Sustained Effectiveness With Long-Term Lanadelumab Treatment: An EMPOWER Subgroup Analysis

Document Type

Conference Proceeding

Publication Date

2-1-2025

Publication Title

J Allergy Clin Immunol

Abstract

Rationale: This post hoc subgroup analysis from the Phase IV observational, non-interventional, multicenter EMPOWER Study (NCT03845400) focused on outcomes in patients who had received ≥ 4 lanadelumab doses prior to enrollment (“established lanadelumab patients”). Methods: Enrolled patients had hereditary angioedema (HAE) Type I/II and were aged ≥ 12 years. Patient attack-diary data was used to calculate HAE attack rates, and treatment-emergent adverse events (TEAEs) were used to assess safety. Results: Ninety-one of 109 patients from EMPOWER with ≥ 1 lanadelumab dose and ≥ 1 post-baseline effectiveness assessment were established on lanadelumab (age 42.2±17.1 years [mean±SD], 69.2% female, 93.4% White, 79.1% HAE Type I). During the overall study period, established patients received lanadelumab treatment for 801.8±319.5 days (mean ± SD) and had an observed mean HAE attack rate of 0.20 (95% CI, 0.10-0.30) attacks/month. Most HAE attacks were mild or moderate in severity (77.7%) and were treated with HAE medications (81.3%), most frequently with icatibant. In the overall EMPOWER safety population (112 patients with ≥ 1 lanadelumab dose), 53 patients reported 139 TEAEs; of these, only 6 events in 2 patients were considered related to lanadelumab (tachycardia, 2 events in 1 patient; fatigue, 3 events in 2 patients; papular rash, 1 event in 1 patient). No injection site reactions were reported. Conclusions: Established lanadelumab patients from the real-world EMPOWER Study reported low HAE attack rates during the study, suggesting sustained lanadelumab effectiveness; lanadelumab safety was consistent with previous studies. These results add to the data supporting lanadelumab as a first-line long-term prophylaxis option.

Volume

155

Issue

2

First Page

1

Find It @ Sladen

Share

COinS