Icatibant for Multiple Hereditary Angioedema Attacks across the Controlled and Open-Label Extension Phases of FAST-3

William R. Lumry, H. Farkas, Dumitru Moldovan, Elias Toubi, Jovanna Baptista, Timothy Craig, Marc Riedl

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Background: In randomized, controlled, double-blind, multicenter phase 3 studies, one icatibant injection was efficacious and generally well tolerated in patients with a single hereditary angioedema (HAE) attack. Here, the efficacy and safety of icatibant for multiple HAE attacks was evaluated across the controlled and open-label extension phases of the For Angioedema Subcutaneous Treatment (FAST)-3 study (NCT00912093). Methods: In the controlled phase, adults with HAE type I or II were randomized (1:1) to receive a single subcutaneous injection of icatibant 30 mg or placebo within 6 h of an attack becoming mild (laryngeal) or moderate (cutaneous/abdominal). Open-label icatibant was administered for severe laryngeal symptoms. In the open-label extension phase, patients could receive up to three icatibant injections per attack. Efficacy and safety were analyzed for the first five icatibant-treated attacks at any location (prospective analysis) and laryngeal attacks (post hoc analysis) across both phases. Efficacy outcomes were based on patient-reported symptom severity (visual analog scale). Results: In groups of patients with one to five icatibant-treated attacks at any location (n = 88), the median times to onset of symptom relief, onset of primary symptom relief and almost complete symptom relief were 1.9-2.1, 1.5-2.0 and 3.5-19.7 h, respectively. The same outcomes for laryngeal attacks (n = 25) were 1.0-2.0, 1.0-2.0 and 1.5-8.1 h, respectively. The most frequently reported adverse events were a worsening or recurrence of HAE attack, headache and nasopharyngitis. Two serious adverse events (arrhythmia and noncardiac chest pain) were considered to be related to icatibant. Conclusions: Icatibant was efficacious and generally well tolerated across multiple HAE attacks, including laryngeal attacks.

Original languageEnglish
Pages (from-to)44-55
Number of pages12
JournalInternational Archives of Allergy and Immunology
DOIs
Publication statusAccepted/In press - Nov 11 2015

Fingerprint

Hereditary Angioedemas
Angioedema
Therapeutics
Hereditary Angioedema Types I and II
Nasopharyngitis
Safety
icatibant
Injections
Subcutaneous Injections
Chest Pain
Visual Analog Scale
Headache
Cardiac Arrhythmias
Placebos
Recurrence

Keywords

  • Abdominal
  • Acute treatment
  • C1-inhibitor deficiency
  • Cutaneous
  • FAST-3
  • Hereditary angioedema
  • Icatibant
  • Laryngeal
  • Open-label extension

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Icatibant for Multiple Hereditary Angioedema Attacks across the Controlled and Open-Label Extension Phases of FAST-3. / Lumry, William R.; Farkas, H.; Moldovan, Dumitru; Toubi, Elias; Baptista, Jovanna; Craig, Timothy; Riedl, Marc.

In: International Archives of Allergy and Immunology, 11.11.2015, p. 44-55.

Research output: Contribution to journalArticle

Lumry, William R. ; Farkas, H. ; Moldovan, Dumitru ; Toubi, Elias ; Baptista, Jovanna ; Craig, Timothy ; Riedl, Marc. / Icatibant for Multiple Hereditary Angioedema Attacks across the Controlled and Open-Label Extension Phases of FAST-3. In: International Archives of Allergy and Immunology. 2015 ; pp. 44-55.
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T1 - Icatibant for Multiple Hereditary Angioedema Attacks across the Controlled and Open-Label Extension Phases of FAST-3

AU - Lumry, William R.

AU - Farkas, H.

AU - Moldovan, Dumitru

AU - Toubi, Elias

AU - Baptista, Jovanna

AU - Craig, Timothy

AU - Riedl, Marc

PY - 2015/11/11

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N2 - Background: In randomized, controlled, double-blind, multicenter phase 3 studies, one icatibant injection was efficacious and generally well tolerated in patients with a single hereditary angioedema (HAE) attack. Here, the efficacy and safety of icatibant for multiple HAE attacks was evaluated across the controlled and open-label extension phases of the For Angioedema Subcutaneous Treatment (FAST)-3 study (NCT00912093). Methods: In the controlled phase, adults with HAE type I or II were randomized (1:1) to receive a single subcutaneous injection of icatibant 30 mg or placebo within 6 h of an attack becoming mild (laryngeal) or moderate (cutaneous/abdominal). Open-label icatibant was administered for severe laryngeal symptoms. In the open-label extension phase, patients could receive up to three icatibant injections per attack. Efficacy and safety were analyzed for the first five icatibant-treated attacks at any location (prospective analysis) and laryngeal attacks (post hoc analysis) across both phases. Efficacy outcomes were based on patient-reported symptom severity (visual analog scale). Results: In groups of patients with one to five icatibant-treated attacks at any location (n = 88), the median times to onset of symptom relief, onset of primary symptom relief and almost complete symptom relief were 1.9-2.1, 1.5-2.0 and 3.5-19.7 h, respectively. The same outcomes for laryngeal attacks (n = 25) were 1.0-2.0, 1.0-2.0 and 1.5-8.1 h, respectively. The most frequently reported adverse events were a worsening or recurrence of HAE attack, headache and nasopharyngitis. Two serious adverse events (arrhythmia and noncardiac chest pain) were considered to be related to icatibant. Conclusions: Icatibant was efficacious and generally well tolerated across multiple HAE attacks, including laryngeal attacks.

AB - Background: In randomized, controlled, double-blind, multicenter phase 3 studies, one icatibant injection was efficacious and generally well tolerated in patients with a single hereditary angioedema (HAE) attack. Here, the efficacy and safety of icatibant for multiple HAE attacks was evaluated across the controlled and open-label extension phases of the For Angioedema Subcutaneous Treatment (FAST)-3 study (NCT00912093). Methods: In the controlled phase, adults with HAE type I or II were randomized (1:1) to receive a single subcutaneous injection of icatibant 30 mg or placebo within 6 h of an attack becoming mild (laryngeal) or moderate (cutaneous/abdominal). Open-label icatibant was administered for severe laryngeal symptoms. In the open-label extension phase, patients could receive up to three icatibant injections per attack. Efficacy and safety were analyzed for the first five icatibant-treated attacks at any location (prospective analysis) and laryngeal attacks (post hoc analysis) across both phases. Efficacy outcomes were based on patient-reported symptom severity (visual analog scale). Results: In groups of patients with one to five icatibant-treated attacks at any location (n = 88), the median times to onset of symptom relief, onset of primary symptom relief and almost complete symptom relief were 1.9-2.1, 1.5-2.0 and 3.5-19.7 h, respectively. The same outcomes for laryngeal attacks (n = 25) were 1.0-2.0, 1.0-2.0 and 1.5-8.1 h, respectively. The most frequently reported adverse events were a worsening or recurrence of HAE attack, headache and nasopharyngitis. Two serious adverse events (arrhythmia and noncardiac chest pain) were considered to be related to icatibant. Conclusions: Icatibant was efficacious and generally well tolerated across multiple HAE attacks, including laryngeal attacks.

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KW - C1-inhibitor deficiency

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KW - Open-label extension

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