Immunomodulation is effective in treating patients with myasthenia gravis (MG), but prior studies have not adequately defined if plasma exchange (PLEX) in superior to intravenous immunoglobulin (IVIG) in the treatment of myasthenia gravis. This study aimed to determine if PLEX was superior to IVIG in the treatment of patients with myasthenia gravis. Patients with MG requiring immunomodulation are randomized to IVIG or PLEX and treated with a full course of immunomodulation. The quantitative myasthenia gravis score (QMGS) will be evaluated as the primary efficacy parameter at day 14 to determine if PLEX is superior to IVIG.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
87
Intravenous immunoglobulin
Plasma exchange: removal of pathogenic antibodies and constituents and replacement with albumin.
University Health Network
Toronto, Ontario, Canada
Change in Quantitative Myasthenia Gravis Score (QMGS) from baseline to day 14 after treatment
QMGS is a validated clinical measure of myasthenia gravis ranging from 0 points (no myasthenic weakness) to a maximum of 39 points, with a defined change of 3.4 units required for clinical significance.
Time frame: QMGS at day 14, and patients followed to day 60
QMGS Score change at days 21 and 28 from start of treatment.
Change in QMGS with time to see if effect ad day 14 is sustained.
Time frame: 28 days
Post intervention status
Categorical scale of improvement, worsening, or no change for myasthenia gravis.
Time frame: Day 14, 21 and 28
Single fiber electromyography: jitter, percent abnormal pair, percent blocking
Electrophysiological assessment of neuromuscular transmission.
Time frame: Days 14 and 28 compared to baseline
Repetitive Nerve stimulation studies
Assessment of decrement
Time frame: Days 14 and 28
Acetylcholine Receptor Antibody titers
Laboratory assay of pathogenic antibody
Time frame: Day 28 (if positive at baseline)
AntiMUSK antibody
Laboratory measure of pathogenic antibody
Time frame: Day 28 (if positive at baseline)
Need for ICU admission, ventilation, intubation
Myasthenic deterioration and crisis
Time frame: 60 days
Hospitalization
Myasthenic deterioration and crisis
Time frame: 60 days
Need for additional myasthenic treatment
Myasthenic deterioration or crisis
Time frame: Day 60
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.