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Safety of tildrakizumab: a disproportionality analysis based on the FDA adverse event reporting system (FAERS)

Jinger Lin1, Xiangqi Chen2, Min Luo1

  • 1Department of Dermatology, The Union Hospital, Fujian Medical University, Fuzhou, Fujian, China.

Frontiers in Pharmacology
|July 25, 2024
PubMed

Insights

This study analyzed U.S. Food and Drug Administration data to identify adverse drug reactions (ADRs) linked to Tildrakizumab. New potential ADR signals were found, aiding clinical monitoring for this IL-23 inhibitor.

Area of Science:

  • Pharmacovigilance
  • Immunology
  • Dermatology

Background:

  • Tildrakizumab is an interleukin-23 (IL-23) inhibitor used for plaque psoriasis and psoriatic arthritis.
  • Existing research indicates various adverse drug reactions (ADRs) associated with Tildrakizumab treatment.

Purpose of the Study:

  • To identify and characterize ADRs associated with Tildrakizumab monotherapy.
  • Utilize the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for signal detection.

Main Methods:

  • Employed disproportionality analyses, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS).
  • Analyzed 1,177 reports where Tildrakizumab was the primary suspect drug out of over 10 million total ADR reports.

Main Results:

  • Identified 32 significant disproportionality Preferred Terms (PTs) across 27 system organ classes (SOCs).
  • Detected potential new ADR signals, including infections (coronavirus, herpes simplex), diverticulitis, atrial fibrillation, and aortic valve incompetence.
  • The median time to ADR onset was 194 days, with most occurring within 1-3 months of Tildrakizumab initiation.

Conclusions:

  • This pharmacovigilance study identified potential new ADR signals for Tildrakizumab.
  • Findings support enhanced clinical monitoring and risk prediction strategies for patients receiving Tildrakizumab.
Keywords:
FAERSadverse drug reactionsdisproportionality analysisplaque psoriasistildrakizumab

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