Ruxolitinib 1.5% cream is a topical Janus kinase (JAK) inhibitor approved by the FDA in September 2021 for the treatment of mild to moderate atopic dermatitis (eczema) in non-immunocompromised patients aged 12 years and older who disease did not respond well to topical prescription therapies or cannot be treated by other medications. The researchers conducted a Maximum-Use Trial (MUsT) in children aged 2-11 years to evaluate efficacy and safety of ruxolitinib 1.5% cream.
In the trial, 29 children aged 2 to 11 years with modarea andsevere atopic dermatitis of at least 3 months duration that affected more than 35% of body surface area, and have an Investigator’s Global Assessment (IGA) score of 3 or greater received twice-daily applications of ruxolitinib 1.5% cream over 4 total weeks to baseline lesions, then as-needed application of the cream to active lesions for a 4 more weeks. From there, patients could continue to use cream as-needed for another 44-weeks.
The researchers found that the mean body surface area impacted by atopic dermatitis had lowered from 58.0% at baseline to 11.4% at the 4-week and continued to decrease to 2.2% by the 52-week. The average amount of treatment applied in the beginning 4-week was 8.5 g/day and this led to a mean plasma concentration of 98.2 nM, which was far lower than the concentration for JAK-mediated myelosuppression among adult patients (281 nM). From the 8 to 52-week (as-needed use), the average amount of cream applied was 3.2 g/day. In addition, 53.8% at week 4 and the same percentage at week 52 achieved IGA–Treatment Success through an IGA score of 0/1 and a ≥2-grade improvement from baseline.
Throughout the entire 52-week, 9 of the 29 patients had the treatment-emergent adverse events. One patient had 2 treatment-related application site reactions (paresthesia and folliculitis). None of these adverse events were serious or led to treatment interruption or discontinuation.
The researchers concluded that ruxolitinib 1.5% cream demonstrated good tolerability and consistent safety over 52 weeks in children aged 2 to 11 years with moderate to severe atopic dermatitis. They also reported that rapid lesion clearance occurred with twice-daily application for 4 weeks which was maintained with as-needed use and with lower amount of cream.
The results of this trial were presented at the Atopic Dermatitis Revolution Conference in June 2024, USA. However, ruxolitinib 1.5% cream has not yet been approved by the FDA for use in young children.
