A Randomized Controlled, Open-label, Rater-blinded Pragmatic trial, “Treatment of Inflammatory Myelitis and Optic Neuritis with Early vs Rescue Plasma Exchange (TIMELY-PLEX)”, comparing these two treatment strategies. 1) Plasma exchange (PLEX) is an established intervention that is commonly used in clinical practice in the United States for the treatment of severe optic neuritis (ON) and transverse myelitis (TM) 2) Based on the existing evidence and society guidelines/expert opinion, there is equipoise as to whether using early PLEX (concurrently with high dose corticosteroids [HDCS]) is associated with better neurological outcomes in ON and TM, as compared to a “traditional” treatment algorithm of initial HDCS followed by rescue PLEX in cases without significant improvement after HDCS 3) Both of these treatment approaches are healthcare options that are available and used in clinical practice in the United States, with an unclear risk-benefit and cost-benefit ratio, representing a challenge for providers, patients, and health systems.
Patients will be recruited from 310 participating sites across the United States. The sites are from a diversity of geographic regions, serving diverse racial/ethnic populations and urban, suburban, and rural populations. A diverse patient population is not only important to increase the generalizability of the trial results, but also to ensure we capture patients with NMOSD, a condition that that appears to exhibit a preponderance for Black and Eastern Asian populations, and presents often with severe ON or TM.