A Systematic Overview of Contraindications and Special Warnings for Biologic and Targeted Synthetic Disease Modifying Antirheumatic Drugs: Establishing a Framework to Create a “Safety Checklist”

Lykke Skaarup, Elvina Ingrid, Alexandre Sepriano, Elena Nikiphorou, René Østgård, Kim Lauper, Ilona Grosse-Michaelis, Margreet Kloppenburg, Bente Glintborg, David F. L. Liew and Tue W. Kragstrup ()
Additional contact information
Lykke Skaarup: Aarhus University
Elvina Ingrid: Austin Health
Alexandre Sepriano: Universidade Nova de Lisboa
Elena Nikiphorou: Leiden University Medical Center
René Østgård: Regional Hospital Silkeborg
Kim Lauper: Geneva University Hospitals
Ilona Grosse-Michaelis: Independent Consultant
Margreet Kloppenburg: Leiden University Medical Center
Bente Glintborg: Copenhagen University Hospital-Rigshospitalet
David F. L. Liew: Austin Health
Tue W. Kragstrup: Aarhus University

Drug Safety, 2024, vol. 47, issue 11, No 2, 1075-1093

Abstract: Abstract Background/Aim The purpose of this review is to provide an overview of the contraindications, special warnings, and boxed warnings with the aim to establish a framework to create a prescription safety checklist for a class of drugs or disease indication. This study covers biologic disease modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs). Methods We identified contraindications, boxed warnings, and special warnings provided by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The study included b/tsDMARDs approved for treating rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (SpA), and juvenile idiopathic arthritis (JIA) within the drug-classes anti-CD20, tumor necrosis factor inhibitors (TNFi), interleukin-1 inhibitors (IL-1i), cytotoxic T-lymphocyte-associated protein (CTLA) 4, interleukin-12/23 inhibitors (IL-12/23i), interleukin 6 receptor inhibitors (IL-6Ri), Janus kinase inhibitors (JAKi), phosphodiesterase 4 inhibitors (PDE4i), interleukin-17 inhibitors (IL-17i), and interleukin-23 inhibitors (IL-23i). Results All drug classes, except PDE4i, had contraindications and/or warnings related to infections, including tuberculosis. A warning about herpes zoster was listed for anti-CD20, IL-1i, IL-6Ri, and JAKi, while a warning about hepatitis reactivation was listed for anti-CD20, TNFi, IL-1i, CTLA4-Ig, IL-6Ri, and JAKi. Malignancy risk was mentioned for all drug classes except PDE4i, IL-17i, and IL-23i. Other warnings included demyelinating disease (TNFi, CTLA4-Ig, and IL-6Ri), heart failure (anti-CD20 and TNFi), major adverse cardiac events (JAKi and IL-12/23) and venous thromboembolism (JAKi), hyperlipidemia (IL-6Ri and JAKi), liver impairment (TNFi, IL-1i, IL-6Ri, and JAKi), kidney impairment (IL-1i, JAKi, and PDE4i), inflammatory bowel disease (IL-17i), gastrointestinal perforation (IL-6Ri, JAKi), cytopenia (anti-CD20, TNFi, IL-1i, IL-6Ri, JAKi), and depression (PDE4i). Contraindications and warnings appeared to increase with the passage of time since the drug’s approval. Conclusion This review provides an overview to establish the framework to create an easily accessible and actionable prescription safety checklist from individual medical product prescription information provided by regulatory medical authorities.

Date: 2024
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DOI: 10.1007/s40264-024-01461-1

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