A Retrospective Evaluation of Conjunctivitis and Keratitis Among Individuals with Moderate-to-severe Atopic Dermatitis Treated with Dupilumab in the United States (US)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42462
• EU PAS number:
  EUPAS42461
• Study ID:
  42462
• Official title and acronym:
  A Retrospective Evaluation of Conjunctivitis and Keratitis Among Individuals with Moderate-to-severe Atopic Dermatitis Treated with Dupilumab in the United States (US)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The objective of this study is to investigate the rate of occurrence, risk factors, and characteristics of conjunctivitis and keratitis-related events and their management among individuals with moderate-to-severe atopic dermatitis (AD) and within the context of dupilumab use in a real-world setting. To best achieve this goal, the first step will be to develop validated claims-based algorithms for moderate-to-severe AD and conjunctivitis and keratitis-related events (henceforth referred to as conjunctivitis and keratitis in this protocol). Primary Objectives: • Objective 1: To develop and validate claims-based algorithms to identify moderate-to-severe AD, conjunctivitis, and keratitis by using medical record review and standardized criteria among individuals seen for clinical care in the US. • Objective 2: To identify demographic, treatment-related, and clinical characteristics associated with conjunctivitis and keratitis among individuals with moderate-to-severe AD in the US. • Objective 3: To quantify the risks of conjunctivitis and keratitis in dupilumab initiators and dupilumab naïve individuals with clinically similar moderate-to-severe AD in the US. Secondary Objective: • Objective 4: To describe patterns in treatment management for conjunctivitis and keratitis among individuals exposed to dupilumab and with moderate-to-severe AD in the US.
• Study status:
  Finalised

Research institutions and networks

Institutions

Regeneron Pharmaceuticals

Study timelines

Date when funding contract was signed

Actual: 23/08/2021

Study start date

Planned: 23/08/2021

Actual: 23/08/2021

Date of final study report

Planned: 15/09/2023

Actual: 13/10/2023

Sources of funding

Non-for-profit organisation (e.g. charity)

Pharmaceutical company and other private sector 

More details on funding

Regeneron Pharmaceuticals, Inc., Sanofi

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

R668-CON-2052