Treatment of ocular cicatricial pemphigoid with tacrolimus (FK 506)

To evaluate the efficacy of tacrolimus (FK 506) therapy in patients with ocular cicatricial pemphigoid (OCP).

In a cohort study, six patients with OCP, in whom the disease was not controlled by conventional immunosuppressive agents administered in high doses for an appropriate period of time, were treated with FK 506. The FK 506 was administered orally at the daily dose of 8 mg. Final clinical response to FK 506 was divided into three categories based on the difference between severity of conjunctival inflammation before and after FK 506 therapy. "Total control" of disease activity was defined as residual inflammatory activity of 0.5 or less in the final examination and an inflammation decrement of at least 0.5 between initial and final examination. "Partial control" was defined as final disease activity 1.0 or 1.5 and at least 0.5 decrement of disease activity between initial and final examination. "Uncontrolled inflammation" was defined as final disease activity above 1.5 or no improvement between initial and final activity.

The average age of the patients was 67.5 years (range 50-75 years). Male to female ratio was 1:1. The average duration of OCP prior to beginning of FK 506 treatment was 6.25 years (range 3-12.5 years). The average duration of treatment with FK 506 was 11 months (range 5-18 months). The average disease activity prior to the administration of FK 506 was 2.6 (range 2.0-3.0). The average disease activity at the time when FK 506 was stopped was 2.0 (range 1.0-2.5). In four patients (67%) FK 506 failed to control activity of OCP, and in two patients (33%) the activity was controlled partially.

Although FK 506 was not used in a prospective randomized trial and although we used the drug only in patients with OCP refractory to conventional immunosuppressive agents, it is likely that FK 506 is incapable of controlling the activity of OCP and inducing a remission.