Kuwabara S, et al. - Experts assessed the efficacy and safety of intravenous immunoglobulin (IVIg) (1.0 g/kg) every 3 weeks for 52 weeks in patients with multifocal motor neuropathy (MMN). Maintenance treatment with 1.0 g/kg IVIg every 3 weeks was determined to be safe and efficacious for MMN patients up to 52 weeks.

Methods

• This was an open-label phase 3 clinical trial.
• A total of 13 MMN patients were recruited and given a maintenance dose (1.0 g/kg) every 3 weeks for 52 weeks after an induction IVIg therapy (0.4 g/kg/d for 5 consecutive days).
• The Medical Research Council (MRC) sum score and hand-grip strength at week 52 served as major outcome measures.

Results

• It was observed that at week 52, 11 of the 13 patients completed the study, and those 11 reported sustained improvement.
• The mean (SD) MRC sum score was 85.6 (8.7) at the baseline, and 90.6 (12.8) at week 52.
• Mean grip strength was 39.2 (30.0) kPa at baseline and 45.2 (32.8) kPa at week 52.
• Two patients dropped out, one due to dysphagia and, the other due to the decision of an investigator.
• Three patients developed coronary spasm, dysphagia, or inguinal herniation, stated as the serious adverse events, but not thought to be linked with the study drug.
• Other adverse effects were mild and were resolved by the end of the study.