Opzelura Cream Safely Eases AD in Young Kids

The study showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator’s Global Assessment Treatment Success.

Incyte’s ruxolitinib cream (Opzelura) cleared skin in significantly more kids with atopic dermatitis (AD) than a nonmedicated topical control,  a new study shows.

The study, which included 300 kids aged ≥2 to <12, met its primary endpoint and showed significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved Investigator’s Global Assessment Treatment Success (IGA-TS) than patients treated with vehicle control. Investigator’s Global Assessment Treatment Success (IGA-TS) is defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline at Week 8. 

The drug is currently approved for eczema patients 12 and older.

The overall safety profile of ruxolitinib cream is consistent with previous data, and no new safety signals were observed. The long-term safety portion of the study will continue as planned.

TRuE-AD3 is a randomized, double-blind, vehicle-controlled Phase 3 study evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in children with atopic dermatitis (AD). 

Patients with an Investigator’s Global Assessment (IGA) score of 2 to 3 (a measure of disease severity), and with AD on 3% to 20% of their Body Surface Area (BSA; excluding scalp) were randomized 2:2:1 to receive ruxolitinib cream 0.75% administered twice daily (BID); ruxolitinib cream 1.5% BID; or vehicle BID. Participants who successfully completed an efficacy assessment at Week 8 were offered participation in the 44-week long-term safety treatment extension period with their same treatment group (ruxolitinib cream 0.75% or 1.5% BID). Participants initially randomized to vehicle cream were re-randomized (1:1) in a blinded manner to one of the active treatment groups.

Secondary endpoints include the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI75) score and the proportion of participants with at least a 4-point improvement in the itch numerical rating scale (NRS). 

The study is also tracking the frequency, duration, and severity of adverse events associated with the use of ruxolitinib cream.

"We have already seen the benefit that ruxolitinib cream can have among adult and adolescent patients with atopic dermatitis in the TRuE-AD1 and TRuE-AD2 studies, and this new positive data reinforces the potential of ruxolitinib cream to offer children a much-needed effective, non-steroidal topical therapy, says Jim Lee, M.D., Group Vice President, Inflammation & AutoImmunity, Incyte, in a news release.  “We look forward to discussing these data with regulatory agencies to determine next steps."

Data from TRuE-AD3 will be submitted for presentation at an upcoming scientific meeting.

Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older. It is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.