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Intrathecal Injections in Children With Spinal Muscular Atrophy: Nusinersen Clinical Trial Experience.

Manon Haché1, Kathryn J Swoboda2, Navil Sethna3

  • 1Division of Pediatric Anesthesia, Columbia University Medical Center, New York, NY, USA mh2289@cumc.columbia.edu.

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Summary

Lumbar punctures for nusinersen treatment in children with spinal muscular atrophy were successful. Adverse events were infrequent and comparable to other pediatric lumbar puncture studies.

Keywords:
antisense oligonucleotidedrug deliverylumbar puncturespinal muscular atrophy

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Area of Science:

  • Neurology
  • Pharmacology
  • Pediatrics

Background:

  • Spinal muscular atrophy (SMA) is a rare genetic neuromuscular disorder.
  • Nusinersen is an antisense oligonucleotide approved for treating SMA.
  • Intrathecal administration of nusinersen requires lumbar puncture procedures.

Purpose of the Study:

  • To summarize the experience and safety of lumbar puncture (LP) procedures in pediatric patients with spinal muscular atrophy (SMA) undergoing nusinersen treatment.
  • To identify factors associated with adverse events during LP in this population.

Main Methods:

  • A review of 73 lumbar puncture procedures performed in 28 pediatric patients (2-14 years) with Type 2/3 SMA during a Phase 1 open-label study and its extension.
  • Analysis of procedural success, complications, and adverse events attributed to lumbar puncture.

Main Results:

  • Lumbar punctures were successfully performed in all pediatric patients with SMA.
  • No major complications were reported.
  • Adverse events related to lumbar puncture occurred in 32% of procedures, with headache, back pain, and post-lumbar puncture syndrome being most common.
  • Older children, those with Type 3 SMA, and the use of larger gauge needles (21- or 22-gauge) were associated with a higher frequency of adverse events.

Conclusions:

  • Lumbar puncture is a feasible and safe method for administering nusinersen in children with spinal muscular atrophy.
  • Understanding risk factors can help optimize procedural safety and patient comfort.