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首页> 外文期刊>Arthritis and Rheumatism >A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus.
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A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus.

机译：在系统性红斑狼疮患者中，belimumab是抑制B淋巴细胞刺激剂的单克隆抗体，其III期随机，安慰剂对照研究。

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OBJECTIVE: To assess the efficacy/safety of the B lymphocyte stimulator inhibitor belimumab plus standard therapy compared with placebo plus standard therapy in active systemic lupus erythematosus (SLE). METHODS: In a phase III, multicenter, randomized, placebo-controlled trial, 819 antinuclear antibody-positive or anti-double-stranded DNA-positive SLE patients with scores >/=6 on the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) version of the SLE Disease Activity Index (SLEDAI) were randomized in a 1:1:1 ratio to receive 1 mg/kg belimumab, 10 mg/kg belimumab, or placebo intravenously on days 0, 14, and 28 and then every 28 days for 72 weeks. The primary efficacy end point was the SLE Responder Index (SRI) response rate at week 52 (an SRI response was defined as a >/=4-point reduction in SELENA-SLEDAI score, no new British Isles Lupus Assessment Group [BILAG] A organ domain score and no more than 1 new BILAG B score, and no worsening in physician's global assessment score versus baseline). RESULTS: Belimumab at 10 mg/kg plus standard therapy met the primary efficacy end point, generating a significantly greater SRI response at week 52 compared with placebo (43.2% versus 33.5%; P = 0.017). The rate with 1 mg/kg belimumab was 40.6% (P = 0.089). Response rates at week 76 were 32.4%, 39.1%, and 38.5% with placebo, 1 mg/kg belimumab, and 10 mg/kg belimumab, respectively. In post hoc sensitivity analyses evaluating higher SELENA-SLEDAI score thresholds, 10 mg/kg belimumab achieved better discrimination at weeks 52 and 76. Risk of severe flares over 76 weeks (based on the modified SLE Flare Index) was reduced with 1 mg/kg belimumab (34%) (P = 0.023) and 10 mg/kg belimumab (23%) (P = 0.13). Serious and severe adverse events, including infections, laboratory abnormalities, malignancies, and deaths, were comparable across groups. CONCLUSION: Belimumab plus standard therapy significantly improved SRI response rate, reduced SLE disease activity and severe flares, and was generally well tolerated in SLE.
机译：目的：评估B淋巴细胞刺激抑制剂贝利木单抗+标准疗法与安慰剂+标准疗法相比在活动性系统性红斑狼疮（SLE）中的疗效/安全性。方法：在一项III期，多中心，随机，安慰剂对照试验中，对819名抗核抗体阳性或抗双链DNA阳性SLE患者在红斑狼疮国家评估中的雌激素安全性评分> / = 6。 ）版本的SLE疾病活动指数（SLEDAI）以1：1：1的比例随机分配，分别在第0、14和28天静脉接受1 mg / kg贝利木单抗，10 mg / kg贝利木单抗或安慰剂，然后每28天一次天72周。主要疗效终点是第52周时的SLE应答者指数（SRI）应答率（SRI应答定义为SELENA-SLEDAI评分降低> / = 4点，不存在新的不列颠群岛狼疮评估组[BILAG] A器官结构得分和新的BILAG B得分不超过1，并且医师的整体评估得分相对于基线没有恶化。结果：10 mg / kg的贝利木单抗加标准疗法达到了主要疗效终点，与安慰剂相比，在52周时产生了显着更高的SRI反应（43.2％比33.5％; P = 0.017）。服用贝利木单抗1 mg / kg的比例为40.6％（P = 0.089）。安慰剂，1 mg / kg贝利木单抗和10 mg / kg贝利木单抗在第76周的缓解率分别为32.4％，39.1％和38.5％。在事后敏感性分析中，评估较高的SELENA-SLEDAI得分阈值，在52周和76周时，贝利木单抗10 mg / kg获得更好的辨别力。在76周内（根据改良的SLE Flare Index），发生严重耀斑的风险降低1 mg / kg贝利木单抗（34％）（P = 0.023）和10 mg / kg贝利木单抗（23％）（P = 0.13）。两组之间的严重和严重不良事件（包括感染，实验室异常，恶性肿瘤和死亡）相当。结论：贝利木单抗加标准疗法可显着提高SRI应答率，减少SLE疾病活动性和严重发作，并且在SLE中一般耐受良好。

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