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Anti-JC virus antibody levels in serum or plasma further define risk of natalizumab-associated progressive multifocal leukoencephalopathy.

Plavina T, Subramanyam M, Bloomgren G, Richman S, Pace A, Lee S, Schlain B, Campagnolo D, Belachew S, Ticho B - Ann. Neurol. (2014)

Bottom Line: Anti-JCV antibody index data were available for serum/plasma samples collected >6 months prior to PML diagnosis from 71 natalizumab-treated PML patients and 2,522 non-PML anti-JCV antibody-positive patients.In patients with no prior immunosuppressant use, anti-JCV antibody index distribution was significantly higher in PML patients than in non-PML patients (p < 0.0001).Continued evaluation of anti-JCV antibody index and PML risk is warranted.

View Article: PubMed Central - PubMed

Affiliation: Biogen Idec, Cambridge, MA.

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Anti–JC virus (JCV) antibody index in non–progressive multifocal leukoencephalopathy (PML) and PML patients. (A) Test data set includes lowest index for 1,039 non-PML patients who tested anti-JCV antibody–positive and 45 PML patients with pre-PML samples >6 months prior to PML diagnosis, as of September 2012. (B) Verification data set includes samples from 1,483 non-PML patients who tested anti-JCV antibody–positive at baseline of STRATIFY-2 and pre-PML samples (>6 months prior to PML diagnosis) from 26 patients who developed PML in STRATIFY-2. For the non-PML group in the verification data set, optical densities >3.0 used to calculate anti-JCV antibody index were reported as 3.0 by the testing laboratory. The lowest index value was used for patients who had multiple samples available. Box = interquartile range; thick black horizontal line = median; horizontal bars = range; x = mean.
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fig01: Anti–JC virus (JCV) antibody index in non–progressive multifocal leukoencephalopathy (PML) and PML patients. (A) Test data set includes lowest index for 1,039 non-PML patients who tested anti-JCV antibody–positive and 45 PML patients with pre-PML samples >6 months prior to PML diagnosis, as of September 2012. (B) Verification data set includes samples from 1,483 non-PML patients who tested anti-JCV antibody–positive at baseline of STRATIFY-2 and pre-PML samples (>6 months prior to PML diagnosis) from 26 patients who developed PML in STRATIFY-2. For the non-PML group in the verification data set, optical densities >3.0 used to calculate anti-JCV antibody index were reported as 3.0 by the testing laboratory. The lowest index value was used for patients who had multiple samples available. Box = interquartile range; thick black horizontal line = median; horizontal bars = range; x = mean.

Mentions: The initial exploratory analysis of the association between index and PML risk using the test data set showed that the distribution of anti-JCV antibody index was significantly higher in pre-PML samples from natalizumab-treated patients who developed PML than in samples from non-PML anti-JCV antibody–positive patients (median = 2.4 vs 1.4; p < 0.0001; Fig 1A). Subsequent analysis using the verification data set confirmed the association between index and PML, with a significantly higher index distribution for pre-PML samples from PML patients than for samples from non-PML patients (median = 2.3 vs 1.9; p = 0.0199; see Fig 1B). In cross-sectional analysis of the combined PML and non-PML population for both data sets, there was no association detected between index and natalizumab treatment duration or prior immunosuppressant use (Fig 2).


Anti-JC virus antibody levels in serum or plasma further define risk of natalizumab-associated progressive multifocal leukoencephalopathy.

Plavina T, Subramanyam M, Bloomgren G, Richman S, Pace A, Lee S, Schlain B, Campagnolo D, Belachew S, Ticho B - Ann. Neurol. (2014)

Anti–JC virus (JCV) antibody index in non–progressive multifocal leukoencephalopathy (PML) and PML patients. (A) Test data set includes lowest index for 1,039 non-PML patients who tested anti-JCV antibody–positive and 45 PML patients with pre-PML samples >6 months prior to PML diagnosis, as of September 2012. (B) Verification data set includes samples from 1,483 non-PML patients who tested anti-JCV antibody–positive at baseline of STRATIFY-2 and pre-PML samples (>6 months prior to PML diagnosis) from 26 patients who developed PML in STRATIFY-2. For the non-PML group in the verification data set, optical densities >3.0 used to calculate anti-JCV antibody index were reported as 3.0 by the testing laboratory. The lowest index value was used for patients who had multiple samples available. Box = interquartile range; thick black horizontal line = median; horizontal bars = range; x = mean.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4282070&req=5

fig01: Anti–JC virus (JCV) antibody index in non–progressive multifocal leukoencephalopathy (PML) and PML patients. (A) Test data set includes lowest index for 1,039 non-PML patients who tested anti-JCV antibody–positive and 45 PML patients with pre-PML samples >6 months prior to PML diagnosis, as of September 2012. (B) Verification data set includes samples from 1,483 non-PML patients who tested anti-JCV antibody–positive at baseline of STRATIFY-2 and pre-PML samples (>6 months prior to PML diagnosis) from 26 patients who developed PML in STRATIFY-2. For the non-PML group in the verification data set, optical densities >3.0 used to calculate anti-JCV antibody index were reported as 3.0 by the testing laboratory. The lowest index value was used for patients who had multiple samples available. Box = interquartile range; thick black horizontal line = median; horizontal bars = range; x = mean.
Mentions: The initial exploratory analysis of the association between index and PML risk using the test data set showed that the distribution of anti-JCV antibody index was significantly higher in pre-PML samples from natalizumab-treated patients who developed PML than in samples from non-PML anti-JCV antibody–positive patients (median = 2.4 vs 1.4; p < 0.0001; Fig 1A). Subsequent analysis using the verification data set confirmed the association between index and PML, with a significantly higher index distribution for pre-PML samples from PML patients than for samples from non-PML patients (median = 2.3 vs 1.9; p = 0.0199; see Fig 1B). In cross-sectional analysis of the combined PML and non-PML population for both data sets, there was no association detected between index and natalizumab treatment duration or prior immunosuppressant use (Fig 2).

Bottom Line: Anti-JCV antibody index data were available for serum/plasma samples collected >6 months prior to PML diagnosis from 71 natalizumab-treated PML patients and 2,522 non-PML anti-JCV antibody-positive patients.In patients with no prior immunosuppressant use, anti-JCV antibody index distribution was significantly higher in PML patients than in non-PML patients (p < 0.0001).Continued evaluation of anti-JCV antibody index and PML risk is warranted.

View Article: PubMed Central - PubMed

Affiliation: Biogen Idec, Cambridge, MA.

Show MeSH
Related in: MedlinePlus