Post-hoc analyses of phase III trials suggest some patients experienced improvements within days of treatment for atopic dermatitis and prurigo nodularis.
Galderma released new clinical data confirming nemolizumab’s rapid onset of action on itch and sleep, with significant improvements observed as early as 48 hours after treatment in some patients with atopic dermatitis and prurigo nodularis.
The findings from post-hoc analyses of the phase III ARCADIA and OLYMPIA clinical trial programs were published in the Journal of the European Academy of Dermatology and Venereology.
Nemolizumab is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signalling of IL-31. IL-31 is a neuroimmune cytokine that drives itch and other symptoms in both atopic dermatitis and prurigo nodularis. These new findings reinforce the critical role of IL-31 pathway inhibition in achieving rapid itch response.
Atopic dermatitis and prurigo nodularis are debilitating skin conditions that significantly affect quality of life, with symptoms such as persistent itch, skin lesions, and poor sleep quality. Itch is one of the most burdensome symptoms of both conditions, with 87% of patients with atopic dermatitis seeking freedom from itch, and 88% of those with prurigo nodularis rating it as their worst symptom.
“These new data reinforce our understanding of nemolizumab’s rapid onset of action in relieving itch and, in turn, improving sleep in patients living with atopic dermatitis and prurigo nodularis, as well as its role in targeting the IL-31 pathway,” says Christophe Piketty, MD, PhD, global program head of therapeutic dermatology at Galderma, in a release.
Rapid Relief of Itch and Sleep Disturbance Observed Within 48 Hours
The relevant analyses focused on data from the ARCADIA 1 and 2 trials in atopic dermatitis and the OLYMPIA 1 and 2 trials in prurigo nodularis. During those trials, patients reported itch intensity and sleep disturbance daily. Daily assessments of patients with atopic dermatitis and prurigo nodularis using a ≥4-point improvement from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) and Sleep Disturbance Numerical Rating Scale (SD-NRS) showed that in some patients:
- Nemolizumab reduced itch within two days (atopic dermatitis: 10.7% nemolizumab-treated compared to 2.9% placebo, 95% CI of the difference: 5.6-10.1; P<0.0001; prurigo nodularis: 17.2% nemolizumab-treated compared to 3.7% placebo; 95% CI of the difference: 6.8-16.7; p<0.0001)
- Nemolizumab improved sleep disturbance within two days (atopic dermatitis: 9.9% nemolizumab-treated compared to 4.6% placebo, 95% CI of the difference: 2.8-7.7; p=0.0001; prurigo nodularis: 13.4% nemolizumab-treated compared to 4.3% placebo; 95% CI – of the difference: 4.0-13.0; p=0.0013)
- By Day 14, a quarter of patients with atopic dermatitis and more than a third of patients with prurigo nodularis achieved significant and clinically meaningful responses in both itch and sleep outcomes
Taken individually, each study (ARCADIA 1 and 2 for atopic dermatitis and OLYMPIA 1 and 2 for prurigo nodularis) also demonstrated a significant PP-NRS response at day two.
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