Tralokinumab Is Effective And Well-Tolerated 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

Document Type

Conference Proceeding

Publication Date

2-26-2026

Publication Title

J Dtsch Dermatol Ges

Keywords

Dermatology

Abstract

Introduction: Hand involvement in atopic dermatitis (AD) causes particular physical and psychological 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. Methods: 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. Results: 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. Conclusions: 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

24

First Page

44

Last Page

45

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