Nemolizumab Delivers Significant Itch-Relief in Phase III Clinical Trials

Phase III ARCADIA 1 and 2 results evaluating the safety and efficacy of nemolizumab in treating atopic dermatitis have been published in The Lancet. These trials reveal nemolizumab’s potential to significantly improve key aspects of atopic dermatitis, including skin lesions, itch and sleep disturbance, in both adolescent and adult patients with moderate-to-severe cases.

Nemolizumab is a monoclonal antibody that targets IL-31, a cytokine responsible for many atopic dermatitis symptoms. The ARCADIA trials involved 1,728 participants, who received either nemolizumab or a placebo alongside topical corticosteroids (TCS) and sometimes topical calcineurin inhibitors (TCI).

The results showed that nemolizumab, given as a subcutaneous injection every four weeks, led to substantial improvements in skin clarity and itch relief by Week 16 compared to the placebo group.

Some of the key observations from the trials were:

• Clear or almost-clear skin: 36 percent and 38 percent of patients in ARCADIA 1 and 2, respectively, vs. 25 percent and 26 percent in placebo
• Improvement in the eczema area and severity index score: At least a 75 percent improvement in the eczema area and severity index score was seen in 44 percent and 42 percent of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, vs. 29 percent and 30 percent in placebo
• Itch-relief: 16 percent of patients in both ARCADIA 1 and 2 achieved an itch-free or nearly itch-free state at Week 4, after just one dose of nemolizumab, vs. four and three percent, respectively, in placebo
• Sleep disturbance improvement: 38 percent and 34 percent of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, reported at least a four-point improvement in the sleep disturbance rating scale by Week 16, vs. 20 percent and 16 percent in placebo

The safety profile of nemolizumab was consistent with the placebo, with most adverse events being mild to moderate.

In the news release, Wendy Smith Begolka, chief strategy officer of the US National Eczema Association described the itch associated with atopic dermatitis as “all-consuming” and a “24/7 symptom”. 74 percent of adults with moderate-to-severe atopic dermatitis rank itch as their most problematic symptom. A 2020 survey conducted under the initiative “More Than Skin Deep” with eczema patients revealed that itch symptoms contributed to shame, poor self-image and physical harm, followed by time-consuming regimens that weren’t guaranteed to work.

Atopic dermatitis patients tend to avoid social interaction due to their condition, and many experience sleep disturbances due to their itching, significantly affecting their quality of life. A more recent survey concluded that adults with severe atopic dermatitis had significantly higher anxiety and depression scores compared to those with clearer skin.

The ARCADIA trials reinforce nemolizumab’s potential as a transformative treatment for atopic dermatitis, offering new hope to patients seeking relief from this burdensome condition.

Galderma is actively seeking regulatory approval for nemolizumab across multiple regions. The US Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for review, with a decision expected by the end of this year.