As-needed ruxolitinib shows successful long-term symptom control in AD

The topical JAK inhibitor ruxolitinib demonstrated good control of atopic dermatitis (AD) including skin lesions, itchiness, and sleep disturbance when used as needed over a 44-week long-term extension period in adults and adolescents. In addition, the cream containing either 0.75% or 1.5% ruxolitinib was well tolerated with no new safety signals.

The quality of life of patients with AD can be significantly reduced by itch and sleep disturbances [1]. The parallel phase 3, randomised TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) trials assessed the long-term maintenance of disease and symptom control using ruxolitinib as needed in adolescent and adult patients with AD [2]. The studies included patients of ≥12 years with AD for at least 2 years who had an Investigator’s Global Assessment (IGA) score of 2 or 3 (0, clear; 1 almost clear; 2, mild; 3, moderate; 4, severe) and 3–20% affected body surface area, excluding the scalp.

After the double-blind study phase, participants who were initially randomised to ruxolitinib (either 0.75% or 1.5% cream, twice daily) subsequently remained on their regimen for the 44-week long-term safety period (i.e. as-needed treatment). “In the long-term safety period, treatment was confined to active lesions, stopped 3 days after clearance, and resumed upon recurrence,” Dr Andrew Blauvelt (Oregon Medical Research Center, OR, USA) explained. Participants were instructed to treat skin area with active AD only, but with the same regimen, twice daily. The participants did not receive concomitant or rescue treatment, and the current analysis included only those who applied ruxolitinib since day 1 (n=837).

Of the participants who applied the lower concentration ruxolitinib cream, 61.8% achieved an IGA of 0 or 1 at week 8 and 76.8% at week 52. The corresponding percentages in the participants that used the higher concentration cream were 67.1% at week 8 and 77.8% at week 52 (see Figure). Moreover, most participants (80–90%) maintained or improved their response between subsequent visits at 4-week intervals.

Figure: Change in IGA scores with as-needed treatment with 1.5% ruxolitinib cream during the long-term safety period [2]



IGA, Investigator’s Global Assessment.

Most participants showed improvement in control of itch and sleep disturbance between consecutive assessments. Ruxolitinib was also well tolerated by the participants with no new safety signals.

The authors concluded that as-needed use of ruxolitinib cream is safe and effective to control AD in adults and adolescents.

1. Silverberg JI, et al. J Invest Dermatol. 2015;135:56–66.
2. Blauvelt A, et al. Ruxolitinib cream demonstrates maintenance of disease and symptom control with as-needed use in adults and adolescents with atopic dermatitis: pooled analysis from the long-term safety periods of two phase 3 studies. P44103, AAD 2023 Annual Meeting, 17‒21 March, New Orleans, USA.

Posted on 15 May 202316 February 2024