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 language | English |
|---|---|
| Pages (from-to) | 62-70 |
| Number of pages | 9 |
| Journal | Ocular Immunology and Inflammation |
| Volume | 25 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2017 Jan 2 |
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All Science Journal Classification (ASJC) codes
- Immunology and Allergy
- Ophthalmology
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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 journal › Article
TY - JOUR
T1 - Safety and Efficacy of Gevokizumab in Patients with Behçet’s Disease Uveitis
T2 - Results of an Exploratory Phase 2 Study
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
PY - 2017/1/2
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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84958040105&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84958040105&partnerID=8YFLogxK
U2 - 10.3109/09273948.2015.1092558
DO - 10.3109/09273948.2015.1092558
M3 - Article
C2 - 26829647
AN - SCOPUS:84958040105
VL - 25
SP - 62
EP - 70
JO - Ocular Immunology and Inflammation
JF - Ocular Immunology and Inflammation
SN - 0927-3948
IS - 1
ER -