Lebrikizumab Improves Atopic Dermatitis in Adult and Adolescent Patients With Skin of Color: 16-Week Results From the ADmirable Study

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Andrew Alexis
Ali Moiin
Jill Waibel
Paul Wallace
David Cohen
Vivian Laquer
Pearl Kwong
Amber Reck Atwater
Jennifer Proper
Maria Silk
Evangeline Pierce
Sreekumar Pillai
Maria Jose Rueda
Angela Moore

Keywords

Lebrikizumab, atopic dermatitis, adolescent, skin of color

Abstract

Introduction: Lebrikizumab is a novel monoclonal antibody that binds with high affinity and a slow off-rate to interleukin (IL)-13, thereby blocking the downstream effects of IL13 with high potency. ADmirable (NCT05372419) is an ongoing, open-label, Phase 3b clinical trial of lebrikizumab in patients with moderate-to-severe atopic dermatitis (AD) and skin of color (SoC). These are the first primary results of any Phase 3 clinical trial studying patients with AD and SoC, a historically underrepresented patient population.


Methods: At baseline and Week 2, patients received 500-mg lebrikizumab loading doses followed by 250-mg every 2 weeks through Week 16. Concomitant topical therapy was allowed. Patients receiving protocol-defined rescue therapy were discontinued. Key eligibility criteria included: ≥12 years of age, self-reported race other than White, Fitzpatrick Phototype IV-VI, and moderate-to-severe AD. This study includes new objective measures of pigment such as PDCA-Derm™. Endpoints are summarized as observed (primary analysis) and using non-responder imputation/multiple imputation (NRI/MI; supporting analysis).


Results: At baseline (N=90), patients had a mean (SD) age of 40.7 (19.6) years, AD disease duration of 19.7 (16.1) years, Eczema Area and Severity Index (EASI) of 26.4 (12.2), and Pruritus Numeric Rating Scale (NRS) of 7.0 (2.2). Forty-three percent of patients were female and 16% were adolescent. Most patients had an Investigator’s Global Assessment (IGA) of 3 (69%). Patients self-reported their race as Black/African American (78%), Asian (11%), American Indian/Alaskan Native (7%), and Native Hawaiian or Other Pacific Islander (4%). Patients had Fitzpatrick Phototypes of IV (43%), V (24%), and VI (32%). At Week 16, 69.2% (54/78) of patients achieved a 75% improvement in EASI (NRI/MI, 66.9%), 44.9% (35/78) achieved a 90% improvement in EASI (NRI/MI, 42.5%), 44.9% (35/78) achieved an IGA 0/1 with ≥2-point improvement (NRI/MI, 44.1%), and 58.1% (36/62) reported ≥4-point Pruritus NRS improvement (NRI/MI, 55.4%). Approximately 50% of patients reported itch improvement within 6 weeks. Using PDCA-Derm™, hypopigmentation and hyperpigmentation improved in 33.3% (4/12) and 63.0% (29/46) of patients, respectively (as observed). Most treatment emergent adverse events (TEAE) were mild-to-moderate in severity. No TEAEs lead to discontinuation and no cases of treatment-related conjunctivitis were reported. No serious adverse events were observed.


Conclusion: Lebrikizumab improved signs and symptoms of disease, including post-inflammatory pigment discoloration, in patients with AD and SoC and demonstrated a favorable safety profile.  

References

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