Q&A: 3-Year Nemolizumab Data Reinforce Long-Term Disease Control in Atopic Dermatitis

New 3-year data from the ARCADIA long-term extension program suggest that nemolizumab (Nemluvio; Galderma) can provide sustained disease control in patients with moderate-to-severe atopic dermatitis (AD), with no new safety signals emerging during extended treatment.

Presented at the 2026 European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria, the findings extend the evidence supporting IL-31 receptor alpha blockade as a long-term approach to AD management. In addition to sustained improvements in skin clearance and pruritus, the data highlight the potential impact of symptom control on sleep and broader quality of life.

Dermatology Times spoke with Christophe Piketty, vice president and head of innovation, therapeutic dermatology at Galderma, during EADV 2026 about the clinical implications of the 3-year findings, the role of IL-31 signaling in AD, and what clinicians can expect next from the nemolizumab clinical development program.

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 sustained, with some increase in response at 3 years from the start of the long-term extension.

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:

How significant are the skin clearance results observed at week 152?

Piketty:

It’s important to remember how we conducted this study. Initially, we had the 2 pivotal studies, ARCADIA 1 and ARCADIA 2, as well as other studies assessing efficacy using different designs. The long-term extension mainly includes patients coming from the 2 pivotal studies, as well as some patients from other smaller studies.

It is open-label, and the main objective is really to demonstrate the long-term safety of nemolizumab for patients suffering from atopic dermatitis. We also generate a lot of other efficacy end points, but one of the main objectives is to demonstrate that the drug is safe over the long term.

That is very important because the first thing is to make sure that, over the long term, there is no additional risk for patients.

Dermatology Times:

What were the key safety findings over the 3-year period?

Piketty:

We did not find anything new, and we showed a decrease in the incidence of adverse events that had been observed throughout the clinical trials.

That is very reassuring because, in a long-term extension study, if you start seeing something new emerge, it can indicate that something is happening. This is definitely not the case here.

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

We initially observed some asthma events in the phase 2 program, but that was not confirmed in the phase 3 program. We did see some asthma events, but they appear consistent with the natural history of patients who have asthma and may sometimes experience asthma flares. They were not considered linked to nemolizumab.

To be fully comprehensive, we also saw some cutaneous adverse events, but as I mentioned, those also decreased over the long term, which is reassuring.

Dermatology Times:

What did you see in terms of long-term efficacy?

Piketty:

The data look great. Looking at EASI 75 and EASI 90 responses, the results are very high and very robust.

The pruritus response is also remarkable. More than 90% of patients are responding on pruritus. I think that is really one of the strengths of the drug: this strong control of symptoms, including sleep disturbance and quality of life.

Dermatology Times:

What should clinicians know about the long-term safety and tolerability findings when discussing nemolizumab with patients?

Piketty:

In the past, we had some debate around asthma because it was something observed in phase 2, and we carefully evaluated this in the phase 3 program and in the pivotal ARCADIA 1 and ARCADIA 2 studies.

We came to the conclusion that there was no imbalance. It was observed at the same incidence rate in the placebo group and the nemolizumab group. We clearly explained and shared these data, and I think prescribers are now reassured about this.

Dermatology Times:

How should clinicians interpret the results given the open-label design of the long-term extension?

Piketty:

I don't think it is really an option to have a controlled study over such a long period. It would not be ethical to maintain patients on placebo for that long.

Even maintaining placebo treatment through 52 weeks is challenging. Dupilumab did that in the past in the CHRONOS study, one of its pivotal studies assessing dupilumab in combination with topical corticosteroids, but no one would do that now. Typically, it is up to week 16, and then that is enough. You cannot maintain patients on placebo for years.

I think an open-label design is the standard way to generate long-term extension data. Of course, we need to interpret the data with caution because they are open-label, but to me, they are very convincing because we are seeing sustained responses and, in some measures, increases in response. It is clearly robust.

Dermatology Times:

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

Piketty:

It is definitely a new target, and we have more and more data on the molecular function of nemolizumab and targeting IL-31.

Targeting the IL-31 receptor allows us to directly target itch because IL-31 is a very important mechanism involved in triggering itch. Targeting the IL-31 receptor is associated with high efficacy on itch, and this is definitely what we observe.

But we also have a lot of data demonstrating that it is not only itch. It is 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 is a drug that can address multiple aspects of the spectrum of atopic dermatitis.

Dermatology Times:

What are the next priorities for nemolizumab research?

Piketty:

The next step is definitely the pediatric data in children aged 2 to 11 years. We have already presented data for the first time this year, and they bring a lot of confidence regarding the efficacy and safety of the drug in children aged 2 to 11 years. It is very efficacious and also very well tolerated.

Now, we are working to bring new data on long-term efficacy, looking at quality of life and examining more detailed end points to demonstrate where nemolizumab is efficacious and how it can improve quality of life.

Dermatology Times:

You also mentioned new analyses examining sleep. What are those findings showing?

Piketty:

We have a novel presentation showing the impact of improving itch on sleep disturbance.

We looked at ARCADIA in atopic dermatitis, but also at the OLYMPIA studies in prurigo nodularis, and we demonstrated the same trend. When looking at different levels of improvement in itch—from moderate to very important improvement—we see a strong correlation with improvements in sleep.

We demonstrate the same trend when looking at improvement in skin lesions. It is closely correlated. If you improve itch, you will improve sleep and quality of life, and we see a similar relationship with improvement in lesions.

Dermatology Times:

How could these sleep findings affect conversations clinicians have with their patients?

Piketty:

The data on sleep improvement look very robust. It is one of the features of the drug and part of improving the symptoms of the disease.

It might be of particular interest for children because one of the questions currently being discussed is the impact of atopic dermatitis on growth. We know that, for children, sleeping well is very important to making sure growth remains within the normal range.

We can hypothesize that by improving itch and sleep disturbance with nemolizumab, there could potentially be an effect on growth outcomes. We don't have those data yet, but I hope this is something we can evaluate going forward. We are looking at it.

Dermatology Times:

What longer-term data should clinicians watch for next?

Piketty:

We are currently working on the final results of the long-term extensions for both ARCADIA and OLYMPIA.

The data will probably be available next year at a future congress. I'm very 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 Congress; September 30-October 3, 2026; Vienna, Austria. Galderma
2. Silverberg JI, 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-blinded, randomised controlled phase 3 trials. Lancet. 2024;404(10451):445-460. doi:10.1016/S0140-6736(24)01203-0. Galderma
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 Congress; September 30-October 3, 2026; Vienna, Austria. Galderma
4. 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. Accessed October 12, 2026.