An analysis of two phase 3 trials evaluated the effect of ruxolitinib cream in adult and adolescent patients with atopic dermatitis (AD). In most patients, as-needed application of ruxolitinib achieved improvement in clearing lesions and controlling symptoms, like itch and sleep disturbance, over 44 weeks.
The phase 3 randomized TRuE-AD1 and TRuE-AD2 trials with identical designs assessed long-term maintenance of disease and symptom control in adolescent and adult patients with AD with ruxolitinib as needed1. Included in the studies were patients aged 12 and older with AD for at least 2 years with 3% to 20% affected BSA, excluding the scalp, and an Investigator’s Global Assessment (IGA) score of 2 or 3. Andrew Blauvelt, MD, MBA, presented these findings at the 2023 American Academy of Dermatology annual meeting.
Participants initially randomized to ruxolitinib (either 0.75% or 1.5% cream) subsequently remained on their regimen for the 44-week long-term safety period after the double-blind study phase. “In the long-term safety period, treatment was confined to active lesions, stopped 3 days after clearance, and resumed upon recurrence,” Dr. Blauvelt said. The participants did not receive concomitant or rescue treatment, and the current analysis included only those who applied ruxolitinib since the beginning (N=837).
Of patients who applied a lower concentration of ruxolitinib cream, 61.8% achieved an IGA of 0 or 1 at week 8 and 76.8% at week 52. For patients who used 1.5% ruxolitinib cream, corresponding percentages were 67.1% at week 8 and 77.8% at week 52. Most patients (80–90%) maintained or improved their response between subsequent visits at 4-week intervals.
Between consecutive assessments, most participants showed improvement in control of itch and sleep disturbance. From a safety perspective, ruxolitinib was also well tolerated by patients.
The authors concluded that as-needed use of ruxolitinib cream is safe and effective to control AD in adults and adolescents.
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