Real-world outcomes associated with abrocitinib for atopic dermatitis
Research type
Research Study
Full title
Real-world outcomes associated with abrocitinib for moderate to severe atopic dermatitis: a retrospective chart review study.
IRAS ID
352961
Contact name
Anthony Paul Bewley
Contact email
Sponsor organisation
Pfizer Inc
Clinicaltrials.gov Identifier
not applicable, Not applicable
Duration of Study in the UK
0 years, 6 months, 27 days
Research summary
Atopic dermatitis (AD) is a common chronic, relapsing inflammatory skin disorder characterised by erythematous, pruritic, dry, scaly lesions. Whilst childhood onset of AD, occurring in up to 34% of children, resolves for the majority of patients by adulthood, AD can persist or even begin in adulthood, such that one in four adults have adult-onset AD. The prevalence of AD in adults has been reported as 4.4% in the European Union (EU).
England and Wales licensed abrocitinib, an oral Janus Kinase (JAK) inhibitor, on 9th September 2021 for moderate-to-severe AD. Given that the drug has only been introduced into clinical practice relatively recently based on the findings from clinical trials, it is necessary to better understand the real-world utilisation and clinical effectiveness of abrocitinib for moderate-to-severe AD.
This is a non-interventional (patients will not receive a medication as part of the study) retrospective (information is collected using past medical records), multi-centre (approximately 8 hospitals) study based in the United Kingdom. The study will aim to recruit up to 150 patients, aged 12 years or older, who started using abrocitinib for moderate-to-severe atopic dermatitis (AD) on or after 3rd August 2022 (date of NICE recommendation). Data capture will involve a retrospective chart review, where research staff will enter data into an electronic case report form (eCRF) using the medical records that are already available. Patients will require a minimum of 12 weeks of treatment with abrocitinib at the start of data collection to be included. Sites will provide information on patient demographics, comorbidities, previous AD treatments (up to 24 months before abrocitinib treatment), abrocitinib treatment dates, dose and reasons for starting/stopping, treatment response scores collected as standard of care at baseline and subsequent follow up.
Only information that cannot reveal the patient's identity will be collected, and the final database will be fully anonymised.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0232
Date of REC Opinion
14 Jul 2025
REC opinion
Favourable Opinion