OBJECTIVE: Uveitis and retinal vasculitis are sight-threatening manifestations 
of Behçet's disease with limited treatment options. This pilot study aimed to 
evaluate the safety, pharmacokinetics and clinical activity of XOMA 052 
(gevokizumab), a recombinant humanised anti-interleukin 1β antibody, in Behçet's 
disease patients with uveitis.
METHODS: Patients with acute posterior or panuveitis, and/or retinal vasculitis, 
resistant to azathioprine and/or ciclosporin, and receiving 10 mg/day or less of 
prednisolone, were enrolled into the 98-day study. Immunosuppressive agents were 
discontinued at baseline. Patients received a single infusion of XOMA 052 (0.3 
mg/kg). The safety and uveitis status and pharmacokinetics of XOMA 052 were 
evaluated.
RESULTS: Seven patients enrolled and completed the study. No treatment-related 
adverse event was observed. XOMA 052 treatment was associated with rapid and 
durable clinical response in all patients. Complete resolution of intraocular 
inflammation was achieved in 4-21 days (median 14 days), with a median duration 
of response of 49 days (range 21-97 days); one patient remained exacerbation 
free throughout the study.
CONCLUSIONS: Well tolerated, XOMA 052 resulted in a rapid onset and sustained 
reduction in intraocular inflammation in patients with resistant uveitis and 
retinal vasculitis. Moreover, the effect was observed despite discontinuation of 
immunosuppressive agents and without the need to increase corticosteroid 
dosages.