[Immune suppression by combination therapy with basiliximab and cyclosporin in high risk keratoplasty. A pilot study]

The risk of postoperative immune reaction/transplant rejection is increased in the presence of distinct risk factors. In these situations, the use of established immunosuppressive agents (steroids, cyclosporin) 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 cyclosporin reduces the risk of acute rejection by 30% against placebo. The aim of this study was to investigate the effect of complementary immune suppression with the IL-2 synthesis inhibitor cyclosporin and the IL-2 receptor antagonist basiliximab on the incidence of transplant rejection after high-risk keratoplasty.

In an open pilot study, seven patients with high-risk keratoplasty were treated with basiliximab perioperatively and cyclosporin postoperatively. All patients had penetrating keratoplasty with a non-HLA-matched corneal graft.

Seven patients were operated on from 12/98 through 12/99 with a corneal transplant diameter between 7.1 and 9.5 mm. Risk factors included extensive corneal neovascularization in all patients (indications for surgery: 4 cases with corneal scars after herpetic disease, 2 cases with conditions after alkali burns, 1 case with corneal ulceration after thermal burn). During the follow-up of 14-25 months, no immune reaction has occurred, and all transplants are clear. The mean visual acuity increased from 0.04 to 0.41 postoperatively.

The preliminary data on a combination therapy with basiliximab and cyclosporin are promising. For further evaluation a prospective multicenter study is planned.