NEWS HIGHLIGHTSMedia Articles Related to Cerezyme (Imiglucerase)
Gene Behind Gaucher Disease a Player in Parkinson's
Source: MedicineNet Gaucher Disease Specialty [2009.10.22]
Title: Gene Behind Gaucher Disease a Player in Parkinson's
Category: Health News
Created: 10/21/2009 4:10:00 PM
Last Editorial Review: 10/22/2009
Published Studies Related to Cerezyme (Imiglucerase)
A randomized trial comparing the efficacy and safety of imiglucerase (Cerezyme) infusions every 4 weeks versus every 2 weeks in the maintenance therapy of adult patients with Gaucher disease type 1. [2009.04]
Imiglucerase (Cerezyme) has been the standard of care for treatment of Gaucher disease, a lysosomal storage disorder resulting from deficiency of glucocerebrosidase, since its approval in 1994. Infusions are typically given once every 2 weeks... Continued monitoring in patients treated with Q4 dosing is required to assess long-term effectiveness.
Low frequency maintenance therapy with imiglucerase in adult type I Gaucher disease: a prospective randomized controlled trial. [2007.02]
BACKGROUND AND OBJECTIVES: Gaucher disease type I can be successfully treated with enzyme replacement therapy (ERT). In order to reduce the burden of the intravenously administered enzyme, a low frequency of administration was prospectively studied in patients with stable and minor disease following ERT... CONCLUSIONS: Low frequency ERT in adult Gaucher type I patients maintains stable disease in most, but not all patients with stable and minimal disease. Close monitoring of all disease parameters remains mandatory.
A randomized trial comparing the efficacy and safety of imiglucerase (Cerezyme) infusions every 4 weeks versus every 2 weeks in the maintenance therapy of adult patients with Gaucher disease type 1. [2009.02.03]
Imiglucerase (Cerezyme((R))) has been the standard of care for treatment of Gaucher disease, a lysosomal storage disorder resulting from deficiency of glucocerebrosidase, since its approval in 1994. Infusions are typically given once every 2 weeks... Continued monitoring in patients treated with Q4 dosing is required to assess long-term effectiveness.
Dose-response relationships for enzyme replacement therapy with imiglucerase/alglucerase in patients with Gaucher disease type 1. [2009.02]
PURPOSE: To determine whether enzyme therapy with imiglucerase/alglucerase demonstrates dose-response relationships with doses and disease parameters used in routine clinical practice for Gaucher disease type 1 patients... CONCLUSIONS: Enzyme therapy with imiglucerase/alglucerase displays a dose-dependent improvement in hematological and visceral parameters in Gaucher disease type 1 patients. Group C displayed greater treatment effects than Groups A or B. Propensity score matching and nonlinear mixed effects model analyses provide a prototype for assessment of treatment outcomes based on observational data from international rare disease registries.
A benchmark analysis of the achievement of therapeutic goals for type 1 Gaucher disease patients treated with imiglucerase. [2008.12]
To assess the extent to which patients with type 1 Gaucher disease (GD1) receiving individualized enzyme replacement therapy with imiglucerase attain six defined therapeutic goals. One hundred and ninety-five GD1 patients enrolled in the ICGG Gaucher Registry, all of whom had data available for hemoglobin, platelet count, liver volume, spleen volume, bone pain, and bone crises at first infusion and after 4 years of therapy with imiglucerase, were evaluated for achievement of published therapeutic goals.
Clinical Trials Related to Cerezyme (Imiglucerase)
Safety and Efficacy of Cerezyme® Infusions Every 4 Weeks Versus Every 2 Weeks in Type 1 Gaucher Disease [Completed]
This is a multicenter, randomized trial to compare the safety and efficacy of two dosing
frequencies of Cerezyme® in patients with Gaucher disease who are currently being treated
with Cerezyme®.
Approximately 90 patients will be randomized in a 2: 1 (q4 : q2) ratio to one of two treatment
arms at up to 26 study centers worldwide. Patients will continue to receive the same total
4-week dose that they were receiving prior to study enrollment, however, they will be
randomized to receive either their total 4-week dose in two infusions, one infusion every 2
weeks or their total 4-week dose in one infusion every 4 weeks. The randomization scheme
will ensure a 2: 1 balance between the every 4-week versus every 2-week infusion groups,
respectively.
A Multicenter Study of the Efficacy of Cerezyme in Testing Skeletal Disease in Patients With Type I Gaucher Disease. [Completed]
This is a multicenter, open-label, prospective study of the efficacy of Cerezyme in treating
patients with skeletal manifestations secondary to Type I Gaucher disease.
The study objective is to evaluate and quantify skeletal responses as compared to baseline in
Type I gaucher disease patients receiving Cerezyme therapy for 48 months. Additional
objectives were to assess the usefulness of various skeletal parameters, such as bone pain,
bone crises, bone mineral density, and serum and urine bone markers, as indicative of
treatment response and may be useful in dose management.
Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) ERT Compared With Imiglucerase in Type I Gaucher Disease [Recruiting]
Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme
glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside
accumulates within macrophages leading to cellular engorgement, organomegaly, and organ
system dysfunction. The purpose of this study is to evaluate the efficacy and safety of
GA-GCB (velaglucerase alfa) administered every other week in comparison to imiglucerase in
treatment naive patients with type 1 Gaucher disease.
A Study of Genz-112638 in Patients With Gaucher Disease Who Have Been Stabilized on Cerezyme [Recruiting]
This Phase 3 study was designed to confirm the efficacy and safety of Genz-112638 in
patients with Gaucher disease type 1 who have been stabilized on Cerezyme
Study of GA-GCB Enzyme Replacement Therapy in Type 1 Gaucher Disease Patients Previously Treated With Imiglucerase [Recruiting]
Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme
glucocerebrosidase (GCB). Due to the deficiency of functional GCB, glucocerebroside
accumulates within macrophages leading to cellular engorgement, organomegaly, and organ
system dysfunction. The purpose of this study is to evaluate the safety and efficacy of every
other week dosing of GA-GCB (velaglucerase alfa) in patients with type 1 Gaucher disease who
were previously treated with imiglucerase.
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