Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Riedl, MA; Maurer, M; Bernstein, JA; Banerji, A; Longhurst, HJ; Li, HH; Lu, P; Hao, J; Juethner, S; Lumry, WR; HELP Investigators,

Published Date

  • November 2020

Published In

Volume / Issue

  • 75 / 11

Start / End Page

  • 2879 - 2887

PubMed ID

  • 32452549

Pubmed Central ID

  • PMC7689768

Electronic International Standard Serial Number (EISSN)

  • 1398-9995

Digital Object Identifier (DOI)

  • 10.1111/all.14416


  • eng

Conference Location

  • Denmark