Ruxolitinib cream 1.5% effective, safe for greater AD surface area in pediatric patients
Key takeaways:
- The mean affected BSA decreased from 58% at baseline to 11.4% at week 4 and 2.2% at week 52.
- 31% of patients reported a treatment-emergent adverse event.
- No serious adverse events were reported.
Ruxolitinib cream 1.5% was safe and effective for the treatment of children and adolescents with a 35% or greater body surface areas affected by atopic dermatitis, according to a study.
Ruxolitinib cream 1.5%, a selective Janus kinase (JAK)-1 and -2 inhibitor, is a nonsteroidal monotherapy for the treatment of atopic dermatitis. While concerns about JAK inhibitors’ safety continue to circulate, the efficacy of these treatments led researchers to evaluate their efficacy in multiple populations, including pediatrics.
A previous maximum-use trial showcased 1.5% ruxolitinib cream’s efficacy and general tolerability in treating atopic dermatitis among children and adolescents with a more than 25%-affected BSA. In the current study, Stein Gold and colleagues analyzed the topical’s efficacy and safety in those with a more than 35% affected BSA.
Twenty-nine patients (median age, 5 years; age range, 2-11 years; 16 girls; 48.3% white; 37.9% Black) applied ruxolitinib cream 1.5% twice daily to all lesions during a 4-week maximum use period, then applied the cream only to active lesions for up to 52 weeks.
“The study found ruxolitinib cream demonstrated consistent safety and efficacy in these pediatric patients with extensive AD,” Jim Lee, MD, PhD, group vice president and head of inflammation and autoimmunity at Incyte, told Healio. “As-needed use of ruxolitinib cream beyond week 4 provided good disease control through week 52 and sustained improvements in patient-reported outcomes.”
The mean affected BSA decreased in the study from 58% at baseline to 11.4% at week 4 and 2.2% at week 52. At week 4, 76.9% of patients achieved EASI 75 and 57.7% reached EASI 90.
Thirty-one percent of patients reported a treatment-emergent adverse event with 24.1% and 27.3% of patients experiencing an adverse event within 8 and 52 weeks, respectively.
No serious adverse events were reported and no treatment-related treatment-emergent adverse events occurred during the as-needed treatment portion of the study.
The mean ruxolitinib concentrations and mean steady-state plasma concentrations during the 4-week maximum-use period were similar across age groups, with the mean ruxolitinib steady-state plasma concentration landing below the half-maximal concentration of JAK-mediated myelosuppression in adults, which is defined as 281 nm. While two patients with a baseline affected BSA of at least 83% did experience levels greater than that maximal concentration limit, they completed the 52-week treatment period without reporting any treatment-emergent adverse events or exhibiting decreases in hematological parameters or bone markers.
“This rapid improvement in both symptoms and signs of AD in moderate to severe patients was seen in previous studies,” Lee explained. “However, it has now been replicated in younger patients, adding more data for patients with more extensive disease.”