Study design of the pivotal 60-week trial 2

Primary efficacy endpoints were mean grip strength in the more affected hand (measured using a digital dynamometer) and deterioration of the upper-limbs [measured using the upper-limb subsection of Guy's Neurological Disability Scale (GNDS)].2

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  • Randomized withdrawal, double-blind, placebo-controlled, cross-over study consisted of five 12-week periods to evaluate the efficacy and safety/tolerability of GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% in 44 adult patients with MMN1
  • Patients were maintained on a stable regimen of intravenous immunoglobulin (existing maintenance dose ranging from 0.5 to 2.0 grams/kg/month) prior to enrollment, therefore the results cannot be generalized to IVIG-naive patients1
  • If a patient's function deteriorated, such that the patient had difficulty in activities of daily living or if a patient experienced ≥50% decline in grip strength in the more affected hand, he or she could move to the next open-label stabilization phase of GAMMAGARD LIQUID ("accelerated switch," a prespecified secondary endpoint) without breaking the blind1
69%
of patients (n=29) required an accelerated switch from placebo to GAMMAGARD LIQUID due to functional deterioration—some in as few as 7 days rather than the planned 12-week schedule (P<0.001)1,2*

*One patient (2.4%) switched to open-label treatment during GAMMAGARD LIQUID blinded cross-over period and did not switch during placebo administration and 28.6% (n= 12) did not switch.1

CI=confidence interval; SD=standard deviation.

References:

  1. Data on file, Baxter Healthcare Corporation. 2011.
  2. Gammagard Liquid [Immune Globulin Infusion (Human)] 10% [package insert]. Westlake Village, CA: Baxter Healthcare Corporation.

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Selected Important Safety Information about GAMMAGARD LIQUID
  • GAMMAGARD LIQUID can cause decreased kidney function or kidney failure, blood clots in the heart, brain, lungs or elsewhere in the body. Call your healthcare professional or go to your emergency department right away if you have: Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem. Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
  • Do not take GAMMAGARD LIQUID if you have a known history of a severe allergic reaction to IgG or other blood products.