FDA Approves New Biologic Treatment for Atopic Dermatitis: Learn How It Can Help You Achieve Clear Skin

People who suffer from moderate to severe illness atopic dermatitis (AD), the most common form of eczemaoften have a hard time finding relief from traditional treatments, such as steroid creams and ointments. However, a new solution has arrived. The U.S. Food and Drug Administration (FDA) recently approved Ebglyss (lebrikizumab-lbkz), a biologic treatment for people 12 years of age 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 targeted systemic treatment to reduce the underlying inflammation responsible for atopic dermatitis. By addressing the root cause, Ebglyss aims to clear the skin and relieve the persistent itching that accompanies this chronic condition.

The approval of Ebglyss comes after several highly anticipated clinical trials demonstrated its efficacy. 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 is particularly strong. While Dr. McMichael was not directly involved in the research, she notes that one of the trials focused on people of color and showed consistent results, regardless of skin tone.

“People can experience a significant reduction in their symptoms, relief from itching and an 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 maker of Ebglyss.

Clinical trial results: skin lightening and itch relief

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

In the ADvocate trials, key findings included:

– Skin lightening: At week 16, 38 percent of participants achieved clear or almost clear skin when treated with Ebglyss, compared to only 12 percent of participants who received a placebo.

– Rapid results: Even after just four weeks of treatment, 10 percent of participants experienced significant skin improvement.

– Long-term efficacy: Among those who experienced clear skin, 77 percent maintained their results with monthly dosing for one year.

– Itch relief: Approximately 43 percent of participants reported substantial itch relief at week 16, with some noticing improvements as early as two weeks of 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.

Improves both skin cleansing and itching relief in different populations

Ebglyss was also shown to be effective in a separate study focusing on people of color. In a small trial involving 50 participants with darker skin tones, including Blacks, Asians, Hispanics/Latinos, and American Indians or Alaska Natives, Ebglyss showed significant improvement in both skin clearing and itch relief. Results at 16 weeks were consistent with those seen in previous trials, with nearly 40 percent of participants achieving clear or nearly clear skin.

Dr. Andrew Alexis, senior author of the study and professor of clinical dermatology at Weill Cornell Medicine, highlighted the importance of this trial. People of color 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 percent of black children have atopic dermatitis, compared to 16 percent of white children and 8 percent of Asian children.

“Historically, people of color have been underrepresented in clinical trials, leaving a gap in data on the efficacy of treatments for these populations,” said Dr. Alexis. “This trial demonstrates that Ebglyss is unequivocally effective for patients of color.”

Dr. McMichael also revealed the importance 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’s efficacy in diverse populations.