2019-09-13 / Conference ECTRIMS 2019
Kapica-Topczewska, K; Czarnowska, A; Collin, F; Tarasiuk, J; Chorąży, M; Kwaśniewski, M; Kochanowicz, J; Kułakowska, A
Background
Presence of anti-JC-virus antibodies (JCVAb) is associated with increased risk of natalizumab-related progressive multifocal leukoencephalopathy (PML). Less it is known about seroconversion rate and time to seroconversion in relapsisng-remitting multiple sclerosis (RRMS) patients treated with natalizumab.
Goals
The aim of the study was to assess JCVAb prevalence, eroconversion rate, time to seroconversion and risk of PML in RRMS patients treated with natalizumab in Poland.
Methods
Demographic and clinical data of all Polish RRMS patients treated with natalizumab reimbursed by National Health Fund (NFZ) were prospectively collected in electronic files using the Therapeutic Program Monitoring System (SMPT) provided by NFZ. The assessment of JCVAb presence (without collection of JCVAb index value) in serum (Unilabs, STRATIFY JCV: anti-JCV antibody ELISA) was done at the beginning of therapy and then repeated every 6 months. The maximum follow-up time was 4 years. In Poland, since 2013, according to the NFZ drug programme guidance only patients with negative JCVAb test have been treated with natalizumab.
Results
In all Polish MS centres 362 patients have been treated with natalizumab since 2013. 210 negative JCVAb patients with at least 12 (±3) months of observation (149 female, 61 male; the median age was 33 years) were included in the study. During follow-up period JCVAb status changed from negative to positive in 33 patients (15%). For half of the patients, the seroconversion was diagnosed one 1 year after starting natalizumab treatment. In 6 (2.9%) patients during follow-up JCVAb status changed again from positive to negative. In Poland, before establishment of NFZ drug programme, 4 cases of PML in patients treated with natalizumab in clinical trial STRATA (NCT00297232) were diagnosed. In the NFZ drug programme, since 2013 no patient treated with natalizumab has been diagnosed with PML.
Conclusions
Natalizumab therapy in JCV seronegative RRMS patients is very safe and results in absence of PML cases. In Poland, JCV seroconversion rate is similar to observed in other European countries.
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