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e-Poster Display Session

43P - Ocular adverse events due to PD-1 and PD-L1 checkpoint inhibitors: A retrospective review of FDA adverse events reporting system (FAERS)


09 Dec 2020


e-Poster Display Session


Immunotherapy;  Supportive Care and Symptom Management

Tumour Site


Yamini Sahu


Annals of Oncology (2020) 31 (suppl_7): S1428-S1440. 10.1016/annonc/annonc391


Y. Sahu1, J. Ensor2, E. Burns3, G. Sahu4, S. Iyer5

Author affiliations

  • 1 Safdarjung hospital, New Delhi/IN
  • 2 Houston methodist research institute, Houston/US
  • 3 Houston Methodist Hospital, Houston/US
  • 4 Creighton University School of Medicine, North Platte/US
  • 5 UT MD Anderson Cancer Center, Houston/US

Abstract 43P


Immune checkpoint inhibitors (ICIs) targeting program cell death protein 1 (PD-1) and program cell death ligand 1 (PD-L1) have improved outcomes for many cancer subtypes but are associated with toxicity due to immune related adverse events (irAEs) which can affect any organ. In this study we queried FAERS (a pharmacovigilance database) to find out rate of ocular toxicity due to ICIs targeting PD-1 and PD-L1.


We retrospectively queried FAERS from January 1,2015 to June 30, 2020 for “dry eyes”, “uveitis”, “eye inflammation”, “retinal detachment”, “ocular myasthenia”, “ulcerative keratitis” and “optic neuropathy” due to five FDA approved PD-1/PD-L1 inhibitors atezolizumab, avelumab, durvalumab, nivolumab and pembrolizumab. Disproportionality signal analysis was done by calculating reporting odds ratio (ROR) with 95% confidence interval (CI). ROR was considered significant when lower limit of 95% CI was >1. Chi-square or fishers exact test was used to calculate p value as appropriate.


Total adverse events (AEs) from all drug were 10,687,588 out of which 78,081 were due to PD-1/PD-L1 ICIs.Total AEs for dry eyes,uveitis,eye inflammation, retinal detachment, ocular myasthenia, ulcerative keratitis and optic neuropathy were 75,204,21,49,16,13 and 11. ROR for dry eyes, uveitis, eye inflammation, retinal detachment, ocular myasthenia, ulcerative keratitis and optic neuropathy was 0.7(95% CI 0.5,0.9) (p=0.005),7.6(95% CI 6.6-8.8) (p<0.0001),0.9(95% CI 0.6-1.5)(p=0.9),2.3(95% 1.7-3.1) (p<0.0001),23.1(95% CI 13.6,39.3) (p<0.001), 1.9(95% CI 1.1,3.3) (p=0.01) and 2.3(95% CI 1.3-4.3) (p=0.0085) respectively.


Ocular irAEs are rare due to PD-1/PD-L1 ICIs. ROR for ocular myasthenia, optic neuropathy, retinal detachment, ulcerative keratitis and uveitis was elevated due to PD-1/PD-L1 ICIs.

Legal entity responsible for the study

The authors.


Has not received any funding.


S.P. Iyer: Research grant/Funding (self): Merck; Research grant/Funding (self): Seattle Genetics; Research grant/Funding (self): rhizen; Research grant/Funding (self): Spectrum; Research grant/Funding (self): Trillium; Research grant/Funding (self): CrisprRx. All other authors have declared no conflicts of interest.

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