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IV immunoglobulin does not reverse established weakness in MS

A double-blind, placebo-controlled trial

From the Departments of Neurology (Drs. Noseworthy, Weinshenker, Windebank, Whisnant, Harper, Low, and Rodriguez, and J.A. Weis), Biostatistics (Dr. O’Brien and T.M. Petterson), Radiology (Dr. Erickson), Physical Medicine and Rehabilitation (Dr. Stolp–Smith), and Orthopedics (Dr. An, L.J. Romme, and M. Johnson), Mayo Clinic, Rochester, MN.

Address correspondence and reprint requests to Dr. John H. Noseworthy, Department of Neurology, Mayo Clinic/Mayo Foundation, 200 First Street, SW, Rochester, MN 55905; e-mail: noseworthy.john{at}mayo.edu

BACKGROUND: Immunoglobulin (Ig) administration induces remyelination in the Theiler’s virus model of MS.

METHODS: A randomized, double-blinded, placebo-controlled trial of IV immunoglobulin (IVIg) was performed in patients with MS who had persistent muscle weakness that had been stable for between 4 and 18 months to determine whether this would improve muscle strength (primary outcome: isometric muscle strength). Patients received either IVIg (0.4 g/kg) or placebo daily for 5 days, then single infusions every 2 weeks for 3 months (total, 11 infusions). Muscle groups identified by clinical measures to have unchanging significant weakness were the major targets for therapeutic response (targeted neurologic deficit [TND]).

RESULTS: IVIg was well tolerated. An interim analysis after 67 patients were enrolled indicated no difference in the degree of change in strength between treatment groups in either the TND or non-TND muscle groups at 6 months, and the trial was terminated. There was no apparent benefit in relapse behavior or impairment measures during the 6-month observation period. Nor was there apparent benefit in either patients who remained clinically stable or in those with evidence of disease activity. Patients with active MS during the trial worsened in both TND and non-TND muscle groups. This worsening was seen regardless of whether the clinical manifestations of disease activity involved the TND muscle groups.

CONCLUSIONS: IVIg does not reverse established weakness in MS. Measurements of isometric muscle strength were reliable (reproducible) indices of strength and may be sensitive, objective methods to document functional changes in impairment in future MS trials.

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