Ruxolitinib Cream Proves Safe for Young Children with Atopic Dermatitis

Results from a new study shared at the Society for Pediatric Dermatology meeting earlier this month showed that the use of ruxolitinib cream twice-daily for eight weeks in children ages 2 to 11 with mild to moderate atopic dermatitis (AD) didn’t cause any significant changes in their hematologic parameters or blood levels, suggesting it doesn’t affect the entire body.

AD is a chronic, itchy and inflammatory skin condition affecting 10% of children in the U.S.

The TRuE-AD3 study presented at the meeting revealed the latest round of data collected in the TRuE-AD1 and TRuE-AD2 series of studies.

In TRuE-AD1 and TRuE-AD2, the first two studies, adults and teens who were ages 12 and older using ruxolitinib cream had low plasma levels of the drug with no significant changes in blood parameters like hemoglobin, platelets or neutrophils, which are often affected by the oral form of the drug.

To examine the effects of ruxolitinib and its blood levels in children aged 2 to 11 with mild to moderate AD over an 8-week period, researchers conducted this study.

Children with an Investigator’s Global Assessment score of 2 or 3, and 3% to 20% of their body affected were were randomly divided into three groups to use either 0.75% ruxolitinib cream, 1.5% ruxolitinib cream or a placebo cream twice daily for 8 weeks.

Blood samples were taken at the start of the study, at week 2 and at week 8. The amount of ruxolitinib in the blood was measured at either week 2 or 4 and again at week 8.

Blood test results from the start of the study, if taken within two weeks of beginning the treatment, were used as baseline values.

Out of 330 children, 134 used 0.75% ruxolitinib cream, 131 used 1.5% ruxolitinib cream and 65 used the placebo cream. About half of the children were aged 2 to 6, 54.2% were female, 54.5% were White and 32.1% were Black.

No significant changes in hemoglobin, platelet and neutrophil counts in any group over the eight weeks were found. Only two children had low neutrophil counts, but no one had issues related to hemoglobin or platelet drops.

It was found that the cream’s ruxolitinib levels in the blood were much lower than the levels needed to cause blood-related side effects.

For example, one child using 0.75% ruxolitinib cream had a higher ruxolitinib level at week 2, but it dropped by week 12, and their blood tests remained normal with no side effects.

Over the eight weeks, no ruxolitinib buildup was seen, and the age of the children didn't affect the results.

Overall, researchers found no link between the ruxolitinib levels in the blood and changes in blood levels and ruxolitinib cream was safe for children in this study.