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. 2025 Oct 13.
doi: 10.1111/jdv.70080. Online ahead of print.

Safety and efficacy of nemolizumab for atopic dermatitis up to 2 years in open-label extension study

Matthias Augustin  1 , Marie Tauber  2 , Robert Sidbury  3 , Jonathan I Silverberg  4 , Kim A Papp  5   6 , Diamant Thaçi  7 , Marjolein S De Bruin-Weller  8 , Adam Reich  9 , Ketty Peris  10   11 , Kirk Barber  12 , Ryszard Galus  13   14 , Andrzej Kaszuba  15 , Matthew Zirwas  16 , Walter K Nahm  17 , Gretel Trullenque  18 , Laura Maintz  19   20 , Sady Alpizar  21 , Sang Wook Son  22 , Vivian Laquer  23 , Linda Stein Gold  24 , Soo Yeon Cheong  25 , Anna Ryzhkova  26 , Agnes Drahos  27 , Liliana Ulianov  27 , Christophe Piketty  26
Affiliations

Safety and efficacy of nemolizumab for atopic dermatitis up to 2 years in open-label extension study

Matthias Augustin et al. J Eur Acad Dermatol Venereol. .

Abstract

Background: Atopic dermatitis (AD) is a common, chronic, relapsing, pruritic, neuroimmune skin disease, requiring long-term symptom control.

Objectives: The ARCADIA long-term extension (LTE) study evaluates nemolizumab safety and efficacy in ≥12-year-old patients with moderate-to-severe AD up to 200 weeks.

Methods: Patients from previous nemolizumab AD trials (Phase 2/3) or newly recruited adolescents with moderate-to-severe AD were enrolled. A background regimen of topical corticosteroids with/without topical calcineurin inhibitors was permitted based on disease control. Long-term safety was the primary endpoint. Efficacy assessments were secondary endpoints, including the proportion of patients achieving Investigator's Global Assessment (IGA) 0/1 (clear/almost clear), Eczema Area and Severity Index (EASI)-75 (75% improvement from lead-in baseline in EASI), Visual Analogue Scale (VAS) Pruritus and VAS sleep loss ≥4-point improvement from lead-in baseline and quality of life. Observed data up to Week (W) 104 are presented for patients with previous nemolizumab experience (PNE) and no previous nemolizumab experience (NNE) at LTE baseline.

Results: At interim analysis data cut-off (21 July 2024), 1062 of 1901 patients completed W104. Exposure to nemolizumab in this study was equal across cohorts. The majority (92.6%) of treatment-emergent adverse events (TEAEs) were mild/moderate in severity; only 22.1% were considered related to nemolizumab. The most common (≥5.0%) TEAEs were COVID-19 (19.6%), nasopharyngitis (19.5%), atopic dermatitis (18.1%), upper respiratory tract infection (12.7%), headache (6.5%) and asthma (5.5%). At LTE baseline, the proportion of PNE and NNE patients was IGA 0/1: 27.1% and 17.1%; EASI-75: 38.8% and 25.8%; VAS Pruritus ≥4-point improvement: 58.7% and 31.6%; and VAS sleep loss ≥4-point improvement: 52.9% and 31.6%, respectively. At W104, this proportion was IGA 0/1: 62.6% and 58.2%; EASI-75: 88.2% and 85.4%; VAS Pruritus ≥4-point improvement: 87.2% and 82.0%; and VAS sleep loss ≥4-point improvement: 70.8% and 68.9%, respectively.

Conclusions: Continuous nemolizumab treatment was well-tolerated through W104 with clinically meaningful improvements in AD signs and symptoms and patient-reported outcomes.

Trial registration: NCT03989206: https://clinicaltrials.gov/search?term=NCT03989206; EUDRACT number: 2019-001889-15. Data available upon request: clinical.studies@galderma.com.

Keywords: IL‐31; Pruritus; adolescent; adult; atopic dermatitis; nemolizumab.

Plain language summary

Atopic dermatitis, also known as eczema, is a common long‐lasting condition that causes itchy, inflamed and irritated skin. It often comes and goes and can have a big impact on well‐being with severe itch, skin pain, sleep deprivation, anxiety and depression. The world‐wide ARCADIA long‐term extension study followed 1901 patients with atopic dermatitis aged 12 years and older for up to 2 years to learn if nemolizumab, a medicine that stops itching and skin inflammation, was safe to use and improved atopic dermatitis and patient well‐being. Patients in the study received nemolizumab injections every 4 weeks, along with other skin creams or ointments. The study included patients who had never used nemolizumab before, and patients who had used nemolizumab in earlier studies. The researchers found that common adverse effects included cold‐like symptoms, worsening of atopic dermatitis, headaches and worsening of asthma. Most adverse effects were mild or moderate. 75% of adverse effects were unrelated to treatment with nemolizumab. After 2 years of treatment with nemolizumab, around 60% of patients had skin that was clear or almost clear of atopic dermatitis, and over 85% of patients had less severe atopic dermatitis. Over 80% of patients felt less itchy. Around 70% of patients slept better, and over 90% of patients said that atopic dermatitis had no or minimal impact on their well‐being. Nemolizumab appears to be a safe and effective long‐term treatment for atopic dermatitis. It can help clear the skin, reduce itching and improve sleep and well‐being.

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References

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