Impacto do uso de natalizumabe em pacientes com esclerose múltipla

Abstract

Introduction: The therapeutic scenario for multiple sclerosis has undergone numerous changes in the last decade. Currently, the tendency is to treat the patient early with highly effective therapy, as these are beneficial in controlling disease activity and crucial to prevent progressive disability. Natalizumab is one of the highly effective drugs and has been linked to benefits in high-activity diseases despite safety observations. Objective: Analyze the impact of using natalizumab Methodology: Observational, prospective and longitudinal study, in patients assisted by the Specialized Component of Pharmaceutical Assistance program in Mato Grosso do Sul, undergoing treatment with natalizumab. Data was collected for two years with interviews and consultation of medical health records every six months. The studies evaluated were the effectiveness of medications on clinical and radiological parameters of the disease; adherence by checking the reason for possession of medications and the Morisky-Green Test; satisfaction by the Questionnaire on Satisfaction with Drug Treatment©, quality of life by the MSQOL-54; safety and discontinuation of drug treatment after two years of follow-up. The database and statistical analyzes were performed using the statistical program SPSS (Statistic Package for Social Sciences, version 22.0 for Windows) and PRISM (GraphPad Software, version 5.01 for Windows). Results: Sixty-two patients were included, with a mean age of 34.97 ± 9.32 years (95% CI 32.60-37.34), between 19 and 62 years old, 72.6% (45) female, 56.5% (35) self-declared white. The relapsing-remitting phenotype was the most frequent, identified in 91.9% of participants. The annualized relapse rate during the follow-up period was 0.09 ± 0.374. In clinical outcomes, 93.5% of patients did not present relapses and 81.7% did not have disability progression, radiological stability was present in 83.3% of participants, with no significant difference between the groups. Respiratory infections were the most recurrent during follow-up.There was a hypersensitivity reaction that led to discontinuation of treatment. The evaluating adherence to natalizumab, using the medication possession ratio, it was found that 96.8% of participants were adherent in the 12th month of follow-up and 94.0% from the 13th to the 24th month of follow-up. Regarding the Morisky Green Test for analyzing adherence, 83.6% were classified as adherent at the 12th month of follow-up and 90.9% at the 24th month. Of the patients, 40.3% (25) discontinued treatment with natalizumab, 27.4% (17) due to a positive John Cunningham Virus antibody index. Treatment satisfaction scores were high for all domains, lower in the convenience domain, and there was no significant difference between the groups. Regarding the quality of life of the participants, the naïve group in the emotional well-being domain showed a significant difference between times, the pre-treated group in the domains concern for physical health and mental health showed a significant difference throughout the follow-up, cognitive function showed worsening during the follow-up. Conclusion: The results obtained in this study confirm the effectiveness of natalizumab in patients with multiple sclerosis in a real-life context. The use of this, as the first therapeutic option in the clinical protocol and therapeutic guidelines, produces notable results, reduces the accumulation of disabilities and disease progression.