Safety and Efficacy of Gevokizumab in Patients with Behcet's Disease Uveitis: Results of an Exploratory Phase 2 Study

Abstract

PURPOSE: To evaluate the safety and efficacy of gevokizumab for the treatment of Behcet's disease uveitis in a prospective, open-label, randomized phase 2 trial. METHODS: Behcet's disease patients with new acute ocular exacerbation or at risk of exacerbation received 30 or 60 mg gevokizumab every 4 weeks intravenously or subcutaneously, on top of a stable regimen of immunosuppressives and corticosteroids (</=20 mg/day equivalent prednisolone). Patients withdrew in cases of ocular exacerbation. RESULTS: A total of 21 patients were included (17 acute and 4 at-risk: mean duration of uveitis 45.6 +/- 37.4 months). There were no serious adverse events related to gevokizumab. Recorded adverse events were mostly associated with exacerbation of uveitis or its complications. Response was evaluated for 14 acute patients and all showed rapid control of acute ocular exacerbation, mostly within 1 week, without any increase in corticosteroid dosage. CONCLUSIONS: Gevokizumab was well tolerated and rapidly controlled acute ocular exacerbations of Behcet's disease uveitis without the need for high-dose corticosteroid.