Atopic dermatitis - Evaluating Oral Systemic Therapies
Research type
Research Study
Full title
A 24-Month Prospective Observational Cohort Study Evaluating Oral Systemic Therapies in the Management of Adult Patients with Atopic Dermatitis in REAL-World Practice (AD-REAL)
IRAS ID
296242
Contact name
Anthony Bewley
Contact email
Sponsor organisation
Eli Lilly and Company
Duration of Study in the UK
3 years, 1 months, 30 days
Research summary
Atopic dermatitis (AD) is a common, chronic, relapsing inflammatory skin disease which significantly affects patients' quality of life. Baricitinib has shown efficacy and safety in patients with moderate-to-severe AD in clinical studies. Marketing authorization for Baricitinib in AD was granted in late 2020 by the European Medicines Agency (EMEA).
Currently, there are a limited number of approved and reimbursed systemic therapies for Atopic Dermatitis (AD).
Treatment guidelines in many European countries recommend the use of non-approved oral immunosuppressant drugs (drugs which dampen the immune response) for the treatment of patients with moderate to severe AD. In addition, treatment patterns in patients with AD receiving systemic therapies are not well documented in clinical practice.
Baricitinib is the first oral JAK-inhibitor approved for AD. (An oral JAK inhibitor is a drug taken by mouth which is able to suppress the immune response in a specific targeted way). It will therefore be critical to understand current treatment patterns of oral systemic therapies and to collect data in clinical practice. These data will be essential in understanding and interpreting clinical trial results within the daily clinical routine, in generating data on broader populations of interest in addition to those evaluated in clinical trials, and in understanding treatment pathways for patients with AD in clinical practice.
REC name
North of Scotland Research Ethics Committee 2
REC reference
21/NS/0085
Date of REC Opinion
8 Jul 2021
REC opinion
Favourable Opinion