皮下注射贝利木单抗治疗狼疮安全…
皮下注射贝利木单抗治疗狼疮安全有效
作者： Sheikh SZ, et al.
翻译:北医三院张警丰
摘要
目的：皮下注射（SC）贝利木单抗治疗系统性红斑狼疮（SLE）的自我管理及药代动力学（PK）。
研究方法：对应用贝利木单抗治疗的患者予以自我管理的方式，应用自动注射设备每周皮下注射贝利木单抗200mg，共8周。主要观察终点是首次和第二次（第一周及第二周）在医疗机构自行注射的患者比例。次要观察终点是第四周和第八周（在医疗机构）以及第3、5、6、7周（在家）可以自行注射的患者比例。同时评估贝利木单抗的药代动力学数据、安全性以及注射局部疼痛情况。
结果：95例患者中91例完成了本实验（3例因严重不良事件退出，失访1例）。93%患者为女性，平均年龄44.8岁。绝大部分患者（99%，89/90，未尝试者5位）在第一和第二周成功的自行皮下注射了贝利木单抗（5例有医务人员辅助），98%（85/87）的患者成功的在第4周和第8周自行注射了贝利木单抗。在第3、5、6、7周在家中自行注射的成功率达93%（81/87）。8周的平均血药浓度为113µg/mL。由静脉途径改为皮下注射途径的间隔时间≤1.5周的患者，第一周的血药浓度较第八周为高( 51%均值)，但仍在静脉给药剂量的范围内。间隔时间≥2.5周的差异几乎为0.不良反应及严重不良反应均很少，无死亡病例，疼痛发生亦很少且随着后续的注射而进一步减少。
结论：SLE患者可成功的应用自动注射设备自行进行贝利木单抗的皮下注射，由静脉途径改为皮下注射血药浓度稳定，不良反应及疼痛均在可接受的水平。贝利木单抗由静脉改为皮下注射的推荐时间间隔为1-4周。
原文
OBJECTIVE:To study self-administration and pharmacokinetics (PK) of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE).
METHODS:Patients previously treated with belimumab self-administered belimumab 200 mg SC weekly for 8 weeks using an autoinjector. The primary endpoint was the proportion of patients able to self-administer their first and second dose (weeks 1 and 2) in the clinic. The proportion able to self-administer at weeks 4 and 8 (clinic) and weeks 3, 5, 6, and 7 (home) were secondary endpoints. Belimumab PK, safety, and injection-site pain were assessed.
RESULTS:91/95 patients completed the study (withdrawals: adverse events (AEs): 3; lost to follow-up: 1). 93% were female, and mean (SD) age was 44.8 (12.50) years. The majority (99%, 89/90; no attempt, n = 5) successfully self-administered belimumab SC at weeks 1 and 2 (5 had clinic staff assistance), and 98% (85/87) successfully self-administered at weeks 4 and 8. Home-administration success rates were high (93%, (81/87) at weeks 3, 5, 6, and 7). Week 8 median trough concentration was 113 µg/mL. For patients with a ≤ 1.5-week interval between IV SC administration, week-1 concentrations were higher vs. week 8 ( 51% median) but within a range observed with IV dosing; those with a ≥ 2.5-week interval had median differences close to 0. AEs and serious AEs were low, with no deaths; pain levels were low and decreased with subsequent injections.
CONCLUSION:Patients with SLE successfully self-administered belimumab SC using a novel autoinjector; the PK profile was stable following a switch from IV with acceptable AE and pain levels. The recommended dosing interval between IV to SC dosing is 1 - 4 weeks.
引自：Sheikh SZ, Hammer AE, Fox NL, et al.Evaluation of a novel autoinjector for subcutaneous self-administration of belimumab in systemic lupuserythematosus.Int J Clin Pharmacol Ther. 2016 Sep 26.
作者： Sheikh SZ, et al.
翻译:北医三院张警丰
摘要
目的：皮下注射（SC）贝利木单抗治疗系统性红斑狼疮（SLE）的自我管理及药代动力学（PK）。
研究方法：对应用贝利木单抗治疗的患者予以自我管理的方式，应用自动注射设备每周皮下注射贝利木单抗200mg，共8周。主要观察终点是首次和第二次（第一周及第二周）在医疗机构自行注射的患者比例。次要观察终点是第四周和第八周（在医疗机构）以及第3、5、6、7周（在家）可以自行注射的患者比例。同时评估贝利木单抗的药代动力学数据、安全性以及注射局部疼痛情况。
结果：95例患者中91例完成了本实验（3例因严重不良事件退出，失访1例）。93%患者为女性，平均年龄44.8岁。绝大部分患者（99%，89/90，未尝试者5位）在第一和第二周成功的自行皮下注射了贝利木单抗（5例有医务人员辅助），98%（85/87）的患者成功的在第4周和第8周自行注射了贝利木单抗。在第3、5、6、7周在家中自行注射的成功率达93%（81/87）。8周的平均血药浓度为113µg/mL。由静脉途径改为皮下注射途径的间隔时间≤1.5周的患者，第一周的血药浓度较第八周为高( 51%均值)，但仍在静脉给药剂量的范围内。间隔时间≥2.5周的差异几乎为0.不良反应及严重不良反应均很少，无死亡病例，疼痛发生亦很少且随着后续的注射而进一步减少。
结论：SLE患者可成功的应用自动注射设备自行进行贝利木单抗的皮下注射，由静脉途径改为皮下注射血药浓度稳定，不良反应及疼痛均在可接受的水平。贝利木单抗由静脉改为皮下注射的推荐时间间隔为1-4周。
原文
OBJECTIVE:To study self-administration and pharmacokinetics (PK) of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE).
METHODS:Patients previously treated with belimumab self-administered belimumab 200 mg SC weekly for 8 weeks using an autoinjector. The primary endpoint was the proportion of patients able to self-administer their first and second dose (weeks 1 and 2) in the clinic. The proportion able to self-administer at weeks 4 and 8 (clinic) and weeks 3, 5, 6, and 7 (home) were secondary endpoints. Belimumab PK, safety, and injection-site pain were assessed.
RESULTS:91/95 patients completed the study (withdrawals: adverse events (AEs): 3; lost to follow-up: 1). 93% were female, and mean (SD) age was 44.8 (12.50) years. The majority (99%, 89/90; no attempt, n = 5) successfully self-administered belimumab SC at weeks 1 and 2 (5 had clinic staff assistance), and 98% (85/87) successfully self-administered at weeks 4 and 8. Home-administration success rates were high (93%, (81/87) at weeks 3, 5, 6, and 7). Week 8 median trough concentration was 113 µg/mL. For patients with a ≤ 1.5-week interval between IV SC administration, week-1 concentrations were higher vs. week 8 ( 51% median) but within a range observed with IV dosing; those with a ≥ 2.5-week interval had median differences close to 0. AEs and serious AEs were low, with no deaths; pain levels were low and decreased with subsequent injections.
CONCLUSION:Patients with SLE successfully self-administered belimumab SC using a novel autoinjector; the PK profile was stable following a switch from IV with acceptable AE and pain levels. The recommended dosing interval between IV to SC dosing is 1 - 4 weeks.
引自：Sheikh SZ, Hammer AE, Fox NL, et al.Evaluation of a novel autoinjector for subcutaneous self-administration of belimumab in systemic lupuserythematosus.Int J Clin Pharmacol Ther. 2016 Sep 26.
收藏
回复(1)举报
参与评论
评论列表
按投票顺序
↘▂_倥絔药在哪里？
举报
2016-11-03 22:18:02 有用(0)
回复(0)
相关推荐
热点推荐
暂无数据
热门帖子
今日推荐
推荐关注
