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Shire Presents Positive Efficacy and Safety Data for velaglucerase alfa in Treatment of Naive Patients With Type 1 Gaucher Disease
Date:2/11/2010

or the long-term clinical efficacy and safety of velaglucerase alfa," said Pramod Mistry, MD, PhD, FRCP, Professor of Pediatrics & Internal Medicine at Yale University School of Medicine. "The Gaucher community is very fortunate to have velaglucerase alfa as an option for patients."

Results from Study TKT032 in Adults and Children

TKT032 was a 12-month, randomized, double-blind, parallel-group global study in 25 treatment-naive patients aged two years and older that evaluated velaglucerase alfa at 45 U/kg and velaglucerase alfa at 60 U/kg. Patients were eligible to participate in the study if they presented with disease-related anemia and had at least one of the following clinical manifestations of Gaucher disease: thrombocytopenia, moderate splenomegaly or a readily palpable enlarged liver.

The primary endpoint was change in hemoglobin concentrations from baseline at 60 U/kg. Secondary endpoints for both doses were changes in platelet counts, changes in organ volumes, changes in surrogate markers of Gaucher disease, and for the 45 U/kg dose only, change in hemoglobin concentrations from baseline.

At 12 months, in the 60 U/kg group, statistically significant changes in mean hemoglobin concentration increased 23.3%, +2.43+/-0.32 g/dL, P< 0.0001; mean platelet count increased 65.9%, +50.9+/-12.2x10(9)/L, P=0.0016; and mean spleen volume decreased 50%, -1.92+/-0.51% body weight, P=0.0032, from 14.0 multiples of normal [MN] at baseline to 5.75 MN. Mean liver volume decreased 17%, -0.84+/-0.33% body weight, P=0.0282, from 1.46 to 1.22 MN.

Results for 45 U/kg were consistent with those observed with 60 U/kg; however a dose-related effect in favor of velaglucerase alfa at 60 U/kg was observed by platelet count increase and liver volume reduction between the 2 dose groups.

Adverse events
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SOURCE Shire plc
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