Natalizumab-related progressive multifocal leukoencephalopathy in Greece
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Dimos D Mitsikostas1, Vasileios Mastorodemos2, Minas Tsagournizakis2
1Neurology Department, Athens Naval Hospital, 40 Deinokratous Street, 77A Vasilissis Sofias Avenue, 11521 Athens, Greece.
Background & Objectives:
Progressive multifocal leukoencephalopathy (PML) may complicate natalizumab treatment in multiple sclerosis patients. We sought to characterize the clinical and laboratory features of natalizumab-related PML (NR-PML) cases from Greece.
Methods:
Pharmaceutical industry, national drug authorities and all neurology departments within the Greek territory were asked to provide data for cases of NR-PML until October 2012. Collected cases were classified according to their level of diagnostic certainty using the five-level system introduced by Mentzer et al. (2012).
Results:
Thirteen NR-PML cases were identified by the neurology departments. Data were provided for only 9 cases. PML manifestations appeared after a median number of 40 (21-52) natalizumab infusions. All but two patients were treated with plasma exchange and some were treated adjunctively with mirtazapine while the others were treated with mefloquine. IRIS developed in 6 cases after a median time of 6 (2-10) weeks from PML presentation and were treated with different regimens of corticosteroids. PML was fatal in 3 cases. The median EDSS after a median follow-up time of 12 (8-23) months in the surviving cases was 4.75 (2-8.5).
Conclusions:
Outcomes for collected NR-PML cases varied from death to returning to baseline. Close surveillance is essential for early diagnosis and treatment of NR-PML patients.
Insights
Progressive multifocal leukoencephalopathy (PML) can occur during natalizumab treatment for multiple sclerosis. This study characterized Greek cases, finding varied outcomes and emphasizing the need for vigilant monitoring and early intervention in natalizumab-related PML.
Area of Science:
- Neuroimmunology
- Neurology
- Infectious Diseases
Background:
- Natalizumab is a disease-modifying therapy for multiple sclerosis.
- Progressive multifocal leukoencephalopathy (PML) is a rare but serious adverse event associated with natalizumab.
- Characterizing natalizumab-related PML (NR-PML) is crucial for patient management.
Purpose of the Study:
- To describe the clinical and laboratory features of NR-PML cases in Greece.
- To analyze treatment strategies and outcomes for NR-PML.
Main Methods:
- Retrospective data collection from Greek neurology departments, pharmaceutical industry, and national drug authorities.
- Classification of NR-PML cases using a five-level diagnostic certainty system.
- Analysis of treatment regimens including plasma exchange, mirtazapine, mefloquine, and corticosteroids.
Main Results:
- Thirteen NR-PML cases were identified, with data available for 9 patients.
- PML onset occurred after a median of 40 natalizumab infusions.
- Immune reconstitution inflammatory syndrome (IRIS) developed in 6 cases; 3 cases were fatal, and surviving patients had a median EDSS of 4.75 after 12 months.
Conclusions:
- Outcomes for NR-PML patients in Greece ranged from death to recovery.
- Early diagnosis and prompt treatment are critical for improving outcomes in NR-PML.
- Close patient surveillance is essential during natalizumab therapy.
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