Stratification and monitoring of natalizumab-associated progressive multifocal leukoencephalopathy risk: recommendations from an expert group.
The use of natalizumab for highly active relapsing-remitting multiple sclerosis (MS) is influenced by the occurrence of progressive multifocal leukoencephalopathy (PML). Through measurement of the anti-JCV antibody index, and in combination with the presence or absence of other known risk factors, it may be possible to stratify patients with MS according to their risk of developing PML during treatment with natalizumab and detect early suspected PML using MRI including a diffusion-weighted imaging sequence. This paper describes a practical consensus guideline for treating neurologists, based on current evidence, for the introduction into routine clinical practice of anti-JCV antibody index testing of immunosuppressant-naïve patients with MS, either currently being treated with, or initiating, natalizumab, based on their anti-JCV antibody status. Recommendations for the frequency and type of MRI screening in patients with varying index-associated PML risks are also discussed. This consensus paper presents a simple and pragmatic algorithm to support the introduction of anti-JCV antibody index testing and MRI monitoring into standard PML safety protocols, in order to allow some JCV positive patients who wish to begin or continue natalizumab treatment to be managed with a more individualised analysis of their PML risk.
Department of Neurology, St Vincent's University Hospital, Dublin, Ireland.
C
C
McGuigan
Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, Oxford, UK.
M
M
Craner
Department of Neurology, Royal Victoria Infirmary, Newcastle Upon Tyne Hospitals Trust, Newcastle, UK.
J
J
Guadagno
National Hospital for Neurology and Neurosurgery, London, UK.
R
R
Kapoor
Department of Neurology, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, UK.
G
G
Mazibrada
Department of Neurology, West Suffolk NHS Foundation Trust, Bury St Edmunds, UK.
P
P
Molyneux
Department of Neurology, Imperial Healthcare NHS Trust, Charing Cross Hospital, London, UK.
R
R
Nicholas
Department of Clinical Neurosciences, John Radcliffe Hospital, Oxford, UK.
J
J
Palace
Department of Neurology, Abertawe Bro Morgannwg University Local Health Board, Swansea, UK.
O R
OR
Pearson
Greater Manchester Neurosciences Centre, Salford Royal NHS Foundation Trust, Salford, UK.
D
D
Rog
Walton Centre NHS Foundation Trust, Liverpool, UK.
C A
CA
Young
D017408:Guidelines as Topic; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D007968:Leukoencephalopathy, Progressive Multifocal / Q000139:chemically induced* / Q000175:diagnosis* / Q000453:epidemiology; D018670:Monitoring, Ambulatory; D009103:Multiple Sclerosis / Q000150:complications / Q000188:drug therapy; D000069442:Natalizumab / Q000009:adverse effects* / Q000627:therapeutic use; D012306:Risk
D007166:Immunosuppressive Agents; D000069442:Natalizumab
MULTIPLE SCLEROSIS