10mg的白介素-6单抗治疗狼疮
10mg的白介素-6单抗治疗狼疮可能有一定疗效
作者：Wallace DJ, et al.
翻译:北医三院张警丰
摘要
目的：本研究为II期临床试验，目的是评估白介素（IL）6单克隆抗体治疗系统性红斑狼疮（SLE）的有效性与安全性。
方法：基础用药维持的SLE病情活动患者随机分为安慰剂组或PF-0423692110 mg, 50 mg或200mg组，每8周给药一次。在24周时评估SLE反应指数（SRI-4；主要终点）以及英国狼疮协作组织狼疮评估标准（BICLA）。在单因素分析的基础之上对大样本人群进行事后分析。
结果：共纳入183例患者（空白对照n=45;10mg, n=45; 50mg, n=47; 200mg, n=46）.考虑到安全性的因素，200mg 剂量未再持续，且未纳入主要有效性分析中。任何剂量组的SRI-4反应率与空白对照相比无明显区别。然而，BICLA反应率在10mg 组中则显著升高(p=0.026)。10mg (n=0) 和50mg (n=2)组与空白对照(n=8; p<0.01)相比，重度发作的例数均显著降低。大样本的基线狼疮活动度较高的患者中SRI-4 (p=0.004) 和BICLA (p=0.012)反应率10mg组显著高于空白对照。共出现4例死亡(200mg, n=3; 10mg, n=1)。最常见的不良反应包括头痛、恶心、腹泻。
结论：与空白对照相比，PF-04236921治疗SLE患者的主要有效终点并无差异。事后分析中可见到10mg 组有效。剂量达50mg的安全性是可接受的。
原文
OBJECTIVES:This phase II trial evaluated the efficacy and safety of an interleukin (IL) 6 monoclonal antibody for systemic lupus erythematosus (SLE).
METHODS:Patients with active disease were randomised to placebo or PF-04236921 10 mg, 50 mg or 200mg, subcutaneously, every 8weeks with stable background therapy. SLE Responder Index (SRI-4; primary end point) and British Isles LupusAssessment Group-based Composite Lupus Assessment (BICLA) were assessed at week 24. Post hoc analysis identified an enriched population based upon planned univariate analyses.
RESULTS:183 patients received treatment (placebo, n=45; 10mg, n=45; 50mg, n=47; 200mg, n=46). The 200mg dose was discontinued due to safety findings and not included in the primary efficacy analysis. The SRI-4 response rates were not significant for any dose compared with placebo; however, the BICLA response rate was significant for 10mg (p=0.026). The incidence of severe flares was significantly reduced with 10mg (n=0) and 50mg (n=2) combined versus placebo (n=8; p<0.01). In patients with greater baseline disease activity (enriched population), the SRI-4 (p=0.004) and BICLA (p=0.012) response rates were significantly different with 10mg versus placebo. Four deaths (200mg, n=3; 10mg, n=1) occurred. The most frequently reported adverse events included headache, nausea and diarrhoea.
CONCLUSIONS:PF-04236921 was not significantly different from placebo for the primary efficacy end point in patients with SLE. Evidence of an effect with 10mg was seen in a post hoc analysis. Safety was acceptable for doses up to 50mg as the 200mg dose was discontinued due to safety findings.
引自：Wallace DJ, Strand V, Merrill JT, et al. Efficacy and safety of an interleukin 6 monoclonal antibody for the treatment of systemic lupus erythematosus: a phase II dose-ranging randomised controlled trial.Ann Rheum Dis. 2016 Sep 26. pii: annrheumdis-2016-209668. doi: 10.1136/annrheumdis-2016-209668.
作者：Wallace DJ, et al.
翻译:北医三院张警丰
摘要
目的：本研究为II期临床试验，目的是评估白介素（IL）6单克隆抗体治疗系统性红斑狼疮（SLE）的有效性与安全性。
方法：基础用药维持的SLE病情活动患者随机分为安慰剂组或PF-0423692110 mg, 50 mg或200mg组，每8周给药一次。在24周时评估SLE反应指数（SRI-4；主要终点）以及英国狼疮协作组织狼疮评估标准（BICLA）。在单因素分析的基础之上对大样本人群进行事后分析。
结果：共纳入183例患者（空白对照n=45;10mg, n=45; 50mg, n=47; 200mg, n=46）.考虑到安全性的因素，200mg 剂量未再持续，且未纳入主要有效性分析中。任何剂量组的SRI-4反应率与空白对照相比无明显区别。然而，BICLA反应率在10mg 组中则显著升高(p=0.026)。10mg (n=0) 和50mg (n=2)组与空白对照(n=8; p<0.01)相比，重度发作的例数均显著降低。大样本的基线狼疮活动度较高的患者中SRI-4 (p=0.004) 和BICLA (p=0.012)反应率10mg组显著高于空白对照。共出现4例死亡(200mg, n=3; 10mg, n=1)。最常见的不良反应包括头痛、恶心、腹泻。
结论：与空白对照相比，PF-04236921治疗SLE患者的主要有效终点并无差异。事后分析中可见到10mg 组有效。剂量达50mg的安全性是可接受的。
原文
OBJECTIVES:This phase II trial evaluated the efficacy and safety of an interleukin (IL) 6 monoclonal antibody for systemic lupus erythematosus (SLE).
METHODS:Patients with active disease were randomised to placebo or PF-04236921 10 mg, 50 mg or 200mg, subcutaneously, every 8weeks with stable background therapy. SLE Responder Index (SRI-4; primary end point) and British Isles LupusAssessment Group-based Composite Lupus Assessment (BICLA) were assessed at week 24. Post hoc analysis identified an enriched population based upon planned univariate analyses.
RESULTS:183 patients received treatment (placebo, n=45; 10mg, n=45; 50mg, n=47; 200mg, n=46). The 200mg dose was discontinued due to safety findings and not included in the primary efficacy analysis. The SRI-4 response rates were not significant for any dose compared with placebo; however, the BICLA response rate was significant for 10mg (p=0.026). The incidence of severe flares was significantly reduced with 10mg (n=0) and 50mg (n=2) combined versus placebo (n=8; p<0.01). In patients with greater baseline disease activity (enriched population), the SRI-4 (p=0.004) and BICLA (p=0.012) response rates were significantly different with 10mg versus placebo. Four deaths (200mg, n=3; 10mg, n=1) occurred. The most frequently reported adverse events included headache, nausea and diarrhoea.
CONCLUSIONS:PF-04236921 was not significantly different from placebo for the primary efficacy end point in patients with SLE. Evidence of an effect with 10mg was seen in a post hoc analysis. Safety was acceptable for doses up to 50mg as the 200mg dose was discontinued due to safety findings.
引自：Wallace DJ, Strand V, Merrill JT, et al. Efficacy and safety of an interleukin 6 monoclonal antibody for the treatment of systemic lupus erythematosus: a phase II dose-ranging randomised controlled trial.Ann Rheum Dis. 2016 Sep 26. pii: annrheumdis-2016-209668. doi: 10.1136/annrheumdis-2016-209668.
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