Trial Outcomes & Findings for The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients (NCT NCT03667014)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

16 weeks

Results posted on

2024-01-09

Participant Flow

Additional participants were recruited due to high number of dropouts related to the COVID19 pandemic

Participant milestones

Participant milestones
Measure	Dupilumab Treatment 34 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
Overall Study STARTED	34
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dupilumab Treatment n=34 Participants 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
Age, Continuous	40.1 years STANDARD_DEVIATION 16.3 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: All patients completing 52 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.

Outcome measures

Outcome measures
Measure	Dupilumab Treatment n=24 Participants 34 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
Psychological General Well-Being Scale (PGWB) Baseline	68.3 score on a scale Standard Deviation 19.5
Psychological General Well-Being Scale (PGWB) Week 16	73.7 score on a scale Standard Deviation 23.7

SECONDARY outcome

Timeframe: 16 weeks

Population: 24 patients who completed 52 weeks of the study

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

Outcome measures

Outcome measures
Measure	Dupilumab Treatment n=24 Participants 34 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
Work Productivity and Activity Impairment Scale (WPAI:SHP) Baseline	0.45 percentage of overall work impairment Standard Deviation 0.26
Work Productivity and Activity Impairment Scale (WPAI:SHP) Week 16	0.24 percentage of overall work impairment Standard Deviation 0.25

SECONDARY outcome

Timeframe: 16 weeks

Population: 24 subjects completing 52 weeks of study

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.

Outcome measures

Outcome measures
Measure	Dupilumab Treatment n=24 Participants 34 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
Dermatology Life Quality Index (DLQI) Baseline	16.4 score on a scale Standard Deviation 7.0
Dermatology Life Quality Index (DLQI) Week 16	8.0 score on a scale Standard Deviation 6.8

SECONDARY outcome

Timeframe: 16 weeks

Population: 24 subjects completing 52 weeks of the study

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.

Outcome measures

Outcome measures
Measure	Dupilumab Treatment n=24 Participants 34 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
Itch Numerical Rating Scale Baseline	7.7 score on a scale Standard Deviation 2.0
Itch Numerical Rating Scale Week 16	3.5 score on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 16 weeks

Population: 24 subjects completing 52 weeks of the study

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.

Outcome measures

Outcome measures
Measure	Dupilumab Treatment n=24 Participants 34 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
Pain Numerical Rating Scale Baseline	5.3 score on a scale Standard Deviation 3.2
Pain Numerical Rating Scale Week 16	2.0 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 16 weeks

Population: 24 patients who completed 52 weeks of study

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.

Outcome measures

Outcome measures
Measure	Dupilumab Treatment n=24 Participants 34 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
PSQI Baseline	10.05 score on a scale Standard Deviation 4.58
PSQI Week 16	6.59 score on a scale Standard Deviation 4.38

Adverse Events

Dupilumab Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dupilumab Treatment n=34 participants at risk 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
Skin and subcutaneous tissue disorders Facial erythema	2.9% 1/34 • 52 Weeks
Skin and subcutaneous tissue disorders Eye redness	2.9% 1/34 • 52 Weeks
Skin and subcutaneous tissue disorders Eyelid swelling	2.9% 1/34 • 52 Weeks

Additional Information

Tina Bhutani

UCSF

Phone: 4153537800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place