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The BRodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) study in electronic healthcare databases

Description

Brodalumab (Kyntheum®) is a new monoclonal antibody for the treatment of moderate to severe plaque psoriasis. It has anti-inflammatory effects as it binds to the human interleukin (IL) 17 receptor A.

Regulatory studies often fail to provide conclusive answers for all safety questions regarding a drug. This was the case with Brodalumab as well. Therefore, in a risk management plan, the European Medicines Agency (EMA) requested Post-Authorization Safety Studies (PASS) after market approval.

Based on data from the German Pharmacoepidemiological Research Database (GePaRD) a study will analyze ten years of data beginning with 2017 to assess the risk of Brodalumab regarding the following outcomes: 1) serious infections, 2) major adverse cardiac events (MACE), 3) suicidal behavior, and 4) malignancies. The risk of these outcomes in psoriasis patients treated with brodalumab will be assessed and compared to the risk of other subcutaneously administered systemic biologics.

The PAS study will be part of a collaborative effort involving additional databases from Denmark, Italy, Netherlands, Norway, and Sweden.

Funding period

Begin:   October 2019
End:   December 2023

Sponsor

  • Pharmaceutical industry

Contact

Prof. Dr. sc. hum. Ulrike Haug

Project management (international)

Prof. Jesper Hallas, University of Southern Denmark