Safety

There were no significant findings or between-group differences in the variety of standard clinical lab studies. Adverse events occurred at similar frequencies in both control and placebo patients, and the most common adverse events were upper respiratory tract infection, rash, and injection site reaction. The most common adverse reactions requiring intervention were infusion-related reactions, particularly flushing. Clinically significant infusion reactions were observed in some patients that were manageable with premedica-tions and infusion slowing. One patient with severe respiratory insufficiency and airway compromise needed an emergency tracheostomy due to an airway problem during a reaction. This event in one patient did end up in the label for Aldurazyme. Antibodies to rhIDU developed in 20 out of 22 patients (91%), and the mean time to conversion was 52.6 d. By the end of the study, many antibody titers were declining.

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