Rituximab and Pyoderma Gangrenosum: An Investigation of Disproportionality Using a Systems Biology-Informed Approach...

Area of Science:

• Pharmacovigilance
• Immunology
• Drug Safety

Background:

• Rituximab use is linked to an increased risk of pyoderma gangrenosum.
• The drug's properties and its use in autoimmune conditions may contribute to this risk.

Purpose of the Study:

• To investigate the association between rituximab and pyoderma gangrenosum using a systems biology approach.
• To determine if rituximab is disproportionally linked to pyoderma gangrenosum.

Main Methods:

• Analysis of 32 pyoderma gangrenosum cases from the FDA Adverse Event Reporting System (FAERS) between 2013-2020.
• Utilized the Bayesian Confidence Propagation Neural Network Information Component to assess disproportionality.
• Compared rituximab to all other drugs, monoclonal antibodies, CD20 antagonists, and drugs for similar indications.

Main Results:

• Pyoderma gangrenosum showed an increased association with rituximab compared to all other medicines.
• No association was found when comparing rituximab to monoclonal antibodies or CD20 antagonists.
• Associations were observed for multiple sclerosis, rheumatoid arthritis, and non-Hodgkin's lymphoma.

Conclusions:

• Pyoderma gangrenosum is reported more frequently with rituximab than with other medications.
• Confounding by indication may explain the observed associations, especially for autoimmune conditions.
• Post-market surveillance of biologics requires a multifaceted approach, considering the underlying disease.