Statistically Significant Improvement in Functioning Compared to Placebo in Primary Efficacy Endpoints 1

In the pivotal clinical trial, GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%:

RELATIVE CHANGE IN GRIP STRENGTHa

  • The difference in relative change in mean grip strength for GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% and placebo of 22.30% (95% CI: 9.92% to 34.67%) was statistically significant (P<0.001)1

DETERIORATION IN GNDSa

  • 3 times more patients on placebo (35.7%) showed deterioration of the upper limbs versus patients on GAMMAGARD LIQUID (11.9%)(P=0.021)1
  • As determined by GNDS scores that include tasks of daily living, including tying shoestrings, zipping and buttoning clothing, and hair washing 1,3

Results Favor GAMMAGARD LIQUID over Placebo in Prespecified Secondary Efficacy Endpoints 1,2

In the pivotal clinical trial, GAMMAGARD LIQUID:

  • 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. By contrast, at the end of the GAMMAGARD LIQUID treatment period, subjects required 1.2% longer to complete the 9-hole peg test for the dominant hand compared to baseline.
  • With the non-dominant hand, subjects required 33% longer to complete the 9-hole peg test at the end of the placebo period and 6.7% longer at the end of the GAMMAGARD LIQUID treatment period compared to baseline.

References:

  1. Gammagard Liquid [Immune Globulin Infusion (Human)] 10% [package insert]. Westlake Village, CA: Baxter Healthcare Corporation.
  2. Data on file, Baxter Healthcare Corporation. 2011.
  3. Sharrack B, Hughes RAC. The Guy's Neurological Disability Scale (GNDS): a new disability measure for multiple sclerosis. Mult Scler. 1999;5(4):223-233.

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Please expand for Indication and Detailed Important Safety Information.

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.