Nemolizumab Safety, Real-World Use in AD, With Matthias Augustin, MD

Patients treated with nemolizumab (Nemluvio) in routine practice are showing responses and tolerability consistent with 3-year clinical trial findings in moderate to severe atopic dermatitis , according to an ARCADIA investigator.

Matthias Augustin, MD, presented week 152 results from the open-label ARCADIA long-term extension (LTE) study at the 2026 European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria.

In observed-case analyses, up to 91% of patients achieved EASI-75, up to 75% achieved EASI-90, and up to 67% achieved clear or almost clear skin (Investigator's Global Assessment [IGA] 0/1). Up to 88% experienced clinically meaningful itch relief, and up to 92% achieved clinically meaningful improvements in dermatology-related quality of life.¹,²

"Here I have the great experience that all those promises which come from the clinical trials, from the randomized controlled trials, and from the long-term extension about sustained long-term effects have also been found in the real-world care that we see," Augustin said in an interview with HCPLive. "In other words, the patients who I treat in practice also have a good response, largely, and have the same level of safety and tolerability as we have seen in the long-term extension in the clinical trials."

Nemolizumab Safety Profile Through Week 152

"The level of subjective tolerability is high. Just very few patients have minor side effects like injection site reaction. Sometimes a bit of flares, but overall the core safety data are excellent," Augustin said.

Through 3 years of treatment, nemolizumab's safety profile remained consistent with previous findings, with no new safety signals identified compared with earlier LTE interim analyses.² The LTE is evaluating treatment in patients aged ≥12 years for up to 200 weeks.²

A separate post hoc analysis of the ARCADIA and OLYMPIA LTE studies, presented as an e-poster at EADV, found a favorable cutaneous safety profile over 2 years in patients with atopic dermatitis and prurigo nodularis.²

IL-31 Response Predictors and Data Beyond Year 3

Augustin pointed to several questions that remain about nemolizumab, including how patients respond over longer periods of treatment, which patients are most likely to benefit, and how the drug affects the skin over time.

Looking ahead, he said he expects data from years 4 and 5 of treatment and wants to better understand why some patients respond to IL-31 blockade. He also highlighted the need to investigate the molecular and cellular mechanisms behind the treatment’s effects, including its apparent benefits for the skin barrier.

Nemolizumab inhibits signaling by IL-31, a neuroimmune cytokine involved in itch, inflammation, and epidermal dysfunction.²

Editor's Note: The ARCADIA LTE study is sponsored by Galderma. Augustin reported consulting fees, honoraria, speaker fees, and/or grant or research funding from AbbVie, Almirall, Amgen, AstraZeneca, Bayer, Beiersdorf, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Centocor, Dermira, Eli Lilly, Fresenius, Galderma, Genzyme, GlaxoSmithKline, Hexal, Incyte, Janssen, LEO Pharma, Medac, Menlo, Merck, MSD, Mundipharma, Mylan, Novartis, Pfizer, Regeneron, Sandoz, Sanofi, Stallergenes, Trevi, UCB, and XenoPort.

References

1. Silverberg JI, et al. Long-term safety and efficacy (up to 152 weeks) of nemolizumab in ARCADIA open-label long-term extension study in adults and adolescents with moderate-to-severe atopic dermatitis. Presented at: European Academy of Dermatology and Venereology Congress; October 1, 2026; Vienna, Austria.

2. Galderma. EADV 2026: Galderma’s new data show sustained improvements with Nemluvio (nemolizumab) for up to three years in patients with moderate-to-severe atopic dermatitis. Published September 30, 2026. https://www.galderma.com/news/eadv-2026-galdermas-new-data-nemluvio-three-years