(183) An Examination of How Serious Infection Are Reported in Spontaneous Reports

Publication Number: 514

Background: The immunosuppressive nature of targeted immune modulators along with other medicines with immunosuppressive effects can result in the occurrence of serious infections, therefore it remains imperative that post authorisation spontaneous adverse event (AE) reports contain sufficient information to determine causality. An internally developed clinical completeness score [Kara et al 2021. Drug Saf 44, 1391–1470]. was adapted following a review of the scientific literature to validate relevance to serious infections e.g. medical history was further sub-categorised into family medical history, immunodeficiency conditions, and prior infection history. The end outcome was n=33 data attributes which were divided across general information (n=2), patient information (n=8), drug-related information (n=9) and AE-related information (n=14).

Objectives: The aim of this study was to assess a sample of spontaneous AE reports utilising the adapted clinical completeness for serious infections to determine the extent of informative data for scientific evaluation.

Methods: Spontaneous AE reports, reported by HCPs from the USA between 01 July 2020 – 30 June 2021, were randomly selected (n=100) from the GSK Safety Database from a pool of 170 reports. The reports were reviewed by HCPs against a clinical completeness score adapted for serious infections.

Results: Across the 100 reports 14 of 33 attributes were complete across both initial and follow-up reports. Follow-up information was received in 68% of cases. The frequency of important data attributes missing across the 100 cases were medical history (family medical history (100), immunodeficiency conditions (77), prior infection history (91)), indication (42), time to onset (63), pathogen details (91), treatment (68), and de-challenge/ re-challenge (94/ 95).

Conclusions: This study demonstrates that there is significant variability in how data of relevance for serious infection is reported in spontaneous reports. There are several limitations of this study including the lack of a globally accepted clinical completeness score and the small sample size.