V 110Immune suppression with a combination of Basiliximab and Ciclosporin in high-risk keratoplasty
K. Schmitz, S. Hitzer, B. Kreutzer, W. Behrens-Baumann
The risk of postoperative immune reaction and subsequent transplant rejection is increased in the presence of distinct risk factors (corneal neovascularization, previous rejection, large transplant diameter, trepanation close to the limbus). In these situations, the use of established immunosuppressive agents (steroids, Ciclosporin) is indicated. However, immune reactions can occur despite this therapy.
Basiliximab is a monoclonal antibody with a high specific binding affinity to the IL-2-receptor of activated T-cells. After renal transplantation, the combination therapy with Basiliximab and steroids reduces the risk of acute rejection by 30% against placebo.
Objective: Does the complementary immune suppression with the IL-2 synthesis inhibitor Ciclosporin and the IL-2-receptor-antagonist Basiliximab reduce the risk of transplant rejection after high-risk keratoplasty?
Patients and methods: In an open pilot study, seven patients with high-risk keratoplasty were treated perioperatively with 2 x 20 mg Basiliximab combined with Ciclosporin (blood concentration 180-200 ng/ml) postoperatively. All patients had a penetrating keratoplasty with a non-HLA-matched corneal graft.
Results: 7 patients (5 male., 2 female.) were operated from 12/98 through 12/99 with a diameter of the corneal transplant between 7.1 and 9.5 mm. Risk factors included in all patients extensive corneal neovascularization. Indications for surgery were in 4 cases corneal scars after herpetic disease, in 2 cases conditions after alkali burns, and in 1 case a corneal ulcer after thermal burn. In one case, the third re-keratoplasty was performed. During the follow-up of 3-14 months, no immune reaction has occurred, all transplants are clear. The mean visual acuity increased from 0.04 to 0.22 postoperatively.
Discussion: The preliminary data of a combination therapy with Basiliximab and Ciclosporin are promising. For further evaluation we are planning the initiation of a prospective randomized study, which should be carried out in a multicenter-design.
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