Ophthalmic Immune-Related Adverse Events after Anti-CTLA-4 or PD-1 Therapy Recorded in the American Academy of Ophthalmology Intelligent Research in Sight Registry

Ocular adverse events in PD-1 and PD-L1 inhibitors

“…[26][27][28] However, we acknowledge that ocular AEs may have been underreported in our cohort, as Bitton et al 11 report a 0.4% prevalence of uveitis in anti-PD-1/PD-L1 immunotherapy. Though not directly comparable to an analysis of reported AEs, Sun et al 19 report that 3.6% of patients seen Open access in ophthalmology offices on checkpoint inhibitors (both anti-CTLA-4 and anti-PD-1/PD-L1) experience immunerelated eye AEs. However, our results are still consistent with drug manufacturers' prescribing information for the PD-1/PD-L1 inhibitors, which report a less than 1% incidence of uveitis or <10% of iridocyclitis.…”

“…Excluding trials that do not report lower grade adverse events to the routine adverse event database results in a higher end estimate of 242/3255 patients on study treatment arms reporting ocular adverse events (7.4% prevalence). Ocular events occurred early after drug initiation (routine database: median 6 weeks, IQR 0-16, serious adverse events database: median 11 weeks, IQR [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21]. The median Common Terminology Criteria for Adverse Events grade was grade 1 (mild) (IQR 1-2) and grade 2 (moderate) (IQR 2-3) for the routine database and the serious adverse events database, respectively.…”

“…Open access these studies have shown that inflammatory eye disease AEs tend to be rare, ranging from a prevalence of <1% of uveitis in drug manufacturers prescribing information [20][21][22][23][24] to 3.6% in a large retrospective review of a large ophthalmology electronic health record registry. 19 In lieu of large prospective observational studies, retrospective analyses of large ocular AE databases can be performed, such as the recent analysis of the Food and Drug Administration's Adverse Events Reporting System Database (FAERS) conducted by Fang et al 18 or the analysis of the American Academy of Ophthalmology Intelligent Research in Sight Registry (IRIS). 19 The FAERS database has a large sample size, but is limited by its lack of clinical and demographic information, while the IRIS registry has detailed ophthalmologic notes but less information on non-ocular conditions.…”

“…19 In lieu of large prospective observational studies, retrospective analyses of large ocular AE databases can be performed, such as the recent analysis of the Food and Drug Administration's Adverse Events Reporting System Database (FAERS) conducted by Fang et al 18 or the analysis of the American Academy of Ophthalmology Intelligent Research in Sight Registry (IRIS). 19 The FAERS database has a large sample size, but is limited by its lack of clinical and demographic information, while the IRIS registry has detailed ophthalmologic notes but less information on non-ocular conditions. In this study, we analyze two databases of AEs from the US National Cancer Institute's Cancer Therapy Evaluation Program (CTEP), the largest public sponsor of oncology clinical trials globally.…”

Ocular Immune-Related Adverse Events Associated With Immune Checkpoint Inhibitors in Lung Cancer

“…The majority of previously described uveitis on ICI therapy exhibited relatively mild to moderate severity, with ≤2+ anterior chamber cells and vitreous cells ( 28 , 30 , 77 ). In our review, 16 patients with uveitis and six patients did not manifest the detailed clinical features.…”