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Ecallantide (DX-88) for acute hereditary angioedema attacks: integrated analysis of 2 double-blind, phase 3 studies.

AbstractBACKGROUND:
Hereditary angioedema (HAE) is a rare disorder characterized by recurrent angioedema attacks. Ecallantide, a novel plasma kallikrein inhibitor, inhibits production of bradykinin, the key mediator of these angioedema attacks.
OBJECTIVE:
We sought to further characterize the safety and efficacy of ecallantide for HAE attacks by performing an integrated analysis of pooled data from 2 phase 3 studies.
METHODS:
An integrated analysis was conducted with data from 2 randomized, double-blind, placebo-controlled studies in which patients with HAE (age ≥10 years) received 30 mg of subcutaneous ecallantide or placebo within 8 hours of onset of a moderate-to-severe attack at any anatomic site. Efficacy was evaluated by using validated patient-reported outcome measures: the Mean Symptom Complex Severity (MSCS) score and the Treatment Outcome Score (TOS).
RESULTS:
Compared with placebo, ecallantide resulted in significantly greater reduction in MSCS scores from baseline to 4 hours after dosing (ecallantide [mean ± SD], -0.97 ± 0.78; placebo, -0.47 ± 0.71; P < .001) and a significantly greater increase in TOSs at 4 hours (ecallantide, 55.5 ± 46.5; placebo, 20.0 ± 58.9; P < .001). Significantly greater symptomatic improvement over placebo occurred through 24 hours after dosing (MSCS score, P = .028; TOS, P = .039). Ecallantide demonstrated efficacy at all attack sites. The incidence of treatment-emergent adverse events was similar between groups.
CONCLUSIONS:
This integrated analysis supports and expands on the results of the phase 3 studies. Ecallantide appears to be effective and well tolerated for the treatment of HAE attacks.
AuthorsAlbert L Sheffer, Marilyn Campion, Robyn J Levy, H Henry Li, Patrick T Horn, William E Pullman
JournalThe Journal of allergy and clinical immunology (J Allergy Clin Immunol) Vol. 128 Issue 1 Pg. 153-159.e4 (Jul 2011) ISSN: 1097-6825 [Electronic] United States
PMID21481442 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
Chemical References
  • Peptides
  • ecallantide
Topics
  • Acute Disease
  • Adult
  • Aged
  • Angioedemas, Hereditary (drug therapy)
  • Child
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Peptides (therapeutic use)
  • Treatment Outcome
  • Young Adult

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