Dupilumab improves sleep quality, continuity in adults with atopic dermatitis

Key takeaways:

• By week 12, dupilumab-treated patients experienced a 47.7% improvement in sleep.
• Dupilumab-treated patients woke up less in the middle of the night compared with placebo-treated patients.

Dupilumab significantly improved sleep quality, reducing the number of times patients with atopic dermatitis woke up in the middle of the night with pain and itchiness, according to a study.

“Sleep disturbance represents one of the prominent symptoms of AD, primarily related to nighttime itching and scratching, affecting the ability to fall and stay asleep, and leading to daytime drowsiness, a high burden of fatigue and reduced productivity and quality of life,” Joseph F. Merola, MD, MMSc, FAAD, vice chair of clinical trials and innovation, department of dermatology, Brigham and Women’s Hospital, and associate professor, Harvard Medical School, and colleagues wrote.

In the phase 4 trial DUPISTAD (Dupilumab Effect on Sleep in AD Patients), researchers assessed dupilumab treatment’s impact on sleep in adults with AD, as well as other patient- and physician-reported outcomes.

A total of 188 patients were randomly assigned to receive either dupilumab (n = 127) 300 mg subcutaneously once every 2 weeks or placebo (n = 61) for 12 weeks. Patients were permitted to use concomitant topical corticosteroids.

Patients then entered an open-label phase in which they received dupilumab 300 mg once every 2 weeks for another 12 weeks.

Results showed that the improvement in the sleep numerical rating scale was significantly greater in the dupilumab group vs. placebo group with a least squares mean of the difference of –15.5% (P < .001) by week 12, meaning those treated with dupilumab experienced a 47.7% improvement in sleep, whereas those taking placebo experienced a 33% improvement (P < .001).

Sleep diary data at week 12 also showed that fewer patients treated with dupilumab woke up in the middle of the night from AD compared with placebo-treated patients, with mean changes from baseline of –1.5 and –0.9, respectively.

As measured by the Epworth Sleepiness Scale, patients treated with dupilumab also experienced less sleepiness than those treated with placebo after 12 weeks of treatment (mean change from baseline, –4.1 vs. –1.3; P < .001).

Clinical signs and symptoms were also improved with dupilumab over placebo with those in the dupilumab group achieving a higher change from baseline compared with placebo (–37.8 vs. –20.6; P < .001). This change from baseline moved dupilumab-treated patients from a severe to mild disease level.

Furthermore, dupilumab proved to be safer than placebo, with only 56.7% of patients treated with dupilumab experiencing treatment-emergent adverse events compared with 67.2% treated with placebo. The most frequently reported adverse events included infections and infestations, nervous system disorders and skin/subcutaneous tissue disorders, and most were considered mild or moderate.

“Dupilumab significantly improved overall sleep continuity and quality and reduced daytime sleepiness, itch and other AD-related signs, symptoms and QoL in adults with moderate to severe AD vs. placebo,” the authors wrote. “These improvements with dupilumab started as early as week 2 and continued throughout the study.”