Artículo
Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial
Malbrán, Alejandro
; 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.; Lum, W.
Fecha de publicación:
07/2014
Editorial:
Wiley
Revista:
Clinical and Experimental Immunology
ISSN:
0009-9104
e-ISSN:
1365-2249
Idioma:
Inglés
Tipo de recurso:
Artículo publicado
Clasificación temática:
Resumen
Hereditary angioedema (HAE) is characterized by potentially lifethreatening 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 icatibantrelated serious adverse events were reported. Icatibant provided consistent efficacy and was well tolerated for repeated treatment of HAE attacks.
Archivos asociados
Licencia
Identificadores
Colecciones
Articulos(SEDE CENTRAL)
Articulos de SEDE CENTRAL
Articulos de SEDE CENTRAL
Citación
Malbrán, Alejandro; Riedl, M.; Ritchie, B.; Smith, W. B.; Yang, W.; et al.; Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial; Wiley; Clinical and Experimental Immunology; 177; 2; 7-2014; 544-553
Compartir
Altmétricas