Treatment of Inflammatory Myelitis and Optic Neuritis with Early Plasma Exchange (TIMELY-PLEX)

Project Summary

Optic neuritis (ON) and transverse myelitis (TM) are caused by inflammation involving the optic nerve(s) and spinal cord, respectively. ON is the most common cause of optic neuropathy affecting young adults and can result in permanent visual disability, including blindness. TM causes weakness, difficulty walking, decreased feeling, and problems with bowel/bladder and/or sexual dysfunction.

Plasma exchange (PLEX) is a procedure commonly used for the treatment of severe ON and TM, with usage increasing over the past 10-20 years. PLEX is a therapy that exchanges out a patient's plasma, which removes pathologic antibodies and decreases inflammation.

Traditionally, PLEX has been used for severe attacks of ON/TM that do not respond to steroids as a rescue therapy. Many retrospective studies have suggested that early PLEX for ON/TM leads to better outcomes than delayed rescue PLEX. This has led to many providers recommending early PLEX for all severe cases of severe ON/TM. However, there are increased costs and potential complications with PLEX, and therefore many providers still prefer the traditional rescue PLEX for attacks that do not respond to steroids.

In this study, the research team will conduct a randomized clinical trial, Treatment of Inflammatory Myelitis and Optic Neuritis with Early vs Rescue Plasma Exchange (TIMELY-PLEX). In this trial, patients with severe ON or TM will be randomized to receive either early PLEX (with steroids) or delayed rescue PLEX (after steroids) if they do not improve with steroids alone.

TIMELY-PLEX will determine if early PLEX leads to better outcomes and helps identify patients that would most benefit from early PLEX.