Q&A: Nemolizumab Sustains Itch, Skin Gains in Early Responders at 3 Years

Nemolizumab (Nemluvio), an interleukin (IL)-31 receptor alpha antibody, was evaluated with topical therapy in 1728 adolescents and adults with moderate-to-severe atopic dermatitis in the replicate phase 3 ARCADIA 1 and ARCADIA 2 trials.² In results published in The Lancet, Investigator’s Global Assessment (IGA) 0/1 at the 16-week mark achieved 36% and 38% with nemolizumab, versus 25% and 26% with placebo (P < .001).²

New 3-year data presented at the 2026 Fall Clinical Dermatology Conference extend those findings to early responders. “As progress in this high-burden disease area accelerates, we are challenged to aim higher in atopic dermatitis care,” said Sarina Berger Elmariah, MD, PhD, MPH, director of the UCSF Center of Excellence for Itch and Neurosensory Disorders.¹ Elmariah, a board-certified dermatologist and neuroscientist, served as first author of the post hoc analysis.¹

The analysis followed 295 patients from the ARCADIA long-term extension (LTE) who achieved a clinical response at Week 16 and continued treatment through Week 152.¹ At Week 56, 77% of these early responders reported IGA 0/1 or at least 90% improvement in Eczema Area and Severity Index (EASI).³ By the 152-week mark, 80% attained EASI-90, 50% attained EASI-100, and 80% noted an itch-free or nearly itch-free state.¹

In the broader prespecified interim analysis of 1903 LTE participants, up to 75% saw EASI-90 scores, and up to 73% attained an itch-free or nearly itch-free state through the 152-week mark.¹ The early-responder data add 3-year durability evidence for IL-31 pathway blockade as the biologic armamentarium for atopic dermatitis continues to expand.

In this new interview, Elmariah spoke with HCPLive at the time of the Fall Clinical Dermatology meeting in Las Vegas regarding the Week 152 results, managing early and delayed responders, and neuroimmune questions for future research:

HCPLive: What are the biggest takeaways from the ARCADIA LTE post hoc analysis of week 16 nemolizumab responders?

Sarina Berger Elmariah, MD, PhD, MPH: This was a post hoc, as-observed case analysis that included 295 of the participants from ARCADIA, the pivotal trials in moderate-to-severe atopic dermatitis with nemolizumab plus TCS and TCI. Essentially, what it found was that of those patients who met the definition of being a clinical responder, either achieving an IGA of 0 to 1 or an EASI-75 during the pivotal phase, which ended at Week 16, those who continued on over the course of 3 years had a very sustained, and even improved, skin clearance.

About 80% of patients, by the time we get to Week 152, so about 3 years out, were able to achieve an EASI-90. Fifty percent were able to achieve completely clear skin, so an EASI-100. The really profound and robust improvement in itch that patients experienced during the earlier pivotal trial and through the maintenance phase was also maintained. About 80% of patients maintained improvement in their itch. So, it was really exciting data suggesting there’s robust maintenance of skin clearance and resolution or control of their itch.

HCPLive: Which Week 152 results stood out most, and what do they suggest about the durability of IL-31 inhibition?

Sarina Berger Elmariah, MD, PhD, MPH: It’s a great question. IL-31 is a novel target in this evolving landscape for patients with atopic dermatitis, and what this suggests is that blocking IL-31 and its signaling cascade is helpful at both delivering on the early itch needs of our patients with atopic dermatitis and reinforcing and maintaining that response. That’s the first thing, because if you look at the broader real-world data and questionnaires on the needs of our patients with atopic dermatitis, itch is the number 1 factor that tends to drive them into the office to seek care, regardless of how severe their disease is. Even when we think of that really inflamed patient, itch is often still one of their paramount concerns. What this tells us is that even 3 years out, our patients are getting complete control over their itch. That’s the first and most important thing.

The other really important factor here, as I said, is we’re entering this world of looking at different mechanisms and having different biologic agents we can use to interrupt the atopic landscape, if you will. What this says is that IL-31 signaling blockade really delivers on skin clearance, and improved skin clearance over time. In early responders, we see that the skin clearance just continues to get better, and patients are actually able to achieve EASI-90, almost clear or completely clear skin. For me, that says a lot about how our understanding of atopic dermatitis is changing.

For so long in dermatology, we have held the hands of our patients and said, “We need to get your inflammation under control first, and then see how your itch responds.” Now we have a clear case of a biologic agent, nemolizumab, that is able to deliver on itch really quickly. We see that in many patients their inflammation improves, but also, even in those where it may have only started to improve a little bit, IL-31 blockade really does deliver on skin clearance as time goes on. It’s shifting the narrative and the discussion. As our armamentarium for atopic dermatitis expands, it’s shedding new light on how we look at atopic dermatitis and how we can deliver for our patients.

HCPLive: How should clinicians use these data when choosing nemolizumab and managing early versus delayed responders?

Sarina Berger Elmariah, MD, PhD, MPH: I think there are 2 ways to look at this. The first is that if your patient shows an early response in skin clearance and even in itch, it is very reassuring that they will continue to respond. For those who stayed on therapy, whether every 4 weeks or every 8 weeks in the maintenance phase (in the long-term extension, all the patients were on every-4-week therapy), we know the skin clearance continues to improve. So, there’s a rapid response on itch that’s sustained, but the skin clearance continues to improve, and I think that’s very reassuring. Practically speaking, if you think a patient is inching along, you can feel pretty confident that those patients who stay on therapy continue to get better, to the point that they achieve skin clearance or near skin clearance.

I would also say, for those who respond more in terms of their itch and where we have to wait a little bit to see how clear their skin gets, it still bodes very, very well. My own personal experience using nemolizumab also suggests that some patients respond very quickly, both in terms of itch and inflammation, as was seen in the pivotal, placebo-controlled phase up to Week 16, but as time goes on, patients continue to do better.

HCPLive: What questions about long-term nemolizumab treatment and atopic dermatitis remain unanswered, and where should future research go?

Sarina Berger Elmariah, MD, PhD, MPH: I think the first major hurdle we have started to overcome is simply recognizing the importance of itch and skin symptoms to our patients, and to the evolution of the disease, beyond itch just being a side effect. We have traditionally thought of atopic dermatitis as an inflammatory skin disease, and now we are starting to redefine what different cytokines, or these inflammatory molecules, are doing in the setting of atopic dermatitis.

Going forward, I think we need to really pursue that understanding from a pathophysiologic mechanism perspective. What does it mean to shut down itch? What does that represent? Are we actually shutting down the nerve? Are we shutting down part of the inflammatory cascade, from a neuroimmune lens or even a neuroepithelial communication lens, as opposed to simply viewing atopic dermatitis as an inflammatory state that only drives neural activity from the perspective of itch? Next steps are really figuring out what that means, not only for on-therapy patient responses, but in the future, for modulating the disease and even modulating comorbidities of the disease.

This is a promise we now have from current agents, because we have a number of different agents, including nemolizumab, that offer safe options for long-term therapy. For me, as an itch specialist, as somebody who is a neuroscientist and loves to think about how nerves are influencing the inflammatory and epithelial landscape, I’m very, very excited. What does this mean for true remission in our patients: disease control on therapy, disease remission, and even potentially modification down the line?

Editor’s Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Elmariah has previously disclosed receiving consultancy and advisory board honoraria from Bambusa Therapeutics, Celldex Therapeutics, Disk Medicine, Galderma, Genzyme, Incyte, Novartis, Pfizer, Regeneron, Sanofi, and ZenZema.

References

1. Galderma. Fall Clinical 2026: Galderma presents new three-year Nemluvio data showing deep and lasting skin lesion and itch responses in patients with atopic dermatitis aged 12 and older. Published October 8, 2026. Accessed October 15, 2026. https://www.galderma.com/news/fall-clinical-2026-galderma-presents-new-three-year-nemluvior-data-showing-deep-and-lasting.

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.

3. Smith T. Nemolizumab sustains atopic dermatitis skin, itch control through 3 years. HCPLive. Published October 10, 2026. Accessed October 15, 2026. https://www.hcplive.com/view/nemolizumab-sustains-atopic-dermatitis-skin-itch-control-through-3-years.