Commentary|Videos|September 28, 2025

First-in-Class Rocatinlimab Aims to Rebalance T Cells in Atopic Dermatitis: Emma Guttman, MD, PhD

Fact checked by: Julia Bonavitacola

At the recent European Academy of Dermatology and Venereology meeting, new data were presented on rocatinlimab for atopic dermatitis, which was investigated in the phase 3 ROCKET-SHUTTLE (NCT05724199) and ROCKET-IGNITE (NCT05724199) trials. These studies are part of the ROCKET (ROCatinlimab in Eczema Trials) phase 3 development program in adult and pediatric patients. The treatment duration for SHUTTLE and IGNITE was 24 weeks, and rocatinlimab is a first-in-class T-cell rebalancing therapy

Trial investigator Emma Guttman, MD, PhD, chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, here explains why targeting the OX40-OX40 ligand pathway is so exciting, in particular because even after 24 weeks of treatment, the efficacy of rocantilimab does not plateau.

This transcript was lightly edited for clarity; captions were auto-generated.

Transcript

What are your expectations for rocantinlimab’s durability of response and its potential for long-term disease medication after treatment?

I'm very passionate about the OX40-OX40 ligand pathway and new treatments that are targeting this pathway because, and people may not know this, I was the first actually to highlight the importance of this pathway in atopic dermatitis, and many people probably would not even know that. That was at a time that actually a study was being conducted in psoriasis in 100 patients with rocatinamab—or at that time, it had a different name—because psoriasis was a very sexy disease at the time and people wanted to go for psoriasis. But in my data, I saw that actually the levels of OX40 and OX40 ligand are much higher in atopic dermatitis compared to psoriasis, so I actually anticipated that it may not work for psoriasis and the right disease is atopic dermatitis, and that that actually was the case.

I'm super excited about this pathway, and I think the beauty of this pathway will be for 2 things. First of all, disease modification, that's very important, and I do think that there are increasing responses. You correctly identified that unlike other drugs that achieve a plateau at week 16, this drug does not achieve a plateau at week 24 even. I think there will be increasing responses between week 24 and 48. What I think may happen is, right now, the EASI-90 [Eczema Area and Severity Index] responses that we have in atopic dermatitis are up to a third of patients, and I think by week 48, we'll achieve much more than that—and that was a JAK [Janus kinase] inhibitor—because here we are talking about a biologic.

I think that will be very meaningful for our patients, and also what will be meaningful for them is that idea of disease modification and the administration of drugs much less frequently afterwards.

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