Trends in the Epidemiology and Treatment of Atopic Dermatitis in the United Kingdom (UK)

Sponsor
Momentum Data (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03823794
Collaborator
Pfizer (Industry), Royal College of General Practitioners Research and Surveillance Centre (Other)
411,931
1
16
25798.7

Study Details

Study Description

Brief Summary

Atopic dermatitis, commonly called eczema, is one of the most frequently occurring skin conditions. It is estimated to affect around one fifth of children in developed countries and is also becoming increasingly common in less developed countries. Exact estimates of how common eczema is, vary considerably and there has not been an in-depth analysis of the number of people with eczema in the UK. It is also unclear which groups of people are most affected and which treatment options are being used.

Most people with eczema are managed by their general practitioner (GP) with only a few people requiring specialist care. GP records therefore provide an excellent opportunity to explore how common eczema is and which treatments are being used currently. This study aims to provide accurate estimates of the number of people with current eczema (prevalence), number developing new onset eczema (incidence), and the pattern of common comorbidities in people with eczema. It also aims describe current treatment patterns by age groups and other factors. It also will look back over the last decade to identify how the number of people with eczema and treatments changing over time. The study will also explore patterns in the people most commonly affected and in the treatments used.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

Objective

This study aims to calculate current and accurate prevalence and incidence estimates for atopic dermatitis (AD) by age group and sociodemographic factors. It also aims to describe the burden of comorbidity in AD with a focus on atopic and mental health conditions. The study also aims to describe the health care resource utilisation of this cohort in terms of prescription use, primary care appointments, and specialist referrals.

Method This study will define AD cases using a previously validated algorithm for case identification use clinical codes form primary care in the UK (Read codes). The study will analyse the population prevalence and incidence of AD using this definition over a 10-year period (2008-2018). Within this population the prevalence of autoimmune conditions (rheumatoid arthritis, inflammatory bowel disease, coeliac disease, type 1 diabetes, and multiple sclerosis) will be reported and compared with a cohort of individuals without a diagnosis of AD, matched by age and sex at GP practice level. In the same cohort, the annual use of topical and oral medications used for the treatment of AD, primary care appointments, and specialist referrals, overall and stratified by sociodemographic factors will also be reported.

Study Design

Study Type:
Observational
Actual Enrollment :
411931 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
The Epidemiology of Atopic Dermatitis, Associated Comorbidities, and Treatment Patterns in the United Kingdom (UK)
Actual Study Start Date :
Feb 1, 2019
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Prevalent case of atopic dermatitis

People with atopic dermatitis meeting the inclusion criteria and registered with one of the study practices for one or more years during the study period.

Other: No intervention
Observational analysis of usual care only

Controls

Age, gender and primary care practice-matched controls without a diagnosis of atopic dermatitis or another exclusion condition (psoriasis, photodermatitis, or ichthyosis) and registered with one of the study practices for one or more years during the study period.

Other: No intervention
Observational analysis of usual care only

Outcome Measures

Primary Outcome Measures

  1. The incidence of atopic dermatitis [Measure will be reported annually by year from 2008-2018]

    Incidence of atopic dermatitis reported by predefined sociodemographic factors

  2. The prevalence of atopic dermatitis [Measure will be reported annually by year from 2008-2018]

    Prevalence of atopic dermatitis reported by predefined sociodemographic factors

  3. The prevalence of diagnosed co-morbidities in people with and without atopic dermatitis [Prevelence reported annually by year from 2008-2018]

    Co-morbidities to be reported comprise; asthma, allergic rhinitis (hay fever), depression, anxiety, attention deficit hyperactivity disorder (ADHD), cardiovascular diseases (CVD; comprising myocardial infarction, angina, heart failure, atrial fibrillation, and stroke), rheumatoid arthritis, inflammatory bowel disease (ulcerative colitis and Crohn's disease), type 1 and type 2 diabetes, multiple sclerosis (MS) and coeliac disease. The presence of these co-morbidities will be identified from existing primary care records.

  4. Annual rates of service utilisation (number of primary and secondary care visits) in people with atopic dermatitis [Measures will be reported annually by year from 2008-2018]

    Service utilisation events comprise; primary care visits related to atopic dermatitis (prescription of treatment or coding of AD related problem), specialist care referrals to dermatology, and emergency admissions to dermatology. These events will also be reported separately.

  5. Annual prescription rates for atopic dermatitis related treatments [Measures will be reported annually by year from 2008-2018]

    Treatment rates will be reported separately and comprise: emollients and soap substitutes, topical steroids, topical antimicrobial therapies, combination topical therapies, topical calcineurin inhibitors, and oral immune modulating treatments, and phototherapy.

Secondary Outcome Measures

  1. Time to occurrence of moderate atopic dermatitis [Models will be devised using data from 2008-2018]

    The impact of sociodemographic predictors on time to first occurrence of moderate atopic dermatitis

  2. Time to occurrence of severe atopic dermatitis [Models will be devised using data from 2008-2018]

    The impact of sociodemographic predictors on time to first occurrence of severe atopic dermatitis

  3. Time to recurrence of active atopic dermatitis [Models will be devised using data from 2008-2018]

    The impact of sociodemographic predictors on time to first recurrence of atopic dermatitis in those with inactive disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All paediatric and adult patients registered with an Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) contributing GP practice during the study period (2008-2018) and with at least one year of follow-up.
Exclusion Criteria:
  • The presence of psoriasis, photodermatitis, or ichthyosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Momentum Data Ltd London United Kingdom WC1X 8QT

Sponsors and Collaborators

  • Momentum Data
  • Pfizer
  • Royal College of General Practitioners Research and Surveillance Centre

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Momentum Data
ClinicalTrials.gov Identifier:
NCT03823794
Other Study ID Numbers:
  • P002
First Posted:
Jan 30, 2019
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2020