AN INVESTIGATIONAL, new ointment targeting the Janus kinase (JAK) pathway has shown promising results for adults with mild-to-moderate atopic dermatitis (AD), offering rapid itch relief and sustained improvements without the long-term risks associated with topical steroids. The findings come from the phase 3 portion of a large seamless phase 2/3 clinical trial conducted at 27 sites across China.
The study evaluated ivarmacitinib ointment, a highly selective JAK1 inhibitor, applied twice daily for eight weeks. Adults aged 18 to 75 with clinically diagnosed mild-to-moderate AD were randomly assigned to one of three groups: ivarmacitinib 0.5%, ivarmacitinib 1%, or a vehicle (placebo) ointment. After the initial eight-week period, patients originally receiving placebo were reassigned to one of the active treatments and continued under blinded conditions through week 52, allowing for extensive long-term safety evaluation.
Ivarmacitinib Ointment: A Steroid-Sparing Alternative
At the eight-week mark, ivarmacitinib clearly outperformed the vehicle across key clinical endpoints. Investigator’s Global Assessment (IGA) response rates doubled in the 0.5% group (21.3% vs. 10.6%) and more than doubled in the 1% group (26.2% vs. 10.6%). Improvements were even more striking for EASI-75, a widely used measure of eczema severity reduction, with response rates of 42.6% for the 0.5% dose and 45.1% for the 1% dose, each more than double the vehicle rate of 17.9%. All comparisons reached statistical significance.
One of the most notable findings was the rapid reduction in itch, often the most burdensome symptom for patients. Participants experienced measurable relief within 48 hours, and these improvements persisted through one year of follow-up. Long-term benefits were also observed across secondary measures, including SCORAD scores, body surface area affected, and quality-of-life assessments.
Safety profiles were generally favourable, with no major safety signals emerging over 52 weeks. Most adverse events were mild and occurred at similar or lower rates than in the vehicle group. Importantly, no cases of skin atrophy, telangiectasia, or application-site irritation, common concerns with topical steroids, were reported. The few events appearing in 2% or more of patients were limited to the 0.5% dose group: folliculitis (4.1%) and elevated uric acid (3.3%).
What This Trial Means for Ivarmacitinib Ointment Use
Overall, the results support ivarmacitinib ointment as a promising steroid-sparing option that delivers rapid, durable symptom control with a favourable safety profile. If approved, it could offer a much-needed alternative for millions living with chronic eczema.
Reference
Wang D et al. Ivarmacitinib ointment for adults with mild-to-moderate atopic dermatitis: phase 3 results from a randomized, double‑blind trial. Br. J. Dermatol. 2025; doi:10.1093/bjd/ljaf482.
