Real Life Experience of First Course of Anti-TNF Treatment in Ankylosing Spondylitis Patients in Brazil

Abstract

Introduction: In Brazil, patients with ankylosing spondylitis (AS) have access to free-of-charge comprehensive therapeutic care through the Brazilian National Health System. We collected prospective data on patients with AS receiving anti-tumor necrosis factor (anti-TNF) therapy through the Brazilian National Health System in Belo Horizonte City in order to evaluate the effectiveness, quality-of-life outcomes and safety of this therapy. Methods: This was a prospective study that included 87 patients receiving their first course of anti-TNF agents (adalimumab, etanercept or infliximab). The effectiveness of treatment was assessed at 6 and 12 months of follow-up using measures of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)], function [Health Assessment Questionnaire (HAQ)] and quality of life (EuroQol-5D). Good clinical response was defined as an improvement of at least 50% or 2 units in the BASDAI. Episodes of adverse events were recorded. Logistic regression was performed, and odds ratios (OR) with 95% confidence interval (95% CI) were calculated to estimate predictors of good clinical response at 6 months. Results: At 6 months of follow-up, 64.9% of patients had a good clinical response, as evidenced by a drop in the median BASDAI score from 5.21 to 2.50 (p < 0.0001) and a reduction in the HAQ score from 1.13 to 0.38 (p < 0.0001). Patients also showed an improvement in health-related quality of life which was sustained after 12 months of follow-up. Female patients achieved a significantly lower clinical response than male patients (OR 0.29, 95% CI 0.11–0.78), but we observed no significant associations between the other variables. At the end of the study, 93 non-serious adverse events had been reported. Conclusion: Treatment with the anti-TNF drugs adalimumab, etanercept and infliximab is effective and well tolerated in patients with AS. The improvement in disease activity, functional parameters and quality of life was sustained for 12 months.