Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial.

Abstract

Hereditary angioedema (HAE) is characterized by potentially life-threatening recurrent episodes of oedema. The open-label extension (OLE) phase of the For Angioedema Subcutaneous Treatment (FAST)-1 trial (NCT00097695) evaluated the efficacy and safety of repeated icatibant exposure in adults with multiple HAE attacks. Following completion of the randomized, controlled phase, patients could receive open-label icatibant (30 mg subcutaneously) for subsequent attacks. The primary end-point was time to onset of primary symptom relief, as assessed by visual analogue scale (VAS). Descriptive statistics were reported for cutaneous/abdominal attacks 1-10 treated in the OLE phase and individual laryngeal attacks. Post-hoc analyses were conducted in patients with ≥ 5 attacks across the controlled and OLE phases. Safety was evaluated throughout. During the OLE phase, 72 patients received icatibant for 340 attacks. For cutaneous/abdominal attacks 1-10, the median time to onset of primary symptom relief was 1·0-2·0 h. For laryngeal attacks 1-12, patient-assessed median time to initial symptom improvement was 0·3-1·2 h. Post-hoc analyses showed the time to onset of symptom relief based on composite VAS was consistent across repeated treatments with icatibant. One injection of icatibant was sufficient to treat 88·2% of attacks; rescue medication was required in 5·3% of attacks. No icatibant-related serious adverse events were reported. Icatibant provided consistent efficacy and was well tolerated for repeated treatment of HAE attacks.

• Authors: A Malbrán, M Riedl, B Ritchie, W B Smith, W Yang, A Banerji, J Hébert, G J Gleich, D Hurewitz, K W Jacobson, J A Bernstein, D A Khan, C H Kirkpatrick, D Resnick, H Li, D S Fernández Romero, W Lumry
• Journal: Clinical and experimental immunology (Clin Exp Immunol) Vol. 177 Issue 2 Pg. 544-53 (Aug 2014) ISSN: 1365-2249 [Electronic] England
• PMID: 24749847 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 British Society for Immunology.

Chemical References

• Bradykinin Receptor Antagonists
• icatibant
• Bradykinin

Topics

• Adult
• Angioedemas, Hereditary (diagnosis, drug therapy)
• Bradykinin (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Bradykinin Receptor Antagonists
• Female
• Humans
• Male
• Middle Aged
• Retreatment
• Treatment Outcome
• Young Adult