The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis

Sanofi184 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

184

Conditions

Atopic Dermatitis

Interventions

DupilumabDRUG

This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Participants with human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses. * Participants on antidepressants/anti-anxiety within 6 months of enrolment or those who are planning to receive antidepressants/anti-anxiety. In addition, those who will use antidepressants/anti-anxiety medications throughout the study will be excluded from the analysis. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (7)

Investigational Site: Hamad Medical Corporation

Doha, Qatar

ACTIVE_NOT_RECRUITING

Investigational Site: Saudi Medical Services (Medical Fakeeh)

Jeddah, Saudi Arabia

RECRUITING

Investigational Site: King Faisal Specialist Hospital

Jeddah, Saudi Arabia

Outcomes

Primary Outcomes

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.

Time frame: Week 24

Proportion of Participants with HADS Depression (HADS-D) Sub-scores of less than 8

Time frame: Week 24

Change from Baseline in HADS Total Score.

Time frame: Baseline to up to Week 24

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.

Time frame: Week 24

Change from Baseline in POEM Total Score.

The 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.

Central Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610 Contact-US@sanofi.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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.

Time frame: Baseline to week 24

Proportion of Participants Achieving More than Equal to 4-point Improvement in DLQI/CDLQI Minimal Clinically Important Difference (MCID)

Time frame: Week 24

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).

Time frame: Baseline to up to Week 24

Proportion of Participants with Impacted Professional Life/Education Status using DermCLCI-p

Time frame: At Baseline and Week 24.