Abstract
Purpose :
Chimeric antigen receptor (CAR) T-cell therapy has been approved for use in the treatment of relapsed and refractory hematological malignancies since 2017, but to date there have been no investigations into possible ocular side effects of these novel drugs. We performed a retrospective analysis of publicly reported FDA data to learn about the rates of eye associated adverse events in patients taking tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta).
Methods :
Publicly reported data in the FDA Adverse Event Reporting System (FAERS) were queried on 10/20/2019 for all cases associated with tisagenlecleucel and axicabtagene ciloleucel. The resulting 1421 cases were filtered by reaction group to isolate eye disorders. Similar adverse events were grouped by category based on the specificity of the reported data, and the resulting data set was evaluated with basic quantitative methods.
Results :
Of the 1421 cases reported, 1.97% (28/1421) involved eye disorders. Tisagenlecleucel accounted for 60.71% (17/28) of the total ocular cases, and its most common reactions were vision change/impairment (35.29%), impaired pupil response (17.65%), papilledema (11.76%), mydriasis (11.76%), and photophobia (11.76%). Notably, in the tisagenlecleucel group there was one case of iritis. Axicabtagene ciloleucel was involved in the other 11 cases (39.29%), and its most common reactions were vision change/impairment (54.55%) and visual tracking test abnormality (18.18%) with one case of retinal detachment and one case of a chorioretinal disorder reported. Although age was not available for all reports, children under 18 years old accounted for 8 of the 17 tisagenlecleucel cases reflecting its indication for patients up to 25 years of age with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL).
Conclusions :
CAR T-cell therapies tisagenlecleucel and axicabtagene ciloleucel do not appear to have a pattern of significant ocular risk, but lack of detail in the FAERS database limits the ability to draw conclusions regarding specific ocular events. The total number of patients who received the drug in the study period is unclear, but rates of ocular adverse events among the total reported events are low. With the development of promising new immunologic cancer therapies, it is important to consider the possibility of harmful side effects and continue close monitoring to ensure the safety of our patients.
This is a 2020 ARVO Annual Meeting abstract.