At the recent Fall Clinical Conference, Galderma presented a post hoc analysis of the randomized, double-blind, multicenter Phase 2B study of nemolizumab in patients with moderate to severe chronic atopic dermatitis.1 Patients were randomized to 1 of 4 treatment groups: nemolizumab 10 mg subcutaneously (SC) every 4 weeks (Q4W), 30 mg SC Q4W, 90 mg SC Q4W, or placebo, all with topical corticosteroid (TCS). This post hoc analysis compared nemolizumab 30 mg (SC Q4W after a 60-mg loading dose) plus TCS (n=50) with placebo plus TCS (n=44) in patients with baseline Eczema Area and Severity Index (EASI) score ≥16. The primary endpoint, improvement in the EASI score at week 24 compared with placebo (-68.8% vs -52.1%, P=.016). was met.2 At week 1, there was improvement in the severity of atopic dermatitis as indicated by SCORing Atopic Dermatitis (SCORAD) scores in the nemolizumab group, with significant improvement at week 16 with nemolizumab 30 mg + TCS compared with placebo + TCS (-57.1% vs -28.2%, P<0.001). At week 16, EASI scores decreased by 68.6% in the nemolizumab + TCS group and 42.6% in the placebo + TCS group. Patients in the nemolizumab treatment group also had improvements in erythema and induration at week 16, suggesting there is an anti-inflammatory effect in addition to the reduction in itch. Treatment-emergent adverse events reported in ≥5% of patients with a baseline EASI score of ≥16 were also included in this poster.
*Nemolizumab is an investigational drug and is not approved for any indication in any country.
References:
1. Bouaziz J, Pinter A, Alavi A, et al. Efficacy of nemolizumab* in atopic dermatitis: rapid impact on EASI and SCORAD components. Poster presented at: Fall Clinical Dermatology Conference; October 20-23, 2022; Las Vegas, NV.
2. Silverberg JI, Pinter A, Pulka G, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi:10.1016/j.jaci.2019.08.013
