Characterization of XXXX After Ecallantide Treatment of @entity1659 Attacks.

@entity1 @entity1659 @entity10056 @entity566 @entity56 @entity375 @entity166 @entity2021
BACKGROUND: Ecallantide is a @entity1 plasma kallikrein inhibitor indicated for treatment of acute attacks of @entity1659 for @entity1 12 years of age and older. Ecallantide is produced in @entity10056 @entity375 cells by recombinant DNA technology. Use of ecallantide has been associated with a risk of @entity56 , including @entity2021 . OBJECTIVE: The objective of this detailed retrospective data review was to characterize @entity2021 cases within the ecallantide clinical trials database. METHODS: Potential cases of @entity56 in the ecallantide clinical development program were identified by examining reported adverse events. The National Institute of @entity566 and @entity166 criteria were used to identify those events that were consistent with @entity2021 ; these cases were then reviewed in detail. Results from investigational antibody testing also were examined. RESULTS: Among @entity1 who received subcutaneous ecallantide (n  = 230 @entity1 ; 1045 doses of 30 mg ecallantide), 8 @entity1 (3.5%) had reactions that met the National Institute of @entity566 and @entity166 criteria for @entity2021 ; none occurred on first exposure to the drug. All 8 reactions had symptom onset within 1 hour of exposure and cutaneous manifestations commonly observed in @entity56 . All the reactions responded to standard management of @entity56 and resolved without fatal outcomes. IgE antibody testing to ecallantide or @entity10056 was not consistently positive in @entity1 who experienced apparent @entity56 . CONCLUSION: @entity2021 episodes after subcutaneous ecallantide exposure have clinical features suggestive of @entity56 . However, anti-ecallantide or anti-P pastoris IgE antibody status was not found to be reliably associated with @entity2021 .
