3PC-021 Anakinra eye drops for the treatment of dry eye associated with graft-versus-host disease (GVHD): case report

<h3>Background and Importance</h3> Severe dry eye syndrome affects the ocular surface, causing discomfort and visual disturbances. <h3>Aim and Objectives</h3> To describe a clinical case of a patient with severe dry eye syndrome treated with 2.5% Anakinra eye drops as an off-label use for topical ophthalmic administration to manage ocular dryness associated with graft-versus-host disease (GVHD). Anakinra, an interleukin-1 (IL-1) receptor antagonist, is commonly used for juvenile idiopathic arthritis and rheumatoid arthritis, but it is not approved for ophthalmic use. <h3>Material and Methods</h3> A 62-year-old male patient with keratopathy due to severe dry eye syndrome secondary to graft-versus-host disease. The patient, who also has leukaemia, received therapy with antibodies and immune system-produced substances (TASPE) in August 2021 and reported a decrease in visual acuity. <h3>Results</h3> The patient, who did not respond to standard treatments (0.05% cyclosporine eye drops, insulin, and 20% autologous serum), received 2.5% Anakinra eye drops as off-label treatment. The ophthalmology service requested the formulation of the eye drops from the pharmacy compounding service. After reviewing the available literature, the eye drops were prepared under sterile conditions using a horizontal laminar flow hood. The total volume of an Anakinra syringe (0.67 ml) was diluted in a carboxymethylcellulose gel (Viscofresh) to achieve the required concentration. The final volume of the preparation was 4 ml, with a shelf life of 7 days when refrigerated. <h3>Conclusion and Relevance</h3> The patient began treatment on 29 March 2023, with a regimen of 1 drop every 8 hours. As of 25 September 2023, the frequency was adjusted to 1 drop every 12 hours. During regular follow-up visits with the ophthalmology service, the patient reported symptomatic improvement. Although the existing literature on the use of 2.5% Anakinra eye drops is very limited, the clinical improvement reported by the patient since the beginning of treatment suggests that this formulation could be a promising alternative for managing severe dry eye syndrome. <h3>References and/or Acknowledgements</h3> <h3>Conflict of Interest</h3> No conflict of interest