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

Background We aimed to investigate course and burden over time of ADRs attributed to TNF alpha-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 TNF alpha-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 TNF alpha-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.