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

• Autores: 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.
• Año de publicación: 2014
• Idioma: inglés
• Tipo de recurso: artículo
• Materia: Bradykinin B2 Receptor Antagonist; C1-Inhibitor Deficiency; Fast-1; Hereditary Angioedema; Icatibant; Ole Phase
• Institución: Consejo Nacional de Investigaciones Científicas y Técnicas

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.
Fil: Malbrán, Alejandro. Hospital Británico de Buenos Aires. Servicio de Alergia e Inmunología Clínica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Riedl, M.. University of California at Los Angeles; Estados Unidos
Fil: Ritchie, B.. University of Alberta; Canadá
Fil: Smith, W. B.. Royal Adelaide Hospital. Clinical Immunology and Allergy; Australia
Fil: Yang, W.. Allergy and Asthma Research Centre; Canadá
Fil: Banerji, A.. Harvard Medical School; Estados Unidos
Fil: Hébert, J.. Centre de Recherche Appliquée en Allergie de Québec; Canadá
Fil: Gleich, G. J.. University of Utah; Estados Unidos
Fil: Hurewitz, D.. Allergy Clinic of Tulsa; Estados Unidos
Fil: Jacobson, K. W.. Allergy and Asthma Research Group; Estados Unidos
Fil: Bernstein, J. A.. University of Cincinnati; Estados Unidos
Fil: Khan, D. A.. University of Texas. Southwestern Medical Center; Estados Unidos
Fil: Kirkpatrick, C. H.. University of Colorado. Health Science Center; Estados Unidos
Fil: Resnick, D.. Columbia University; Estados Unidos
Fil: Li, H.. Shire; Estados Unidos
Fil: Fernández Romero, D. S.. Hospital Británico de Buenos Aires; Argentina
Fil: Lum, W.. AARA Research Centre; Estados Unidos