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

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Atopic Dermatitis; Atopic Dermatitis Eczema

Treatments: Drug: Dupilumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03667014

Dupilimuab Quality of Life

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Dupilumab treatment

Experimental group

Description:

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).

Treatment:

Drug: Dupilumab