Safety, efficacy, and pharmacokinetics of Flebogamma® 5% [immune globulin intravenous (human)] for replacement therapy in primary immunodeficiency diseases
Safety, efficacy, and pharmacokinetics of Flebogamma® 5% [immune globulin intravenous (human)] for replacement therapy in primary immunodeficiency diseases
复制标题
DOI：
10.1023/b:joci.0000029108.18995.61
复制
发表时间：
2004-07-01
影响因子：
9.1
通讯作者：
Pinciaro, PJ
中科院分区：
文献类型：
--
作者：
Berger, M;Pinciaro, PJ
本研究的目的是评价Flebogramma（R）5%（一种免疫球蛋白静脉注射产品）用于原发性免疫缺陷患者替代治疗的安全性、有效性和药代动力学。美国食品药品监督管理局提出，新产品的使用必须导致小于或等于1例严重细菌感染/受试者/年，具有可接受的安全性和耐受性，并具有与内源性IgG和其他市售免疫球蛋白产品相似的药代动力学特性。在7个临床研究中心，对51名患有明确定义的原发性免疫缺陷疾病的14-74岁受试者给予Flebogamma（R）5%，剂量为300-600 mg/kg，每21-28天一次，持续12个月。意向治疗人群的严重感染率计算值为0.061/受试者/年。认为与Flebogamma（R）可能相关的不良事件发生率为5%，并且在完成输注期间或输注后72小时内发生的不良事件发生率约为8%。总IgG的半衰期为37天。Flebogamma（R）5%有效、安全且耐受性良好，不会使受试者发生不良事件的风险增加，但接受任何免疫球蛋白产品的原发性免疫缺陷受试者中可合理预期的不良事件除外。
The purpose of the study was to evaluate the safety, efficacy, and pharmacokinetics of Flebogamma(R) 5%, an immune globulin intravenous product, for replacement therapy in primary immunodeficient patients. The US Food and Drug Administration has proposed that the use of new products must result in less than or equal to1 serious bacterial infection/subject/year, have acceptable safety and tolerability, and have pharmacokinetic properties similar to endogenous IgG and other commercially available immune globulin products. Flebogamma(R) 5% was administered at seven clinical sites to 51 subjects aged 14-74 years with well-defined primary immunodeficiency diseases at a dose of 300-600 mg/kg every 21-28 days for 12 months. The calculated serious infection rate for the intent-to-treat population was 0.061/subject/year. The incidence of adverse events considered potentially related to Flebogamma(R) 5%, and occurring during or within 72 h after completing the infusion was approximately 8%. The half-life of total IgG was 37 days. Flebogamma(R) 5% is efficacious, safe, and well-tolerated, and does not put subjects at increased risk of adverse events other than those that could be reasonably expected in primary immunodeficient subjects who are receiving any immune globulin product.