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

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.

• Authors: William R Lumry, Henriette Farkas, Dumitru Moldovan, Elias Toubi, Jovanna Baptista, Timothy Craig, Marc Riedl
• Journal: International archives of allergy and immunology (Int Arch Allergy Immunol) Vol. 168 Issue 1 Pg. 44-55 ( 2015) ISSN: 1423-0097 [Electronic] Switzerland
• PMID: 26556097 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 S. Karger AG, Basel.

Chemical References

• Bradykinin B2 Receptor Antagonists
• icatibant
• Bradykinin

Topics

• Adult
• Angioedemas, Hereditary (drug therapy)
• Bradykinin (adverse effects, analogs & derivatives, therapeutic use)
• Bradykinin B2 Receptor Antagonists (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Injections, Subcutaneous (methods)
• Male
• Prospective Studies
• Recurrence
• Treatment Outcome