Diamant Thaçi, MD, PhD: Understanding the Impact of Nemolizumab Efficacy Post Approvals in EU, UK, and Switzerland

The European Commission recently approved Galderma’s nemolizumab (Nemluvio) for the treatment of moderate to severe atopic dermatitis (AD) in patients aged 12 and older and moderate to severe prurigo nodularis (PN) in adults.¹ Additionally, nemolizumab was also approved for the same indications in the UK and Switzerland.²

Approval was based on strong phase 3 ARCADIA and OLYMPIA trial results, demonstrating rapid and sustained efficacy. With its first-in-class mechanism and 4-week dosing interval, nemolizumab offers a promising new option for dermatologists and patients in these regions.

Dermatology Times spoke with one of the researchers involved in the studies, Diamant Thaçi, MD, PhD, a university professor at University of Lübeck in Germany, to discuss the data supporting the approval and what the action means for patients with AD and PN.

These conditions, often characterized by severe and persistent itch, pose significant treatment challenges, making the results of these trials particularly relevant to clinical practice.

"In both clinical trials, in the ARCADIA and OLYMPIA programs, this has been a very comprehensive program investigating efficacy and safety of nemolizumab in 2 very important indications," Thaçi said.

Clinical Outcomes: Rapid and Significant Itch Relief

A key takeaway from the trials was the rapidity of symptom relief observed with nemolizumab. Thaçi emphasized the importance of treatments that deliver fast results, particularly for patients suffering from severe itching.

"It is very important that the treatment options that we have nowadays, that they are not only effective, let's say after 2 or 3 months, but that they have a rapid response," he noted. "This is especially [true for] diseases which are compared with itch, and we are talking about a bothering itch, a very severe itch... improvement of the itch within hours and days."

This rapid onset of action differentiates nemolizumab from other available treatments and provides a critical benefit for patients whose quality of life is significantly impacted by persistent pruritus, he added.

Efficacy Across Different Patient Profiles

Thaçi also highlighted the drug’s effectiveness across various patient populations. While it was initially believed that patients with more severe itch might respond better, the trials demonstrated efficacy across the spectrum.

"We do see that patients who are prone to be more itchy, who have a more severe itch, that [their] perception [is that] they do respond better. However, in the clinical trials, they have been shown that in the vast majority of the patients, there was no big difference between the patient who has a severe or less severe itch," he said.

This finding suggests that nemolizumab can be a viable option for a broad range of patients, not just those experiencing extreme symptoms.

A New Mechanism of Action in Dermatology

Unlike existing therapies, nemolizumab targets interleukin-31 (IL-31), a cytokine known to play a central role in itch signaling.

"Also in this population, we had a very nice response showing that nemolizumab, with the inhibition of IL-31, offers a little bit more from the treatment options which are already on the market," Thaçi said.

By blocking IL-31, nemolizumab effectively disrupts the itch-scratch cycle, providing relief and potentially improving skin healing over time.

Safety Considerations and Clinical Implications

While efficacy remains paramount, Thaçi underscored the significance of safety in managing chronic dermatological conditions.

"In my personal opinion, efficacy is very important, but in diseases like atopic dermatitis and prurigo nodularis, safety plays a very important role," he said.

Phase 3 trial results indicated a favorable safety profile, further supporting nemolizumab's potential as a long-term treatment option.

References

1. Galderma’s Nemluvio (nemolizumab) approved in the European Union for moderate-to-severe atopic dermatitis and prurigo nodularis. News release. February 14, 2025. Accessed February 25, 2025. https://www.galderma.com/news/galdermas-nemluvior-nemolizumab-approved-european-union-moderate-severe-atopic-dermatitis-and
2. Galderma’s Nemluvio (nemolizumab) granted marketing authorization in the United Kingdom and Switzerland for moderate-to-severe atopic dermatitis and prurigo nodularis. News release. February 18, 2025. Accessed February 25, 2025. https://www.galderma.com/news/galdermas-nemluvior-nemolizumab-granted-marketing-authorization-united-kingdom-and-0