Diabetic Eye Disease Worst in Hispanic, Latino Patients

CHICAGO — A post-market study of the retina drug faricimab that enrolled only minority populations historically underrepresented in drug clinical trials found Hispanic and Latino patients had worse disease upon enrollment but also benefited the most in terms of improvements in vision and anatomical markers of their condition, according to results reported at the 2024 Annual Meeting of the American Academy of Ophthalmology.

The ELEVATUM study evaluated the effect of faricimab (Vabysmo), a dual-action drug that targets two pathways in retina disease: Excessive vascular endothelial growth factor and angiopoietin-2. The study enrolled 59 African American patients and 56 Hispanic/Latino patients with previously untreated diabetic macular edema. The Food and Drug Administration approved faricimab in 2022.

“What we found was that Hispanic patients presented with thicker retinas and worse vision by a few letters, but with treatment according to the clinical trial protocol, they gained the most,” Jeremiah Brown, Jr, MS, MD, a retina specialist with Retina Consultants of Texas and the Brown Retina Institute in San Antonio and member of the research team, told Medscape Medical News.

ELEVATUM patients received intraocular injections of faricimab every 4 weeks for the first 2 weeks and then every 8 weeks afterward for a year, according to the drug label. The pivotal phase 3 trials of the drug used the same protocol.

ELEVATUM Trial Results

Upon enrollment, Hispanic and Latino patients had average best corrected visual acuity of 59.2 letters vs 62.2 for African American patients. Central subfield thickness, a key biomarker of retinal disease, was 491.1 microns vs 467.4 microns. The thicker the retina, the more severe the retinal disease.

The Hispanic/Latino patients also tended to have more severe diabetic retinopathy (DR) at baseline, with 39.3% having moderately severe to severe nonproliferative DR vs 13.6% among African American patients, and 16.1% having proliferative DR vs 8.5%, respectively.

With more room for improvement, Hispanic and Latino patients had a more robust response to treatment, Brown said. “They gained about 14 letters of vision over a 1-year period,” he said. “The visual gains were early and continued through the study. African American patients also gained; they didn’t gain as much, but they were starting from a better baseline.”

At 20 weeks, 39.5% of Hispanic and Latino patients had more than a two-step improvement in Diabetic Retinopathy Severity Scale score vs 11.5% of African American patients. At 1 year, that disparity was 41.5% and 17.6%, respectively.

The incidence of adverse events in the trial was in line with the pivotal clinical trials, Brown said. Three patients had mild iritis. They were treated with topical corticosteroids and continued in the study. One patient had endophthalmitis but no cases of vasculitis, Brown said.

The ELEVATUM study will continue with a long-term extension study evaluating extended durability outcomes.

“My take-home message is this: In this group of patients that we could think are going to be more difficult, that it’s going to be hard to get the results that we want to get, that actually if we treat them on label in a consistent manner we can get very good results in just 1 year, which is not always the case with diabetic retinopathy,” Brown said.

“These patients may present with worse disease, but don’t give up and be encouraging and be positive with your patients and tell them that there’s a good chance we’re going to improve your vision,” he added.

Roomasa Channa, MD, a retina specialist at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin, called the study design noteworthy. “In general, minorities are underrepresented in clinical trials, and therefore, it was good to see that this study specifically focused on enrolling minorities,” Channa said.

But she said she was interested in ways of making these treatments available to populations from different socioeconomic backgrounds.

“Race/ethnicity and social determinants of health are inextricably linked with each other in how they impact patient outcomes,” she said, citing her group’s own work that showed neighborhood socioeconomic disadvantage is linked to advanced DR.

“I would like to know what the barriers for these patients were to get these treatments and how did the study group address those barriers,” she added. “Studies have shown that Hispanic and non-Hispanic Black patients are more likely to have a lapse in care for diabetic retinopathy compared to Whites, and I think that is the root problem to address to reduce the high rates of vision loss in these populations.”

Whether these treatments will work in minority patients isn’t a question, Channa said, “but instead how to get these medically underserved populations access to effective treatments. With the growing number of patients with diabetes in the United States, many of them living in medically underserved communities, we can’t really ignore the problem of how to make treatments more accessible.”

The study was funded by Genentech/Roche. Brown disclosed financial relationships with Genentech/Roche, Regeneron Pharmaceuticals, Allergan/AbbVie, and Outlook Therapeutics. Channa reported no relevant financial disclosures.

Richard Mark Kirkner is a medical journalist based in the Philadelphia area.