Analysis of hereditary angioedema attacks requiring a second dose of ecallantide

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

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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

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology
  • Pulmonary and Respiratory Medicine

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    Li, H. H., Campion, M., Craig, T., 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