Long-term efficacy and safety of topical tacrolimus in the management of ulcerative/erosive oral lichen planus.

The long-term safety and clinical benefit of topical tacrolimus for the management of erosive or ulcerative oral lichen planus has not been evaluated. 50 adults (39 female 11 male; group median age 59, range 29-88 years) with symptomatic, erosive or ulcerative lichen planus recalcitrant to topical corticosteroids applied 0.1% topical tacrolimus ointment twice daily to symptomatic mucosal lesions. Topical tacrolimus was applied for a median time of 19.8 months (range 2-39 months) in this patient group. Fourteen percent of the patients had complete resolution of ulcers or erosions, 80% partial resolution and 6% reported no clinical benefit. The most common adverse effects were a burning sensation (16%) at the site of application and transient taste disturbance (8%). No significant, long-standing changes in hepatic or renal biochemistry were observed. The mean tacrolimus level decreased with duration of therapy from 2.7 microg/l (week 1) to 0.5 microg/l (week 32). 0.1% topical tacrolimus is an effective means of controlling the symptoms and signs of erosive or ulcerative oral lichen planus and has no notable adverse effects over a mean duration of application of 19.8 months.