Ruxolitinib cream 1.5% exhibits long-term safety in pediatric atopic dermatitis
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Key takeaways:
- AD affected more than 35% body surface area of study participants.
- Ruxolitinib plasma concentrations were 98.2 nm, which falls well below immunosuppression levels.
Year-long ruxolitinib cream 1.5% treatment among children aged 2 to 11 years with extensive moderate to severe atopic dermatitis is safe, according to results presented at the Revolutionizing Atopic Dermatitis Conference.
“The most important thing when we’re treating children with atopic dermatitis is to be able to be reassured about safety,” Amy S. Paller, MS, MD, Walter Hamlin Professor and Chair of Dermatology, professor of pediatrics and director of the Skin Biology and Diseases Resource-based Center at Northwestern University’s Feinberg School of Medicine, told Healio. “Of course we want efficacy too, but if we can’t do it safely in children, then that’s not something we as pediatric dermatologists or dermatologists will recommend.”
The question of safety often arises when discussing Janus kinase (JAK) inhibitors. Ruxolitinib cream 1.5%, a topical JAK inhibitor, may cause some parents to worry about the safety of their child. However, these new long-term data show this treatment option is very safe, according to Paller.
Built upon results from a previous 8-week maximum-use trial of children treated with ruxolitinib cream for their moderate to severe AD, these new data are from the first long-term report to come from the same study.
In the study, 29 patients aged 2 to 11 years with more than 35% AD-affected body surface area received twice-daily applications of ruxolitinib cream 1.5% to baseline lesions for 4 weeks. This was followed by an as-needed application of the cream to active lesions for another 4 weeks. From there, patients were allowed to use ruxolitinib cream as needed for the remainder of the study, which was another 44 weeks.
Results showed that 31% of patients experienced treatment-emergent adverse events through the 52 weeks of treatment. None of these events were serious or resulted in the discontinuation of treatment.
The mean application quantity of ruxolitinib cream was 8.5 g per day which was associated with a mean ruxolitinib plasma concentration of 98.2 nm — a level that is well below the half-maximal concentration of JAK-mediated myelosuppression in adults which is 281 nm.
“Although we should follow the advice on the label as much as possible and minimize the use to those areas that are needed, we no longer have to worry about even larger body surface areas being treated with topical ruxolitinib,” Paller said.
In addition to positive safety results, ruxolitinib cream 1.5% demonstrated efficacy in the treatment of these patients with IGA 0/1 being achieved by 53.8% of the 26 patients at week 4 and the same percentage of 13 patients at week 52.
Mean body surface area involvement also decreased from 58% at baseline to 11.4% at week 4 and 2.2% at week 52.
“It is really critical to do these studies in children and not just extrapolate findings from adolescents and adults,” Paller told Healio. “Now we know that we can use this medication in children, and we can reassure families that these studies have been done, there’s minimal absorption and laboratory testing does not need to be done.”