Purpose: The new microemulsion preconcentrate (MEPC) formulation of ciclosporin has been developed to reduce problems in intestinal absorption and to stabilize fluctuations in blood levels. A multicenter, open-label clinical trial of MEPC was conducted to assess its efficacy and safety in Behçet's disease patients with ocular involvement.
Methods: The patient population comprised 17 de novo patients (patients not previously treated with ciclosporin in the currently available formulation) and 30 patients whose ciclosporin formulation was switched from the conventional formulation to MEPC. The patients were treated with the test formulation for 16 weeks in the former (de novo) group and for 12 weeks in the latter (switched) group.
Results: In the de novo group, ocular attacks decreased significantly as compared to the pretreatment incidence in 11 of the 14 patients (78.6%) evaluated after MEPC therapy. Ocular attacks also decreased significantly in the switched group. In the de novo group, visual acuity improved with MEPC therapy in 20 of the 28 eyes (71.4%) examined, and the overall efficacy evaluation was "improved" or "markedly improved" in 13 of the 16 patients evaluated (81.3%). The one case each of onset of neuro-Behçet's disease and intestinal Behçet's disease observed in the de novo group were regarded as adverse reactions.
Conclusion: It was concluded that ciclosporin MEPC is useful for controlling the ocular symptoms of Behçet's disease, and that it can be used as effectively and safely as the conventional formulation.