The Roche study confirms the effectiveness of Vabysmo in minorities

A study has shown that Roche’s diabetic macular edema (DME) therapy Vabysmo is effective in patients who identify as African American, Black, Hispanic and Latino, closing a gap in the data for the drug.

Vabysmo (faricimab) has been approved by the FDA for the treatment of DME since 2022 and quickly became one of the Swiss pharmaceutical group’s fastest growing products with sales of $1.1 billion in the first half of the year.

The new data from the ELEVATUM study is important because African American, Black, Hispanic and Latino peoples are generally underrepresented in clinical trials – and are also disproportionately affected by diabetes and at higher risk of developing DME, which is an important cause of eyesight. loss.

The study of 124 American subjects found that after one year of treatment with Vabysmo, they could read approximately two and a half lines (12.3 letters) more on an eye chart, a result consistent with the Phase 3 studies that approved the approval of Vabysmo supported. mainly white populations.

Furthermore, there was little difference between the different racial and ethnic groups included in ELEVATUM, proving that the drug can benefit patients regardless of their background. Safety data also revealed no difference between the groups and the population studied in larger studies, where no new safety events were recorded.

According to Roche, Hispanics and Latinos were the most likely to have severe DME at the start of the study, and also saw the most benefit — an increase of 14.1 letters, or about three lines on a graph — while black subjects saw an increase of 11. Saw 3 letters. improvement.

“As a physician who serves patients from these communities who are so often underrepresented in clinical trials, I felt it was important to participate in this groundbreaking study,” said researcher Jeremiah Brown of Retina Consultants of Texas, who presented the results. at the American Academy of Ophthalmology (AAO) in Chicago.

He added that the doctors behind the study “hope that the findings will inform and improve the care we provide to our patients every day in the clinic.”

Despite comprising 39% of the U.S. national population, racial and ethnic minority groups are more likely to suffer from chronic conditions but constitute only 2% of patients involved in biomedical research, revealing the urgent need to apply the principles of diversity fit, equity, and inclusion (DEI) in clinical research.

To attempt to address access barriers, ELEVATUM was conducted in sites serving a high proportion of African American, Black, Hispanic, and Latino populations in urban, rural, and community locations, broadening the patient recruitment network and obstacles such as low thresholds are overcome. health literacy and language barriers.

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