This is a single-arm, open-label study, which will examine the effect of dupilumab on quality of life in atopic dermatitis patients.
This is a single center, open-label study, which will examine the effect of dupilumab on quality of life in atopic dermatitis (AD). Thirty patients with moderate to severe AD will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 48). Improvement in patient quality of life after 52 weeks of treatment with dupilumab will be evaluated using validated dermatologic and non-dermatologic psychometric instruments. The primary endpoint is the improvement in quality of life measured by change in Psychological General Well-Being scale (PGWB) at Week 16 from baseline. Additionally, patients will be given a video recording device to document their experience with the study drug at home. Video footage of patient experiences will be compiled at the end of the study. The compiled video footage will subsequently be watched and analyzed to further understand the experiences of atopic dermatitis patients, and how undergoing dupilumab treatment alters these patients' experiences and attitudes with their skin disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Dupilumab treatment
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, United States
Psychological General Well-Being Scale (PGWB)
The primary endpoint is the improvement in quality of life measured by change in Psychological General Well-Being scale (PGWB) at Week 16 from baseline. It is a self-reported, 22 item questionnaire, scored 0-5 and summed. PGWB will be administered at every study visit.
Time frame: 16 weeks
Work Productivity and Activity Impairment Scale (WPAI:SHP)
Improvement in work productivity measured by change in Work Productivity and Activity Impairment scale (WPAI) at Week 16 from baseline. It measures the effect of health and symptom severity on work productivity and nonwork activities by assessing absenteeism, presenteeism, and impairment of daily activities. There are 6 questions, each with unique answers. WPAI outcomes are expressed as impairment percentages (0-100), with higher numbers indicating greater impairment and less productivity. Scoring equations: 1. Percent work time missed due to problem: Q2/(Q2+Q4) 2. Percent impairment while working due to problem: Q5/10 3. Percent overall work impairment due to problem: Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4)))x(Q5/10)\] 4. Percent activity impairment due to problem: Q6/10
Time frame: 16 weeks
Dermatology Life Quality Index (DLQI)
Improvement in quality of life measured by change in Dermatology Life Quality Index (DLQI) at Week 16 from baseline. It is a 10 item questionnaire with a final score calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time frame: 16 weeks
Itch Numerical Rating Scale
Improvement in itch scores using numerical rating scales at Week 16 from baseline. This is a 0-10 scale with 0 equaling No itch, and 10 being Worst imaginable itch. Patients will circle number that describes the itch experienced from atopic dermatitis.
Time frame: 16 weeks
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Pain Numerical Rating Scale
Improvement in pain scores using numerical rating scales at Week 16 from baseline. This is a 0-10 numerical scale with 10 as the worst imaginable itch. Patients circle the number that best describes the pain experienced from atopic dermatitis.
Time frame: 16 weeks
PSQI
Improvement in sleep quality measured by the Pittsburgh Sleep Quality Assessment (PSQI) at Week 16 from baseline. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time frame: 16 weeks