GAMMAGARD LIQUID is indicated as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN). GAMMAGARD LIQUID for MMN is for intravenous use only.

Intended for US Healthcare Professionals only

    GAMMAGARD LIQUID 

    MMN Clinical Trial Results

    MMN=Multifocal Motor Neuropathy.

    Study design

    Largest controlled clinical trial for MMN to date1

    A phase III, randomized withdrawal, double-blind, placebo-controlled, cross-over, 60-week study to assess the efficacy, safety, and tolerability of GAMMAGARD LIQUID in 44 adult patients with MMN.1

    Open-label GAMMAGARD LIQUID

    Graph of 12-week open-label data.

    Patients were randomized 1:1 to either double-blind treatment of GAMMAGARD LIQUID followed by placebo for 12 weeks each or the reverse. Open-label IVIG was administered for 12 weeks at the beginning and end of the study for clinical stabilization, and between double-blinded periods to prevent a carry-over effect.1,2

    Efficacy endpoints

    The coprimary efficacy endpoints were maximal grip strength in the more affected hand measured with a DynEx digital dynamometer, and disability as determined by the upper limb portion of GNDS.1,2 

    Secondary efficacy outcomes included requirement for accelerated switch, and time required for the 9-hole peg board test with the dominant and non-dominant hand.1 

    GNDS=Guy’s Neurological Disability Scale. 

    Improved grip strength2

    GAMMAGARD LIQUID significantly improved grip strength in the more affected hand compared with placebo.2 

    The difference in relative change in mean grip strength for GAMMAGARD LIQUID and placebo of 22.30% (95% CI 9.92–34.67) was statistically significant (P<0.001).2* 

    SEQUENCE 1: GAMMAGARD LIQUID to placebo

    Placebo -30.52% (SD 29.68); GAMMAGARD LIQUID -16.36% (SD 32.84).2

    Relative mean change calculated by subtracting the GAMMAGARD LIQUID value from the placebo value.

    SEQUENCE 2: Placebo to GAMMAGARD LIQUID

    GAMMAGARD LIQUID +1.46% (SD 10.72); placebo -29.19% (SD 39.95).2

    Relative mean change calculated by subtracting the placebo value from the GAMMAGARD LIQUID value.

    *Measured in the more affected hand following treatment (ITT; N=41).

    CI=confidence interval; GNDS=Guy’s Neurological Disability Scale; ITT=intent to treat; SD=standard deviation.

    Graph depicting relative mean change in grip strength.

    Click for Important Safety Information

    Reduced disability1,2 

    Three times more patients receiving placebo had worsening disability than those receiving GAMMAGARD LIQUID (P=0.021).1,2 

    Proportion of patients who deteriorated according to the upper limbs section of the GNDS (%) 

    Reduced disability image.

    Adapted from Hahn et al. 2023.1 ITT; N=42.

    Demonstrated efficacy in dexterity1,2 

    GAMMAGARD LIQUID maintained dexterity, measured by time to complete 9-hole peg board test, compared with a decrease in dexterity with placebo (P<0.001).1,2 

    9-hole peg board test image.

    Adapted from Hahn et al. 2023.1

    9-hole peg board test results 

    With the dominant hand, subjects required: 

    • 17% longer to complete the 9-hole peg test (a measure of dexterity) at the end of the placebo period compared with baseline1,2 
    • 1.2% longer to complete the 9-hole peg test at the end of the GAMMAGARD LIQUID treatment period compared with baseline1,2 

    With the non-dominant hand, subjects required: 

    • 33% longer to complete the 9-hole peg test at the end of the placebo period compared with baseline1,2 
    • 6.7% longer to complete the 9-hole peg test at the end of the GAMMAGARD LIQUID treatment period compared with baseline1,2 

    Functional deterioration: accelerated switch1,2

    Over two-thirds of patients required an accelerated switch from blinded treatment to open-label GAMMAGARD LIQUID vs one patient treated with GAMMAGARD LIQUID (P<0.001).1,2

    Accelerated switch graph.

    Adapted from Hahn et al. 2023.1

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    References:

    1. Hahn AF, Beydoun SR, Lawson V, et al. A controlled trial of intravenous immunoglobulin in multifocal motor neuropathy.  J Peripher Nerv Syst. 2013;18(4):321-330. 
    2. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%. Prescribing Information. Takeda Pharmaceuticals U.S.A., Inc.; 2024.