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Antibody response in patients with Gaucher disease after repeated infusion
with macrophage-targeted glucocerebrosidase
SM Richards, TA Olson and JM McPherson
Genzyme Corp, Framingham, MA 01701.
Recent clinical data have shown that enzyme replacement therapy with
macrophage-targeted glucocerebrosidase (GCR) can be effective in treating
type 1 Gaucher disease. Sera from 262 patients, repeatedly infused with
GCR, were assessed for the presence of antibodies to this therapeutic
protein. Patient serum samples obtained at 3-month intervals were assessed
by enzyme-linked immunosorbent assay and those with values greater than two
standard deviations above the mean value obtained with a pool of normal
human sera were further characterized by radioimmunoprecipitation. At the
time of these analyses, the duration of patient treatment varied from 3
months to approximately 3 years. Of the 262 patients analyzed, 34 (12.9%)
showed IgG antibodies, as confirmed by radioimmunoprecipitation. All
patients who seroconverted did so within 1 year of treatment. The
predominant antibody developed was the IgG1 subclass. Fourteen patients in
the study experienced periodic symptoms suggestive of immediate
hypersensitivity. Nine of these 14 patients had antibody to GCR as
determined by radioimmunoprecipitation, whereas 5 patients were antibody
negative. There was no evidence of the development of IgE antibodies in
these 14 patients. The presence of GCR antibodies did not appear to effect
efficacy of therapy in any of the patients treated to date.
Volume 82,
Issue 5,
pp. 1402-1409,
09/01/1993
Copyright © 1993 by The American Society of Hematology
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