Using topical tacrolimus ophthalmic suspension 0.1% over a 24-month period is an effective treatment for patients with vernal (VKC) and atopic keratoconjunctivitis (AKC), reaching—and keeping—stable stages of the allergic conjunctival disease, according to a study published in Cornea.

The 2-year retrospective observational study assessed 36 eyes of 36 patients with VKC and AKC who received treatment with the macrolide antibiotic drug. Researchers collected demographic data from patients’ medical files and assessed clinical scores, remission rates, number of relapses, concomitant use of steroids, and refractive indices. They measured clinical outcomes with papillae–limbus–cornea (PLC) and 5-5-5 exacerbation grading scale scores and determining clinical characteristics associated with patients who require concomitant steroid eye drops administration.

The team found that during month 6, PLC scores improved significantly compared with those recorded at baseline. At the 18th, 21st, and 24th month follow-ups, PLC scores improved compared with month 6. At the conclusion of the study, remission rates diachronically and significantly increased, achieving a value of 92%. And for every 10-year increase in patient age, the risk of needing concomitant administration of steroid eye drops was reduced by half (OR, 0.53; 95% CI, 0.29–0.96).


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Investigators note that adverse reactions occurred in 19.4% of the study participants. “There is considerable concern about the adverse effects of the prolonged use of tacrolimus ophthalmic suspension 0.1%; however, the details are unclear,” according to the report. “The adverse reactions recorded in this study are comparable with those previously reported, indicating that there are no specific adverse reactions associated with the prolonged use of tacrolimus ophthalmic suspension 0.1%.”

Study limitations include its retrospective nature, the absence of a control group, small sample size, and single center design. The exclusion of participants who could not complete a 2-year follow-up may also have created selection bias. 

Reference

Hirota A, Shoji J, Inada N, Shiraki Y, Yamagami S. Evaluation of clinical efficacy and safety of prolonged treatment of vernal and atopic keratoconjunctivitis Using topical tacrolimus. Cornea. 2022;41(1):23-30. doi:10.1097/ICO.0000000000002692