DARWIN EU® - Characterising the use of JAK inhibitors in Europe: a Drug Utilisation Study Update

08/05/2026
08/05/2026
EU PAS number:
EUPAS1000000998
Study
Ongoing
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Study identification

EU PAS number

EUPAS1000000998

Study ID

1000000998

Official title and acronym

DARWIN EU® - Characterising the use of JAK inhibitors in Europe: a Drug Utilisation Study Update

DARWIN EU® study

Yes

Study countries

Croatia
Denmark
Finland
Germany
Spain
Sweden

Study description

JAK inhibitor (JAKi) therapy has been gaining popularity for the treatment of several autoimmune conditions, including rheumatoid arthritis, inflammatory bowel disease, and atopic dermatitis. Previous evidence suggests that JAKi use is associated with an increased risk of cardiovascular events, cancer, and opportunistic infections; however, these findings were mainly in rheumatoid arthritis (RA) populations, while evidence is limited for other indications with different demographics by short follow up durations and small sample sizes. Further research is needed to better establish the risks associated with JAKi use, especially for indications where JAKi use was only recently approved.
The current study aims to identify the incidence of new JAKi initiation over time and to characterise new use of JAKi in Europe to inform the feasibility of future safety studies. This is a rerun of a previous study with the same aim, which intends to expand on the countries, as well as the period, covered by the previous report.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Amy Lam

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable