Long-term follow-up of tacrolimus ointment for treatment of atopic keratoconjunctivitis.

PURPOSE: To evaluate the long-term clinical outcomes of 0.1% tacrolimus dermatologic ointment (Protopic) in cases of refractory atopic keratoconjunctivitis (AKC).

DESIGN: Prospective, nonrandomized, noncontrolled case series.

METHODS: Twenty-two eyes from 11 patients with severe AKC who were treated with 0.1% tacrolimus ointment were followed prospectively. The mean age of the patients was 32.27 ± 12.7 years (range, 19-61 years). Each patient completed a follow-up period of at least 48 months, during which the signs and symptoms of AKC were assessed. Changes in the total scores of signs and symptoms from baseline were recorded at each visit, and the main outcome measure was the clinical response to topical tacrolimus treatment.

RESULTS: Dramatic improvements in clinical signs and symptoms were achieved 1 week after starting topical tacrolimus treatment, and complete clinical resolution was observed in almost all patients 6 weeks after starting treatment. Treatment was gradually reduced, with increasing intervals between applications. Eight patients remained asymptomatic for up to 3 years, although recurrence occurred in 3 patients who attempted to discontinue treatment. All patients complained of a mild burning sensation upon application of the ointment. No additional medications were required to provide relief, and no patient discontinued treatment because of adverse drug effects. No drug-related ocular complications were encountered, and no significant changes in visual acuity or refraction were documented.

CONCLUSIONS: Tacrolimus dermatologic ointment is a potentially safe and effective treatment for AKC cases refractory to standard treatment and may substitute for steroid treatments aimed at controlling disease activity.