In an unprecedented study, a new medicine showed positive effects in the treatment of atopic dermatitis moderate to severe in people with ethnic skin. In dermatology, the term is used to designate individuals from racial or ethnic groups with skin darker than Caucasian, such as Asians, Africans, people originating from the Americas and Pacific Islands.
The drug, lebrikizumab was developed by the pharmaceutical company Eli Lilly and Company and the results of the phase 3 study (carried out in humans to test safety and efficacy) were presented in March at the last annual meeting of the American Academy of Dermatology.
According to the study, 68% of participants showed an improvement in at least 75% of the extent and severity of the disease; 39% experienced improvement in the resolution of blemishes, and 55%, relief from itching in regions affected by atopic dermatitis.
The results of the research presented are consistent with data found in other phase 3 studies carried out with lebrikizumab, which reinforces the drug's potential for the treatment of moderate to severe atopic dermatitis following topical prescription therapies in ethnic skin.
Atopic dermatitis is a chronic and hereditary disease that causes the skin inflammation , leading to symptoms such as reddish spots, lesions and itching. Its exact cause is still unknown, but its origin is genetic. According to the Brazilian Society of Dermatology, the disease can be accompanied by asthma, rhinitis or conjunctivitis.
Lebrikizumab is an experimental monoclonal antibody that targets the inhibition of the protein (interleukin) responsible for the inflammation that results in the classic symptoms of atopic dermatitis.
“People with ethnic skin are disproportionately affected by atopic dermatitis, often experiencing more severe symptoms, delayed diagnosis and a longer time frame to find appropriate treatment. They have also historically been underrepresented in clinical trials, meaning there has been a lack of data regarding the treatment of these patients,” says Andrew Alexis, professor of clinical dermatology and vice chair of Diversity and Inclusion in the Department of Dermatology at Weil Cornell Medicine and lead study author.
For Luiz Magno, senior medical director at Eli Lilly do Brasil, the study is particularly relevant in Brazil. “We are in a country in which 55% of the population identifies as black or brown, as shown in the 2022 Census. Patients with ethnic skin generally present distinct skin and capillary characteristics, disorders and reaction patterns, as well as diverse cultural practices that affect the skin care. More than ever we need a close look at them to offer equity and the best treatments,” he says. The drug has not yet been approved in Brazil.
How was the study carried out and what were the main results?
The phase 3 lebrikizumab program consists of five global studies evaluating more than 1,300 patients, including two monotherapy studies (ADvocate 1 and 2), a topical corticosteroid combination study (ADhere), and long-term extension studies (ADjoin ) and open to teenagers (ADore).
The phase 3 study in people with ethnic skin, called ADmirable, lasted 24 weeks and evaluated the safety and efficacy of lebrikizumab in 50 patients, including adults and adolescents, with moderate to severe atopic dermatitis and skin tones of different tones measured by Fitzpatrick scale.
For the study, people identifying as Black or African American (80%), Asian (14%), American Indian or Alaska Native (6%) were included, with 11 participants also identifying as Hispanic/Latino (22 %).
All participants received 500 mg of lebrikizumab subcutaneously initially. After two weeks, they received another 250 mg every two weeks until week 16.
The researchers evaluated the use of the drug through measurements of pigment, erythema and post-inflammatory hyper- and hypopigmentation. The study also included a physician assessment of changes in post-inflammatory pigmentation using the PDCA-Derm scale.
The results after this period were consistent with the results of the ADhere and ADvocate 1 and 2 studies, carried out over the same period of time. The ADmirable study demonstrated that:
- 68% of participants experienced significant improvement in at least 75% of disease extent and severity;
- 46% of individuals experienced at least a 90% improvement in the extent and severity of the disease;
- 39% achieved resolution or almost complete resolution of the spots caused on the skin by atopic dermatitis, with a reduction of at least two points in relation to the baseline;
- 55% of people experienced clinically significant relief from itching.
“Lebrikizumab is the first investigational treatment for atopic dermatitis to release robust efficacy data specifically for this portion of the population who may face barriers to treatment or inequitable care,” said Mark Genovese, senior vice president of Immunology Development at Lilly. “Through clinical trials like this, we hope to deliver further advances to improve the lives of people who have been underserved.”
According to the study, no serious adverse events were reported. Full efficacy and safety results will be shared at future conferences. There is also a study carried out on patients previously treated with dupilumab (ADapt), the results of which should be shared at the end of 2024.
Source: CNN Brasil
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