Study identification

PURI

https://redirect.ema.europa.eu/resource/104432

EU PAS number

EUPAS104431

Study ID

104432

Official title and acronym

Baricitinib Drug Utilisation Study: Assessment of Effectiveness of New Recommendations for Use Based on Secondary Data Sources in France, Germany, The Netherlands, and Sweden (I4V-MC-B038)

DARWIN EU® study

No

Study countries

France
Germany
Netherlands
Sweden

Study description

Olumiant™ (baricitinib) is a selective and reversible inhibitor of Janus Kinase (JAK)1/JAK2 indicated for the treatment of moderate-to-severe active rheumatoid arthritis, moderate-to-severe atopic dermatitis, and severe alopecia areata. Following the safety review of JAK inhibitors initiated at the request of the European Commission (EC) under Article 20 of Regulation (EC) No 726/2004, EMA’s human medicines committee endorsed new recommendations by the Pharmacovigilance Risk Assessment Committee to minimise the risk of serious adverse events with JAK inhibitors. These adverse events include cardiovascular conditions, blood clots, cancer, and serious infections. EMA requested Lilly to conduct a drug utilisation study for baricitinib to assess the effectiveness of the new recommendations resulting from the Article 20 referral. These recommendations state that JAK inhibitors should be used in the following patients only if no suitable treatment alternatives are available: those aged 65 years or above, those at increased risk of major cardiovascular problems (such as heart attack or stroke), those who smoke or have done so for a long time in the past, and those at increased risk of cancer. JAK inhibitors should be used with caution in patients with risk factors for blood clots in the lungs and in deep veins (venous thromboembolism). Furthermore, the doses should also be reduced in patient groups who are at risk of VTE, cancer, or major cardiovascular problems, where possible. Additional risk minimisation measures (aRMMs) communication channels for these recommendations include Direct Healthcare Professional Communication (DHPC), Healthcare Professional educational materials, and a Patient Alert Card (PAC).

Study status

Planned
Research institutions and networks

Institutions

Contact details

David Merola

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly
Study protocol
Initial protocol

Study B038 Non-interventional PASS Protocol v0.2.pdf

English (1.2 MB - PDF)View document
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)