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Long-term results of topical 0.02% tacrolimus ointment for refractory ocular surface inflammation in pediatric
Kyungmin Koh1, Ikhyun Jun2, Tae-Im Kim2
1Kim's Eye Hospital, Seoul, Republic of Korea.
Insights
Topical tacrolimus ointment effectively treated refractory ocular surface inflammation in pediatric patients. Long-term use (over 12 months) demonstrated safety and efficacy with improved clinical signs and symptoms.
Area of Science:
- Ophthalmology
- Pediatric Dermatology
- Immunomodulatory Therapy
Background:
- Limited research exists on the long-term efficacy and safety of topical tacrolimus for pediatric ocular surface inflammation.
- Refractory ocular surface inflammation in children poses a significant clinical challenge.
Purpose of the Study:
- To evaluate the long-term safety and effectiveness of topical 0.02% tacrolimus ointment in pediatric patients with refractory ocular surface inflammation.
- To assess changes in clinical signs, symptoms, and side effects associated with prolonged tacrolimus use.
Main Methods:
- Retrospective review of medical records for pediatric patients treated with topical 0.02% tacrolimus ointment between 2010 and 2018.
- Utilized a scoring system to grade ocular surface signs, clinical symptoms, and concurrent steroid use.
- Assessed the presence of side effects and compared disease severity and symptoms from baseline to post-treatment.
Main Results:
- Out of 72 patients, 25 fully recovered before 12 months. Six patients ceased treatment due to burning sensations.
- Thirty-four patients were treated for over 12 months (average 23.1 months), with all showing improved clinical signs and symptoms.
- No adverse reactions were noted in patients receiving long-term tacrolimus treatment.
Conclusions:
- Long-term topical tacrolimus 0.02% ointment is a safe and effective treatment for refractory ocular surface inflammation in pediatric patients.
- The study supports the use of topical tacrolimus as a maintenance therapy for this condition in children.
Background:
No studies have been reported on the efficacy and safety of long-term (≥12 months) use of topical tacrolimus for refractory ocular surface inflammation in pediatric patients.
Methods:
Medical records of pediatric patients who were prescribed topical 0.02% tacrolimus ointment for refractory ocular surface inflammation between January of 2010 and March of 2018 were reviewed retrospectively. Changes in ocular surface signs during slit-lamp examination, clinical symptoms and concurrent steroid use were graded with a scoring system. The presence of side effects was also assessed. The changes in disease severity and patient symptoms were compared between baseline and after the treatment.
Results:
Among 72 patients (55% males, mean age 10.8 ± 3.9 years, range 3 to 17 years), 25 patients (48% males, mean age 11.4 ± 3.9 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, mean age 11.2 ± 4.2 years, range 3 to 17 years) were treated with tacrolimus ointment for over 12 months (average 23.1 ± 19.1 months, range 12 to 98 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 inflammation in pediatric patients.

