New data show adults receiving the biologic for eczema may see improvements in sleep disturbance within 4 weeks.
Treatment of atopic dermatitis with biologic dupilumab may reduce adult patient’s frequency of sleep disturbance quickly and continually through 24 weeks of treatment, according to new findings.
In new data presented at the Society of Dermatology Physician Assistants (SDPA) 2022 Annual Meeting in Miami, FL this week, a team of investigators reported that dupilumab may improve patient-reported measures of sleep quality as soon as 4 weeks into administration for the primary treatment of atopic dermatitis. What’s more, findings suggest the sleep-quality benefit is sustained over approximately 6 months, at a trend consistent with the drug’s benefit for atopic dermatitis symptoms.
A team sponsored by Sanofi and Regeneron and led by Joseph Merola, MD, MMSc, vice chair of clinical trials and innovation in the department of dermatology at Brigham and Women’s Hospital, sought to evaluate the effect of dupilumab on sleep disturbances in adults with moderate to severe atopic dermatitis through 24 weeks.
The team noted that findings from the phase 4 DUPISTAD trial showed the interleukin 4 and 13 (IL-4; IL-13) inhibitor biologic therapy was able to significantly improve sleep quality through 12 weeks in adults with atopic dermatitis. This newest analysis essentially lengthens the duration of assessment into such outcomes.
“Sleep disturbance represents one of the prominent symptoms of atopic dermatitis, primarily related to night-time itching and scratching, affecting ability to fall and stay asleep, and leading to daytime drowsiness, and reduced productivity and quality of life,” investigators wrote. “Dupilumab…has been shown to provide early and sustained improvement in sleep quality in moderate-to- severe atopic dermatitis in phase 3, randomized clinical trials.”
The randomized, placebo-controlled trial assigned patients to either 300 mg dupilumab every 2 weeks or placebo to week 12; both treatment arms received open-label dupilumab for another 12 weeks afterward. The trial’s primary endpoiont was mean percent change from baseline to week 12 in Sleep Quality Numerical Rating Scale (NRS) scores, an 11-point scale in which 0 indicates “worst possible sleep” and 10 indicates “best possible sleep.”
Merola and colleagues additionally sought exploratory endpoint analyses including mean percent change from baseline to week 24 in patient Sleep NRS score, Peak Pruritus NRS score, 104-point SCORing Atopic Dermatitis (SCORAD) total score, and SCORAD Sleep visual analog scale score (VAS).
The trial included 188 patients, 127 of whom received continuous dupilumab and 61 received placebo before switching to open-label dupilumab at week 12. Mean patient age was 35.7 years old; 51.6% of patients were female. Mean body surface area involvement of disease was 46.6%; mean baseline EASI was 26.1, and Sleep Quality NRS score was 6.8.
Investigators observed a mean percent change of -47.7% in dupilumab-treated patients’ Sleep NRS scores at trial’s end, versus -33.0% among patients treated with placebo then dupilumab (-15.5 percentage points; 95% CI, -24.1 to -6.9; P <.001). The team additionally observed gradual improvements to treated patients’ mean Peak Pruritus NRS scores, SCORAD total scores and SCORAD Sleep VAS scores from baseline to week 24, relative to the placebo-dupilumab arm.
In safety outcomes, 70.1% of patients only receiving dupilumab reported a treatment-emergent adverse event (TEAE) over 24 weeks, compared to 75.4% of patients receiving placebo then dupilumab. Serious TEAEs were limited to just 2.4% and 1.6% of the treatment arms, respectively; no patient deaths were reported over 24 weeks.
Investigators concluded that dupilumab provided “rapid and sustained improvements” in patient measures for sleep quality—as soon as in 4 weeks and carrying through 24 weeks—among adults with moderate to severe atopic dermatitis. Additionally, patients who switched from placebo to dupilumab showed a similarly rapid improvement in Sleep Quality NRS.
“A similar pattern of sustained improvement was observed with dupilumab treatment in the severity of the signs and symptoms of atopic dermatitis,” investigators wrote. “Dupilumab safety was consistent with its known safety profile.”
The study, “Dupilumab Ameliorates Sleep Disturbance and Relieves Itch in Adults with Moderate-to-Severe Atopic Dermatitis over 24 Weeks,” was presented at SDPA 2022.