What Does New Phase 3 Amlitelimab Data Suggest for Atopic Dermatitis?

In this segment of ABCs in Dermatology, hosts Christopher Bunick, MD, PhD, and Lindsay Ackerman, MD, discussed why the phase 3 amlitelimab data in atopic dermatitis may be more clinically meaningful than headline efficacy numbers alone initially suggest.

Bunick emphasized that understanding the study population is critical when interpreting the results from the COAST 1, COAST 2, and SHORE trials. Across the studies, each enrolled roughly 600 patients with moderate-to-severe atopic dermatitis, representing a sizable late-stage clinical program. He highlighted the diversity of the enrolled population, noting relatively strong representation of Black patients compared with many dermatology trials, alongside a notably large proportion of Asian participants, reflecting a broader global patient population.

The hosts also underscored the substantial disease burden among trial participants. According to Bunick, patients had lived with atopic dermatitis for nearly two decades on average, and many entered the studies with extensive body surface area involvement and high baseline disease severity. A large percentage had also previously received systemic therapies, including biologics, JAK inhibitors, and traditional immunosuppressive agents, suggesting investigators were studying a particularly treatment-resistant population rather than patients with milder disease.

Another point Bunick stressed was the rigor of the statistical analysis. The trials used nonresponder imputation methodology, meaning any participant who discontinued treatment, deviated from protocol, or required rescue therapy was automatically counted as a treatment failure. He argued that this conservative approach makes the efficacy findings more impressive when viewed in context.

Ackerman expanded on the significance of the long-term response patterns seen with amlitelimab, particularly the durability of efficacy through 52 weeks and the similarity between dosing every 4 weeks and every 12 weeks. She contrasted this upstream immune modulation strategy with more downstream approaches such as cytokine blockade or JAK inhibition, suggesting that targeting the OX40 ligand pathway may allow for broader recalibration of immune activity rather than suppression of isolated inflammatory signals.

She also noted that responses appeared to deepen over time, with later efficacy outcomes surpassing those seen at earlier time points despite the increasingly stringent nature of long-term analyses. Ackerman suggested this pattern could reflect gradual restoration of immune balance through preservation of regulatory T-cell function and normalization of aberrant T-cell memory responses, raising the possibility that upstream pathway modulation may eventually reshape how chronic inflammatory diseases such as atopic dermatitis are treated.

Editor’s note: This segment was summarized with the help of AI tools.

Relevant disclosures for Bunick include AbbVie, South Beach Symposium, Almirall, Apogee Therapeutics, Arcutis Biotherapeutics, Daiichi Sankyo, Eli Lilly, LEO Pharma, US, Novan, Novartis, Ortho Dermatologics, Palvella Therapeutics, Pfizer Inc., Sanofi, Sun Pharmaceutical Industries Ltd., Timber Pharmaceuticals, and UCB. Relevant disclosures for Ackerman include AbbVie, Alumis, Amgen, Arcutis, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Galderma, L'Oréal, Novartis, Sun Pharmaceutical, and UCB.

References

1. Sanofi. Press Release: AAD: new results from Sanofi’s amlitelimab phase 3 studies in atopic dermatitis presented in late-breaking research session. Sanofi.com. Published March 28, 2026. Accessed May 28, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-03-28-15-00-00-3264184.

2. Kyowa Kirin. Kyowa Kirin Announces Discontinuation of Rocatinlimab Clinical Trials - Kyowa Kirin. Kyowakirin.com. Published March 3, 2026. Accessed May 28, 2026. https://www.kyowakirin.com/media_center/news_releases/2026/e20260303_01.html.