A new study suggests that lanadelumab may be safe and effective in ethnic and racial minority subgroups of patients with hereditary angioedema (HAE). However, the study, published in Allergy, Asthma & Clinical Immunology, notes that minority participants are poorly represented in clinical trials, which impedes the ability to reach firm conclusions.

“The majority of patients included in clinical trials for HAE are white; thus minorities are vastly underrepresented, which may lead to racial and ethnic disparities in healthcare for patients with HAE,” the authors wrote. “Findings from an analysis of the effectiveness and safety of lanadelumab in subgroups of race and ethnicity in these 2 phase 3 clinical studies are presented herein.”

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The research team analyzed data from the HELP (n=125) and HELP OLE (n=212) clinical studies, which enrolled patients aged 12 or more years with HAE type 1 or type 2 who received lanadelumab or placebo.

The vast majority of patients in both studies were White and non-Hispanic/non-Latino. The studies were conducted in the United States, Canada, Europe, and Jordan, but all participants of racial or ethnic minority origin were from the United States.

For both studies, the primary endpoint was the rate of HAE attacks compared with baseline. Both studies found that lanadelumab was effective in reducing the number of monthly HAE attacks across all racial and ethnic groups. Furthermore, the safety profile was similar across groups based on adverse event reporting.

However, the authors caution that the very small number of minority trial participants limits the power of the statistical analysis as well as the ability to draw firm conclusions about the effect of lanadelumab in any particular ethnic or racial group. They recommend targeted efforts to increase minority recruitment into clinical trials.

Reference

Craig TJ, Zaragoza-Urdaz RH, Li HH, et al; HELP and HELP OLE Study Investigators. Effectiveness and safety of lanadelumab in ethnic and racial minority subgroups of patients with hereditary angioedema: results from phase 3 studies. Allergy Asthma Clin Immunol. 2022;18(1):85. doi:10.1186/s13223-022-00721-y