Ciclosporin microemulsion preconcentrate treatment of patients with Behcet's disease

Purpose: The new microemulsion preconcentrate (MEPC) formulation of ciclosp orin 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 Behcet's d isease 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 conve ntional formulation to MEPC. The patients were treated with the test formul ation for 16 weeks in the former (de novo) group and for 12 weeks in the la tter (switched) group. Results: In the de novo group, ocular attacks decreased significantly as co mpared to the pretreatment incidence in 11 of the 14 patients (78.6%) evalu ated after MEPC therapy. Ocular attacks also decreased significantly in the switched group. In the de novo group. visual acuity improved with MEPC the rapy in 20 of the 28 eyes (71.4%) examined, and the overall efficacy evalua tion was "improved" or "markedly improved" in 13 of the 16 patients evaluat ed (81.3%). The one case each of onset of neuro-Behcet's disease and intest inal Behcet's disease observed in the de novo group were regarded as advers e reactions. Conclusion: It was concluded that ciclosporin MEPC is useful for controllin g the ocular symptoms of Behcet's disease, and that it can be used as effec tively and safely as the conventional formulation. Jpn J Ophthalmol 1999;43 :318-326. (C) Japan Ophthalmological Society.