- Meeting abstract
- Open Access
Analysis of icatibant for the treatment of laryngeal hereditary angioedema attacks in the FAST-3 study
Allergy, Asthma & Clinical Immunology volume 10, Article number: A51 (2014)
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.
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.
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.
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.
About this article
Cite this article
Yang, W., Hébert, J., Ritchie, B. et al. Analysis of icatibant for the treatment of laryngeal hereditary angioedema attacks in the FAST-3 study. All Asth Clin Immun 10, A51 (2014). https://doi.org/10.1186/1710-1492-10-S2-A51
- Airway Obstruction
- Symptom Relief
- Control Phase
- Consecutive Measurement