People suffering from moderate-to-severe atopic dermatitis (AD), the most common form of eczema, often struggle to find relief from traditional treatments such as steroid creams and ointments. However, a new solution has arrived. The U.S. Food and Drug Administration (FDA) has recently approved Ebglyss (lebrikizumab-lbkz), a biologic treatment for people aged 12 years and older.

Ebglyss is an injectable drug that belongs to a class of medications known as interleukin-13 (IL-13) inhibitors. Administered once a month, it provides a targeted systemic treatment to reduce the underlying inflammation responsible for atopic dermatitis. By addressing the root cause, Ebglyss aims to clear the skin and alleviate the persistent itch that accompanies this chronic condition.

The approval of Ebglyss comes after several highly anticipated clinical trials demonstrated its effectiveness. According to Dr Amy McMichael, a dermatologist at Atrium Health Wake Forest Baptist in North Carolina, the data from the phase 3 studies supporting Ebglyss are particularly strong. While Dr McMichael was not directly involved in the research, she notes that one of the trials focused on people of colour and showed consistent results, regardless of skin tone.

"People can experience a significant reduction in their symptoms, relief from itching, and improved quality of life as they regain the ability to function normally," says Dr Mark Genovese, senior vice president of immunology development at Eli Lilly, the manufacturer of Ebglyss.

The FDA's approval of Ebglyss is based on the results from three pivotal phase 3 trials, ADvocate 1, ADvocate 2, and ADhere. These trials included more than 1,000 participants aged 12 and older with moderate-to-severe eczema who had not been able to manage their symptoms with topical treatments alone.

In the ADvocate trials, key findings included:

- Skin Clearance: By week 16, 38 per cent of participants achieved clear or almost-clear skin when treated with Ebglyss, compared to only 12 per cent of participants receiving a placebo.

- Quick Results: Even after just four weeks of treatment, 10 per cent of participants experienced significant skin clearance.

- Long-Term Efficacy: Among those who experienced clear skin, 77 per cent maintained their results with once-monthly dosing over a year.

- Itch Relief: Approximately 43 per cent of participants reported substantial relief from itching by week 16, with some noticing improvements as early as two weeks into treatment.

The most common side effects reported during the trials were eye and eyelid inflammation (such as redness, swelling, and itching), injection site reactions, and shingles (herpes zoster).

Ebglyss also proved effective in a separate study focusing on people of colour. In a small trial involving 50 participants with darker skin tones, including Black, Asian, Hispanic/Latinx, and American Indian or Alaska Native people, Ebglyss showed significant improvement in both skin clearance and itch relief. Results at 16 weeks were consistent with those seen in earlier trials, with nearly 40 per cent of participants achieving clear or almost clear skin.

Dr Andrew Alexis, the lead author of the study and a professor of clinical dermatology at Weill Cornell Medicine, emphasized the importance of this trial. People of colour are disproportionately affected by atopic dermatitis and often experience more severe symptoms, delayed diagnoses, and longer times to find effective treatment. A recent national survey found that nearly 19 per cent of Black children have atopic dermatitis, compared with 16 per cent of white children and 8 per cent of Asian children.

“Historically, people of colour have been underrepresented in clinical trials, leaving a gap in the data regarding the effectiveness of treatments for these populations,” said Dr Alexis. "This trial shows that Ebglyss is unequivocally effective for patients with skin of colour."

Dr McMichael also revealed the significance of these findings, noting that in the absence of such data, healthcare providers often have to assume that treatments will work for all races and ethnicities. This trial, however, provides concrete evidence of Ebglyss’ efficacy in diverse populations.

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