A Post-Authorization Safety Study to Evaluate the Safety of Abrocitinib Exposure During Pregnancy in United States Healthcare Databases

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000096
• EU PAS number:
  EUPAS1000000096
• Study ID:
  1000000096
• Official title and acronym:
  A Post-Authorization Safety Study to Evaluate the Safety of Abrocitinib Exposure During Pregnancy in United States Healthcare Databases
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This US population-based, non-interventional, cohort study will evaluate the risk of adverse pregnancy and infant outcomes among women with moderate-to-severe AD who are exposed to abrocitinib during pregnancy compared to those unexposed during pregnancy. Pregnancies with start dates occurring during the period 14 January 2022 to Q4 2025, and infants born to the women, will be included. The main outcome of interest will be MCMs. Additional outcomes of interest include other adverse infant outcomes (preterm birth, SGA) and pregnancy outcomes (stillbirth, spontaneous abortion).
• Study status:
  Ongoing

Research institution and networks

Institutions

Pfizer

Harvard Pilgrim Health Care Institute

Study timelines

Date when funding contract was signed

Planned: 07/09/2022

Actual: 07/09/2022

Study start date

Planned: 31/12/2022

Actual: 31/12/2022

Data analysis start date

Planned: 01/03/2024

Actual: 17/04/2024

Date of final study report

Planned: 30/06/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

B7451098_ABROCITINIB UPDATED PROTOCOL_18NOV2022_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable