Prevalence and clinical patterns of ocular complications associated with anti-PD-1/PD-L1 anticancer immunotherapy

Abstract Purpose Immune checkpoint inhibitors (ICI) targeting the programmed cell death protein 1 (PD-1), or its ligand PD-L1, are the mainstay of metastatic cancer treatment. Patients receiving these treatments may develop immune-related adverse events (irAEs). This study aimed to estimate the prevalence and describe the clinical patterns of moderate to severe ocular irAEs-associated with anti-PD-(L)1 treatment. Design Prospective case series. Methods This study included patients recruited via i) a single-center prospective cohort and ii) a national pharmacovigilance registry between June 2014 and March 2018, and focused on patients with moderate to severe ocular irAEs following anti-PD-(L)1. All patients underwent a comprehensive ophthalmological assessment. The main outcome measure was the prevalence of moderate to severe ocular irAEs. Results Of a total of 745 patients included in the prospective cohort, three developed moderate to severe ocular irAEs, providing a prevalence of 0.4% and an incidence of 0.7 per 1000 patient-months of treatment. An additional five cases of moderate to severe ocular irAEs were reported through the national registry. From these eight patients, five presented with intraocular inflammation, two with ocular surface disease and one with orbital myopathy. Five patients (62.5%) experienced additional extra-ophthalmological irAEs. Ocular irAEs led to permanent discontinuation of anti-PD-(L)1 in 4 patients. Treatment by local and/or systemic corticosteroids allowed resolution or control of the ocular symptoms in 7/8 patients. Conclusion While uncommon, anti-PD-(L)1-associated ocular complications may be sight-threatening and lead to discontinuation of anti-PD-(L)1 treatments. Patients complaining of eye problems while receiving ICI treatment should immediately be seen by an ophthalmologist.