Safety

Hypersensitivity responses were observed in some patients during infusions but, in general, these responses declined or resolved with continued weekly therapy. One patient had several recurrences of fever and chills and four others had recurrent episodes of urticaria (hives) and, on occasion, symptoms of angioedema (swelling in the tongue or throat). No clinically significant adverse laboratory results were observed in the patients. All patients developed antibodies to the rhIDU; the titers peaked by 12 to 26 weeks and declined with time over 52 and 104 weeks. Further evaluations of these patients using epitope scanning technology confirmed that the patients tolerated all iduronidase epitopes over a 104-week period [29]. Complement activation was observed in four patients when comparing pre-and postinfusion specimens, but no significant clinical symptoms were observed. Peak consumption of complement occurred at weeks 6 and 12. By weeks 26 and 52, significant complement activation did not occur during infusions.

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