Efficacy and safety of benvitimod 1% cream for atopic dermatitis in patients aged 2 years and older: A phase III randomized clinical trial.
Yan Zhao, Zhu Wei, Yanyan Feng et al.
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In 30 seconds
This phase III randomized controlled trial compared benvitimod 1% cream with vehicle in 271 Chinese patients aged 2 years or older with atopic dermatitis. Participants applied treatment twice daily for 8 weeks. At week 8, EASI 75 was achieved by 54.4% of the benvitimod group versus 25.5% of the vehicle group (P <0.001). Benvitimod also outperformed vehicle on the reported secondary efficacy endpoints. Treatment-emergent adverse events occurred in 51.4% versus 43.2%, respectively, and were mostly mild to moderate. A subset entered a 44-week open-label extension.
Key findings
- At week 8, EASI 75 was achieved by 54.4% with benvitimod versus 25.5% with vehicle (P <0.001).
- IGA 0/1 responses were 46.2% versus 21.4%, and EASI 90 responses were 33.9% versus 13.5% (both P <0.001).
- A ≥3-point PP-NRS reduction occurred in 54.0% versus 27.9% (P <0.01).
- Treatment-emergent adverse events occurred in 51.4% with benvitimod and 43.2% with vehicle; most were mild to moderate.
Why it matters
The trial provides controlled evidence of short-term topical efficacy in both adult and pediatric patients, including improvement in disease severity and itch. The higher adverse-event proportion with benvitimod is relevant when weighing its efficacy, although most reported events were mild to moderate. These findings add evidence for a potential topical option in atopic dermatitis but do not establish longer-term comparative safety or effectiveness.
What to keep in mind
The controlled comparison lasted 8 weeks; the longer extension was open-label and included only a subset of patients.