Response to lanadelumab is not affected by race and ethnicity: findings from phase 3 studies

Abstract

Increasing attention has been drawn to racial and economic disparities in health care. We thus initiated an analysis to determine the impact of race and ethnicity on lanadelumab safety and efficacy. We searched the databases of the HELP and HELP OLE studies for minority subjects. In HELP, patients ≥12 years old with HAE-1/2 received placebo or lanadelumab (150mg Q4W, 300mg Q4W, 300mg Q2W) for 6 months. In HELP OLE, patients received one dose of 300mg lanadelumab on Day 1 then 300mg Q2W after their first attack (rollovers), or 300mg Q2W starting on Day 1 (nonrollovers) for ≤132 weeks. HELP OLE data collected up to 31August2018 were analyzed. HELP (N=125) included n=10 Black, n=2 Asian, and n=113 White patients; n=9 were Hispanic, and n=115 were non-Hispanic. HELP OLE (N=212) included n=10 Black, n=2 Asian, n=198 White, n=13 Hispanic, and n=198 non-Hispanic patients. In HELP, lanadelumab reduced attack rates from 2.0 attacks/month at baseline to 0.5 during treatment (79.0% reduction from baseline) in Black patients, and 3.7–0.4 (88.2%), 3.7–0.3 (92.5%), and 3.5–0.5 (84.1%) in White, Hispanic, and non-Hispanic patients, respectively. In HELP OLE, attack rates were reduced from 1.8–0.3 (78.3% reduction from baseline), 3.1–0.3 (87.4%), 3.4–0.1 (97.0%), and 3.0–0.3 (86.2%) attacks/month in Black, White, Hispanic, and non-Hispanic patients, respectively. Adverse event occurrence was comparable between race and ethnicity groups in both studies. Although there were few non-White and Hispanic patients enrolled in these studies, the response to lanadelumab was similar regardless of race and ethnicity.