Safety and Effectiveness of Interferon Alpha-2a in Treatment of Patients with Behcet's Uveitis Refractory to Conventional Treatments

Safety and Effectiveness of Interferon Alpha-2a in Treatment of Patients with Behcet's Uveitis Refractory to Conventional Treatments
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DOI:
10.1016/j.ophtha.2009.11.022
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发表时间:
2010-07-01
期刊:
影响因子:
13.7
通讯作者:
Bayraktar, M. Zeki
Bayraktar, M. Zeki
中科院分区:
医学1区
文献类型:
--
作者:
Sobaci, Gungor;Erdem, Uzeyir;Bayraktar, M. Zeki

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目的:评价干扰素α-2a的中期安全性和有效性干扰素α 2a在皮质类固醇和免疫抑制剂难治性白塞葡萄膜炎(BU)患者中的应用。设计:开放、非随机、非对照、干预性、前瞻性研究。参与者:53例患者(106只眼)患有活动性、威胁视力的BU,常规治疗无效。干预:在53例患者中,使用有效剂量的泼尼松龙(1-2 mg/kg/天,在4-6周内逐渐减少至10 mg)抑制了急性炎症。患者在前3个月接受IFN α 2a 450万国际单位(MIU)每周3次治疗,随后在接下来的3个月接受IFN α 2a 3 MIU每周3次治疗。观察或其他治疗方法进行根据决策树开发的本study.Main结果Measures:缓解和完全反应(主要结果措施),葡萄膜炎发作的频率,视力(VA),和不良反应(次要结果措施)。在1年随访结束时,53例患者中有45例(84.9%)获得治疗反应。平均发作率从每年3.6 +/- 1.1(范围,2-8)降至每年0.56 +/- 0.75(范围,0-4)(P=0.001)。30眼(28.3%)视力提高(最小分辨角单位的对数>= 0.2),12眼(11.3%)视力下降。5例患者(9.4%)对初始治疗无反应,3例患者(5.6%)出现严重不良反应,包括银屑病、癫痫发作和极度疲劳。15例患者(28.3%)停止治疗的所有药物和疾病免费为28 +/- 13.1个月(范围,12-50 months)。结论:这些结果表明,IFN α 2a可能是一个有价值的治疗选择,在BU是难治性皮质类固醇和传统的免疫抑制剂。IFN α 2a作为BU的一线药物的可能作用应在针对新描述的生物制剂的随机对照临床试验中进行验证。财务披露:作者在本文中讨论的任何材料中没有专有或商业利益。Ophthalmology 2010; 117:1430-1435(C)2010,美国眼科学会。
Purpose: To evaluate the intermediate-term safety and effectiveness of interferon alpha-2a (IFN alpha 2a) in patients with Behcet's uveitis (BU) refractory to corticosteroids and immunosuppressive agents.Design: Open, nonrandomized, uncontrolled, interventional, prospective study.Participants: Fifty-three patients (106 eyes) with active, vision-threatening BU who failed to respond to conventional treatments.Intervention: In 53 patients, acute inflammation was suppressed with effective prednisolone dosage (1-2 mg/kg/day, tapered to 10 mg within 4-6 weeks). The patients were treated with IFN alpha 2a 4.5 million international units (MIU) 3 times per week for the first 3 months followed by IFN alpha 2a 3 MIU 3 times per week for the next 3 months. Observation or other treatment methods were performed according to the decision tree developed for this study.Main Outcome Measures: Remission and complete response (primary outcome measures), frequency of uveitis attacks, visual acuity (VA), and adverse effects (secondary outcome measures).Results: During 2 years of follow-up (median 65 months, range 12-130months), compliance with the therapy was excellent. At the end of 1-year follow-up, treatment response was obtained in 45 of 53 patients (84.9%). The mean attack rate of 3.6 +/- 1.1 per year (range, 2-8) decreased to 0.56 +/- 0.75(range, 0-4) per year (P=0.001). Visual acuity improved (>= 0.2 logarithm of the minimum angle of resolution units from initial VA) in 30 eyes (28.3%) and worsened in 12 eyes (11.3%). Five patients (9.4%) did not respond to the initial treatment, and 3 patients (5.6%) developed severe adverse effects, including psoriasis, epileptic seizure, and extreme tiredness. Fifteen patients (28.3%) were off treatment for all the medications and disease free for 28 +/- 13.1 months (range, 12-50 months).Conclusions: These results suggest that IFN alpha 2a may be a valuable treatment option in BU that is refractory to corticosteroids and conventional immunosuppressive agents. The possible role of IFN alpha 2aas a first-line agent in BU should be validated in randomized controlled clinical trials against newly described biologic agents.Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Ophthalmology 2010; 117: 1430-1435 (C) 2010 by the American Academy of Ophthalmology.