Atopic Eczema Skin and Connective Tissue Diseases Childhood and adult atopic eczema
Conditions
Interventions
During the observation period, participants will be assessed on a regular (3-6 monthly basis) to collect data on disease severity and other clinical outcomes (such as quality of life), adverse events,
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Paediatric and adult patients with atopic eczema who due to the severity of their disease and/or impact on quality of life are commencing on or switching to another systemic immuno-modulatory agent (e.g. CyA, AZA, MTX or biologic treatments). 2. Written informed consent for study participation obtained from the patient or parents / legal guardian, with assent as appropriate by the patient, depending on the level of understanding. 3. Consent to participate in long-term follow up and access to all medical records, including hospital admission records and linkage to data held by NHS bodies or other national providers of healthcare data. 4. Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria. 5. Willingness to comply with all study requirements. 6. Competent use of English language, according to patient’s age (capable of understanding patient questionnaires).
Exclusion criteria
Exclusion criteria: 1. Insufficient understanding of the study by the patient and/or parent/guardian. 2. Patients who are currently participating in a randomised clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment effectiveness will be assessed at the baseline, after 4 weeks, 12 weeks, 6 months, 9 months, 12 months and every 3-6 months thereafter using the following: 1. Physician-assessed severity measures assessed through changes in the following at the baseline, after 4 weeks, 12 weeks, 6 months, 9 months, 12 months and every 3-6 months thereafter: 1.1. EASI (Eczema Area and Severity Index) 1.2. EASI-50 1.3. EASI-75 1.4. IGA (Investigator's Global Assessment) 2. Patient-reported severity measures, assessed through changes in the following at the baseline, 12 weeks and every 6 months thereafter: 2.1. POEM score (Patient Oriented Eczema Measure) 2.2. Quality of life (DLQI/CDLQI/IDQOL) (Dermatology/Children’s Dermatology Life Quality Index)/EQ-5D) 2.3. ACQ score (Asthma control Questionnaire) in patients with a diagnosis of eczema 3. Disease control, assessed as totally or well controlled weeks at the baseline, after 4 weeks, 12 weeks, 6 months, 9 months, 12 months and every 3-6 months thereafter 4. Drug survival and long-term control of disease (time to discontinuation of treatment), assessed using the Kaplan-Meier survival technique and Cox regression analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacovigilance/safety reporting: All (S)AEs will be recorded at the baseline, after 4 weeks, 12 weeks, 6 months, 9 months, 12 months and every 3-6 months thereafter. Long term linkage data will be used for this purpose as well. 2. Cost-effectiveness analysis: We will calculate the mean costs and assess generic quality of life with the EQ-5D, assessed at the baseline, after 12 weeks, 12 months and every 6 months after, for each treatment group/pathway to inform the development of an economic model. This will be in adherence to NICE (2013) methods guidance – whose objective is to estimate (i) long-term cost and QALYs for each treatment options, and (ii) incremental cost-effectiveness estimates to assess the value for money of each intervention. Value of information analysis will be used to identify those areas for further research which have the highest return in terms of population health 3. Standardised biorepository: blood, leukocytes, serum, skin and swabs collected at the baseline, after 4 weeks, 12 weeks and 12 months. | — |
Countries
England, Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactPrakash Patel
Outcome results
None listed