title: Safety and Efficacy of Gevokizumab in Patients with Behçet's Disease Uveitis: Results of an Exploratory Phase 2 Study.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of gevokizumab for the treatment of Behçet's disease uveitis in a prospective, open-label, randomized phase 2 trial.
  
  
  METHODS
  Behçet'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 Behçet's disease uveitis without the need for high-dose corticosteroid.
authors.affiliation: a Department of Ophthalmology , Istanbul University, Istanbul Faculty of Medicine , Istanbul , Turkey.
authors.forename: Ilknur
authors.initials: I
authors.lastname: Tugal-Tutkun
authors.affiliation: b Department of Ophthalmology , Hacettepe University School of Medicine , Ankara , Turkey.
authors.forename: Sibel
authors.initials: S
authors.lastname: Kadayifcilar
authors.affiliation: c Department of Ophthalmology, Fattouma Bourguiba University Hospital, Faculty of Medicine , Monastir University , Monastir , Tunisia.
authors.forename: Moncef
authors.initials: M
authors.lastname: Khairallah
authors.affiliation: d Institute of Vision Research, Department of Ophthalmology , Severance Eye and ENT Hospital, Yonsei University College of Medicine , Seoul , South Korea.
authors.forename: Sung Chul
authors.initials: SC
authors.lastname: Lee
authors.affiliation: e Ulucanlar Eye Hospital , Ankara , Turkey.
authors.forename: Pinar
authors.initials: P
authors.lastname: Ozdal
authors.affiliation: f Department of Ophthalmology , Istanbul University, Cerrahpasa Faculty of Medicine , Turkey.
authors.forename: Yilmaz
authors.initials: Y
authors.lastname: Özyazgan
authors.affiliation: g Department of Ophthalmology , Ajou University School of Medicine , Suwon , South Korea.
authors.forename: Ji Hun
authors.initials: JH
authors.lastname: Song
authors.affiliation: h Department of Ophthalmology , Seoul National University College of Medicine , Seoul , South Korea.
authors.forename: Hyeong Gon
authors.initials: HG
authors.lastname: Yu
authors.affiliation: i Institute de Recherches Internationales Servier , Suresnes , France.
authors.forename: Valerie
authors.initials: V
authors.lastname: Lehner
authors.affiliation: i Institute de Recherches Internationales Servier , Suresnes , France.
authors.forename: Agnès
authors.initials: A
authors.lastname: de Cordoue
authors.affiliation: i Institute de Recherches Internationales Servier , Suresnes , France.
authors.forename: Oana
authors.initials: O
authors.lastname: Bernard
authors.affiliation: j Department of Internal Medicine , Division of Rheumatology, Istanbul University, Istanbul Faculty of Medicine , Istanbul , Turkey.
authors.forename: Ahmet
authors.initials: A
authors.lastname: Gül
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D001528:Behcet Syndrome / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D014605:Uveitis / Q000188:drug therapy* / Q000503:physiopathology; D014792:Visual Acuity
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; C547697:gevokizumab
keywords: Behçet’s disease; gevokizumab; interleukin-1 beta; retinal vasculitis; uveitis