TY - JOUR
T1 - Analysis of hereditary angioedema attacks requiring a second dose of ecallantide
AU - Li, H. Henry
AU - Campion, Marilyn
AU - Craig, Timothy
AU - Soteres, Daniel F.
AU - Riedl, Marc
AU - Lumry, William R.
AU - Macginnitie, Andrew J.
AU - Shea, Elizabeth P.
AU - Bernstein, Jonathan A.
N1 - Funding Information:
Funding Sources: This study was funded by Dyax Corp , Burlington, Massachusetts.
Copyright:
Copyright 2013 Elsevier B.V., All rights reserved.
PY - 2013/3
Y1 - 2013/3
N2 - Background: Effective treatment of acute attacks is critical in managing hereditary angioedema (HAE). Ecallantide, a plasma kallikrein inhibitor, is approved for the treatment of HAE attacks. Occasionally, a second dose is needed when treating attacks of HAE. Objective: To evaluate the characteristics of HAE attacks requiring a second dose (dose B) of ecallantide. Methods: Data from all ecallantide clinical trials (EDEMA2, EDEMA4, and DX-88/19) that allowed an open-label dose B were included in this analysis. Patient and attack characteristics potentially predictive of dose B after ecallantide were analyzed by logistic regression. A multivariate model was built using a backward selection process, incorporating variables from the univariate model with P <.20 and removing factors with the highest P value until only significant (P <.05) factors remained. Results: The analysis included 732 ecallantide-treated HAE attacks in 179 patients. Dose B was required in 88 attacks (12.0%), most (80.5%) for incomplete response. By attack location, 31 of 325 abdominal attacks (9.5%), 17 of 158 laryngeal attacks (10.8%), and 40 of 242 peripheral attacks (16.5%) required dose B. On the basis of the univariate analysis, baseline severity (odds ratio = 1.33, P =.15) and peripheral attack (odds ratio = 1.80, P =.01) were identified as potential predictive factors; abdominal attacks had an inverse correlation (odds ratio = 0.64, P =.055). However, the multivariate analysis identified only peripheral attacks as statistically significantly correlated (P <.05) with dose B requirement. Conclusion: A single, 30-mg dose of ecallantide was effective for most HAE attacks (88.0%). Patients with peripheral attacks of HAE were more likely to require a second dose of ecallantide after 4 hours. Trial Registration: clinicaltrials.gov Identifiers: not applicable for EDEMA2 (trial was conducted before registration requirements were implemented), NCT00457015 for EDEMA4, and NCT00456508 for DX-88/19.
AB - Background: Effective treatment of acute attacks is critical in managing hereditary angioedema (HAE). Ecallantide, a plasma kallikrein inhibitor, is approved for the treatment of HAE attacks. Occasionally, a second dose is needed when treating attacks of HAE. Objective: To evaluate the characteristics of HAE attacks requiring a second dose (dose B) of ecallantide. Methods: Data from all ecallantide clinical trials (EDEMA2, EDEMA4, and DX-88/19) that allowed an open-label dose B were included in this analysis. Patient and attack characteristics potentially predictive of dose B after ecallantide were analyzed by logistic regression. A multivariate model was built using a backward selection process, incorporating variables from the univariate model with P <.20 and removing factors with the highest P value until only significant (P <.05) factors remained. Results: The analysis included 732 ecallantide-treated HAE attacks in 179 patients. Dose B was required in 88 attacks (12.0%), most (80.5%) for incomplete response. By attack location, 31 of 325 abdominal attacks (9.5%), 17 of 158 laryngeal attacks (10.8%), and 40 of 242 peripheral attacks (16.5%) required dose B. On the basis of the univariate analysis, baseline severity (odds ratio = 1.33, P =.15) and peripheral attack (odds ratio = 1.80, P =.01) were identified as potential predictive factors; abdominal attacks had an inverse correlation (odds ratio = 0.64, P =.055). However, the multivariate analysis identified only peripheral attacks as statistically significantly correlated (P <.05) with dose B requirement. Conclusion: A single, 30-mg dose of ecallantide was effective for most HAE attacks (88.0%). Patients with peripheral attacks of HAE were more likely to require a second dose of ecallantide after 4 hours. Trial Registration: clinicaltrials.gov Identifiers: not applicable for EDEMA2 (trial was conducted before registration requirements were implemented), NCT00457015 for EDEMA4, and NCT00456508 for DX-88/19.
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U2 - 10.1016/j.anai.2012.12.004
DO - 10.1016/j.anai.2012.12.004
M3 - Article
C2 - 23548526
AN - SCOPUS:84875230696
SN - 1081-1206
VL - 110
SP - 168
EP - 172
JO - Annals of Allergy, Asthma and Immunology
JF - Annals of Allergy, Asthma and Immunology
IS - 3
ER -