Discussing Interim Findings on Nemolizumab for Atopic Dermatitis, with Diamant Thaçi, MD

In recent interim findings presented at the 2024 European Academy of Dermatology & Venereology Congress, nemolizumab (Nemluvio) therapy was shown to result in continuous improvements in signs and symptoms of patients with atopic dermatitis.^1,2

These new data demonstrated that clinically meaningful improvements were observed in atopic dermatitis-related skin lesions which continued to increase up to the 56-week mark. The HCPLive team spoke with Diamant Thaçi, MD, lead investigator of the ARCADIA long-term extension analysis and professor at the University of Lubeck in Germany.

“Nemolizumab is an receptor antagonist which binds to IL-31 receptors, which is extremely important in type 2 inflammation,” Thaçi said. “It is one of the key cytokines that is important in itch. But we have relatively a better understanding of this cytokine as being part of the type 2 inflammation family, together with IL-4, together with 13, 5, and this makes the cytokine important and interesting. We are talking more about neuroinflammation”

Thaçi was asked about the interim ARCADIA trial analysis leading up to the new data, specifically highlighting the most significant results of these programs presented at EADV. 47% of patients were successful in achieving clear or almost clear skin, a notable increase from 29% earlier in this analysis.

The ARCADIA investigators also found that 73% of these subjects had an improvement of 75% in their Eczema Area and Severity Index (EASI) scores, noted as being up from 38%.

“If we go to the higher level of EASI 90, we saw a very valuable improvement of the signs and symptoms, something that probably was not expected by many people,” Thaçi explained. “Especially considering that nemolizumab is probably excellent in improving itch, but not having such substantial improvement of the EASI score. I think this was a confirmation that in long-term management of atopic dermatitis, there will be definitely a place for nemolizumab as a valuable treatment option.”

Thaçi was also asked about the safety profile of nemolizumab throughout the trial program thus far, including any adverse events resulting from the medication.

“We have seen no surprises, and also in the long-term,” Thaçi said. “Furthermore, in long-term management, we also see a numerical decrease of adverse events. There was no conjunctivitis, which is also very good, especially for the patients who cannot receive other biologics. There was no risk of infection increase.”

Thaçi was later asked about what these data could mean for clinicians and other providers viewing the findings seeking alternative options for their patients with atopic dermatitis.

“Is not yet approved in Europe but we are hoping to get approval very soon next year,” he explained. “And once we have it, I think the next step will be to find out what we are finding for clinical trials, whether it is also mirrored in daily practice. So we are very confident, according to this data that we have seen, not only in the short term, but also in the long term. Of course, there will be a lot of investigation also on characterizing this neuroinflammation, about the importance of IL-31 in type 2 inflammation in general.”

To learn more, view the full interview posted above this summary.

The quotes used in this summary of the interview were edited for clarity.

Thaçi reported receiving personal fees from Boehringer Ingelheim during the conduct of the study as well as receiving grants and personal fees from AbbVie, Novartis, LEO Pharma; personal fees from Allmiral, Amgen, Bristol-Myers Squibb, Celltrion, New Bridge, Eli Lilly and Co, Gallapagos, Galderma, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Janssen Pharmaceuticals.

References

1. ^{Smith T. Positive Long Term Findings on Nemolizumab Observed for Atopic Dermatitis, Prurigo Nodularis. HCPLive. September 26, 2024. https://www.hcplive.com/view/positive-long-term-findings-nemolizumab-observed-for-atopic-dermatitis-prurigo-nodularis. Date accessed: September 27, 2024.}
2. ^{EADV 2024 Late Breaking News Sessions: New Galderma Data Demonstrating Nemolizumab’s Long-term Efficacy and Safety in Atopic Dermatitis and Durability in Prurigo Nodularis to Be Shared During Three Oral Presentations. Galderma. September 25, 2024. https://www.businesswire.com/news/home/20240924578710/en/EADV-2024-Late-Breaking-News-Sessions-New-Galderma-Data-Demonstrating-Nemolizumab%E2%80%99s-Long-term-Efficacy-and-Safety-in-Atopic-Dermatitis-and-Durability-in-Prurigo-Nodularis-to-Be-Shared-During-Three-Oral-Presentations.}