(8) Brodalumab Assessment of Hazards: A Multinational Safety (BRAHMS) Study of a Biological Anti-Psoriatic Drug Across Six European Countries

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1053

Presenting Author(s)

Mette Reilev, MD PhD
– Researcher, University of Southern Denmark, Odense C, Syddanmark, Denmark

Co-Author(s)

Peter Jensen
– Clinical Pharmacology, Pharmacy and Environmental Medicine, Department of Public Health, University of Southern Denmark, Denmark, Denmark
Henrik Støvring
– 1. Clinical Pharmacology, Pharmacy and Environmental Medicine, Department of Public Health, University of Southern Denmark, Denmark, Denmark
Lise Skov Ranch
– Leo Pharma A/S, Denmark, Hovedstaden, Denmark
Rosa Gini, PhD
– Agenzia Reg Della Sanit, Firenze, Firenze, Italy
Claudia C. Bartolini
– ARS Toscana, Florence, Italy, Florence, Toscana, Italy
Gianluca Trifiro, MD, FISPE
– Full Professor of Pharmacology, University of Verona, Verona, Italy
Ursula Kirchmayer, MPH, FISPE
– MPH, FISPE, ASL Roma 1 Regione Lazio, Roma, Roma, Italy
Alessandro Cesare Rosa
– Servizio Sanitario Regionale del Lazio, Italy, Roma, Roma, Italy
Valeria Belleudi
– Statistician, Department of Epidemiology, ASL Roma 1, Lazio Regional Health Service, Rome, Italy, Roma, Italy
Ulrike Haug
– Prof. Dr. sc. hum., Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany
Sarina Schwarz
– Leibniz-Institute for Prevention Research and Epidemiology-BIPS, Germany, Germany
Wiebke Schaefer, MSc
– Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany
Ron Herings, PharmD, PhD, FISPE
– Director, PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands, Utrecht, Utrecht, Netherlands
Elisabeth Smits
– PHARMO Institute for Drug Outcomes Research, the Netherlands, Utrecht, Utrecht, Netherlands
Jetty Overbeek
– PHARMO Institute, Utrecht, Utrecht, Netherlands
Emily Holthuis
– PHARMO Institute for Drug Outcomes Research, Utrecht, the Netherlands, Netherlands
Kari Furu
– Department of Chronic Diseases, Norwegian Institute of Public Health, Norway, Norway
Karin Gembert
– Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden, Sweden
David Hägg
– Karolinska Institute, Sweden, Stockholm, Sweden
Michele Tari
– Pharmacist, Caserta LHU, Italy, Italy
Valentina Ientile
– University of Messina, Italy, Italy
Ylenia Ingrasciotta
– Messina, Messina, Italy
Alexander Egeberg, MD, PhD
– Department of Dermato-Venereology & Wound Healing Centre, Bispebjerg Hospital, Copenhagen, Denmark, Denmark
Jesper Hallas, MD, PhD, FISPE
– University of Southern Denmark, Odense C, Syddanmark, Denmark

Background: Brodalumab is a biological anti-psoriatic drug marketed in Europe since 2017. A post-authorization safety study was commissioned by the EMA to investigate safety of brodalumab in a real-world context, with regards to 1) serious infections, 2) major adverse cardiac events, 3) suicidal behavior, and 4) malignancies.

Objectives: The present abstract introduces the BRAHMS study and provides an overview of the underlying research collaboration and methods. Further, the first results on the study population are provided.

Methods: A collaborative consortium including data sources from Denmark, Norway, Sweden, Germany, PHARMO Database Network in the Netherlands, and Italy was established, in total accounting for an overall population of ~50 million inhabitants. All brodalumab users with a diagnosis of psoriasis from 2017-2028 are enrolled and compared with users of other biological anti-psoriatic drugs including TNF-alfa inhibitors (etanercept and adalimumab), IL-12 and IL-23 inhibitors (ustekinumab), and other IL-17A inhibitors (secukinumab and ixekizumab). Multiple designs are used, including active comparator new user design, case-time control design and comparative designs for cumulative drug exposure.
Each site transforms data into a BRAHMS-specific common data model. Analysis code is prepared centrally and run on the local instances of the common data model. Only aggregate results are shared between sites. A framework for defining study variables is developed which allows flexible site-specific adaptations hereof.
The study is approved by EMA and conducted according to the ENCePP code of conduct.

Results: Until December 2021, we have identified approx. 1,150 brodalumab users since the launching of brodalumab in 2017 (with varying data availability). At least 30,000 users of comparator biologics were identified during the same period.

Conclusions: The BRAHMS study offers the opportunity to broadly investigate brodalumab safety in psoriasis patients in Europe. Future emerging issues in this field can be addressed as well.