Analysis of hereditary angioedema attacks requiring a second dose of ecallantide

H. Henry Li, Marilyn Campion, Timothy J. Craig, Daniel F. Soteres, Marc Riedl, William R. Lumry, Andrew J. Macginnitie, Elizabeth P. Shea, Jonathan A. Bernstein

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)168-172
Number of pages5
JournalAnnals of Allergy, Asthma and Immunology
Volume110
Issue number3
DOIs
StatePublished - Mar 1 2013
Externally publishedYes

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Pulmonary and Respiratory Medicine

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    Li, H. H., Campion, M., Craig, T. J., Soteres, D. F., Riedl, M., Lumry, W. R., Macginnitie, A. J., Shea, E. P., & Bernstein, J. A. (2013). Analysis of hereditary angioedema attacks requiring a second dose of ecallantide. Annals of Allergy, Asthma and Immunology, 110(3), 168-172. https://doi.org/10.1016/j.anai.2012.12.004