New Drug Effective, Safe in the Long-term Treatment of Moderate to Severe Atopic Dermatitis


eMediNexus    10 February 2023

A recent study has shown that patients with moderate to severe atopic dermatitis experienced significant improvement during and up to 20 weeks after treatment with rocatinlimab.


Rocatinlimab showed significance in all doses compared to placebo in primary and secondary endpoints. Furthermore, it targeted memory T-cells, including memory type 2 T-cells, which may indicate disease modification.


This phase 2b multicenter, double-blind, the placebo-controlled study recruited 274 adults with moderate to severe atopic dermatitis who were randomized to subcutaneous rocatinlimab 150 mg or 600 mg every 4 weeks; rocatinlimab 300 mg or 600 mg every 2 weeks or subcutaneous placebo up to week 18. Additionally, it saw an 18-week active-treatment extension and 20-week follow-up.


Patients taking rocatinlimab experienced significantly greater least-squares mean percent change in Eczema Area and Severity Index (EASI) score from baseline compared with placebo. Improvements in disease severity observed at week 16 were maintained through the extension period to week 36. Most participants in the rocatinlimab groups with EASI 75 response rates maintained rates during off-drug follow-up. Additionally, patients of the rocatinlimab groups with EASI 75 at week 36 showed a 73% to 96% probability of not relapsing at week 56.


Adverse events remained similar among rocatinlimab groups, with the most common being pyrexia (17%), nasopharyngitis (14%), chills (11%), headache (9%), aphthous ulcer (7%) and nausea (6%).


The phase 3 trial, all set to start in 2023, will include adolescents, and if the study shows promising results, it will provide an opportunity to treat children early enough to prevent the development of asthma and, potentially, the entire atopic march.


Source: Healio [Internet]. New drug effective, safe in long-term treatment of moderate to severe atopic dermatitis. December 09, 2022. Available from: https://www.healio.com/news/dermatology/20221209/new-drug-effective-safe-in-longterm-treatment-of-moderate-to-severe-atopic-dermatitis

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