Treatment of Inflammatory Myelitis and Optic Neuritis With Early Versus Rescue Plasma Exchange

Project Summary

This study compares the effectiveness of two different treatment approaches, early versus rescue plasma exchange, for transverse myelitis (TM) and optic neuritis (ON).

Who will this research inform?

Plasma exchange (PLEX) is a procedure commonly used for the treatment of severe TM and ON, which are common manifestations of autoimmune/inflammatory disorders of the central nervous system, but the optimal timing and effectiveness of this treatment is unclear. Results of this study will be informative to individuals with TM and ON, clinicians, payers and policymakers to optimize the use of PLEX in TM and ON and improve quality of life.

What is the research team doing?

DesignRandomized controlled trialPopulation382 individuals within 8 days of symptom onset, including:182 individuals with severe TM defined as a 3.0 or worse on the Expanded Disability Status Scale (EDSS)200 individuals with severe ON defined as a visual acuity of 20/200 or worseInterventions/ComparatorsEarly PLEX: PLEX plus high dose corticosteroids (HDCS) initiated concurrently at the time of clinical presentationRescue PLEX: HDCS with escalation to PLEX if insufficient response to HDCSPrimary OutcomeEDSS score at 6 months in individuals with TMHigh-contrast visual acuity at 6 months in individuals with ONSecondary OutcomesDomain-specific physical function and quality of life at 6 months in individuals with TMOptical coherence tomography and visual quality of life at 6 months in individuals with ONPatient and Community EngagementPatients, clinicians and patient-led advocacy organizations are working with researchers on this study.