Pulmonary toxicity assessment of tumor necrosis factor α inhibitors in the treatment of IBD: a real world study based on US food and drug administration adverse events reporting system (FAERS).

Background: Tumor necrosis factor α (TNF-α) inhibitors are widely used in the treatment of inflammatory bowel disease (IBD), but there is still a lack of systematic risk assessment for pulmonary toxicity.

Methods: We calculated the pulmonary-related risk signals for four TNF-α inhibitors using the disproportionality analysis and also compared them with the pulmonary-related signals of seven other therapies.

Results: There were 8736 reports of pulmonary-related adverse events (AEs) to TNF-α inhibitors as the 'primary suspect (PS)' therapies. The median time to incident for pulmonary-related AEs was 148 (interquartile range [IQR] 21-721) days. TNF-α inhibitors exhibited the strongest signal of pulmonary toxicity compared to Interleukin 12/23 (IL-12/23) inhibitors, Integrin blockers, Jak inhibitors, and S1P receptor modulator. Golimumab exhibited the strongest signal compared to infliximab, certolizumab pegol, and adalimumab. The strongest signal corresponding to pneumonia, pulmonary tuberculosis, asthma, chronic obstructive pulmonary disease (COPD), pulmonary thrombosis, and pulmonary fibrosis is golimumab, infliximab, infliximab, natalizumab, upadacitinib, and adalimumab.

Conclusions: TNF-α inhibitors had the strongest signal of pulmonary toxicity relative to other control therapies. Golimumab had the strongest signal of pulmonary toxicity relative to other TNF-α inhibitors. When TNF-α inhibitors are used in the treatment of IBD, pulmonary-related AEs should be vigilant.