Tanaka Yoshiya, Takeuchi Tsutomu, Akashi Naotsugu, Takita Yasushi, Kovacs Birgit, Kariyasu Sawako
a The First Department of Internal Medicine , School of Medicine, University of Occupational and Environmental Health , Kitakyushu , Japan.
b Division of Rheumatology, Department of Internal Medicine , Keio University School of Medicine , Tokyo , Japan.
Mod Rheumatol. 2017 Mar;27(2):284-291. doi: 10.1080/14397595.2016.1206260. Epub 2016 Jul 29.
To assess the efficacy and safety of tabalumab, an anti-B cell activating factor (BAFF) antibody, in combination with standard of care (SoC) therapy in Japanese patients with active systemic lupus erythematosus (SLE).
A subgroup analysis was conducted in Japanese patients (n = 45) enrolled in ILLUMINATE-1, a phase III global trial in SLE patients (N = 1164). Patients received SoC plus tabalumab or placebo, starting with a loading dose (240 mg) at week 0, followed by 120 mg every 4 weeks (120 Q4W, n = 15), 120 mg every 2 weeks (120 Q2W, n = 15), or placebo Q2W (n = 15). The primary endpoint was proportion achieving SLE Responder Index-5 (SRI-5) improvement at week 52.
A numerically greater SRI-5 response rate was achieved with 120 Q2W (46.7%; p = 0.059 vs. placebo) compared with 120 Q4W (20.0%) and placebo Q2W (13.3%). The proportion of patients with severe SLE flare was lower for 120 Q2W (0%) and 120 Q4W (6.7%) than for placebo (26.7%). The rates of serious adverse events (AEs) and treatment-emergent AEs were similar across treatments.
In Japanese SLE patients, tabalumab 120 Q2W improved SRI-5 response rate and reduced the frequency of severe flares compared with placebo. Safety profiles were similar with tabalumab and placebo.
评估抗B细胞活化因子（BAFF）抗体他巴鲁单抗联合标准治疗（SoC）方案治疗日本活动性系统性红斑狼疮（SLE）患者的疗效和安全性。
对参加ILLUMINATE-1（一项针对SLE患者的III期全球试验，N = 1164）的日本患者（n = 45）进行亚组分析。患者接受SoC加他巴鲁单抗或安慰剂治疗，在第0周开始给予负荷剂量（240mg），随后每4周给予120mg（120 Q4W，n = 15）、每2周给予120mg（120 Q2W，n = 15）或安慰剂每2周一次（n = 15）。主要终点是在第52周时达到系统性红斑狼疮反应指数5（SRI-5）改善的患者比例。
与120 Q4W（20.0%）和安慰剂Q2W（13.3%）相比，120 Q2W组的SRI-5反应率在数值上更高（46.7%；与安慰剂相比p = 0.059）。120 Q2W组（0%）和120 Q4W组（6.7%）严重SLE病情加重的患者比例低于安慰剂组（26.7%）。各治疗组的严重不良事件（AE）和治疗期间出现的AE发生率相似。
在日本SLE患者中，与安慰剂相比，每2周一次给予120mg他巴鲁单抗可提高SRI-5反应率并降低严重病情加重的频率。他巴鲁单抗和安慰剂的安全性概况相似。
