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Regular Twelve-Dose Multidrug Therapy for Leprosy Patients Has a Low Rate of Relapse: A 20-Year Cohort Study in a Brazilian Reference Center
27 Pages Posted: 30 May 2020
More...Abstract
Background: The World Health Organization has raised concerns about the increasing number of leprosy relapses worldwide, with Brazil, India and Indonesia reporting the highest number of relapse cases. However, in this study, a large cohort of multibacillary (MB) patients was followed for up to 20 years, and indicates that relapses after full fixed-dose multidrug therapy (MDT) are a rare event.
Methods: The incidence density of relapse was estimated in a cohort of MB-classified patients (bacillary index (BI) > 0, without previous MDT) diagnosed between September 1997-June 2017 and treated with 12-dose MB-MDT at a leprosy reference center in Rio de Janeiro, Brazil.
Findings: The incidence rate observed in this cohort of 714 patients followed-up for a mean of 10·6 years was 1·19 cases per 1000 person-year (95% CI=0·58-2·19). No groups were identified to be at higher risk of relapse, this included sex, disability grade (DG) or BI. Patients with BI > 3·50 at release from treatment had an incidence of 1·97/1000 person-year (95% CI=0·72-4·28). The accumulated risk was 0·025 in 20 years.
Interpretation: Relapses are considered an important indicator of MDT effectiveness, and could reflect therapy failure as well as antimicrobial resistance, bacilli persistence, or re-infection. Relapse is also a potential marker for development or progression of disability. The very low risk observed in this cohort of 12-dose-treated MB patients reinforces the success of the current MDT scheme. This finding is essential at present, when there is ongoing debate on reducing MB-MDT to 6 months.
Funding Statement: Fiocruz
Declaration of Interests: No conflict of interest to disclose.
Ethics Approval Statement: Approval given in 10/04/2018 for Project CAAE. 86568618.1.0000.5248 by Oswaldo Cruz Foundation - FIOCRUZ/IOC Ethics committee.
Keywords: relapse; incidence rate; risk; multidrug therapy; multibacillary leprosy
Suggested Citation: Suggested Citation