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FRIDAY, May 31, 2024 (HealthDay News) -- Long-term intermittent use of ruxolitinib cream is well tolerated and provides disease control in adolescent patients with atopic dermatitis (AD), according to a study published online May 2 in the American Journal of Clinical Dermatology.
Lawrence F. Eichenfield, M.D., from the University of California San Diego, and colleagues assessed the safety and efficacy of 1.5 percent ruxolitinib cream versus vehicle and long-term disease control of ruxolitinib cream among adolescents using pooled data from phase 3 studies. The analysis included 245 adolescents (aged 12 to 17 years) with AD for at least two years.
The researchers found that at week 8, substantially more patients who applied 1.5 percent ruxolitinib cream versus vehicle achieved Investigator's Global Assessment (IGA) treatment success (50.6 versus 14.0 percent), ≥75 percent improvement in the Eczema Area and Severity Index (60.9 versus 34.9 percent), and a 4-point improvement or greater in the itch numerical rating scale (52.1 versus 17.4 percent). During the long-term safety period, mean trough steady-state ruxolitinib plasma concentrations at weeks 12 and 52 were 27.2 and 15.5 nM, respectively. With ruxolitinib, the percentage of patients achieving an IGA score of 0 or 1 was sustained or further increased. Application site reactions through 52 weeks occurred in 1.8 percent of participants applying 1.5 percent ruxolitinib cream at any time. No patients reported serious adverse events.
"Treatment with 1.5 percent ruxolitinib cream in adolescent patients with mild-to-moderate atopic dermatitis had anti-inflammatory and antipruritic effects comparable with those observed in the overall study population," the authors write.
The study was funded by Incyte, the manufacturer of ruxolitinib.