Effectiveness and safety of Lanadelumab according to disease activity: pooled analysis of EMPOWER/ENABLE

Abstract

Methods: Patients with HAE type I/II, aged ≥12 years, were included from the EMPOWER and ENABLE studies, who received lanadelumab at the approved dose and had data on the initial attack rate. Subgroups were created based on baseline HAE activity (moderate: ≥1 to <2, high: ≥2 to <3, very high: ≥3 attacks/month). The effectiveness of lanadelumab was measured by the reduction in monthly attacks compared to baseline. Safety was assessed by treatment-emergent adverse events (TEAEs).

Results: A total of 123 patients were analyzed, divided into subgroups by baseline activity: moderate (29), high (15), and very high (79). The mean follow-up duration ranged from 577.5 ± 251.7 days (moderate) to 741.1 ± 281.0 days (high). Average HAE attack rates decreased in all three subgroups after lanadelumab initiation: moderate (1.3 ± 0.3 to 0.3 ± 0.4), high (2.0 ± 0.2 to 0.5 ± 0.5), and very high (5.8 ± 3.0 to 0.4 ± 0.7). TEAEs were not severe, mild/moderate, and unrelated to lanadelumab treatment.

Conclusion: HAE attack rates decreased after lanadelumab initiation, regardless of baseline activity. Safety was similar across groups; most TEAEs were mild and unrelated to treatment. These data support lanadelumab as a first-line option for long-term prophylaxis.

Keywords: Lanadelumab; EMPOWER; Enable; Hereditary angioedema; Disease activity.