Postmarketing Analysis of Aflibercept-Related Sterile Intraocular Inflammation
Postmarketing Analysis of Aflibercept-Related Sterile Intraocular Inflammation
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DOI：
10.1001/jamaophthalmol.2014.5650
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发表时间：
2015-04-01
影响因子：
8.1
通讯作者：
Dugel, Pravin U.
中科院分区：
文献类型：
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作者：
Hahn, Paul;Chung, Mina M.;Dugel, Pravin U.
重要性Aflibercept相关的无菌性炎症，一个事件是知之甚少，一直是正在进行的上市后reports.OBJECTIVE分析病例报告的aflibercept相关的无菌性炎症报告的美国视网膜专家协会（ASRS）治疗监测委员会（TSC），一个独立的工作组，形成监测药物和设备相关的安全性事件。和参与者对55例患者的56例病例进行了回顾性分析，这些病例是2011年12月1日至2012年2月12日由美国各地的12家诊所自愿报告给ASRS TSC的阿柏西普注射后的所有无菌性炎症病例。2014.主要结果和测量分析阿柏西普相关的无菌性炎症病例的基线和人口统计学信息、呈现的症状和发现、视力变化、注射技术，结果在56例报告的无菌性炎症病例中，平均发病时间为3.5天（中位数为2天，范围为0 - 30天）。大多数病例包括最初的视力丧失和眼内炎症，没有明显的发红、剧烈疼痛或前房积脓。37例（66%）接受局部皮质类固醇和/或单独观察治疗。平均至消退时间为28.6天（中位数，28天;范围，4 - 84天）。虽然最终视力总体上没有变化，但一些患者发生了永久性视力丧失，这可能是由炎症和/或基础疾病进展引起的。年龄大于80岁与视力结果较差相关。无菌性炎症患者单独接受局部治疗与侵入性手术（玻璃体活检和/或玻璃体内抗生素给药和/或玻璃体切除术）的视力结果无差异.结论和相关性据我们所知，报道的阿柏西普相关无菌性炎症病例数最多，该分析表明该事件的典型结果和通常有利的预后.对真实的世界上市后数据的分析具有局限性，这些结果应被视为假设生成评估，而不是对该事件或其典型过程的明确反映。无菌性炎症和感染性眼内炎在就诊时往往难以区分，因此需要对这些患者进行谨慎的评估和处理。ASRS TSC鼓励所有医生进行积极的上市后监测。
IMPORTANCE Aflibercept - related sterile inflammation, an event that is poorly understood, has been the subject of ongoing postmarketing reports.OBJECTIVE To analyze cases of aflibercept - related sterile inflammation reported to the American Society of Retina Specialists (ASRS) Therapeutic Surveillance Committee (TSC), an independent task force formed to monitor drug - and device - related safety events.DESIGN, SETTING, AND PARTICIPANTS A retrospective review of 56 cases in 55 patients was performed of all cases of sterile inflammation after aflibercept injection that were voluntarily reported by 12 practices throughout the United States to the ASRS TSC from December 1, 2011, through February 12, 2014.MAIN OUTCOMES AND MEASURES Cases of aflibercept - related sterile inflammation were analyzed for baseline and demographic information, presenting symptoms and findings, visual acuity changes, injection technique, and management details.RESULTS Among 56 reported cases of sterile inflammation, mean time to onset was 3.5 days (median, 2 days; range, 0 - 30 days). Most cases consisted of initial loss of vision and intraocular inflammation without prominent redness, severe pain, or hypopyon. Thirty - seven cases (66%) were treated with topical corticosteroids and/or observation alone. Mean time to resolution was 28.6 days (median, 28 days; range, 4 - 84 days). Although final vision was overall unchanged, some patients developed permanent vision loss, which may have resulted from inflammation and/or progression of the underlying disease. Age older than 80 years was associated with worse visual outcomes. No difference in visual outcome was detected in patients with sterile inflammation undergoing topical therapy alone vs invasive procedures (vitreous biopsy and/or intravitreal antibiotic administration and/or vitrectomy).CONCLUSIONS AND RELEVANCE With the largest number of reported cases of aflibercept - related sterile inflammation to our knowledge, this analysis suggests typical findings and an often favorable prognosis of this event. Analysis of real - world, postmarketing data has limitations, and these findings should be considered as hypothesis - generating assessments rather than a definitive reflection of this event or its typical course. Distinguishing sterile inflammation and infectious endophthalmitis at the time of presentation may often be difficult, and cautious evaluation and management of these patients are warranted. The ASRS TSC encourages active postmarketing surveillance by all physicians.