Avaliação do uso de terapias biológicas em pacientes com artrite reumatoide no Estado de Mato Grosso, Brasil
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2012-08-09
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Universidade Federal de Goiás
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RA is debilitating autoimmune disease with serious physical, emotional and economic consequences, which affects about 0.5 to 1% of the adult population worldwide. Significant advances in the recognition of the pathophysiology of disease and injury mechanisms allowed the development of new treatment options with drugs that block inflammatory mediators involved in the mechanism of the disease, known as biologics. These drugs are expensive and of continuous use. They are complex to use due care and management of storage and the risk of immediate and delayed adverse reactions. These therapies are available at the Health System for 12 years, is necessary to evaluate the effectiveness of this drug group in the Brazilian public health system in the treatment of rheumatoid arthritis. OBJECTIVES: a) analyze the effectiveness of biological therapies in patients with rheumatoid arthritis of the State of Mato Grosso, through the assessment of disease activity index DAS28-ESR b) Review the laboratory characteristics of these patients; c) examine the safe use these therapies and to describe adverse events. d) analyze the efficiency of the program dispensing of biological therapies in the State of Mato Grosso, Brazil. METHODS: Two groups of patients with rheumatoid arthritis users Pharmacy High Cost of the State Secretariat of Health of Mato Grosso (FAC / SES) or the University General Hospital. Group I included 68 patients who were already in use of biological therapies. These were assessed for disease activity at the time of inclusion in the study and asked about the historical use of biological drugs, satisfaction with access to treatment and adverse events. Laboratory tests prior to treatment were obtained retrospectively. In group II were enrolled and followed prospectively for 24 weeks, 30 patients with early use of biologic therapies. They were evaluated at baseline and at weeks 4, 8, 12 and 24, the disease activity by DAS28-ESR, laboratory tests, satisfaction with access to treatment and adverse events. RESULTS: The groups were similar in demographic characteristics and laboratory related to rheumatoid arthritis. In group I, 80.6% of patients expressed satisfaction with the care of the FAC / SES. The average use of biological was 12.3 months, and 20.9% (14/68) reported an adverse event, all non-serious. The first medication was discontinued in 26.5% (18/68) of patients, 55.6% (10/18) for loss of efficacy and 22.2% (4/18) adverse events. The mean value of DAS28-ESR was 3.8, and 41.2% were in remission or low disease activity, 39,7% in moderate activity and 19,1% in intense activity. In group II, 91.7% of patients expressed satisfaction with the care provided by FAC / SES. Laboratory evaluation was significant change in the conversion of ANA from 13.3% to 23.3% and anti-DNA (ds), 0 to 6.7%, but no clinical significance. The anti-CCP (2) remained positive and stable at 63.3%. There was an adverse reaction in 23% (7/30) of patients. The only suspension of the first plants were by no severe adverse event (hypersensitivity). Following the DAS28-ESR was a significant reduction in the initial mean value of 4.3 to 3.3 (p = 0.002) after 24 weeks of treatment, 60% of patients were in remission or low disease activity, 23, 3% in moderate activity and 16.7% in intense activity. The average value of ESR-DAS28 after use of the biologic group II was significantly lower than in group I (p= 0.042). CONCLUSIONS: 1) Treatment with biologic therapies in the State of Mato Grosso was effective in prospective group. The response in DAS28-ESR was significantly better in the group where the monitoring and control has been programmed with a routine test and calculate the index of disease activity were used. 2) Among the laboratory characteristics were significant conversion in the profile of autoantibodies, confirming the potential immunogenicity of these drugs inducing the formation of autoantibodies, but no clinical significance in the study group. The anti-CCP remained stable in 63% of patients (group II). 3) Biological therapies were safe. There were no serious adverse events reported. There were no reports of infection or death. The most common reason for discontinuation of the first was the loss of biological effectiveness. 4) Patients with rheumatoid arthritis in the use of biologic therapies in the State of Mato Grosso showed satisfaction with the services offered by SES / MT and the majority of users in the metropolitan area of Cuiabá. The program dispensing biological therapies showed higher efficiency when linked to a reference center for this particular type of treatment.
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FERNANDES, Vander. Evaluation of the use of biologic therapies in patients with rheumatoid arthritis in the State of Mato Grosso, Brazil. 2012. 85 f. Tese (Doutorado em Ciencias da Saude) - Universidade Federal de Goiás, Goiânia, 2012.