Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks

for the HELP Investigators

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Lanadelumab demonstrated efficacy in preventing hereditary angioedema (HAE) attacks in the phase 3 HELP Study. Objective: To assess time to onset of effect and long-term efficacy of lanadelumab, based on exploratory findings from the HELP Study. Methods: Eligible patients with HAE type I/II received lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo. Ad hoc analyses evaluated day 0-69 findings using a Poisson regression model accounting for overdispersion. Least-squares mean monthly HAE attack rate for lanadelumab was compared with placebo. Intrapatient comparisons for days 0-69 versus steady state (days 70-182) used a paired t test for continuous endpoints or Kappa statistics for categorical endpoints. Results: One hundred twenty-five patients were randomized and treated. During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) vs placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs 1.66) and moderate/severe attacks (0.31-0.48 vs 1.33, all P ≤.001). More patients receiving lanadelumab vs placebo were attack free (37.9%-48.1% vs 7.3%) and responders (85.7%-100% vs 26.8%). During steady state, the efficacy of lanadelumab vs placebo was similar or improved vs days 0-69. Intrapatient differences were significant with lanadelumab 300 mg q4wks for select outcomes. Lanadelumab efficacy was durable—HAE attack rate was consistently lower vs placebo, from the first 2 weeks of treatment through study end. Treatment emergent adverse events were comparable during days 0-69 and 70-182. Conclusion: Protection with lanadelumab started from the first dose and continued throughout the entire study period.

Original languageEnglish (US)
Pages (from-to)2879-2887
Number of pages9
JournalAllergy: European Journal of Allergy and Clinical Immunology
Volume75
Issue number11
DOIs
StatePublished - Nov 1 2020

Keywords

  • durable efficacy
  • hereditary angioedema
  • long-term prophylaxis
  • onset of action

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Fingerprint Dive into the research topics of 'Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks'. Together they form a unique fingerprint.

Cite this