Summary of NEMLUVIO in Atopic Dermatitis

NEMLUVIO, a humanized monoclonal antibody, is approved for treating adults and pediatric patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD). It is used in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCIs) when the condition is inadequately controlled by topical prescription therapies. NEMLUVIO works by selectively binding to the IL-31 receptor alpha (IL-31 RA), inhibiting IL-31 signaling. IL-31 is a cytokine involved in pruritus, inflammation, epidermal dysfunction, and fibrosis.

NEMLUVIO is administered via subcutaneous injection using a dual-chamber, pre-filled pen, starting with a 60 mg dose, followed by 30 mg every 4 weeks. For patients who achieve clear or almost clear skin after 16 weeks of treatment, the dosage is reduced to 30 mg every 8 weeks.

In two Phase 3 clinical trials (ARCADIA 1 and 2), NEMLUVIO was tested in 1,728 patients aged 12 years and older with moderate-to-severe AD.

In ARCADIA 1, EASI-75 response rates were 44% for NEMLUVIO versus 29% for placebo, and in ARCADIA 2, the response rates were 42% for NEMLUVIO versus 30% for placebo. IGA success was 36% versus 25% (ARCADIA 1) and 38% versus 26% (ARCADIA 2) for the treatment and placebo groups, respectively.

The most common adverse reactions observed in both trials at week 16, occurring in more than 1% of patients and more frequently than with placebo, included headache (including migraine), arthralgia, urticaria, and myalgia. Hypersensitivity reactions have also been reported with NEMLUVIO. Please refer to the full USPI for additional details.

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Elevate-Derm Alliance Editorial Committee