TRALOKINUMAB IS EFFECTIVE AND WELLTOLERATED IN ADULTS WITH ATOPIC DERMATITIS WITH MODERATE-TO-SEVERE HAND INVOLVEMENT WHO ARE CANDIDATES FOR SYSTEMIC THERAPY: WEEK 16 RESULTS FROM THE PHASE 3B ADHAND TRIAL
Recommended Citation
Ehst B, Warren R, Chih-Ho H, Silvestre JF, Lee D, Balakirski G, Metelista A, Bennike NH, Festini T, Safavimanesh F, Stein Gold LF. TRALOKINUMAB IS EFFECTIVE AND WELLTOLERATED IN ADULTS WITH ATOPIC DERMATITIS WITH MODERATE-TO-SEVERE HAND INVOLVEMENT WHO ARE CANDIDATES FOR SYSTEMIC THERAPY: WEEK 16 RESULTS FROM THE PHASE 3B ADHAND TRIAL. Acta Derm Venereol 2025; 105:44-45.
Document Type
Conference Proceeding
Publication Date
10-23-2025
Publication Title
Acta Derm Venereol
Keywords
placebo, tralokinumab, adult, adverse drug reaction, atopic dermatitis, conference abstract, controlled study, double blind procedure, female, hand eczema, human, major clinical study, male, mental stress, multicenter study, phase 3 clinical trial, pruritus, randomized controlled trial, side effect, systemic therapy, topical drug administration, topical treatment, World Health Organization
Abstract
Hand involvement in atopic dermatitis (AD) causes particular physical and psychologic burden and has limited treatment options. Tralokinumab showed efficacy and safety in moderate-to-severe AD. ADHAND (NCT05958407) is a phase 3b randomized, 32-week trial of AD patients with moderate-to-severe hand involvement (HandAD). To investigate the efficacy and safety of tralokinumab treatment during the 16-week double-blind period in HandAD patients. 235 patients were randomized 2:1 to receive tralokinumab 300 mg or placebo (PBO) Q2W. Inclusion criteria were: Investigator's Global Assessment for Atopic Hand Eczema (IGA-AHE) score 3 or 4; Hand Eczema Symptom Diary (HESD) itch score ≥ 4; inadequate response to topical medications; AD involvement of ≥ 1 location other than hands/wrists. The primary endpoint was the proportion achieving IGA-AHE 0/1 at Week 16. Key secondary endpoints included proportions achieving Hand Eczema Severity Index (HECSI)-90/-75, and ≥ 4-point reductions in HESD itch/pain scores at Week 16. At Week 16, significantly more patients receiving tralokinumab (40.0% of 156 [95% CI: 31.3;49.4]) vs PBO (10.6% of 79 [5.0;20.9]) achieved IGA-AHE 0/1. The proportions of participants achieving HECSI-90/-75 were 41.7% [33.0;50.9] / 64.1% [55.3;72.0]. ≥ 4-point reductions in HESD itch and HESD pain were observed in nearly half of patients receiving tralokinumab. Rates of reported adverse events (AEs), serious AEs, and AEs leading to withdrawal from trial were low and similar between tralokinumab and PBO. Tralokinumab demonstrated superior efficacy vs PBO across all primary and key secondary endpoints at 16 weeks, with an overall frequency of AEs consistent with PBO, in HandAD patients, offering tralokinumab as a potentially valuable treatment option for this hard-to-treat population.
Volume
105
First Page
44
Last Page
45
