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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.
DECLARATION OF INTEREST
Ahmet Gül has received lecture fees, honoraria and travel grants from Servier and Novartis. Sibel Kadayifcilar has acted as an investigator for Servier, Santen, Novartis, and Bayer, and has received travel grants from Novartis, Allergan, and Bayer, and honoraria for advisory board meetings from Bayer and Allergan. Moncef Khairallah has acted as a consultant for Servier. Sung Chul Lee, none. Pinar Ozdal, none. Yilmaz Özyazgan is Consultant for the Advisory Board of Servier. Ji Hun Song has received lecture fees from Allergan and a travel grant from Servier. Ilknur Tugal-Tutkun has received lecture fees, honoraria and travel grants from Servier. Valerie Lehner, Agnès de Cordoue and Oana Bernard are employees of Servier. Hyeong Gon Yu, none.
Additional information
Notes on contributors
Ilknur Tugal-Tutkun
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.
Sibel Kadayifcilar
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.
Moncef Khairallah
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.
Sung Chul Lee
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.
Pinar Ozdal
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.
Yilmaz Özyazgan
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.
Ji Hun Song
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.
Hyeong Gon Yu
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.
Valerie Lehner
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.
Agnès de Cordoue
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.
Oana Bernard
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.
Ahmet Gül
All authors participated in the study design, interpretation of the results, development and writing of the manuscript, and the decision to submit for publication. The sponsor was responsible for data management and the final data analyses.