This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.
Participants who have moderate to severe AD with signs and symptoms of anxiety and/or depression.
Participants who initiate dupilumab therapy within 30 days of enrolment, based on the treating physician's decision, independently of study participation
Participants and/or their legally approved representatives (LAR in case of the minor subject) must agree to sign an informed consent or an assent.
Females who are pregnant, lactating, or planning/intending to be pregnant in the next 6 months.
Participants who are participating in another trial.
Participants with active chronic or acute infection requiring systemic treatment.
Participants who are diagnosed with active endoparasite infection or are suspected of being at high risk of infection.
The study will recruit participants from AD patients who are already receiving dupilumab treatment (Dupixent®) (within 30 days of enrolment) at the start of the study or for whom the investigator has decided to initiate dupilumab therapy (Dupixent®) independently from the study entry. Eligible patients include those who started dupilumab treatment up to 30 days before enrollment and have a baseline Hospital Anxiety and Depression Scale (HADS-A and/or HADS-D) score of more than (≥) 8 (±3 days from treatment initiation). Each enrolled participant will undergo a 6-month observational study period
Cohort
Prospective
Dupilumab
DrugThis study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety.
Proportion of Participants with HADS Depression (HADS-D) Sub-scores of less than 8
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of depression.
Change from Baseline in HADS Total Score.
The HADS is a 14-item patient-reported outcomes measure used to assess states of anxiety and depression over the past week. It is comprised of 7 items assessing anxiety and depression respectively. A Total score is out of 42 (21 per subscale). Higher scores indicate greater levels of anxiety and/or depression.
Proportion of Participants with More Than or Equal to 4-point Improvement in POEM Total Score
The Patient Oriented Eczema Measure (POEM) is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicate more severe disease and poor quality of life.
Change from Baseline in Dermatology Life Quality Index (DLQI)/Children's DLQI total score.
DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patients more than equal to \[≥\] 17 years of age) and the CDLQI for patients 12-17 years of age. Each question is scored on a four-point Likert scale. The DLQI is calculated by adding 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. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Proportion of Participants Achieving More than Equal to 4-point Improvement in DLQI/CDLQI Minimal Clinically Important Difference (MCID)
DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL). The DLQI is designed for use in adults (patients more than equal to \[≥\] 17 years of age) and the CDLQI for patients 12-17 years of age. Each question is scored on a four-point Likert scale. The DLQI is calculated by adding 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. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Proportion of Participants with Impacted Psychological Status using Dermatological Cumulative Life Course Impairment-Prospective (DermCLCI-p)
DermCLCI-p is the predictive tool of 30 questions that assesses the current cumulative life course impairment (CLCI) status and future risk. This tool consists of 30 items, items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).
Proportion of Participants with Impacted Professional Life/Education Status using DermCLCI-p
DermCLCI-p is the predictive tool of 30 questions that assesses the current cumulative life course impairment (CLCI) status and future risk. This tool consists of 30 items, items 1 to 28 are answered on a 4-point Likert scale ranging from 0 (not at all) to 3 (very). Items 29 and 30 are answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very).
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Sanofi
Lead sponsor
Regeneron Pharmaceuticals
Collaborator