Lebrikizumab Leads to Atopic Dermatitis Improvements in Patients with Skin of Color

Lebrikizumab (Ebglyss) treatment of atopic dermatitis in adult and adolescent patients with skin of color and atopic dermatitis results in itch and disease severity improvements over 24 weeks, according to new phase 3b findings.1

This late-breaking data, titled ‘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,’ was presented at the 2025 Revolutionizing Atopic Dermatitis (RAD) Annual Meeting in Nashville, Tennessee.

The phase 3b ADmirable study was authored by such investigators as Andrew F. Alexis, MD, MPH, professor of clinical dermatology and vice-chair for diversity and inclusion at Weill Cornell Medicine. Alexis and colleagues highlighted the lack of robust data prior to the ADmirable study to inform the diagnosis and treatment of atopic dermatitis in those with skin of color.

Such patients represent a group that has been historically underrepresented in clinical trial research. In their current study, Alexis et al presented the 24-week findings from the phase 3b ADmirable analysis (NCT05372419). The study, Alexis and colleagues noted, was the first to be designed specifically to assess lebrikizumab in adolescents and adults with moderate-to-severe atopic dermatitis and skin of color.

There were 90 participants involved in the study, all of whom were at least 40 kg and aged 12 years and older. They each reported having Fitzpatrick skin phototypes IV, V, or VI and self-identified as a race other than White. 250 mg of lebrikizumab was administered to the trial subjects via subcutaneous injection on an every 2 week basis (Q2W).

This course followed a 500 mg loading dose at the point of baseline and at the 2-week mark, for the first 16 weeks. Between the 16 and 24-week marks, those who met response criteria—either achieving an Investigator’s Global Assessment (IGA) score of 0 or 1 with an improvement of 2 points at minumum, or at least a 75% improvement in participants’ scores on the Eczema Area and Severity Index (EASI 75)—transitioned to lebrikizumab 250 mg Q4W.

Those deemed to be non-responders continued their Q2W dosing. The investigative team’s nalyses included both observed data and imputed data, with the Q2W and Q4W cohorts being combined for the evaluation of Weeks 16–24. Alexis et al’s primary efficacy measure was determined to be EASI 75 at the 16-week mark. In terms of any secondary and exploratory outcomes, examples included the PDCA Derm scale (an investigator-evaluated measure of post-inflammatory hyper- and hypopigmentation) along with safety data.

Among the participants, Fitzpatrick skin phototype distribution was noted by the investigators as 43.3% type IV, 24.4% type V, and 32.2% type VI. At the point of baseline, the team observed that subjects’ average EASI score was 26.4, and the mean Pruritus Numeric Rating Scale (NRS) score was determined to be 7.0.

Additionally, there was a mean age of 40.7 years and 43.3% of whom were reported as female. The research team noted that 68.9% of participants had moderate disease (IGA score of 3). By the 16-week mark, attainment of an EASI 75 score was done by 69.2% of those taking part in the analysis. Alexis and coauthors found that EASI 90 was achieved by 44.9%, and IGA 0/1 by 44.9%.

Additionally, it was noted that 58.1% of trial participants had a reported reduction of ≥4 points in the severity of their itch level (Pruritus NRS). By the 24-week mark, the investigators’ pooled data demonstrated that EASI 75, EASI 90, and IGA 0/1 were attained by 78.4%, 47.3%, and 54.1% of those involved in the study, respectively.

They also noted that 61.5% of those involved in ADmirable experienced a ≥4-point improvement in their itch. Improvement in Dermatology Life Quality Index (DLQI) was observed by at least 4 points in 71.7% and 72.9% of subjects at the 16 and 24-week marks, respectively.

They found that Week 16 responders (n=56), EASI 75 response rates were shown to have been sustained through the 24-week mark (94.6% versus 90.7%). Among the 21 individuals who the investigative team found did not respond at 16 weeks, 45.0% went on to report attaining an EASI 75 score by the 24-week mark.

Stratified by skin phototype, the investigators found that rates of EASI 75 rates at Week 16 were 62.2% for type IV, 82.4% for type V, and 70.8% for type VI. The rates were also found to have risen by the 24-week mark to 62.9%, 88.2%, and 95.5%, respectively. Additionally, hyperpigmentation improvement was seen in 64.4% of those who had hyperpigmented lesions at baseline,

The team also found that 25.0% of those with hypopigmented lesions had progress toward normal skin tone by the 24-week mark. In their safety analysis, most of the treatment-emergent adverse events (93.1%) were shown to be mild to moderate in severity and there were no serious events or treatment discontinuations, though a single case each of conjunctivitis and injection site reaction did take place.

References

1. Alexis A, Moiin A, Moore A, 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 the Revolutionizing Atopic Dermatitis (RAD) 2025 Annual Meeting June 6 – 7, 2025. Nashville, TN.