4CPS-318 Compounding tacrolimus ophthalmic ointment 0.02% in the treatment of inflammatory and autoimmune ophthalmic syndromes: effectiveness and safety assessment

Background and importance Inflammatory/autoimmune ophthalmic syndromes (IAOS) are often treated with corticosteroids in severe cases. However, in some cases, corticosteroids can be contraindicated, poorly tolerated or ineffective. This situation is common in paediatric patients who have a worse risk–benefit balance. Currently, evidence about using ophthalmic tacrolimus in IAOS is based in studies with monitoring duration reaching at most 4 weeks. Aim and objectives To assess the effectiveness, tolerance and safety of compounded tacrolimus ophthalmic ointment 0.02% (CTOO) in the treatment of IAOS in paediatric and adult patients. Material and methods We conducted observational retrospective research in paediatric and adult patients, recruited in our hospital with IAOS. Patients started treatment with CTOO once–twice/day+adjuvant therapy (AT) in January 2016 to April 2020, for 1 year at least. Effectiveness was assessed with hyperaemia grade (none, mild, moderate, severe) at 3, 6, 12 months, and grade of change noticed (GCN) at 1 and 12 months as a patient reported outcome. Tolerance/safety was determined at 1 week and 1 year. Every discontinuation was notified. Results 30 patients (54 sick eyes) were recruited (27 women and 27 men). 32/54 were paediatric patients. The most common syndromes were vernal keratoconjunctivitis (18 eyes; 33.3%); atopic keratoconjunctivitis (14 eyes; 25.9%) and allergic conjunctivitis (8 eyes; 14.8%). Hyperaemia was moderate–severe in 28 eyes (51.8%). It was reduced to 22.2% at 3 months, and to 9.3% at 12 months. No hyperaemia on day 0 was found in 21 eyes (38.9%) and which increased to 30 eyes (55.6%) at 3 months and to 41 (75.9%) at 12 months. After 1 month, 15 eyes (27.7%) had recovery of big or cleared grade, in 32 eyes (59.2%) recovery was mild–moderate and in 7 eyes (13.0%) no improvement was noticed. After a year, 15 eyes (27.7%) had reached the cleared grade. In contrast, 4 eyes had a deterioration after the treatment. Tolerance in the first week was: good (23 eyes; 42.6%), moderate (25 eyes; 46.3%) and poor in 6 eyes (11.1%) with no discontinuations. Tolerance at 1 year was good in 40 eyes (74.1%). However, in two eyes herpes virus infection was reported. Conclusion and relevance This study had strong limitations: lack of placebo group, patients belonged to the same geographic zone and different adjuvant treatments were used. Strengths of the study were a balanced population, high prevalence of paediatric patients and a long monitoring period. CTOO+AT have shown effectiveness and safety, based on the outcomes considered, in IAOS. It might be a good alternative in cases of contraindications, poor tolerance or inefficacy to corticosteroids, especially in paediatric patients. References and/or acknowledgements Conflict of interest No conflict of interest