Drug Trial Shows Improved Quality of Life with Atopic Dermatitis Treatment

A potential treatment for atopic dermatitis (AD) appears to improve patients' quality of life--including enabling many trial subjects to be more productive at work or school.

In an early, phase II clinical trial of the monoclonal antibody dupilumab (Regeneron/Sanofi) researchers examined effects on the burden of illness, in addition to the customary assessment of safety and efficacy.

The treatment was associated with improved sleep and health-related quality of life (HRQoL) measures in addition to reduced itch and related symptoms in the phase IIb trial. The report was posted on-line June 4 in the Journal of the American Academy of Dermatology.

Lead author Eric Simpson, MD, Department of Dermatology, Oregon Health and Science University and colleagues said that this study included HRQoL measures to complement separate investigations with physician-assessed clinical outcomes.

He added that the population in the study has a substantial disease burden..

"Given the patient burden associated with AD and the increasing importance of incorporating the patient perspective in clinical trials, patient-reported outcomes were included in this phase IIb study as secondary or exploratory end points to evaluate treatment effects of dupilumab on symptoms and HRQoL," Simpson and colleagues explained.

The study population was comprised of 380 adults with moderate to severe AD, inadequately controlled with topical medications. They were randomized to receive 16 weeks of double-blind subcutaneous treatment with active agent or placebo. With a phase II trial to establish safe and efficacious dosage range, the active dupilumab groups received either 100mg every 4 weeks, 200mg every two weeks, 300mg every 2 weeks, or 300mg once weekly.

All active doses over 100mg reduced peak itch at 16 weeks relative to placebo by 1.1 to 3.2 points on a pruritus numeric rating scale, with the 300mg weekly dosing associated with the greatest reduction. There were similar rates of treatment emergent adverse events in active and placebo groups, and the investigators characterized dupilumab as "generally well tolerated" and without "important deleterious safety signals."

Significant sleep improvement relative to placebo was attained with all doses over 100mg, and significant improvements in depression and anxiety were associated with both weekly and biweekly 300mg dosing. In addition, among those who were full-time employees or students, a loss of productivity as reflected in number of missed days was numerically greater with placebo (mean 3.5 days) than with any active treatment (mean 0.5 to 2.1 days).

"These results suggest that dupilumab reduces disease activity with concomitant clinically relevant benefits across multiple domains related to the patient burden associated with AD," Simpson and colleagues concluded.