Ruxolitinib cream 1.5% Demonstrates Tolerability, Safety Over 52 Weeks in Children

Ruxolitinib cream 1.5% demonstrated consistently good tolerability and safety over 52 weeks in children 2 to 11 years old with extensive moderate-to-severe atopic dermatitis (AD) in a study presented this month at the Revolutionizing Atopic Dermatitis (RAD) Conference in Chicago, Illinois.

Eight-week safety and tolerability, efficacy, and limited systemic absorption in an open-label, single-arm, maximum-use trial had been previously described, but the first report of longer-term data from the same study came in “Ruxolitinib cream 1.5% twice daily for the treatment of extensive atopic dermatitis in children aged 2–11 years: 52 week results from a maximum-use trial,” presented at RAD by Robert Bissonnette, MD, and colleagues.

The maximum-use trial included 29 patients with moderate-to-severe AD. Treatment- emergent adverse events through Week 52 occurred in 31.0% of patients. One patient (3.4%) had two treatment-related application site reactions (paresthesia and folliculitis); no adverse events resulted in treatment interruption/discontinuation; none were serious or suggested systemic JAK inhibition.

“Through the 4-week continuous-use twice-daily treatment period, the mean (SD) application quantity was 8.5 (6.29) g/day, which was associated with a mean steady-state ruxolitinib plasma concentration of 98.2 nM, well below half-maximal concentration of JAK–mediated myelosuppression in adults (281 nM),” the presenters noted. “From Week 8 to Week 52 (as-needed use), mean (SD) application quantity was 3.2 (2.79) g/day, consistent with lower, as-needed use in this long-term safety period. At Weeks 4 and 52 (assessed in n=26 and n=13 patients, respectively), 53.8%/53.8% achieved IGA–Treatment Success (IGA 0/1 with ≥2-grade improvement from baseline). Mean BSA decreased from 58.0% (range, 35.0%–92.0%) at baseline (n=29) to 11.4% at Week 4 and continued to decrease to 2.2% through Week 52 (n=26 and n=14, respectively). Patient-reported outcomes, such as the Patient-Oriented Eczema Measure, Children's Dermatology Life Quality Index, and Infants' Dermatitis Quality of Life Index, were collected through Week 52.”