Ruxolitinib improves sleep quality in patients with AD

Treatment with ruxolitinib cream improves sleep-related impairment (SRI) and sleep disturbance in adolescent and adult patients with atopic dermatitis (AD), based on two phase III studies presented at AAD 2021.

“[As] most patients with AD report poor sleep quality, … the therapeutic, anti-inflammatory, and antipruritic effects of topical Janus kinase (JAK) inhibition observed with ruxolitinib cream provide clinically relevant improvement in sleep parameters in adolescents and adults with AD,” said Dr Eric Simpson from Oregon Health & Science University in Portland, Oregon US.

TRuE-AD1* and TRuE-AD2** trials involved 1,249 patients (median age 32.0 years, 61.7 percent female) with AD for ≥2 years who were randomized in a 2:2:1 ratio to receive ruxolitinib cream 1.5% (n=499) or 0.75% (n=500) or vehicle cream (n=250) twice daily during an 8-week double-blind treatment period. PROMIS*** SRI and sleep disturbance 24-hour recall scores were used to assess sleep quality. [AAD 2021, abstract 26887]

At week 8, patients who received either ruxolitinib 1.5% or 0.75% had a significantly greater reduction in PROMIS score for SRI (mean change from baseline, -3.5; p<0.001 and -3.4; p<0.01, respectively, vs -1.8) than those who received vehicle treatment.

The ruxolitinib arms also demonstrated a significant reduction in PROMIS score for sleep disturbance (mean change from baseline, -3.6; p<0.0001 [for 1.5%] and -3.3; p<0.01 [for 0.75%] vs -1.6) compared with the vehicle arm.

A higher percentage of patients on ruxolitinib achieved a ≥6-point improvement in SRI, indicating less impairment, from baseline to week 8 (22.3 percent; p<0.01 [for 1.5%] and 20.1 percent; p<0.05 [for 0.75%] vs 13.3 percent) than those on vehicle treatment.

More ruxolitinib recipients also achieved a ≥6-point improvement in sleep disturbance at week 8 (23.8 percent; p<0.01 [for 1.5%] and 20.9 percent; p<0.05 [for 0.75%] vs 14.2 percent) compared with the vehicle recipients.

In addition, more patients in the ruxolitinib arm did not experience any sleep disturbances at night (71.6 percent [for 1.5%] and 66.1 percent [for 0.75%] vs 44.3 percent) and demonstrated an improved sleep quality, as shown by a greater reduction in SCORAD⁺ sleeplessness score from baseline (-2.5 [for 1.5%] and -2.2 [for 0.75%] vs -1.5) than those in the vehicle arm.

Overall, the use of ruxolitinib cream was well tolerated, and showed similar safety profile to vehicle, with no serious adverse events.

“[The findings showed that] ruxolitinib cream produced early and progressive improvements in sleep quality and related impact as demonstrated by mean change from baseline in PROMIS SRI and sleep disturbance scores,” Simpson concluded.

Notably, majority of the participants on ruxolitinib achieved a clinically meaningful ≥6-point improvement in sleep scores and reported no nights of disturbed sleep, he added.

*TRuE-AD1: Topical ruxolitinib evaluation in atopic dermatitis study 1

**TRuE-AD2: Topical ruxolitinib evaluation in atopic dermatitis study 2 

***PROMIS: Patient-Reported Outcomes Measurement Information System

⁺SCORAD: SCORing Atopic Dermatitis