Atopic Dermatitis, Atopic Dermatitis Eczema
Conditions
Keywords
atopic dermatitis, eczema, dupilumab
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.
Interventions
DRUGDupilumab
Dupilumab treatment
Sponsors
Regeneron Pharmaceuticals
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Additional participants were recruited due to high number of dropouts related to the COVID19 pandemic
Participants by arm
| Arm | Count |
|---|---|
| Dupilumab Treatment 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).
Dupilumab: Dupilumab treatment | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Dupilumab Treatment |
|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 16.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 3 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
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
Population: All patients completing 52 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab Treatment | Psychological General Well-Being Scale (PGWB) | Baseline | 68.3 score on a scale | Standard Deviation 19.5 |
| Dupilumab Treatment | Psychological General Well-Being Scale (PGWB) | Week 16 | 73.7 score on a scale | Standard Deviation 23.7 |
Secondary
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
Population: 24 subjects completing 52 weeks of study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab Treatment | Dermatology Life Quality Index (DLQI) | Baseline | 16.4 score on a scale | Standard Deviation 7 |
| Dupilumab Treatment | Dermatology Life Quality Index (DLQI) | Week 16 | 8.0 score on a scale | Standard Deviation 6.8 |
Secondary
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
Population: 24 subjects completing 52 weeks of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab Treatment | Itch Numerical Rating Scale | Baseline | 7.7 score on a scale | Standard Deviation 2 |
| Dupilumab Treatment | Itch Numerical Rating Scale | Week 16 | 3.5 score on a scale | Standard Deviation 2.6 |
Secondary
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
Population: 24 subjects completing 52 weeks of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab Treatment | Pain Numerical Rating Scale | Baseline | 5.3 score on a scale | Standard Deviation 3.2 |
| Dupilumab Treatment | Pain Numerical Rating Scale | Week 16 | 2.0 score on a scale | Standard Deviation 2.3 |
Secondary
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
Population: 24 patients who completed 52 weeks of study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab Treatment | PSQI | Baseline | 10.05 score on a scale | Standard Deviation 4.58 |
| Dupilumab Treatment | PSQI | Week 16 | 6.59 score on a scale | Standard Deviation 4.38 |
Secondary
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
Population: 24 patients who completed 52 weeks of the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dupilumab Treatment | Work Productivity and Activity Impairment Scale (WPAI:SHP) | Baseline | 0.45 percentage of overall work impairment | Standard Deviation 0.26 |
| Dupilumab Treatment | Work Productivity and Activity Impairment Scale (WPAI:SHP) | Week 16 | 0.24 percentage of overall work impairment | Standard Deviation 0.25 |