The US Food and Drug Administration approved ruxolitinib cream 1.5% (Opzelura, Incyte) for the short-term and noncontinuous chronic treatment of mild-to-moderate atopic dermatitis in nonimmunocompromised children aged 2 to 11 years whose disease is not adequately controlled with topical prescription therapies or when those therapies are not recommended. Ruxolitinib cream is the first topical Janus kinase inhibitor approved in the US for this patient population.

Approval was supported by the phase 3 TRuE-AD3 trial, which enrolled more than 300 pediatric patients with atopic dermatitis for at least 3 months and body surface area involvement of 3% to 20%. Patients were randomized to receive ruxolitinib cream 0.75% or 1.5% twice daily or vehicle. The primary endpoint, Investigator’s Global Assessment–treatment success at week 8, was achieved in a significantly greater proportion of patients receiving ruxolitinib cream compared with vehicle. Secondary endpoints, including achievement of at least 75% improvement in the Eczema Area and Severity Index, were also met.

The safety profile in TRuE-AD3 was consistent with previous data, and no cases of serious infection, major adverse cardiovascular events, malignancy, or thrombosis were reported during the 8-week vehicle-controlled period. Ruxolitinib cream carries class warnings for infection, malignancy, cardiovascular events, thrombosis, cytopenias, and lipid abnormalities, and use is not recommended in patients with active infections. The most common adverse event was upper respiratory tract infection.

Source: Incyte