PAS-study for upadacitinib


Upadacitinib (Rinvoq®) is a so-called Januskinase (JAK)-inhibitor which is approved for the treatment of chronic rheumatic diseases such as ulcerative colitis, rheumatic arthritis and atopic dermatitis. The use of JAK-inhibitors causes a reduction of inflammatory processes and other disease-specific symptoms. JAK-inhibitors are a treatment alternative to disease modifying antirheumatic drugs (DMARDs) and biologics that usually are used for teh treatment of chronic rheumatic diseases, especially for patients where treatment with DMARDs or biologics did not (fully) lead to the desired effects.

In January 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) endorsed the introduction of additional measures to reduce the risk for severe adverse drug reactions related to the use of JAK-inhibitors, such as cardiovascular events, thrombo-embolic events, cancer and serious infections. It is requested that the safety of JAK-inhibitors and the effectiveness of the additional risk minimization measures are investigated in multi-national studies.

The EMA has obligated the market authorization holder of upadacitinib, AbbVie, to conduct a post-approval safety study (PASS) to assess the effectiveness of the additional risk minimization measures for upadacitinib in the indication of atopic dermatitis. This PASS is part of a consortium of multiple data bases based on data from Denmark, Spain, Sweden and Germany. Annual progress reports will be provided. The final report is planned for 2026.

Funding period

Begin:   February 2023
End:   October 2026


  • AbbVie Inc.


 Wiebke Schäfer

Project management (international)

Johan Reutfors, MD, PhD, Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Schweden