Phase 3 data support nemolizumab for atopic dermatitis, prurigo nodularis treatment
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Key takeaways:
- Nemolizumab improved atopic dermatitis-induced lesions and itch in two phase 3 studies, ARCADIA 1 and 2.
- Significant improvement was also seen in patients with prurigo nodularis in OLYMPIA 1.
Galderma has announced positive data from three phase 3 studies that evaluated nemolizumab for the treatment of atopic dermatitis and prurigo nodularis, according to a company press release.
“While atopic dermatitis and prurigo nodularis are distinct diseases, their commonality lies in the severe, persistent itch, which leads to poor quality sleep and negatively impacts mental health,” Flemming Ørnskov, MD, MPH, CEO of Galderma, said in the release. “These important results highlight nemolizumab’s potential to be an effective and convenient treatment for the millions of people globally who live with these conditions.”
Nemolizumab is an investigational monoclonal antibody that inhibits interleukin-31, a key player in both atopic dermatitis and prurigo nodularis. Results from two atopic dermatitis studies, ARCADIA 1 and 2, and one prurigo nodularis study, OLYMPIA 1, were presented at a late-breaking session at the European Academy of Dermatology and Venereology 2023 Congress.
The ARCADIA studies showed that nemolizumab significantly improved lesions and itch in adolescents and adults with moderate to severe atopic dermatitis. A greater proportion of nemolizumab-treated patients vs. placebo-treated patients achieved IGA 0/1 in both ARCADIA 1 (35.6% vs. 24.6%; P < .0006) and ARCADIA 2 (37.7% vs. 26%; P = .001).
EASI 75 was achieved in ARCADIA 1 by 43.5% of nemolizumab-treated patients vs. 29% of placebo-treated patients (P < .0001). This finding was similar in ARCADIA 2, in which 42.1% of those treated with nemolizumab and 30.2% of those treated with placebo achieved EASI 75 (P = .0011).
Nemolizumab also demonstrated significant improvement in itch and skin lesions in adults with moderate to severe prurigo nodularis in the OLYMPIA 1 trial. A 4-point reduction in itch was achieved by 58.4% of nemolizumab-treated patients compared with 16.7% of those treated with placebo (P < .0001). Similarly, 26.3% of patients in the nemolizumab group reached IGA 0/1 vs. 7.3% of patients in the placebo group (P < .0001).