Fig 1.
Flow-diagram of the Fiocruz Hansen disease Reference Center Cohort.
The inclusion criteria considered patients who exhibited a BI higher than 0 at diagnosis, were treated with the 12-dose MB-MDT scheme between 1998–2018, and who were followed-up at the Souza Araujo Outpatient Clinic after release from treatment. Patients were followed-up at least annually (except for those censored because of age or death). Linkage of the clinic data with the National HD registry SINAN database was performed to retrieve any relapse cases not diagnosed at the clinic due to change of address. Then, the patients in the follow-up cohort were grouped according to the length of the 12-dose MB-MDT treatment. BI, bacillary index; MB, multibacillary; MDT, multidrug therapy.
Table 1.
Epidemiological and clinical characteristics at diagnosis of the 713-patient cohort treated with multibacillary multidrug therapy at Souza Araújo Outpatient Clinic, Fiocruz, during 1997–2017.
Table 2.
Demographic and clinical characteristics of the ten patients diagnosed with Hansen disease relapse.
Fig 2.
Spline curve of the annual bacillary index (BI) mean values in 12-dose MB-MDT Hansen disease patients.
Progressive decrease of the BI obtained from slit-skin smear samples of non-relapse cases during the first years after release from treatment (full line). Observe that positive BI values remain long after release from treatment. Relapse cases (dotted line), however, show greater variability, possibly due to the small number, and display BI increases before relapse.
Table 3.
Laboratory characteristics of the ten patients diagnosed with Hansen disease relapse.
Fig 3.
Kaplan-Meier Cumulative Risk of relapse in 713 patients treated with 12-dose MB-MDT.
The survival curve shows the proportion of people affected by Hansen disease without relapse according to the period of follow-up. Y-axis of the curve is the cumulative probability of relapse. The X-axis represents the survival duration. The length of the horizontal lines is the interval terminated by the occurrence of relapse events and the heights between horizontal lines illustrate the change in the cumulative probability.