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Myasthenia Gravis

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Antibodies

Immunoglobulins

Immunoglobulins, Intravenous

gamma-Globulins

Rho(D) Immune Globulin

Intravenous Immunoglobulin, 2G/Kg, infused over 2 days in the Medical Day Unit of the University Health Network

Patients received one plasma volume plasma exchanges with 5% albumin replacement fluid. Five plasma exchange procedures occurred every second day with breaks over the weekend allowed. Patients treated in the apheresis units at the University Health Network.

IVIG

Plasma exchange: removal of pathogenic antibodies and constituents and replacement with albumin.

PLEX

Vera Bril, BSc, MD, FRCPC

David Barth, MD

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.

Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis

A Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia Gravis

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.

Change in QMGS with time to see if effect ad day 14 is sustained.

Categorical scale of improvement, worsening, or no change for myasthenia gravis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis	NCT01179893	Myasthenia Grav...	IVIG PLEX	18 Years -	University Health Network, Toronto
Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis	NCT01179893	Myasthenia Grav...	IVIG PLEX	18 Years -	University Health Network, Toronto

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