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Surveillance for progressive multifocal leukoencephalopathy during natalizumab therapy for patients with multiple sclerosis and no prior immunosuppressive treatment

Surveillance for progressive multifocal leukoencephalopathy during natalizumab therapy for patients with multiple sclerosis and no prior immunosuppressive treatment
JCV antibody status* PML risk with natalizumab Suggested monitoring* Management issues*
Anti-JCV antibody negative <1:10,000 Anti-JCV antibody every 6 months; obtain brain MRI scan at baseline and every 12 months Natalizumab continued as indicated for MS

Anti-JCV antibody positive and anti-JCV antibody index <0.9

<1:10,000 for months 1 to 24

~1:748 for >24 months

 Anti-JCV antibody index every 6 months; brain MRI scan every 12 months Patient and clinician should review the benefits and risks of continuing natalizumab beyond 24 months

Anti-JCV antibody positive and anti-JCV antibody index ≥0.9

~1:1062 for months 1 to 24

~1:101 for >24 months

 Further anti-JCV antibody index testing not required; brain MRI scan at one year and then every 6 months beginning at 18 monthsΔ We suggest discontinuing natalizumab after 24 months due to mounting risk of PML
This table is intended to provide guidance for clinicians about the risk of PML associated with natalizumab therapy for patients with relapsing-remitting MS without prior immunosuppressant treatment (beta interferons or glatiramer acetate are not considered immunosuppressants in this paradigm). However, the risks of PML are estimates and subject to change as more data accrue. The surveillance steps outlined here may not apply to all patients; clinical judgement and vigilance are required at all times.
JCV: JC virus; MRI: magnetic resonance imaging; MS: multiple sclerosis; PML: progressive multifocal leukoencephalopathy.
* PML monitoring and management suggestions are based on the patient's current JCV antibody status, which should be assessed at baseline and reassessed periodically. A baseline brain MRI scan should be obtained prior to initiating therapy with natalizumab.
¶ Natalizumab should be discontinued in any patient with MRI findings suggestive of PML.
Δ Some experts recommend MRI scanning every 3 to 4 months after 18 months of therapy for patients with an anti-JCV index ≥0.9.
Data from:
  1. McGuigan C, Craner M, Guadagno J, et al. Stratification and monitoring of natalizumab-associated progressive multifocal leukoencephalopathy risk: recommendations from an expert group. J Neurol Neurosurg Psychiatry 2016; 87:117.
  2. Plavina T, Subramanyam M, Bloomgren G, et al. Anti-JC virus antibody levels in serum or plasma further define risk of natalizumab-associated progressive multifocal leukoencephalopathy. Ann Neurol 2014; 76:802.
  3. Kuesters G, Plavina T, Lee S, et al. Anti-JC virus (JCV) antibody index differentiates risk of progressive multifocal leukoencephalopathy (PML) in natalizumab-treated multiple sclerosis (MS) patients with no prior immunosuppressant (IS) use: An updated analysis. Poster presentation, 67th American Academy of Neurology Annual Meeting, April 22, 2015 Washington DC, USA. www.abstracts2view.com/aan/view.php?nu=AAN15L1_P4.031 (Accessed on February 04, 2016).
  4. Schwab N, Schneider-Hohendorf T, Melzer N, et al. Natalizumab-associated PML: Challenges with incidence, resulting risk, and risk stratification. Neurology 2017; 88:1197.
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