Objectives: To retrospectively determine (1) the long-term efficacy and (2) the frequency and nature of adverse side effects (ASEs) of topical tacrolimus in a substantial cohort of patients with OLP.
Methods: Outcomes of 86 patients (59 female and 27 male; mean age 57.1 years (range 18.3-90.4) with OLP who received topical tacrolimus were retrospectively analysed. Outcome was based upon (i) a comparison between disease status before therapy and last review, and (ii) the serial measurements of disease status at 6-month reviews using a 3-point scoring system. The frequency and nature of ASEs including oral dysplasia/neoplasia were also determined.
Results: The mean treatment period with tacrolimus was 2.1 years (median 1.9, range 0.05-6.11). Analyses of the overall and serial outcomes indicated that 86.0% of patients had complete resolution or only had mild erosive disease following therapy. Similarly most (88.7%) patients developed asymptomatic disease or experienced minimal symptoms after tacrolimus therapy. A total of 23 ASEs were recorded in 18 (21%) patients including disturbance of taste, or a local tingling and burning sensation. 4 patients developed areas of dysplasia/ neoplasia.
Conclusion: Tacrolimus is an effective and safe for the treatment of symptomatic oral lichen planus. It lessens both signs and symptoms and does not seem to lead to an increased number of dysplastic/neoplastic events.