Lebrikizumab Improves Atopic Dermatitis in Adult and Adolescent Patients With Skin of Color: 16-Week Results From the ADmirable Study
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Le résumé fourni par la source
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.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Lebrikizumab Improves Atopic Dermatitis in Adult and Adolescent Patients With Skin of Color: 16-Week Results From the ADmirable Study
- Date Crossref
- 13/01/2025
- Éditeur
- Dermsquared
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Cornell University pays non établi dans la noticeUniversité ou école supérieure
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Weill Cornell Medicine pays non établi dans la noticeUniversité ou école supérieure
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Comprehensive Urology pays non établi dans la noticeÉtablissement de santé
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Miami Dermatology and Laser Institute pays non établi dans la noticeÉtablissement de santé
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Orange Coast Memorial Medical Center pays non établi dans la noticeÉtablissement de santé
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Eli Lilly (United States) pays non établi dans la noticeEntreprise
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Baylor University Medical Center pays non établi dans la noticeÉtablissement de santé
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Arlington Center for Dermatology pays non établi dans la noticeStructure de recherche
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Comprehensive Dermatology Center pays non établi dans la noticeInstitution
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Wallace Skin Research Center pays non établi dans la noticeStructure de recherche
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Skin Care Physicians of Georgia pays non établi dans la noticeInstitution
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First OC Dermatology Research pays non établi dans la noticeInstitution
Cornell University, Weill Cornell Medicine et Comprehensive Urology, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.