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首页> 美国卫生研究院文献>Wiley-Blackwell Online Open >Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects
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Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects

机译：在健康受试者中皮下注射预先注射的针剂或自动注射器对Belimumab单剂量的相对生物利用度

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Intravenous belimumab is approved for the treatment of systemic lupus erythematosus; subcutaneous self‐administration would enable greater patient access. This study assessed relative bioavailability, tolerability, and safety of 1 subcutaneous dose of self‐administered belimumab by healthy subjects using a single‐use autoinjector or prefilled syringe. Subjects (randomized 1:1:1:1) self‐administered belimumab 200 mg subcutaneously (abdomen or thigh) by prefilled syringe or autoinjector. Pharmacokinetics, adverse events (AEs), injection‐site pain, and administration errors were recorded. Of 81 subjects, 5 experienced administration errors and were excluded from pharmacokinetic analyses. Mean serum belimumab concentration profiles were similar for both devices, with a weak trend toward higher concentrations for thigh injection compared with abdominal injections. Maximum observed serum concentration was slightly higher with the autoinjector (27.0 vs 25.3 µg/mL) and area under the concentration–time curve slightly lower (701 vs 735 day · μg/mL), compared with the prefilled syringe. Incidence of AEs was 51% (41 of 81 subjects; headache was most common), with no serious or severe AEs. Median injection‐site pain scores were low (0 after 1 hour). Device handling was reported as acceptable by ≥95% of autoinjector users and ≥90% of prefilled syringe users for each characteristic assessed. These results support the use of either device for belimumab subcutaneous administration.
机译：静脉注射贝利木单抗被批准用于治疗系统性红斑狼疮；皮下自我管理将使更多的患者进入。这项研究评估了健康受试者使用一次性自动注射器或预填充注射器对1皮下剂量自我施用的belimumab的相对生物利用度，耐受性和安全性。受试者（随机1：1：1：1）通过预先填充的注射器或自动注射器皮下（腹部或大腿）自我施用200μmg贝利木单抗。记录药物动力学，不良事件（AE），注射部位疼痛和给药错误。在81位受试者中，有5位经历了给药错误，并从药代动力学分析中排除。两种设备的平均血清贝利木单抗浓度曲线相似，与腹部注射相比，大腿注射的浓度升高趋势较弱。与预装注射器相比，自动注射器的最高观察到的血清浓度略高（27.0 vs25.3μg/ mL），而浓度-时间曲线下的面积略低（701 vs 735天μg/ mL）。不良事件的发生率为51％（81名受试者中的41名；头痛是最常见的），没有严重或严重的不良事件。注射部位的疼痛中位数较低（1小时后为0）。对于每种评估的特征，据报告≥95％的自动注射器用户和≥90％的预填充注射器用户可接受设备处理。这些结果支持将任一种装置用于贝利木单抗皮下给药。

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