Study identification

EU PAS number

EUPAS1000000282

Study ID

1000000282

Official title and acronym

An Active Surveillance Study to Monitor the Safety of Abrocitinib Among Real-World Patients with Atopic Dermatitis (AD) in the European Union (EU)

DARWIN EU® study

No

Study countries

Denmark
France
Sweden

Study description

The primary objective of the study is to estimate the IRs of the safety events of interest among patients with AD receiving abrocitinib and patients with AD receiving biologic and/or non biologic (non-JAKi) chronic systemic treatments for AD (herein referred to as “comparator treatments”) in a real-world setting.
The following are the safety events of interest for this study:
• VTE
• HZ
• Serious infections and opportunistic infections
• Rhabdomyolysis
• GI perforation
• MACE
• Fractures
• Malignancy excluding NMSC
• NMSC
• All-cause mortality
• Height as a measure of impaired bone growth in adolescents (Denmark only).

This will be a longitudinal, register-based, non-interventional post-authorisation safety cohort study using routinely collected (secondary) population-based data.

Study status

Ongoing
Research institutions and networks

Institutions

Pfizer
First published:
01/02/2024
Institution

Networks

The SIGMA Consortium (SIGMA)
Denmark
European Union
France
Germany
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom
First published:
16/12/2024
Network
ENCePP partner

Contact details

Henrik Toft Sorensen

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)