Repeat treatment with icatibant for multiple hereditary angioedema attacks: FAST-2 open-label study

M. Baş, J. Greve, T. K. Hoffmann, A. Reshef, W. Aberer, M. Maurer, S. Kivity, H. Farkas, B. Floccard, F. Arcoleo, L. Martin, B. Sitkauskiene, L. Bouillet, P. Schmid-Grendelmeier, H. Li, A. Zanichelli

Research output: Contribution to journalArticlepeer-review

34 Scopus citations


Background The For Angioedema Subcutaneous Treatment (FAST)-2, a phase III, double-blind, randomized, multicenter, placebo-controlled study ( identifier: NCT00500656), established the efficacy and safety of single injections of icatibant, a bradykinin B2 receptor antagonist, in the treatment of hereditary angioedema (HAE) attacks. Here, we evaluate the efficacy and safety of repeated treatment with icatibant in adult patients experiencing HAE attacks during the FAST-2 open-label extension (OLE) phase. Methods Patients completing the controlled phase were eligible to participate in the OLE phase and receive open-label icatibant (30 mg subcutaneously) for the treatment of cutaneous, abdominal, and/or laryngeal HAE attack(s) severe enough to warrant treatment. Time to onset of symptom relief was calculated for each attack. Descriptive analyses (median, 95% CIs) were performed for all attacks; post hoc analyses were conducted in patients with at least five icatibant-treated attacks throughout the FAST-2 OLE phase. Safety was also monitored. Results Fifty-four patients received icatibant for 374 attacks (176 cutaneous, 168 abdominal, and 30 laryngeal). For cutaneous and/or abdominal attacks (attacks 2-5), the median times to onset of symptom relief ranged between 2.0 and 2.5 h. For all laryngeal attacks, the median times to regression (start of improvement) of symptoms ranged between 0.3 and 4.0 h. Post hoc analyses showed that the overall median time to onset of symptom relief was 2.0 h. Overall, 89.8% of attacks resolved with a single icatibant injection. No drug-related serious adverse events were reported. Conclusions These findings have demonstrated the efficacy and safety of repeated icatibant treatment for HAE attacks.

Original languageEnglish (US)
Pages (from-to)1452-1459
Number of pages8
JournalAllergy: European Journal of Allergy and Clinical Immunology
Issue number11
StatePublished - Nov 2013
Externally publishedYes


  • For Angioedema Subcutaneous Treatment-2 (FAST-2)
  • bradykinin B receptor antagonist
  • hereditary angioedema
  • icatibant
  • open-label extension phase

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology


Dive into the research topics of 'Repeat treatment with icatibant for multiple hereditary angioedema attacks: FAST-2 open-label study'. Together they form a unique fingerprint.

Cite this