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

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.

• Authors: Ilknur Tugal-Tutkun Md, Sibel Kadayifcilar Md, Moncef Khairallah Md, Sung Chul Lee Md PhD, Pinar Ozdal, Yilmaz Özyazgan, Ji Hun Song Md, Hyeong Gon Yu Md PhD, Valerie Lehner PhD, Agnès de Cordoue Md, Oana Bernard Md, Ahmet Gül Md
• Journal: Ocular immunology and inflammation (Ocul Immunol Inflamm) Vol. 25 Issue 1 Pg. 62-70 (Feb 2017) ISSN: 1744-5078 [Electronic] England
• PMID: 26829647 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antibodies, Monoclonal, Humanized
• Glucocorticoids
• Immunosuppressive Agents
• gevokizumab

Topics

• Adult
• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Behcet Syndrome (drug therapy, physiopathology)
• Female
• Glucocorticoids (administration & dosage)
• Humans
• Immunosuppressive Agents (adverse effects, therapeutic use)
• Injections, Intravenous
• Injections, Subcutaneous
• Male
• Middle Aged
• Prospective Studies
• Treatment Outcome
• Uveitis (drug therapy, physiopathology)
• Visual Acuity