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Dermatitis: Phase III ARCADIA Trials Demonstrate Nemolizumab’s Efficacy in Atopic Dermatitis

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Dermatitis is a chronic inflammatory skin condition that significantly affects patients’ quality of life. Detailed results from the phase III ARCADIA 1 and 2 trials evaluating the safety and efficacy of nemolizumab in atopic dermatitis were published for the first time in The Lancet. Data from this phase III program demonstrate the potential of nemolizumab (in combination with background therapy) to improve key aspects of atopic dermatitis, including skin lesions, itch, and sleep disturbance in adolescent and adult patients with moderate-to-severe atopic dermatitis.

The ARCADIA trials were randomized, multinational, double-blinded, and vehicle-controlled, enrolling a total of 1,728 adolescent and adult patients with moderate-to-severe chronic hand eczema. Patients were randomly assigned in a 2:1 ratio to receive either delgocitinib cream 20 mg/g or a cream vehicle twice daily for 16 weeks. The primary endpoint was the Investigator’s Global Assessment of Chronic Hand Eczema (IGA-CHE) treatment success at week 16, defined as an IGA-CHE score of 0 (clear) or 1 (almost clear). Secondary endpoints included a reduction in the Hand Eczema Symptom Diary itch and pain scores and at least 75% and 90% improvement in the Hand Eczema Severity Index (HECSI-75 and HECSI-90) scores from baseline at week 16.

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Dermatitis Treatment: Nemolizumab Shows Significant Itch Improvement Within One Week by Inhibiting IL-31

Statistically significant improvements in itch were observed as early as one week after nemolizumab treatment initiation. Nemolizumab is a first-in-class monoclonal antibody that inhibits the signaling of IL-31, a neuroimmune cytokine known to drive key signs and symptoms of atopic dermatitis.

36% and 38% of nemolizumab-treated patients in ARCADIA 1 and 2 achieved clear skin, defined by an investigator’s global assessment score of clear (0) or almost-clear (1), when compared to the placebo group (25% and 26%, respectively; p<0.001). 44% and 42% of nemolizumab-treated patients in ARCADIA 1 and 2 achieved at least a 75% improvement in the eczema area and severity index score, when compared to the placebo group (29% and 30%, respectively; p<0.001).

Clinically meaningful improvements in itch were observed as early as one week after nemolizumab treatment initiation when compared to placebo. An itch-free or nearly itch-free state (defined as a score of <2 on the peak pruritus numerical rating scale) was achieved by 16% of patients in both ARCADIA 1 and 2 at week 4, after just one dose of nemolizumab, when compared to the placebo group (4% and 3%, respectively; p<0.001).

Dermatitis

Dermatitis Trials: Nemolizumab Achieves Significant Sleep Improvement at Week 16 in ARCADIA Studies

At week 16, 38% and 34% of nemolizumab-treated patients in ARCADIA 1 and 2 achieved at least a four-point improvement in the sleep disturbance numerical rating scale, when compared to the placebo group (20% and 16%, respectively; p<0.001).

The safety profile was consistent between nemolizumab and placebo groups; most treatment-emergent adverse events were non-serious and of mild-to-moderate severity. The most common adverse events were COVID-19, nasopharyngitis, and headache.

“Publication of the phase III ARCADIA program results for the first time in The Lancet reinforces both the robustness of our trial design and the potential of nemolizumab as an effective treatment option for patients living with atopic dermatitis. We are working closely with regulators in the U.S., Europe, and elsewhere to bring nemolizumab to those in need as soon as possible,” stated Baldo Scassellati Sforzolini, M.D., Ph.D., Global Head of R&D at Galderma.

Based on the results of the ARCADIA 1 and 2 trials, the U.S. Food and Drug Administration (FDA) accepted for review Galderma’s Biologics License Application for nemolizumab for the treatment of adolescents and adults with moderate-to-severe atopic dermatitis, with a decision expected by the end of the year. Galderma is awaiting decisions from several other regulatory authorities on its filing applications for both atopic dermatitis and prurigo nodularis, including the European Medicines Agency, Health Canada, and the Access Consortium. Regulatory submissions to other healthcare authorities around the world are ongoing.

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The detailed results from the phase III ARCADIA trials highlight the significant potential of nemolizumab in improving the treatment landscape for patients with moderate-to-severe atopic dermatitis. By effectively addressing skin lesions, itch, and sleep disturbance, nemolizumab offers a promising therapeutic option that could significantly enhance the quality of life for many patients. With regulatory reviews underway, the potential for nemolizumab to become a widely accessible treatment option is on the horizon.

Resource: Business Wire, July 25, 2024


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