Article Text

other Versions

PDF
Concise report
Interleukin-1β-regulating antibody XOMA 052 (gevokizumab) in the treatment of acute exacerbations of resistant uveitis of Behçet's disease: an open-label pilot study
  1. Ahmet Gül1,
  2. Ilknur Tugal-Tutkun2,
  3. Charles A Dinarello3,
  4. Leonid Reznikov3,
  5. Bahar Artim Esen1,
  6. Amer Mirza4,
  7. Patrick Scannon4,
  8. Alan Solinger4
  1. 1Department of Internal Medicine, Division of Rheumatology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey
  2. 2Department of Ophthalmology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey
  3. 3University of Colorado Denver, Department of Medicine, Division of Infectious Diseases, Aurora, Colorado, USA
  4. 4XOMA (US) LLC, Berkeley, California, USA
  1. Correspondence to Ahmet Gül, Department of Internal Medicine, Division of Rheumatology, Istanbul University, Istanbul Faculty of Medicine, 34390 Istanbul, Turkey; agul{at}istanbul.edu.tr

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.

Statistics from Altmetric.com

Footnotes

  • AG and ITT contributed equally to this study

  • Funding These studies were supported in part by NIH grant AI-15614 (to CAD). The current study was an investigator-initiated trial and was conducted with the financial support of XOMA (US) LLC, Berkeley, California, USA.

  • Ethics approval This study was conducted with the approval of the local ethics committee of Istanbul Faculty of Medicine and the central ethics committee, Ministry of Health, Turkey.

  • Provenance and peer review Not commissioned; externally peer reviewed.

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.