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Analysis and visualization of the course and burden over time of adverse drug reactions (ADRs) attributed to TNFα-inhibitors in patients with inflammatory rheumatic diseases (IRDs)

  • Merel de Boer*
  • , Helen R Gosselt
  • , Jurriaan Jansen
  • , Martijn B A van Doorn
  • , Frank Hoentjen
  • , Michael T Nurmohamed
  • , Phyllis I Spuls
  • , Sander W Tas
  • , Harald E Vonkeman
  • , Naomi T Jessurun
  • *Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

BACKGROUND: We aimed to investigate course and burden over time of ADRs attributed to TNFα-inhibitors in IRD-patients, and whether Sankey diagrams and polar plots can visualize this.

RESEARCH DESIGN AND METHODS: Data on ADRs experienced during the Dutch Biologic Monitor (January 2017 till December 2022) were used in this study. We selected IRD-patients using a TNFα-inhibitor, reporting skin reactions/infections/injection site reactions and completing ≥3 questionnaires (i.e. the initial report and ≥2 follow-ups). Course was scored as worsening/improving/remaining stable/resolving and as (non-)recurrent. Patients scored burden from 1 (no burden) to 5 (very high burden). Sankey diagrams and polar plots visualized this.

RESULTS: 202 patients were included, reporting 353 ADRs. Most skin reactions were stable (25.0%). Most infections resolved (50.8%). Injection site reactions were mostly recurrent (72.3%). Skin reactions and infections tended to decrease in burden . Infections had highest burden at start, which mostly decreased over time. Injection site reactions had a low and stable burden.

CONCLUSIONS: Skin reactions attributed to TNFα-inhibitors by IRD-patients are stable with a slightly decreasing burden over time. Infections have highest burden at start but resolved mostly. Injection site reactions have a low and stable burden. Sankey diagrams and polar plots are suitable to visualize this.

Original languageEnglish
Pages (from-to)195-202
Number of pages8
JournalExpert Opinion on Drug Safety
Volume22
Issue number3
DOIs
Publication statusPublished - Mar 2023
Externally publishedYes

Keywords

  • Drug-Related Side Effects and Adverse Reactions
  • Humans
  • Injection Site Reaction
  • Rheumatic Diseases/drug therapy
  • Surveys and Questionnaires
  • Tumor Necrosis Factor-alpha

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