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Biological therapy for ocular Behçet’s disease with off-label drug prescription in Turkey
  1. Mehmet Citirik1,
  2. Cemile Ucgul Atilgan1,
  3. Hanife Rahmanlar2,
  4. Ali Alkan2,
  5. Hakki Gursoz2
  1. 1Ophthalmology, University of Health Sciences, Ankara Ulucanlar Eye Education and Research Hospital, Ankara, Turkey
  2. 2Turkish Medicines and Medical Devices Agency, Ankara, Turkey
  1. Correspondence to Professor Mehmet Citirik, Ophthalmology, University of Health Sciences, Ankara Ulucanlar Eye Education and Research Hospital, Ankara 06240, Turkey; mcitirik{at}hotmail.com

Abstract

Objective The use of biological agents in the treatment of ocular Behçet’s disease has recently become more frequent. The use of two agents, infliximab (IFX) and adalimumab (ADA), for the treatment of Behçet’s disease requires prior approval by the Turkish Medicines and Medical Devices Agency. We report on a review of such applications with a view to informing on how such agents are used off-label in Turkey.

Methods Prescriptions for off-label use of IFX or ADA sent from hospitals in Turkey to the Turkish Medicines and Medical Devices Agency in 2018 were evaluated. Demographic data, previous treatment regimens and reasons for referral were extracted from the files of the cases.

Results A total of 662 patients were considered for off-label use of IFX or ADA for the treatment of ocular Behçet’s disease. The mean age of the patients was 35.7±10.8 years (range 12–76); 61.5% of patients were men and 38.5% were women. Of the applications, 345 (52.1%) were for IFX and 317 (47.9%) for ADA. Among the referring hospitals, the public university hospitals ranked first, accounting for 77.9% of IFX and 88.6% of ADA prescriptions. Most applications were made after the failure of conventional therapy, which included steroids and immunosuppressive agents.

Conclusion IFX and ADA are rarely used as initial therapy. Stepwise treatment is still preferred in the treatment of ocular Behçet’s disease in Turkey. Our report informs on the management of this difficult-to-treat condition.

  • drug monitoring
  • drug-related side effects and adverse reactions
  • ethics
  • pharmacy
  • ophthalmology
  • public health

Data availability statement

Data are available upon reasonable request.

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