Interleukin-1β-regulating antibody XOMA 052 (gevokizumab) in the treatment of acute exacerbations of resistant uveitis of Behcet's disease: an open-label pilot study
Interleukin-1β-regulating antibody XOMA 052 (gevokizumab) in the treatment of acute exacerbations of resistant uveitis of Behcet's disease: an open-label pilot study
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DOI：
10.1136/annrheumdis-2011-155143
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发表时间：
2012-04-01
影响因子：
27.4
通讯作者：
Solinger, Alan
中科院分区：
文献类型：
--
作者：
Gul, Ahmet;Tugal-Tutkun, Ilknur;Solinger, Alan
目的葡萄膜炎和视网膜血管炎是白塞病的主要临床表现，治疗方法有限。这项试点研究的目的是评估的安全性，药代动力学和临床活性的XOMA 052（吉伐单抗），重组人源化抗白细胞介素1 β抗体，白塞病患者与葡萄膜炎。方法急性后或全葡萄膜炎，和/或视网膜血管炎，耐硫唑嘌呤和/或环孢素，并接受10毫克/天或更少的泼尼松龙，患者被纳入98天的研究。在基线时停用免疫抑制剂。患者接受单次输注XOMA 052（0.3 mg/kg）。对XOMA 052的安全性、葡萄膜炎状态和药代动力学进行了评价。未观察到治疗相关不良事件。XOMA 052治疗与所有患者的快速和持久临床反应相关。眼内炎症的完全解决是在4-21天（中位数14天），平均持续时间为49天（范围21-97天）的反应，一个病人仍然恶化免费在整个study.Conclusions耐受性良好，XOMA 052导致快速发病和持续减少眼内炎症患者的抵抗性葡萄膜炎和视网膜血管炎。此外，尽管停用免疫抑制剂，但仍观察到该效果，且无需增加皮质类固醇剂量。
Objective Uveitis and retinal vasculitis are sight-threatening manifestations of Behcet's disease with limited treatment options. This pilot study aimed to evaluate the safety, pharmacokinetics and clinical activity of XOMA 052 (gevokizumab), a recombinant humanised anti-interleukin 1 beta antibody, in Behcet's disease patients with uveitis.Methods Patients with acute posterior or panuveitis, and/or retinal vasculitis, resistant to azathioprine and/or ciclosporin, and receiving 10 mg/day or less of prednisolone, were enrolled into the 98-day study. Immunosuppressive agents were discontinued at baseline. Patients received a single infusion of XOMA 052 (0.3 mg/kg). The safety and uveitis status and pharmacokinetics of XOMA 052 were evaluated.Results Seven patients enrolled and completed the study. No treatment-related adverse event was observed. XOMA 052 treatment was associated with rapid and durable clinical response in all patients. Complete resolution of intraocular inflammation was achieved in 4-21 days (median 14 days), with a median duration of response of 49 days (range 21-97 days); one patient remained exacerbation free throughout the study.Conclusions Well tolerated, XOMA 052 resulted in a rapid onset and sustained reduction in intraocular inflammation in patients with resistant uveitis and retinal vasculitis. Moreover, the effect was observed despite discontinuation of immunosuppressive agents and without the need to increase corticosteroid dosages.