A Retrospective study to analyse the treatment outcomes of patients with severe atopic dermatitis (AD) who were enrolled in the Early Access to Medicines Scheme (EAMS) for dupilumab

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28597
• EU PAS number:
  EUPAS28596
• Study ID:
  28597
• Official title and acronym:
  A Retrospective study to analyse the treatment outcomes of patients with severe atopic dermatitis (AD) who were enrolled in the Early Access to Medicines Scheme (EAMS) for dupilumab
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  The aim of this study, funded by Sanofi is to retrospectively analyse treatment outcomes of patients with severe atopic dermatitis (AD) who were enrolled into the Early Access to Medicines Scheme (EAMS), a scheme by the Medicines and Healthcare products Regulatory Agency (MHRA). The medical rationale is to understand the efficacy of dupilumab for the treatment of AD in a real world clinical setting. Response to treatment will be assessed by the change from baseline in validated measures of AD disease severity including Eczema Area Severity Index (EASI). Investigator Global Assessment (IGA) and Dermatology Life Quality Index (DLQI). Sanofi did not proactively collect efficacy data for patients treated with dupilumab during EAMS but following faesability analysis, it is evident that clinicians collect severity scores as part of routine clinical practice. Patient consent was obtained at the start of EAMS. Data will only be collected for patients who consented to data collection.
• Study status:
  Finalised

Research institution and networks

Institutions

Sanofi

NA

University Hospital Southampton NHS Foundation Trust Southampton, UK, Belfast Health & Social Care Trust Belfast, UK, University Hospitals Birmingham NHS Trust Birmingham, UK, University Hospitals Bristol NHS Foundation Trust Bristol, UK, Royal Devon and Exeter NHS Foundation Trust Exeter, UK, Leeds Teaching Hospitals NHS Foundation Trust Leeds, UK, Sheffield Teaching Hospitals NHS Foundation Trust Sheffield, UK, Portsmouth Hosptials NHS Foundation Trust Portsmouth, UK

Study timelines

Date when funding contract was signed

Actual: 12/03/2018

Study start date

Actual: 22/03/2018

Date of final study report

Actual: 29/08/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi

Study protocol

Initial protocol

QSD-012814 Protocol HEOR template EAMS outcome analysis v2.0

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

DUPILL09236