Q&A: Three-Year Nemolizumab Data Highlight Sustained Control of Atopic Dermatitis

New 3-year data from the ARCADIA long-term extension study demonstrated sustained improvements in skin lesions, itch, sleep disturbance, and quality of life with nemolizumab (Nemluvio) among adults and adolescents with moderate-to-severe atopic dermatitis (AD).

At week 152, up to 91% of patients achieved at least a 75% improvement in Eczema Area and Severity Index (EASI-75), while up to 75% achieved EASI-90 and 67% achieved clear or almost clear skin. Additionally, up to 88% achieved clinically meaningful itch relief and 92% experienced clinically meaningful improvements in dermatology-related quality of life. The safety profile remained consistent with previous findings, with no new safety signals identified through 3 years of treatment.

At the 2026 European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, Dermatology Times spoke with Christophe Piketty, MD, PhD, global program head of therapeutic dermatology at Galderma, about the long-term findings, the role of IL-31 signaling in AD, and what ongoing research could reveal about the relationship between itch, sleep, and overall disease burden.

Dermatology Times:

What is the main takeaway from the 3-year ARCADIA extension data?

Piketty:

The key message is that the data definitely show that the efficacy of nemolizumab is maintained and even sustained, with some increase in response at 3 years.

It really demonstrates that nemolizumab is a therapeutic solution for patients over the long term, allowing for very good control of the disease with a very good safety profile. I'm very happy with the data.

Dermatology Times:

What stands out about the skin clearance results observed at week 152?

Piketty:

The long-term extension is open-label. We mainly have patients coming from the 2 pivotal studies, ARCADIA 1 and ARCADIA 2, as well as some patients from other smaller studies.

One of the main objectives is really to demonstrate the long-term safety of nemolizumab for patients suffering from atopic dermatitis. We also generate a lot of efficacy end points, but one of the main objectives is to demonstrate that the drug is safe over the long term. This is very important because the first thing is to make sure that, over the long term, there is no risk for patients.

Looking at EASI-75 and EASI-90 responses, the efficacy data are very high and robust. We also see strong responses for pruritus. I think that's really the beauty of the drug: this control of symptoms, including itch and sleep disturbance.

Dermatology Times:

What should clinicians know about the long-term safety findings?

Piketty:

We did not find something new, and we saw a decrease in the incidence of adverse events that could be observed in the clinical trials.

That's very reassuring because, in a long-term extension study, if you start seeing something new appearing, it could mean that something is happening. That is definitely not the case here.

We looked at different periods during the long-term extension and saw a decrease in incidence over the long term.

Dermatology Times:

How should clinicians interpret these efficacy findings given the open-label design?

Piketty:

We need to interpret the data with caution because it's open-label, but I think this is the standard way to generate long-term extension data.

It would be very challenging to maintain patients on placebo for that length of time. Now, placebo-controlled periods generally do not extend that long.

To me, the findings are convincing because what we see is not only maintenance; there is actually an increase in response. It's clearly robust.

Dermatology Times:

How does targeting IL-31 signaling differentiate nemolizumab within the AD treatment landscape?

Piketty:

It's definitely a new target. We have more and more data on the molecular function of nemolizumab and targeting IL-31.

Targeting the IL-31 receptor allows us to target itch because it's a very important mechanism triggering itch. But we also have data demonstrating that it's not only itch. It's also targeting inflammation and barrier disruption.

Nemolizumab is able to act on these 3 pillars—not only itch, but also skin inflammation and barrier disruption. I think it's a drug that could address different aspects of the spectrum of atopic dermatitis.

Dermatology Times:

What are you learning about the relationship between itch, sleep, and quality of life?

Piketty:

We have a novel presentation showing the impact of improving itch on sleep disturbance. We looked at ARCADIA in atopic dermatitis as well as the OLYMPIA studies in prurigo nodularis, and we demonstrate the same trend.

Looking at different levels of improvement in itch, we see a strong correlation with sleep improvements. We demonstrate a similar trend when looking at improvements in skin lesions.

If you improve itch, you will improve sleep and quality of life, and we see the same relationship with improvement of the lesions.

Dermatology Times:

What are the next priorities for nemolizumab research?

Piketty:

We have already presented pediatric data in children aged 2 to 11 years, and it brings a lot of confidence again in the efficacy and safety of the drug.

Now we are working to bring new data on efficacy over the long term, looking at quality of life and looking in more detail at different end points to demonstrate where nemolizumab is efficacious and how it could improve quality of life.

We are also working on the final results of the long-term extensions for both ARCADIA and OLYMPIA. I'm excited to see the final results with almost 4 years of follow-up.

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 (EADV) Congress; September 30-October 3, 2026; Vienna, Austria. Galderma
2. Silverberg JI, Wollenberg A, Reich A, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 and ARCADIA 2): results from two replicate, double-blind, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi:10.1016/S0140-6736(24)01203-0. Dermatology Times
3. Legat FJ, et al. Comparative effects of itch, skin lesion severity and nemolizumab on sleep disturbance in atopic dermatitis and prurigo nodularis. Presented at: European Academy of Dermatology and Venereology (EADV) Congress; September 30-October 3, 2026; Vienna, Austria. Galderma
4. Ständer S, et al. Quantifying the impact of itch and skin lesion severity on quality of life in atopic dermatitis: a longitudinal analysis of the ARCADIA trials. Presented at: European Academy of Dermatology and Venereology (EADV) Congress; September 30-October 3, 2026; Vienna, Austria.