Post-hoc analyses of the effect of AN2728 topical ointment, 2% on atopic dermatitis-associated pruritus
J Invest Dermatol
Two pooled analyses limited to assessment of anti-pruritic activity of AN2728 topical ointment, 2% (AN2728) were conducted using data from patients with atopic dermatitis (AD) from 4 studies: study 1: phase 1b trial of AN2728 systemic exposure, safety, and pharmacokinetics (PK) under maximal-use conditions in children and adolescents; study 2: phase 2a trial of AN2728 safety, tolerability, and pharmacokinetics in adolescents; study 3: phase 2a trial of AN2728 efficacy, safety, and tolerability in adults; study 4: phase 2 trial of AN2728 efficacy and safety in adolescents. Pooled data from studies 1 and 2 included whole-body assessments excluding scalp and venous access areas; studies 3 and 4 included assessments of 2 target lesions per patient treated with AN2728 or vehicle. Pruritus severity was assessed using a 4-point rating scale from 0 (none) to 3 (severe). Efficacy assessments included change from baseline in mean±standard deviation (SD) pruritus severity scores at days 8 (initial assessment), 15, 22, and 29 (whole-body assessments) or days 15 (initial assessment), 22, and 29 (target lesions). Paired t-tests comparing change from baseline against zero were used to calculate P values. The pooled analysis of studies 1 and 2 included 57 patients. Reductions vs baseline in mean±SD pruritus severity scores during treatment with AN2728 occurred at day 8 (-1.32±0.94) and were maintained through day 29 (-1.37±0.89; P<0.001 for each). The pooled analysis of studies 3 and 4 included 67 patients. Reductions in mean ± SD pruritus severity scores during treatment with AN2728 were observed at day 15 (-1.54±0.81) and were maintained through day 29 (-1.70±0.70; P<0.001 for each). These findings provide preliminary evidence of the efficacy of AN2728 topical ointment, 2% in relieving pruritus, one of the most burdensome AD symptoms.