title: Interleukin-1β-regulating antibody XOMA 052 (gevokizumab) in the treatment of acute exacerbations of resistant uveitis of Behcet's disease: an open-label pilot study.
abstract: 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.
authors.affiliation: Department of Internal Medicine, Division of Rheumatology, Istanbul Faculty of Medicine, Istanbul University, Turkey. agul@istanbul.edu.tr
authors.forename: Ahmet
authors.initials: A
authors.lastname: Gül
authors.forename: Ilknur
authors.initials: I
authors.lastname: Tugal-Tutkun
authors.forename: Charles A
authors.initials: CA
authors.lastname: Dinarello
authors.forename: Leonid
authors.initials: L
authors.lastname: Reznikov
authors.forename: Bahar Artim
authors.initials: BA
authors.lastname: Esen
authors.forename: Amer
authors.initials: A
authors.lastname: Mirza
authors.forename: Patrick
authors.initials: P
authors.lastname: Scannon
authors.forename: Alan
authors.initials: A
authors.lastname: Solinger
mesh_terms: D000208:Acute Disease; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D001528:Behcet Syndrome / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D053583:Interleukin-1beta / Q000037:antagonists & inhibitors; D008297:Male; D010865:Pilot Projects; D031300:Retinal Vasculitis / Q000097:blood / Q000188:drug therapy / Q000503:physiopathology; D016896:Treatment Outcome; D014605:Uveitis / Q000097:blood / Q000188:drug therapy / Q000503:physiopathology; D014792:Visual Acuity / Q000187:drug effects
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D053583:Interleukin-1beta; C547697:gevokizumab