Geographic, race disparities revealed in HAE clinical trials
Researchers call for 'global efforts' to improve trial inclusivity
Race and geographic disparities are common in clinical trials of hereditary angioedema (HAE), with non-white patients and countries outside the U.S. and Europe underrepresented, a study by an international team of researchers has found.
While participation from European and Asian nations in HAE trials has increased significantly in the last decade, that was not the case for “other geographies,” the study revealed, noting a lack of inclusion among people from countries in Africa and South America.
Moreover, more than 85% of participants in HAE trials worldwide are white individuals, data showed.
“Further global efforts to improve inclusiveness and advocate for more equitable HAE care and research should be encouraged,” the researchers wrote.
The study, “Disparities in geography and race in hereditary angioedema: Analysis of 64 trials & 4354 patients,” was published in The Journal of Allergy and Clinical Immunology: In Practice.
Race disparities primarily seen among Black, white patients
HAE is a rare disorder characterized by recurrent swelling attacks in the deeper layers of the skin or the mucus membranes lining the respiratory and gastrointestinal tracts. In severe cases, it can become life-threatening and require immediate medical attention.
Clinical trials have played a key transformative role in the management of HAE, enabling the approval of multiple medications to both prevent and treat swelling attacks. However, these studies have mostly been conducted in Western countries and enrolled a disproportionate number of white people as participants.
“As of now, the extent of racial and geographic disparities remains unknown,” the researchers wrote. “Therefore, we investigated changes in the proportion of participating countries and race in HAE trials over the past 2 decades.”
In their study, the team, led by researchers from Hong Kong, looked for Phase 2 and Phase 3 trials of HAE that had been registered on the U.S. National Library of Medicine trial registry in 2023, from January to September.
In total, the team found 64 trials encompassing 4,354 participants. The majority of the studies were conducted in countries in Europe (70.3%) and North America (67.2%).
Demographic data on the participants were available for 46 trials, involving a total of 3,222 patients. That data indicated the vast majority of participants were white individuals (88%), with 6.9% being Asian patients and 2.7% being Black patients.
The researchers then divided the trials into two groups according to their start date — from 2003 to 2010, and from 2011 to 2023 — and compared the characteristics of patients in the two groups.
Compared with trials started sometime in the earlier decade, those conducted more recently had a significant increase in the participation of individuals from Asia and Europe, but not from other geographical regions. Participation rates in Asia increased from 16% to 61.5%, while those in Europe increased from 56% to 79.5%. Increases primarily were seen in countries like Germany and Japan.
We hope that by increasing awareness of the vast disparities in clinical care and research, more global efforts to improve inclusiveness and narrow disparities for HAE patients can be encouraged in the future.
In terms of race, the proportion of Asian participants increased from 1.4% to 7.8%. However, the proportion of Black participants in fact decreased, from more than 3% to slightly more than 2.5%. White participants were always the majority, making up approximately 90% of the patients participating in clinical trials across both decades.
In the last decade, a shift in racial groups also was observed, with the proportion of white participants dropping from 89.9% in 2014-2018 to 75.3% in 2019-2023. In the same period, the proportion of Asian patients increased from 4.9% to 22.4% and that of Black patients dropped from 3.2% to 2.6%.
“Racial disparities in HAE trials have significantly improved but remain pervasive,” even though “HAE affects patients of all races, ethnicities and geographies,” the researchers wrote.
“We hope that by increasing awareness of the vast disparities in clinical care and research, more global efforts to improve inclusiveness and narrow disparities for HAE patients can be encouraged in the future.”
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