Long-term Results of Topical 0.02% Tacrolimus Ointment for Refractory Ocular Surface Inflammation in Pediatric Patients

Background: To investigate the efficacy and safety of long-term treatment with topical 0.02 % tacrolimus ointment for ocular inflammation in pediatric patients. No studies have been reported on the outcome of long-term (≥12 months) use of topical tacrolimus in pediatric patients for treatment of ocular surface diseases. Methods: A total of 144 eyes of 72 pediatric patients who were prescribed topical 0.02% tacrolimus ointment between January of 2010 and March of 2018 for anterior segment inflammatory disorders refractory to conventional steroid therapy were included. Patients completed questionnaires and underwent slit-lamp examinations for evaluation of symptoms and signs at baseline. Patients were followed 1, 2, 3, 6, 9 and 12 months after initiation of tacrolimus treatment. After 12 months, patients were followed every 3 months for monitoring of possible adverse events and clinical outcomes. Changes in ocular surface parameters during slit-lamp examination, clinical symptoms and concurrent steroid use were graded with a scoring system. The presence of side effects was also verified.Results: Among 72 patients (56 % males, age 10.79 ± 3.96 years), 25 patients (48% males, age 11.42 ± 3.91 years) fully recovered, resulting in discontinuance of the ointment treatment before 12 months. Six patients experienced intolerable burning sensation, which required treatment cessation. Cessation days of those who quit were 1,5,14,20,26, and 35 days. Seven patients were lost during follow-up. Thirty-four patients (56% males, age 11.20 ± 4.21 years) were treated with tacrolimus ointment for over 12 months (average 23.12 ± 19.07 months). During the follow-up period, all patients showed improved clinical signs and symptoms, and no adverse reaction was noted. Conclusions: Long-term maintenance of topical tacrolimus 0.02% ointment is safe and effective in improving refractory ocular surface inflammatory diseases in pediatric patients.