A Prospective, Observational Study to Assess the Long-Term Safety of Abrocitinib Treatment in Adult Patients with Moderate-to-Severe Atopic Dermatitis

Study identification

• EU PAS number:
  EUPAS1000000420
• Study ID:
  1000000420
• Official title and acronym:
  A Prospective, Observational Study to Assess the Long-Term Safety of Abrocitinib Treatment in Adult Patients with Moderate-to-Severe Atopic Dermatitis
• DARWIN EU® study:
  No
• Study countries:
  European Union

  United States
• Study description:
  As part of the abrocitinib pharmacovigilance plan, a non-interventional study (NIS) using real-world data from routine clinical care is being conducted to actively monitor safety events of interest associated with exposure to abrocitinib in the post-approval setting. The study will be designed to estimate the incidence of total malignancies excluding nonmelanoma skin cancer (NMSC), but including lymphoma, lung cancer, and other malignancies, NMSC, MACE, serious infections, opportunistic infections, herpes zoster (HZ), retinal detachment, thrombosis (including deep venous thrombosis, pulmonary embolism and arterial thrombosis), and hepatotoxicity including drug induced liver injury (DILI) in abrocitinib-treated patients and patients treated with comparator biologic and nonbiologic (non-JAKi) chronic systemic treatments for atopic dermatitis.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

CorEvitas

Study timelines

Date when funding contract was signed

Planned: 14/04/2023

Actual: 14/04/2023

Study start date

Planned: 01/06/2028

Date of interim report, if expected

Planned: 15/12/2028

Date of final study report

Planned: 31/10/2034

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

B7451097