The value of anti-JCV antibody index assessment in multiple sclerosis patients treated with natalizumab with respect to demographic, clinical and radiological findings

Kolčava, Jan; Hulová, Monika; Benešová, Yvonne; Bednařík, Josef; Šťourač, Pavel

doi:10.1016/j.msard.2019.02.019

Cited by 12 publications

(11 citation statements)

References 26 publications

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“…NAT therapy conducted according to the rules of PML risk stratification seems to be safe. In agreement with the Czech study [19], which showed no PML cases during NAT treatment, also in Poland, since 2013, no patient has been diagnosed with PML. There is a need to the development of new biomarkers that may better predict an individual’s risk of PML and further improve upon NAT safety.…”

Section: Discussionsupporting

confidence: 91%

“…Seroconversion was observed within 1 year (±3 months) of NAT therapy among 52.9% RRMS patients. The results obtained in our study are similar to previously published data, which showed the worldwide JCVAb seroconversion rates in RRMS patients [19][20][21]. In the systematic review and meta-analysis, the incidence of seroconversion was reported between 6 and 41%.…”

Section: Color Version Available Onlinesupporting

confidence: 91%

“…According to the results of our study, the JCVAb status changed from positive to negative in 4 patients (1.9%) during the period of observation up to 48 (±3) months and was in line with other studies [19]. In the systematic review and meta-analysis, the incidence of seroreversion was reported between 1 and 11% [6].…”

Section: Color Version Available Onlinesupporting

confidence: 91%

“…In the study published by Jan Kolcava et al [19], there was no significant correlation between JCVAb index and NAT treatment duration, but there was a positive correlation between the baseline JCVAb index and patient’s age. In contrary to these results, in our study, patients’ age, disease duration, and baseline EDSS score seem not to be a risk factor for seroconversion in Polish patients with RRMS.…”

Section: Discussionmentioning

confidence: 96%

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John Cunningham Virus Status, Seroconversion Rate, and the Risk of Progressive Multifocal Leukoencephalopathy in Polish John Cunningham Virus-Seronegative Patients with Relapsing-Remitting Multiple Sclerosis

Kapica-Topczewska

Collin²,

Tarasiuk

et al. 2020

Eur Neurol

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Introduction: Presence of anti-JC-virus antibodies (JCVAbs) is associated with the increased risk of natalizumab (NAT)-related progressive multifocal leukoencephalopathy (PML). Little is known about seroconversion rate and time to seroconversion in relapsing-remitting multiple sclerosis (RRMS) patients treated with NAT in Poland. The aim of the study was to assess the true risk of PML, seroconversion rate, and time to seroconversion in all JCVAb-negative RRMS patients treated with NAT in Poland. Methods: Demographic and clinical data of all Polish RRMS patients treated with NAT reimbursed by National Health Fund (NFZ) were prospectively collected in electronic files using the Therapeutic Programme Monitoring System 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 program guidance, only patients with negative JCVAb test have started treatment with NAT. Results: In all Polish multiple sclerosis centers, 210 negative JCVAb RRMS patients with at least 9 (±3) months of observation (146 females, 64 males, and the median age at baseline: 33 years) were included in the study. During the follow-up period, JCVAb status changed from negative to positive in 34 patients (16.2%). For half of the patients, the seroconversion was diagnosed 1 year after starting NAT treatment. In 4 patients (1.9%) during follow-up, JCVAb status changed again from positive to negative. In Poland, before establishment of NFZ drug program, 4 cases of PML in patients treated with NAT in clinical trials were diagnosed. In the NFZ drug program, since 2013, no patient treated with NAT has been diagnosed with PML. Conclusions: NAT therapy in JCV-seronegative RRMS patients is safe and results in the absence of PML cases. In Poland, JCV seroconversion rate is similar to that observed in other European countries.

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Section: Discussionsupporting

confidence: 91%

Section: Color Version Available Onlinesupporting

confidence: 91%

Section: Color Version Available Onlinesupporting

confidence: 91%

Section: Discussionmentioning

confidence: 96%

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John Cunningham Virus Status, Seroconversion Rate, and the Risk of Progressive Multifocal Leukoencephalopathy in Polish John Cunningham Virus-Seronegative Patients with Relapsing-Remitting Multiple Sclerosis

Kapica-Topczewska

Collin²,

Tarasiuk

et al. 2020

Eur Neurol

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“…The existing data on the seroprevalence of anti-JCV Ab and anti-JCV AI levels in the population of MS patients mainly originate from trials in which PwMS were receiving disease-modifying therapy (DMT), especially natalizumab [ 23 , 24 , 25 , 26 , 27 , 28 ]. The vital characteristic of our study cohort comprising MS patients is the fact that nearly one half of them were treatment naïve, while the remaining study population was receiving DMT with the use of immunomodulatory or immunosuppressive agents; the proportion of patients treated with natalizumab was minimal.…”

Section: Discussionmentioning

confidence: 99%

JC Virus Seroprevalence and JCVAb Index in Polish Multiple Sclerosis Patients Treated with Immunomodulating or Immunosuppressive Therapies

Bonek¹,

Guenter

Jałowiński

et al. 2021

JCM

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The use of a highly-effective treatment for multiple sclerosis (MS) is associated with a severe risk of developing complications, such as progressive multifocal leukoencephalopathy (PML) caused by the John Cunningham virus (JCV). The aim of this study was to evaluate the correlation between anti-JCV Ab seroprevalence, anti-JCV AI, demographic and clinical factors as well as the type of therapy used in the Polish MS population. This is a multicentre, prospective and cross-sectional study involving 1405 MS patients. The seroprevalence of anti-JCV Ab and anti-JCV AI levels as well as AI categories were analysed with the use of a second-generation two-step ELISA test (STRATIFY JCV DxSelect). The overall prevalence of anti-JCV Ab was 65.8%. It was shown that seroprevalence increases with the patient’s age. The seroprevalence was significantly associated with the treatment type, and the highest values (76%) were obtained from immunosuppressant-treated patients. Overall, 63.3% of seropositive patients had an antibody index (AI) level of >1.5. In the seropositive patient group, the mean AI level amounted to 2.09. Similarly to the seroprevalence, AI levels correlated with the patient’s age; AI level for patients above 40 years old and from subsequent age quintiles plateaued, amounting to at least 1.55. Patients treated with immunosuppressants and immunomodulatory drugs obtained the highest (1.67) and lowest (1.35) AI levels, respectively. Of the immunosuppressants used, the highest mean AI levels were observed in mitoxantrone and cladribine groups, amounting to 1.75 and 1.69, respectively. In patients treated with immunomodulatory drugs, the lowest AI levels were observed in the dimethyl fumarate (DMF) group (1.11). The seroprevalence rate in the Polish MS population is one of the highest in Europe. The majority of seropositive patients had an anti-JCV Ab level qualifying them for a high-risk category. The highest mean AI levels are observed in patients receiving immunosuppressants, especially mitoxantrone and cladribine. Patients receiving immunomodulatory drugs have lower AI levels compared to treatment-naïve subjects, especially when treated with DMF. Further studies, especially longitudinal studies, are required to determine the impact of MS drugs on the seroprevalence of anti-JCV Ab and AI levels.

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The impact of lymphocytosis and CD4/CD8 ratio on the anti-JCV antibody index and clinical data in patients treated with natalizumab

et al. 2020

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The value of anti-JCV antibody index assessment in multiple sclerosis patients treated with natalizumab with respect to demographic, clinical and radiological findings

Cited by 12 publications

References 26 publications

John Cunningham Virus Status, Seroconversion Rate, and the Risk of Progressive Multifocal Leukoencephalopathy in Polish John Cunningham Virus-Seronegative Patients with Relapsing-Remitting Multiple Sclerosis

John Cunningham Virus Status, Seroconversion Rate, and the Risk of Progressive Multifocal Leukoencephalopathy in Polish John Cunningham Virus-Seronegative Patients with Relapsing-Remitting Multiple Sclerosis

JC Virus Seroprevalence and JCVAb Index in Polish Multiple Sclerosis Patients Treated with Immunomodulating or Immunosuppressive Therapies

The impact of lymphocytosis and CD4/CD8 ratio on the anti-JCV antibody index and clinical data in patients treated with natalizumab

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