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Type: Journal article
Title: Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial
Author: Malbrán, A.
Riedl, M.
Ritchie, B.
Smith, W.B.
Yang, W.
Banerji, A.
Hébert, J.
Gleich, G.J.
Hurewitz, D.
Jacobson, K.W.
Bernstein, J.A.
Khan, D.A.
Kirkpatrick, C.H.
Resnick, D.
Li, H.
Fernández Romero, D.S.
Lumry, W.
Citation: Clinical and Experimental Immunology, 2014; 177(2):544-553
Publisher: Wiley-Blackwell
Issue Date: 2014
ISSN: 0009-9104
Statement of
A. Malbrán, M. Riedl, B. Ritchie, William. B. Smith, W. Yang, A. Banerji ... et al.
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.
Keywords: Bradykinin B2 receptor antagonist; C1‐inhibitor deficiency; FAST‐1; hereditary angioedema; icatibant; OLE phase
Rights: © 2014 British Society for Immunology.
DOI: 10.1111/cei.12358
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