Dados do Trabalho

Título

Dupilumab Treatment in Patients With Hand and Foot Atopic Dermatitis: Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial

Resumo

Background: Atopic dermatitis (AD) of the hands and/or feet is often chronic, difficult to treat, and substantially impacts patient quality of life. We investigated the efficacy/safety of dupilumab in patients with hand and foot (H/F) AD using dedicated/validated clinical and patient-reported instruments.

Type of study: Phase 3 trial.

Methods: The phase 3, randomized, double-blind LIBERTY-AD-HAFT (NCT04417894) trial enrolled patients ≥12 years with moderate-to-severe (Investigator’s Global Assessment [IGA] 3/4) H/F AD. Patients were randomized to dupilumab monotherapy 300mg q2w in adults; 200/300 mg every 2 weeks in adolescents, or placebo for 16 weeks. The primary endpoint was IGA (H/F) 0/1 score at Week 16. Safety/tolerability was assessed.

Results: The 133 patients enrolled were randomized to dupilumab (n=67) or placebo (n=66). At Week 16, the primary and all secondary endpoints were met. Significantly more patients in the dupilumab vs placebo group achieved IGA 0/1 (40.3% vs 16.7%; P=0.003; primary endpoint) and ≥4-point improvement in the H/F Peak Pruritus Numerical Rating Scale (52.2% vs 13.6%; P<0.0001; a key secondary endpoint). Dupilumab-treated patients experienced significant improvement in percent change from baseline in the modified Total Lesion Sign Score for H/F lesions vs placebo (LS mean [SE] −69.4 [5.8] vs −31.0 [5.9]; P<0.0001) and Hand Eczema Severity Index (LS mean [SE] −74.8 [6.3] vs −39.9 [6.2]; P<0.0001). The most common TEAEs (≥10%) were nasopharyngitis (16% vs 11%) and dermatitis atopic (5% vs 18%).

Conclusions: Dupilumab significantly improved signs and symptoms in patients with H/F AD and had an acceptable safety profile.