisation.

Factors which influenced the decentralisation of leprosy control activities in the municipality of Betim, Minas Gerais State, Brazil.

UNLABELLED: This is the second part of a study conducted to evaluate the decentralisation of leprosy control activities in Betim, Minas Gerais, Brazil. OBJECTIVES: To identify factors which hindered or facilitated the decentralisation of leprosy control activities in Betim municipality and to evaluate the quality of care after decentralisation. DESIGN: The study comprised a 2 1/2 hour focus group discussion with 10 professionals who participated in the decentralisation process. The group included health service managers and professionals from different backgrounds and types of health services involved in leprosy control. RESULTS: The following factors were identified as having hindered decentralisation: staff attitude, lack of staff training, stigma and health system organisation and management. The facilitating factors were: staff training in Betim, existence of a Municipal Reference Centre. The group considered that quality of care improved after decentralisation. CONCLUSIONS: The problems identified cannot be addressed with simple, immediate solutions. They require coordination with partners both within and outside the municipal health secretariat. Ongoing staff training is essential and should be done using existing expertise in the municipality. An easily accessible reference centre is important as a place for training and backup for newly trained professionals.

Sixteen-Year Cohort of Liver Transplantation in the National Health System in Brazil: Analysis of Immunosuppression Maintenance Therapies.

OBJECTIVE: To evaluate factors related to liver graft survival with a focus on immunosuppressive schemes based on calcineurin inhibitors (tacrolimus or cyclosporine). METHODOLOGY: This study was carried out through an open cohort constructed by deterministic and probabilistic matching through three databases of the SUS with assessment of liver graft survival from 2000 to 2015 in Brazil. From this first cohort, a second cohort was constructed by pairing 1: 1 to more precisely assess the effect of the immunosuppressive scheme on graft survival. The Kaplan-Meier method and was used to estimate the probability of survival. Cox's model of proportional risks was used to assess factors related to graft loss. RESULT: We found 12,687 patients in the Full cohort and 470 patients in the Matched cohort. The overall graft survival rates at 1, 5, 10, and 16 years were 72.6, 63.3, 52.8, and 45.3%, respectively. Patients younger had a longer graft survival than older ones. In the Full cohort, male patients had a higher survival rate than female ones. Therapeutic schemes based on tacrolimus were more prevalent and had a better survival rate when compared to schemes that used cyclosporine. Tacrolimus without association with antiproliferative agents or rapamycin inhibitors was the therapeutic scheme associated with greater survival rate in both cohorts (HR = 0.81, 95% CI = 0.72-0.91), (HR = 0.50, 95% CI = 0.30-0.85). In addition, white-skinned patients had longer survival rate in both cohorts (HR = 0.55, 95% CI = 0.50-0.61 and HR = 0.50, 95% CI = 0.34-0.75). On the other hand, patients who a greater time ratio without using an immunosuppressant had lower graft survival rate (HR = 6.46, 95% CI = 5.05-8.27 and HR = 6.57, 95% CI = 2.66-16.22). CONCLUSION: This 16-year cohort showed that the older age and the greater time ratio without using an immunosuppressant are risk factors for liver graft loss. White-skinned patients and tacrolimus-based regimens, especially tacrolimus without other immunosuppressants, are factors of better prognosis to the graft.

Drug-drug interactions associated with length of stay and cost of hospitalization.

PURPOSE: To evaluate the prevalence of drug-drug interactions (DDI) in prescriptions of hospitalized patients and to identify risk factors associated. METHODS: A retrospective cross-sectional analysis of prescription data and medical records from a public hospital in Brazil was conducted to identify potential DDI. An inappropriate drug combination was identified and classified with a standard drug interaction source. The main diagnoses were classified with Charlson Comorbidity Index (CCI). Sex, age, polypharmacy and length of stay, among other variables, were correlated with the frequency of potential DDI. RESULTS: The study included 589 patients and 3,585 prescriptions. Thirty-seven percent of the patients were exposed to at least one potential interaction during their stay in the hospital. The most frequent interacting pair was Digoxin+Furosemide (11%). In univariate analysis, several variables were associated with DDI, including sex, age, number of prescribed drugs, length and cost of hospitalization and CCI. Multivariate analysis showed that the adjusted odds of being prescribed a potential DDI among patients in polypharmacy was almost five-fold that of patients taking less than five drugs. Further, length of stay, CCI and cost of hospitalization were independently associated with DDI. CONCLUSION: Analysis of prescription data found that a substantial number of potential DDI were identified. Results of this study indicate that DDI is associated with number of prescribed drugs, increased duration of stay in the hospital and cost, which suggest that DDI are a significant clinical and economic problem. Potential damage to patients could be avoided.

Building the National Database of Health Centred on the Individual: Administrative and Epidemiological Record Linkage - Brazil, 2000-2015.

INTRODUCTION: In Brazil, the National Health System (SUS) provides healthcare to the public. The system has multiple administrative databases; the major databases record hospital (SIH) and outpatient (SIA) procedures. Epidemiological information is collected for all populations in subsystems, such as mortality (SIM), live births (SINASC) and diseases of compulsory declaration (SINAN). Each subsystem has its own information system, which is able to provide information about consultations, clinical information and medicines dispensed. However, these systems are not linked, thereby preventing individual-centred analysis. OBJECTIVE: To describe the methods and results of parameter setting that are needed to execute the probabilistic deduplication of large administrative and epidemiological databases in Brazil and to create a National Health Database Centred on the individual. METHODS: This paper shows the results of a record linkage model to integrate data from SIH, SIA, SIM, and SINAN, which have different formats and attributes between them and over time. These data consist of 1.3 billion records from 2000-2015. Probabilistic and deterministic record linkages were used to deduplicate these data. The Kappa statistic and clerical review were used to ensure the quality of the linkage. The graph algorithm and depth-first search were used to generate the identifiers. RESULTS: The deterministic deduplication process resulted in a database with 403,113,527 possible unique individuals. After the probabilistic deduplication process of the former database was performed, 159,703,805 unique individuals were identified. This result had an estimated a false positive error rate of 3.3%, and the false negative error was estimated at 12.3%. CONCLUSIONS: The National Health Database centred on the individual was generated and will allow researchers to use real-world evidence to conduct clinical, epidemiological, economic and other studies. This database represents a significant cohort, spanning 15 years of historical data and preserving patient privacy. The success of the process described will allow repeating and appending the data for future years and enable important studies to promote SUS efficiency and provide better treatments for patients.

Ten-year kidney transplant survival of cyclosporine- or tacrolimus-treated patients in Brazil.

BACKGROUND: Cyclosporine and tacrolimus are well established immunosuppressants; however little is known about long term survival rates. The project aim was to compare 10-year graft survival and associated factors among kidney transplant patients within the Brazilian Public Health System (SUS) prescribed either immunosuppressant. METHODS: Analyze a national cohort of kidney transplant recipients within SUS. Graft loss defined by death or dialysis for more than three months. Kaplan-Meier method used to estimate cumulative probabilities of survival. Cox proportional hazards model used to evaluate factors associated with progression to graft loss. RESULTS: 13,811 patients were included, 5,887 used cyclosporine and 7,924 tacrolimus. A higher risk of graft loss was associated with tacrolimus, a deceased donor, additional years of age, median period of dialysis greater than 47 months, diagnosis of diabetes as the primary cause of chronic kidney disease and transplantation between 2005 and 2009. CONCLUSIONS: Among other factors, tacrolimus-based regimens were associated with worse graft survival.

Poorer functionality is related to better quality of life response following the use of biological drugs: 6-month outcomes in a prospective cohort from the Public Health System (Sistema Único de Saúde), Minas Gerais, Brazil.

We aim to analyze factors associated with the quality of life (QOL) response of individuals with rheumatic diseases treated by the Public Health System (Sistema Único de Saúde) with biological disease-modifying antirheumatic drugs (bDMARDs). Data from 428 patients using bDMARDs were collected using a standardized form at baseline and 6 months after the onset of treatment. The average reduction of the scores on EuroQol-five dimension was 0.11 ± 0.18 6 months after the onset of treatment with bDMARDs, denoting significant improvement of the participants' QOL. All the investigated types of disease exhibited significant improvement at the 6-month assessment, without any difference among them (p = 0.965). The participants with baseline poorest functionality and best QOL exhibited the best QOL outcomes after 6 months of treatment. Our study showed that the use of biological drugs induced considerable improvement in the participants' QOL.

Profile of patients with rheumatic diseases undergoing treatment with anti-TNF agents in the Brazilian Public Health System (SUS), Belo Horizonte - MG

The aim of this study was to describe the baseline demographic and clinical characteristics as well as the functional status of a prospective cohort of patients with rheumatic diseases assisted by the Brazilian Public Health System (SUS). Data for 302 patients receiving tumor necrosis factor α inhibitors (anti-TNF agents) was collected through a standard form. Among patients, 229 (75.8%) were female and 155 (51.3%) were Caucasian; the mean age was 50.3 ± 12.8 years, and the mean disease duration was 9.9 ± 8.7 years. Among them 214 patients (70.9%) received adalimumab, 72 (23.8%) etanercept, and 16 (5.3%) infliximab. Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) was 1.37 ± 0.67 for all participants. Poor functional response was associated with female gender, married patients and with a score of < 0.6 on the EuroQoL-5 dimensions (EQ-5D). Significant correlation was found between the HAQ-DI values, disease activity and quality of life (QOL). The results obtained in this study contribute to a better understanding of the clinical and demographic characteristics of patients with rheumatic diseases at the beginning of anti-TNF-agent treatment by SUS. Furthermore, our findings are consistent with another Brazilian and foreign cross-sectional investigations. This knowledge can be of great importance for further studies evaluating the effectiveness of biological agents, as well as, to contribute to improve the well-being of the patients with rheumatic diseases.

O objetivo do estudo foi descrever as características demográficas e clínicas iniciais, bem como o estado funcional de uma coorte de pacientes com doenças reumáticas tratados pelo Sistema Único de Saúde (SUS). Dados de 302 pacientes em uso de inibidores do fator de necrose tumoral (agentes anti-TNF) foram coletados por formulário padronizado. Desses, 229 (75.8%) eram mulheres e 155 (51.3%) eram brancos; a idade média foi 50,3 ± 12,8 anos, e a duração média da doença foi de 9,9 ± 8,7 anos. Entre os pacientes 214 (70,9%) usaram adalimumabe, 72 (23,8%) etanercepte e 16 (5,3%) infliximabe. A média do Health Assessment Questionnaire-Disability Index (HAQ-DI) foi 1,37 ± 0,67 para a população total. Pior resposta funcional estava associada com mulheres, pacientes casados e com um valor de EuroQoL-5 dimensions (EQ-5D) < 0.6. Correlação significativa foi obtida entre os valores de HAQ-DI, atividade das doenças e qualidade de vida. Os resultados obtidos no estudo contribuem para o melhor entendimento das características clínicas e demográficas de pacientes com doenças reumáticas iniciando a terapia com agentes anti-TNF pelo SUS. Além disso, nossos achados são consistentes com resultados obtidos em outros estudos transversais nacionais e estrangeiros. Este conhecimento pode ser de grande importância para estudos futuros que avaliem a eficácia de agentes biológicos, assim como, para contribuir para a melhoria do bem-estar das pessoas com doenças reumáticas.