Evaluation of uveitis events in real-world patients receiving immune checkpoint inhibitors based on the FAERS database

AbstractPurpose Immune checkpoint inhibitors (ICIs) have emerged as a novel class of drugs carrying a potential risk of uveitis. Due to the rarity, current knowledge on this safety issue is still incomplete. This study employed the post-marketing surveillance data to comprehensively describe and assess the uveitis events after the use of ICIs.Methods Data between 2004 and 2021 were downloaded from the Food and Drug Administration Adverse Event Reporting System (FAERS), and the uveitis events reported for ICIs were identified and included in this study. Clinical details of these reports were collected and analysed. Four data mining methods were utilised to investigate the potential associations between uveitis and different ICI regimens.Results Overall, 461 uveitis cases after exposure to ICI therapies were reported. Melanoma (58.79%) was revealed as the most common indication for receiving ICIs. The median onset time of uveitis was 41 (interquartile range 18–91) days after ICI initiation. 9.54% of these cases resulted in disability. Data mining results showed 5 ICIs generated positive uveitis signals when used alone. Ipilimumab yielded the most noticeable uveitis signal with the highest reporting odds ratio (ROR = 6.73, 95% two-sided CI = 5.26, 8.60), proportional reporting ratio (PRR = 6.69, χ2=308.52), information component (IC = 2.74, IC025 = 2.14) and empirical Bayes geometric mean (EBGM = 6.66, EBGM05 = 5.42), followed by pembrolizumab, cemiplimab, nivolumab and atezolizumab. When nivolumab, pembrolizumab or atezolizumab was administrated together with ipilimumab, obviously stronger uveitis signal was detected than that for either of them.Conclusions This study provided an overview of the clinical features of ICI-related uveitis cases in the FAERS. Data mining results revealed that positive uveitis signals commonly existed within this drug class, but signal strength varied among ICIs. When ICIs were used in a combined way, uveitis signals became obviously stronger. Therefore, early ophthalmic monitoring is important when applying ICIs to patients, especially those with a tendency for uveitis, such as melanoma patients.Keywords: Adverse event reporting systemimmune checkpoint inhibitorpharmacovigilancereal-world datauveitis Disclosure statementNo potential conflict of interest was reported by the author(s).Data availability statementAll data have been presented in the manuscript. Other related information is available under request to the corresponding author.Additional informationFundingThe author(s) reported there is no funding associated with the work featured in this article.