Safety and Efficacy of Gevokizumab in Patients with Behçet’s Disease Uveitis: Results of an Exploratory Phase 2 Study

Ilknur Tugal-Tutkun, Sibel Kadayifcilar, Moncef Khairallah, Sungchul Lee, Pinar Ozdal, Yilmaz Özyazgan, Ji Hun Song, Hyeong Gon Yu, Valerie Lehner, Agnès de Cordoue, Oana Bernard, Ahmet Gül

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

Purpose: 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.

Original languageEnglish
Pages (from-to)62-70
Number of pages9
JournalOcular Immunology and Inflammation
Volume25
Issue number1
DOIs
Publication statusPublished - 2017 Jan 2

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Uveitis
Safety
Adrenal Cortex Hormones
Immunosuppressive Agents
Prednisolone
Disease Progression
gevokizumab

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Ophthalmology

Cite this

Tugal-Tutkun, Ilknur ; Kadayifcilar, Sibel ; Khairallah, Moncef ; Lee, Sungchul ; Ozdal, Pinar ; Özyazgan, Yilmaz ; Song, Ji Hun ; Yu, Hyeong Gon ; Lehner, Valerie ; de Cordoue, Agnès ; Bernard, Oana ; Gül, Ahmet. / Safety and Efficacy of Gevokizumab in Patients with Behçet’s Disease Uveitis : Results of an Exploratory Phase 2 Study. In: Ocular Immunology and Inflammation. 2017 ; Vol. 25, No. 1. pp. 62-70.
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Tugal-Tutkun, I, Kadayifcilar, S, Khairallah, M, Lee, S, Ozdal, P, Özyazgan, Y, Song, JH, Yu, HG, Lehner, V, de Cordoue, A, Bernard, O & Gül, A 2017, 'Safety and Efficacy of Gevokizumab in Patients with Behçet’s Disease Uveitis: Results of an Exploratory Phase 2 Study', Ocular Immunology and Inflammation, vol. 25, no. 1, pp. 62-70. https://doi.org/10.3109/09273948.2015.1092558

Safety and Efficacy of Gevokizumab in Patients with Behçet’s Disease Uveitis : Results of an Exploratory Phase 2 Study. / Tugal-Tutkun, Ilknur; Kadayifcilar, Sibel; Khairallah, Moncef; Lee, Sungchul; Ozdal, Pinar; Özyazgan, Yilmaz; Song, Ji Hun; Yu, Hyeong Gon; Lehner, Valerie; de Cordoue, Agnès; Bernard, Oana; Gül, Ahmet.

In: Ocular Immunology and Inflammation, Vol. 25, No. 1, 02.01.2017, p. 62-70.

Research output: Contribution to journalArticle

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AU - Tugal-Tutkun, Ilknur

AU - Kadayifcilar, Sibel

AU - Khairallah, Moncef

AU - Lee, Sungchul

AU - Ozdal, Pinar

AU - Özyazgan, Yilmaz

AU - Song, Ji Hun

AU - Yu, Hyeong Gon

AU - Lehner, Valerie

AU - de Cordoue, Agnès

AU - Bernard, Oana

AU - Gül, Ahmet

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Y1 - 2017/1/2

N2 - Purpose: 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.

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