Late Breaking Data: Lebrikizumab Demonstrates Efficacy in AD Patients with Skin of Color

Image Credit: © dermnetnz.org

At this year’s Revolutionizing Atopic Dermatitis (RAD) conference in Nashville, Tennessee, Eli Lilly and Company shared final results from the phase 3b ADmirable trial of lebrikizumab (Ebglyss).¹ This is the first study to evaluate lebrikizumab’s effectiveness and safety in adult and adolescent patients with pigmented skin and atopic dermatitis (AD), as this population is typically underrepresented in clinical trials.

The open-label study (NCT05372419) included 90 patients aged 12 and older (weight: ≥40 kg) with moderate-to-severe AD and pigmented skin, according to the Fitzpatrick skin type scale (IV, V, or VI). Participants self-identified as Black or African American, Asian, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander. The mean age of patients was 40.7 years. About 43.3% of participants had a Fitzpatrick skin phototype of IV.

"Skin pigmentation matters in evaluating patients with atopic dermatitis, because from a medical perspective, the disease presents differently in darker skin tones vs lighter (eg, redness can be more subtle, pigmentation more prominent, and diagnosis and evaluation more challenging). Additionally, in the next 20 years, people who identify as American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian, or other Pacific Islander are projected to represent more than half of all Americans, which drives our urgency to invest in clinical research that helps address longstanding medical gaps in these populations. ADmirable is the first dedicated study to evaluate the efficacy and safety of EBGLYSS in adult and adolescent patients with AD in these patients frequently underrepresented in clinical trials," said Anabela Cardoso, MD, senior vice president of immunology medical affairs at Eli Lilly and Company, in an interview with Dermatology Times.

The patients received lebrikizumab 250 mg (500 mg loading dose at baseline and week 2) subcutaneously every 2 weeks for 16 weeks. Then, from weeks 16 to 24, those who responded to treatment received lebrikizumab 250 mg once every 4 weeks while inadequate responders continued with the dosage every 2 weeks.

Respondents were defined as having an Investigator’s Global Assessment score of 0 or 1 with a ≥2-point improvement (IGA 0/1) or ≥75% improvement in Eczema Area and Severity Index (EASI 75). The primary endpoint of the study was achieving an EASI score of 75 at week 16. Secondary endpoints revolved around safety and efficacy using PDCA Derm, assessing cutaneous post-inflammatory hyperpigmentation and hypopigmentation.

Approximately 68.9% of patients began the trial with moderate disease (IGA=3) with a mean EASI of 26.4 and an average Pruritus Numeric Rating Scale (NRS) score of 7. At week 16, EASI 75, EASI 90, and IGA 0/1 were achieved by 69.2%, 44.9%, and 44.9% of patients, respectively. This includes more than 88% of patients with the darkest skin tones (Fitzpatrick V and VI). Approximately 73% of respondents were able to switch to a once-monthly maintenance dose after 16 weeks.

Nearly 60% of patients observed a ≥4-point improvement in Pruritus NRS. These numbers increased at week 24 with EASI 75, EASI 90, and IGA 0/1 achieved by 78.4%, 47.3%, and 54.1% of patients, respectively. Moreover, 61.5% of participants had a ≥4-point Pruritus NRS improvement.

Additionally, ≥4-point improvements in the Dermatology Life Quality Index were reached by 71.7% and 72.9% of patients at Weeks 16 and 24, respectively. Over 64% of patients with hyperpigmented lesions and 25% with hypopigmented lesions showed improvement after 24 weeks. Most treatment-emergent adverse effects were mild or moderate, with only 1 reported case of conjunctivitis and injection site reaction. None of the adverse events were serious, and the drug did not need to be discontinued. This safety profile is consistent with previous long-term trials of lebrikizumab, regardless of dosage and frequency.²

Overall, patients with skin of color and moderate to severe AD severity responded well to lebrikizumab after 24 weeks, with improvements in symptoms such as itch and hyperpigmentation. Response was noted as early as week 16 and continued to improve throughout the trial with a favorable safety profile.

"These new, 24-week data from ADmirable – the first dedicated study for evaluating the efficacy and safety of EBGLYSS in adult and adolescent patients with pigmented skin and moderate-to-severe atopic dermatitis – reinforce the efficacy and safety of EBGLYSS as a first-line biologic, following prescription topicals, with once-monthly maintenance dosing after the four-month initial dosing for adults and adolescents, regardless of skin tone. These add to the robust and extensive data supporting EBGLYSS’s value for a broad range of patients with moderate to severe atopic dermatitis," concluded Cardoso.

References

1. Alexis A, Moiin A, Waibel J, et al. Efficacy and safety of lebrikizumab in adult and adolescent patients with skin of color and moderate-to-severe atopic dermatitis: Final 24-Week results from the phase 3b, open-label ADmirable study. Presented at: 2025 Revolutionizing Atopic Dermatitis (RAD) Conference; June 6-7, 2025; Nashville, TN.

2. Lilly's EBGLYSS (lebrikizumab-lbkz) single monthly maintenance injection achieved completely clear skin at 3 years in half of patients with moderate-to-severe atopic dermatitis. News release. Eli Lilly. Published March 7, 2025. Accessed June 7, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyssr-lebrikizumab-lbkz-single-monthly-maintenance