An observational study of the effectiveness and safety of natalizumab in the treatment of XXXX .

@entity1 @entity56 @entity2287 @entity15
AIM: To analyse the safety and effectiveness of natalizumab in the treatment of @entity15 in a real clinical practice setting and according to the approved indications. @entity1 AND METHODS: All @entity1 with @entity15 treated with natalizumab in our centre were evaluated. The clinical and radiological disease activity during the first year of treatment was analyzed in @entity1 who received at least 12 doses of the drug. The data regarding moderate and severe adverse events in the entire study sample was also evaluated. RESULTS: A total of 112 @entity1 were included in the study, of which 110 had been previously treated with other drugs and 76 had received at least 12 doses of natalizumab. In this group, the annualized relapse rate was reduced by 89% compared to the preceding year and 80% of @entity1 were free from relapses after one year of treatment. Nine percent of @entity1 exhibited 3-month confirmed disability progression. At month 12, the mean number of @entity2287 -enhancing lesions on brain MRI was decreased by 99% compared to the pre-treatment MRI. During the first year of treatment, 76% of @entity1 remained free from clinical activity and 33% remained free from both clinical and radiological disease activity. Twenty-nine percent of @entity1 had at least one moderate or severe adverse event, which led to treatment discontinuation in 6%. Four percent of @entity1 experienced immediate @entity56 reactions. CONCLUSION: This study suggests that natalizumab is effective in reducing disease activity in @entity1 with relapsing @entity15 and inadequate response to other therapies, with a favorable risk-benefit ratio.
