Volume 10 Supplement 2

Canadian Society of Allergy and Clinical Immunology and AllerGen Abstracts 2014

Open Access

Analysis of icatibant for the treatment of laryngeal hereditary angioedema attacks in the FAST-3 study

  • William Yang1,
  • Jacques Hébert2,
  • Bruce Ritchie3,
  • Jovanna Baptista4,
  • Marc Riedl5 and
  • William R Lumry6
Allergy, Asthma & Clinical Immunology201410(Suppl 2):A51

https://doi.org/10.1186/1710-1492-10-S2-A51

Published: 18 December 2014

Background

The efficacy and safety of icatibant for the treatment of edematous hereditary angioedema (HAE) attacks was established in three Phase III trials, including the For Angioedema Subcutaneous Treatment-3 study (FAST-3; NCT00912093). Here, data from the double-blind, controlled phase and open-label extension (OLE) of FAST-3 were analyzed post-hoc to specifically evaluate icatibant for the treatment of laryngeal attacks, which can cause potentially fatal airway obstruction.

Methods

Controlled phase: adults with HAE type I/II were randomized to a single subcutaneous injection of icatibant 30 mg or placebo for their first mild-to-moderate laryngeal attack or moderate-to-very severe cutaneous/abdominal attack; severe laryngeal attacks were treated with open-label icatibant. OLE: attacks were treated with up to three icatibant injections, at ≥6-hour intervals. Three outcomes were analyzed for first icatibant-treated laryngeal attacks: 1) time to onset of symptom relief (earliest of three consecutive measurements for which there was a 50% reduction of patient–assessed 5-symptom composite 100 mm visual analog scale [VAS]); 2) time to almost complete symptom relief (earliest of three consecutive measurements for which all VAS symptom scores <10 mm); 3) patient- and investigator-assessed time to initial symptom improvement. Reinjection rates were also recorded.

Results

For first icatibant-treated laryngeal attacks in the controlled phase or OLE (n=27), median (95% CI) time to onset of symptom relief was 2.0 (1.5-3.5) hours, median (95% CI) time to almost complete symptom relief was 6.0 (3.0–24.3) hours, and median (95% CI) patient- and investigator-assessed time to initial symptom improvement was 0.7 (0.4-0.9) and 0.8 (0.5-1.1) hours, respectively. In the OLE, 41/43 (95.3%) laryngeal attacks were treated with one icatibant injection, 2/43 (4.7%) were treated with two injections, and none required three injections.

Conclusions

Icatibant provided symptom relief for mild-to-severe laryngeal HAE attacks in FAST-3. In the OLE, almost all laryngeal attacks were treated with one injection only.

Authors’ Affiliations

(1)
Allergy & Asthma Research Centre
(2)
Centre de Recherche Appliquée en Allergie de Québec
(3)
University of Alberta
(4)
Shire
(5)
University of California - San Diego
(6)
AARA Research Center

Copyright

© Yang et al; licensee BioMed Central Ltd. 2014

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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