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Retrospective multicenter study on cryptogenic NORSE/FIRES patients treated with anakinra.

G Giussani1, E Bianchi1, C M Bonardi2

  • 1Laboratory of Neurological Disease, Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.

Seizure
|July 4, 2025
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Summary

Anakinra treatment for cryptogenic new-onset refractory status epilepticus (cNORSE) showed no long-term neurological benefit, despite its use in intensive care. Further trials are needed to confirm its efficacy and role in treating this neurological emergency.

Keywords:
Cryptogenic NORSE (cNORSE)Febrile infection-related epilepsy syndrome (FIRES)Interleukin-1 inhibitorNew-onset refractory status epilepticus (NORSE)Refractory status epilepticus (RSE)

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Area of Science:

  • Neurology
  • Immunology

Background:

  • Refractory status epilepticus (RSE) is a critical neurological condition.
  • New-onset RSE (NORSE) affects previously healthy individuals, with cryptogenic NORSE (cNORSE) having an unknown cause.
  • Febrile-infection related epilepsy syndrome (FIRES) is a subtype of cNORSE preceded by fever.

Purpose of the Study:

  • To evaluate the efficacy of anakinra as a second-line immunotherapy for cNORSE, including FIRES.
  • To provide a historical reference for future clinical trials on anakinra in cNORSE treatment.

Main Methods:

  • A retrospective study of 14 patients with cNORSE (including FIRES) treated with anakinra in Italy.
  • Data collected prior to the implementation of international treatment recommendations.

Main Results:

  • A longer intensive care unit stay was associated with later anakinra administration.
  • No significant evidence of anakinra's efficacy on long-term neurological outcomes was found in this cohort.

Conclusions:

  • Anakinra's benefit for long-term neurological outcomes in cNORSE remains uncertain.
  • High-quality, multicenter prospective trials are essential to determine anakinra's true efficacy.
  • Biomarkers may be crucial for guiding treatment decisions in cNORSE.