Lebrikizumab Shows Promise for Patients with Skin of Color and AD

Image Credit: © Gorodenkoff - stock.adobe.com

Following the FDA approval of lebrikizumab (Ebglyss; Lilly) for moderate to severe atopic dermatitis (AD), additional interim results from ADmirable, a phase 3b study assessing the drug in patients with skin of color (SOC), were presented in a poster at the Maui Derm NP+PA Fall conference in Nashville, Tennessee. The IL-13 inhibitor is intended for adults, as well as pediatric patients who weigh at least 88 pounds (40 kg), and whose AD has not yet been controlled through the use of topical therapies.^1-2

“There is a paucity of data to guide the treatment of moderate to severe AD in populations traditionally under-represented in clinical trials, including patients with skin of color,” researchers wrote.

Methods

Participants in the study received a 500 mg loading dose of lebrikizumab followed by 250 mg every 2 weeks through week 16. To participate in the study, patients met the following criteria:

• At least 12 years old
• Fitzpatrick Phototype IV-VI
• Chronic AD for ≥1 year
• History of inadequate response to topical medications
• Naive to biologics for AD
• Baseline Eczema Area and Severity Index (EASI) ≥16
• Investigators Global Assessment (IGA) ≥3
• ≥10% body surface area (BSA) of AD involvement

Endpoints of the study were measured by the patient proportion achieving ≥75% or ≥90% EASI reduction, IGA 0 or 1 with ≥2-point improvement from baseline, ≥3-point and ≥4-point Pruritus Numeric Rating Scale (NRS) improvement from baseline, mean percentage change in EASI and Pruritus NRS, and changes in post-inflammatory hyperpigmented (PIH) lesions, which were evaluated using PDCA-Derm.

Results

Overall, 50participants were enrolled in the trial including: 40 Black/African American participants (80%), 7 Asian (14%), 3 American Indian/Alaska Native (6%), and 11 Hispanic/Latino (22%). Researchers stated 8 of the participants were adolescents, 23 were women, and patient proportions based on Fitzpatrick type IV-VI were 42%, 22%, and 36%, respectively.

Image Credit: © Dermatology Times

At baseline, researchers reported the mean BSA affected to be 41.7% (20.8), and 64% of patients presented with IGA=3. Mean EASI reported at baseline was 28.1 (12.4) and mean pruritus NRS was 7.2 (2.2).

According to researchers, 40 participants completed the trial. The poster reported 68% of participants reaching EASI 75 at week 16, 46% reaching EASI 90, 39% reaching IGA 0 or 1, and 66% and 56% reaching ≥3-point and ≥4-point Pruritus NRS improvement, respectively. The improved mean percentage change from baseline was reported to be -79.1% for EASI and -53.9% for Pruritus NRS.At week 16, researchers found 12 out of 21 patients with baseline hyperpigmented lesions had improved PDCA-Derm and 6 out of 21 lesions achieved normal skin tone. Researchers reported no serious adverse events within the trial.

Conclusion

During their interim analysis of the phase 3b trial, researchers found that lebrikizumab improved AD signs and symptoms in patients with SOC as measured by the trials’ primary endpoints.

Lebrikizumab was approved by the European Commission in 2023,³ Japan in January 2024, and Canada in June 2024.⁴

Lebrikizumab will be available as a 250 mg/2 mL injection and may be used with or without topical corticosteroids. Lilly anticipates the drug will become available in the US in a matter of weeks.

Kristin Belleson, president and CEO of the National Eczema Association, weighed in on the approval's significance for patients.

"Eczema can affect people of all skin tones, ethnicities, genders and ages. Nearly 16.5 million adults in the US have eczema, with 6.6 million experiencing moderate-to-severe symptoms like itchiness, dry and scaly skin, discoloration and rashes, which can lead to more scratching that may cause skin to crack and bleed," Belleson said. "The approval of Ebglyss provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms."

References

1. FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis. News release. Lilly. September 13, 2024. Accessed September 15, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and#:~:text=INDIANAPOLIS%20%2C%20Sept.%2013%2C%202024,88%20pounds%20(40%20kg)%20with
2. Alexis A, Moiin A, Waibel J, et al. Interim results from ADmirable, a phase 3b open-label study assessing lebrikizumab in patients with skin of color and moderate-to-severe atopic dermatitis. Poster presented at Maui Derm NP+PA Fall 2024, September 15-18; Nashville, Tennessee.
3. Almirall. Almirall receives European Commission approval of Ebglyss (lebrikizumab) for moderate-to-severe atopic dermatitis. News release. November 17, 2023. Accessed September 15, 2024. https://www.almirall.com/newsroom/news/almirall-receives-european-commission-approval-of-ebglyss-lebrikizumab-for-moderate-to-severe-atopic-dermatitis
4. Health Canada authorizes Lilly's Ebglyss (lebrikizumab) for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older. News release. Cision; Eli Lilly Canada Inc. June 25, 2024. Accessed September 15, 2024. https://www.newswire.ca/news-releases/health-canada-authorizes-lilly-s-ebglyss-tm-lebrikizumab-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-in-adults-and-adolescents-12-years-and-older-833722064.html