Evaluating adverse events in databases

• Published in: Pharmacology research & perspectives Vol. 11; no. 5; p. e01129
• Main Authors: Lovell, Katie, Feldman, Steven R
• Format: Journal Article
• Language: English
• Published: United States John Wiley & Sons, Inc 01-10-2023; John Wiley and Sons Inc; Wiley
• Subjects: adverse events; Bias; Conflicts of interest; Cytokines; drug safety; IL‐23 inhibitors; Ligands; Pharmacology; Psoriasis; spontaneous reporting database; adverse events; spontaneous reporting database; IL-23 inhibitors; drug safety
• ISSN: 2052-1707; 2052-1707
• DOI: 10.1002/prp2.1129

Abbreviations IL-23 interleukin-23 In this issue, Calapai et al. reported a potential association between oncologic adverse reactions and interleukin-23 (IL-23) 1 inhibitor use in psoriasis patients using the EudraVigilance database for spontaneous adverse event reports. 2 The study evaluated suspected adverse events from 2020 to 2022 with a reported 53 events related to oncologic disease development following the use of IL-23 blockers: guselkumab, risankizumab, or tildrakizumab. 2 The reporting odds ratio (ROR) for risankizumab and tildrakizumab was >1 when comparing each drug to the other two, concluding a potential association between IL-23 inhibitors and the occurrence of oncologic adverse events. 2 While adverse event reporting databases can be valuable resources to monitor drug safety, there are major limitations to drawing definite conclusions. An increased risk between psoriasis and subsequent overall malignancy has been identified in many prior studies, 4–7 with persistent immune activation and inflammatory response as possible mechanisms. [...]the utilization of a control group in this population is needed to strengthen the claim that increased oncologic events are due to a biologic medication rather than a natural progression of the disease. The Weber and notoriety effects are two notable forms of selection bias often observed, and critically, only a fraction of the actual number of adverse events are reported. 3 This can be secondary to selection bias or due to the lack of time for or knowledge of reporting processes among healthcare providers and the public. [...]when relying on spontaneous reporting, we lack information on both the numerator and the denominator of risk for both the exposed and unexposed populations.