Respiratory infections in patients receiving Immune Checkpoint Inhibitors using the World Health Organization pharmacovigilance database - VigiBase

<bold>Background:</bold> Immune checkpoint inhibitors (ICI) have emerged as a novel therapeutic modality for the treatment of various cancers. Their immune-mediated adverse effects are well-documented. Nonetheless, the putative role of ICI in pulmonary infection occurrence, needs to be clarified. <bold>Method:</bold> We performed a disproportionality analysis of ICI induced pulmonary infections using VigiBase, the World Health Organization pharmacovigilance database; using the information component (IC), an IC0.25>0 was considered statistically significant. Data were extracted on 22/12/2021. <bold>Results:</bold> Globally, the mean IC0.25 for Pneumocystis pneumonia (PCP), pulmonary aspergillosis (PA) and lung tuberculosis (TB) were 2.2, 1.3, 0.1 respectively in ICI receiving patients. A total of 3,836 respiratory infections were included. Most of patients were male (68%), receiving ICI (39% Nivolumab, 28% Pembrolizumab and 12% Atezolizumab) for lung (51%) or melanoma (12%). At the time of infection, ICI were given alone (72%), with concomitant chemotherapy (18%) and steroid therapy (13%). As part of Covid-19 and Influenza outbreaks, we reported 136 (3%) PCP, 47 (1%) lung tuberculosis (TB) and 70 (2%) pulmonary aspergillosis (PA). Among patients with respiratory infection the occurrence of PA was more frequently associated with the use of immunosuppressive therapies: steroids, TNF inhibitors, and rituximab. TB reactivation were more frequently observed in patients receiving anti-PD1/PD-L1 than anti-CTLA4 inhibitors. <bold>Conclusion:</bold> Respiratory infections under ICI are not uncommon; some of them may warrant prophylactic measures and screening.