Study identification

EU PAS number

EUPAS1000000424

Study ID

1000000424

Official title and acronym

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

DARWIN EU® study

Yes

Study countries

Finland
Germany
Netherlands
Norway
Spain

Study description

Janus kinase inhibitor (JAKi) therapy has been gaining popularity for the treatment of several autoimmune conditions, including rheumatoid arthritis, inflammatory bowel disease, and atopic dermatitis.
The first JAKi, tofacitinib, was approved by the European Medicines Agency (EMA) for the management of rheumatoid arthritis in 2017.
An FDA-requested study (the Oral Rheumatoid Arthritics Trial (ORAL) Surveillance trial) showed a higher risk of major adverse cardiovascular events (MACE), cancer and adjudicated opportunistic infection with tofacitinib compared to tumour necrosis factor (TNF) inhibitors in patients aged 50 years or older with at least one cardiovascular risk factor.
Further research has been conducted on the safety profile of JAKi for other indications, including psoriatic arthritis, ulcerative colitis and atopic dermatitis.
It was shown that risk of venous thrombotic events of JAKi users was similar to placebo users in patients with atopic dermatitis and ulcerative colitis.
Incidence of adverse events, including herpes zoster infection and thrombotic events, remained similar with longer follow-up up to two years in psoriatic arthritis patients with JAKi. However, especially in these newer indications, the available evidence has been limited by short duration of follow-up and limited sample size.
The current study aims to identify the incidence of new JAKi use over time, and to characterise new users of JAKi in Europe to inform the feasibility of future safety studies.

Study status

Finalised
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:
Actual:
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