Opzelura effective, well tolerated in children aged at least 2 years with atopic dermatitis

Key takeaways:

• The primary endpoint was met with more patients treated with Opzelura vs. vehicle achieving IGA 0/1 (56.5% and 36.6% vs. 10.8%).
• Opzelura was well tolerated with no serious adverse events.

Opzelura achieved significant efficacy for the treatment of atopic dermatitis in children aged as young as 2 years, Incyte announced in a press release.

Opzelura (ruxolitinib) cream, a selective Janus kinase 1/2 inhibitor, is FDA-approved for the treatment of nonsegmental vitiligo and the short-term treatment of mild to moderate atopic dermatitis in nonimmunocompromised patients aged at least 12 years whose disease is not well controlled by topical prescription therapies.

According to a press release, data from Incyte’s TRuE-AD3 study, a phase 3 study evaluating the efficacy and safety of Opzelura cream in children aged 2 to 12 years, were presented at the European Academy of Dermatology and Venerology 2023 Congress in Berlin.

"The TRuE-AD3 data presented today at EADV reinforce the strong safety and efficacy profile of ruxolitinib cream and its potential to treat younger age groups,” Jim Lee, MD, group vice president of inflammation and autoimmunity at Incyte, said in the release.

The study enrolled 300 patients randomly assigned to receive twice-daily doses of Opzelura 0.75%, Opzelura 1.5% or vehicle for 8 weeks.

Results showed that the study met its primary endpoint with a higher proportion of Opzelura-treated patients achieving an IGA of 0 or 1 by week 8 compared with vehicle-treated patients, including 56.5% of patients treated with Opzelura 1.5% and 36.6% of those treated with Opzelura 0.75% vs. 10.8% of those treated with vehicle (P < .0001 for both).

The secondary endpoint of time to a 4-point or greater improvement in itch Numerical Rating Scale (NRS) was also achieved by 43.4% of patients aged 6 to 12 years treated with Opzelura 1.5%, 37.5% of the same age group treated with Opzelura 0.75% and 29.7% of those treated with vehicle.

EASI 75 was also achieved by more than half of patients treated with Opzelura 1.5% and 0.75% (67.2% and 51.5%, respectively) vs. 15.4% of vehicle-treated patients (P < .0001 for both).

No serious adverse events were reported with the only treatment-related adverse events being application site pain (Opzelura, 2.7% vs. vehicle, 0%). Overall, Opzelura was considered well tolerated, according to the press release.

“There is still a significant medical need for a nonsteroidal topical treatment that provides rapid and effective control of the signs and symptoms of AD in children,” Lee said.