French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)

Sanofi600 enrolled

Overview

The objective of the study is to describe the therapeutic management of patients more than or equal to 18 years old eligible for systemic therapy or treated by systemic therapy for atopic dermatitis (AD). This study will be proposed to a sample of French dermatologists experienced in the management of AD, practicing in hospital centers and/or office-based dermatologists. The study will be conducted in real conditions of practice, systemic treatment decisions will be taken at the sole initiative of the participating physician irrespective of the patient enrollment decision. Each patient will be followed-up in routine care setting for 1 year.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Atopic Dermatitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent form. * Patient with moderate to severe AD according to the Investigator's judgment and 1. Patient eligible to systemic treatment as Atopic Dermatitis Control Tool (ADCT) more than or equal to (≥) 7 and/or use topical corticosteroids (TCS) more than (\>) 90 gram (g)/month and/or TCS are not advisable. or 2. Patient currently under systemic treatment. * Able to understand and complete study-related questionnaires. Exclusion Criteria: * Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing, as per routine care, the schedule of visits and assessments * Patient receiving systemic therapy only for a disease other than AD. * Patient participating in any interventional clinical trial at the time of enrolment. * Patient is under tutorship or curatorship; patient under safeguard of justice or deprived of his/her liberty by an administrative or court decision The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Outcomes

Primary Outcomes

Previous and Current Treatments for Atopic Dermatitis (AD)

List of previous and current treatments for AD based on physician-reported data will be assessed.

Time frame: Baseline, month 6 and month 12

Atopic Comorbidities: Previous and Current Therapeutic Management

Description of previous and current therapeutic management of atopic comorbidities over time based on physician-reported data will be assessed.

Time frame: Baseline, month 6 and month 12

Change from Baseline in Drug Survival for Systemic Treatments for AD by Name and Dose

Drug survival is defined as the time from the start of treatment to the end or discontinuation of treatment with no changes. If a patient has multiple drug survival events for the same treatment, the longest drug survival will be used in the data summarization. The drug survival will be illustrated using a Kaplan-Meier plot.

Time frame: Baseline, month 6 and month 12

Compliance for AD Treatments

Compliance for AD treatments will be assessed by the physician.

Time frame: Baseline, month 6 and month 12

Secondary Outcomes

Demographic Characteristics of Participants

Demographics characteristics including birth date, gender, and socio-professional category, height, weight, phototype (type I to type VI according to Fitzpatrick's classification).

Time frame: Baseline

Medical History and AD history

Medical history will be summarized using the Medical Dictionary for Regulatory Activities (MedDRA) codes of System Organ Class (SOC) and Preferred Terms (PT).

Time frame: Baseline

Change from Baseline in AD Severity

Change from baseline in AD severity assessed through physician-reported persistence with prescribed therapy.

Time frame: Baseline, month 6 and month 12

Atopic Comorbidities

Description of the presence, evolution, and therapeutic management of atopic comorbidities over time based on physician-reported data.

Time frame: Baseline, month 6 and month 12

Non-atopic Comorbidities

Description of the presence, evolution, and therapeutic management of non-atopic comorbidities over time based on physician-reported data.

Time frame: Baseline, month 6 and month 12

Use of Psychoactive Substances

Description of the use of psychoactive substances over time based on patient-reported data.

Time frame: Baseline, month 6 and month 12

Change from Baseline in Itch Assessment

Itch assessment (Worst-Itch Numeric Rating Scale, WI-NRS) will be rated from 0 to 10 on average during the past 7 days, completed by the observing physician after questioning of patient; 0 = no itch and 10 = the worst imaginable itch.

Time frame: Baseline, month 6 and month 12

Change from Baseline in Sleep Disturbance NRS

NRS sleep disturbance will be rated from 0 to 10 on average during the past 7 days, completed by the observing physician after questioning of patient; 0 = "sleep not disturbed at all" (best possible sleep) and 10 = "sleep extremely disturbed (worst possible sleep)".

Time frame: Baseline, month 6 and month 12

Change from Baseline in Skin Pain NRS

Skin pain NRS will be rated from 0 to 10 on average during the past 7 days prior to the visit. On a scale of 0 to 10, with 0 being 'no skin pain at all' and 10 being 'the worst imaginable skin pain'.

Time frame: Baseline, month 6 and month 12

Change from Baseline in AD Disease Control Using the Atopic Dermatitis Control Tool (ADCT)

ADCT is a questionnaire to assess patient-self-perceived control of their AD with a total score from 0 to 24; higher scores indicate lower AD control.

Time frame: Baseline, month 6 and month 12

Change from Baseline in Dermatology Life Quality Index (DLQI)

DLQI is a 10-item questionnaire to measure dermatology specific quality of life (QoL). 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, month 6 and month 12

Change from Baseline in Psychological Comorbidities Assessed using Hospital Anxiety and Depression Scale (HADS)

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.

Time frame: Baseline, month 6 and month 12

Cumulative Life Course Impairment (CLCI) - for Physicians in Hospital Centers

CLCI-r instrument determines retrospectively which changes and effects the patients have already experienced due to the disease over their entire disease course. CLCI-p determines the patient's current situation and thus identifies risk areas in which the patient could experience burdens in the future.

Time frame: Baseline, month 6 and month 12

Change from Baseline in Patient's Treatment Satisfaction Score Using the Patient Global Assessment of Treatment Effect (PGATE)

Patient's treatment satisfaction score will be assessed using Patient Global Assessment of Treatment Effect (PGATE). PGATE is an assessment tool used to rate the treatment effect of the medication on atopic dermatitis (AD), with scores ranging from 0 to 4 (0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent), i.e., higher score indicated higher treatment effect.

Time frame: Baseline, month 6 and month 12

Evolution of Atopic Comorbidities

Evolution of atopic comorbidities over time, assessed through physician-reported status, occurrence of new diagnoses and persistence of existing conditions.

Time frame: Baseline, month 6 and month 12

Management of AD from First Diagnosis

History of healthcare pathway of participant related to AD will be assessed by the physician (if participant had appointment with other healthcare provider for AD).

Time frame: Baseline, month 6 and month 12

Therapeutic Education

History of healthcare pathway of participant related to AD will be assessed by the physician (if participant received therapeutic education).

Time frame: Baseline, month 6 and month 12

Cost of Emollients and Hygiene Products

Cost of emollients, hygiene products etc. during the last month of the study visit will be assessed.

Time frame: At month 12

Sick Leaves Related to AD

Number of sick leaves participant has taken related to AD since the last visit or over the last 6 months.

Time frame: Baseline, month 6 and month 12

Hospitalization with Overnight Stay Related to AD

Overnight hospitalization related to AD since the last visit or over the last 6 months.

Time frame: Baseline, month 6 and month 12

French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)

Overview

Conditions

Eligibility

Locations (62)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts