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)

Expert Opin Drug Saf. 2023 Mar;22(3):195-202. doi: 10.1080/14740338.2022.2110237. Epub 2022 Aug 10.

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.

Keywords: Adverse drug reaction; Sankey diagrams; burden; course; polar plots.

MeSH terms

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

Substances

  • Tumor Necrosis Factor-alpha