The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients

Phase 4

Completed

Conditions: Atopic Dermatitis
Atopic Dermatitis Eczema

Interventions: Drug: Dupilumab

Registration Number: NCT03667014

Lead Sponsor: University of California, San Francisco

Brief Summary: This is a single-arm, open-label study, which will examine the effect of dupilumab on quality of life in atopic dermatitis patients.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

Inclusion Criteria

Ability to provide written informed consent and comply with the protocol
At least 18 years of age
Diagnosis of atopic dermatitis at least 6 months prior to enrollment, having stable (unchanged) disease for at least 2 months
Non-immune-compromised status
Subjects have moderate-to-severe atopic dermatitis, classified as Eczema Area and Severity Index (EASI) score greater than or equal to 6
Subject is considered a candidate for phototherapy or systemic therapy
Subjects of child-bearing potential must have a negative urine pregnancy test within 7 days prior to first dose of dupilumab
Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study
Subject meets concomitant medication requirements (see below)

Exclusion Criteria

Younger than 18 years of age
Has mild atopic dermatitis, classified as EASI score less than 6
History of known or suspected intolerance to any of the ingredients of the investigational study product
Evidence of skin conditions other than atopic dermatitis that would interfere with study-related evaluations of atopic dermatitis.
History of immune-compromised status [e.g. human immunodeficiency virus (HIV) positive status or other immune suppressing drug] or a congenital or acquired immunodeficiency or subject testing positive for HIV during screening procedures
Has a poorly controlled medical condition including, but not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any other condition for which, in the opinion of the investigator, participation in the study would place the subject at risk
Has a history of or ongoing drug or alcohol abuse
Is not willing to comply with concomitant medication requirements
Is known, or suspected of being unable to comply with the study protocol
Subjects who are well controlled on current treatment for atopic dermatitis and participation in the study may worsen disease control significantly

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dupilumab treatment	Dupilumab	30 subjects will receive dupilumab for a treatment period of 52 weeks. All patients quality of life measures will be assessed with Psychological General Well-Being scale (PGWB), Work Productivity and Activity Impairment scale (WPAI), and Dermatology Life Quality Index (DLQI). Symptom and satisfaction will be assessed with Treatment Satisfaction Questionnaire for Medication (TSQM), Itch Numerical Rating Scale, Pain Numerical Rating Scale, and Pittsburgh Sleep Quality Assessment (PSQI).

Primary Outcome Measures

Name	Time	Method
Psychological General Well-Being Scale (PGWB)	16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
PSQI	16 weeks	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.
Work Productivity and Activity Impairment Scale (WPAI:SHP)	16 weeks	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
Dermatology Life Quality Index (DLQI)	16 weeks	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.
Itch Numerical Rating Scale	16 weeks	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.
Pain Numerical Rating Scale	16 weeks	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.