MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial.
MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial.
复制标题
MOR103，一种对粒细胞巨噬细胞刺激因子的人类单克隆抗体，用于治疗中等类风湿关节炎患者：IB/IIA期随机，双盲，安慰剂对照，剂量 - 剂量 - 降低试验的结果。
DOI：
10.1136/annrheumdis-2013-204816
复制
发表时间：
2015-06
影响因子：
27.4
通讯作者：
Burkhardt H
中科院分区：
文献类型：
--
作者：
Behrens F;Tak PP;Østergaard M;Stoilov R;Wiland P;Huizinga TW;Berenfus VY;Vladeva S;Rech J;Rubbert-Roth A;Korkosz M;Rekalov D;Zupanets IA;Ejbjerg BJ;Geiseler J;Fresenius J;Korolkiewicz RP;Schottelius AJ;Burkhardt H
确定MOR 103（一种抗粒细胞-巨噬细胞集落刺激因子（GM-CSF）的人单克隆抗体）在类风湿关节炎（RA）患者中的安全性、耐受性和疗效体征。活动性、中度RA患者参加了一项随机、多中心、双盲、安慰剂对照、剂量递增试验，每周一次静脉注射MOR 103（0.3、1.0或1.5 mg/kg），持续4周，随访至16周。 主要结局是安全性。在96名随机化和治疗的受试者中，85名完成了试验（对于合并的安慰剂和MOR 103 0.3、1.0和1.5 mg/kg，分别为n=27、24、22和23）。 M0 R 103组中的治疗后出现的不良事件（AE）的强度为轻度或中度，并且通常以与安慰剂组相似的频率报告。最常见的AE为鼻咽炎。在2例病例中，AE因住院而被归类为严重：安慰剂组受试者的甲沟炎和MOR 103 0.3 mg/kg组受试者的胸膜炎。 两名患者均完全康复。在探索性功效分析中，M0 R 103 1.0和1.5mg/kg组中的受试者显示出疾病活动性评分-28评分和关节计数的显著改善以及比接受安慰剂的受试者显著更高的欧洲抗风湿联盟应答率。 MOR 103 1.0 mg/kg与疾病活动性参数的最大降低相关。 MOR 103耐受性良好，并显示出在活动性RA患者中有效的初步证据。这些数据支持进一步研究这种抗GM-CSF的单克隆抗体在RA患者中的作用，并可能在其他免疫介导的炎症性疾病中发挥作用。NCT01023256
To determine the safety, tolerability and signs of efficacy of MOR103, a human monoclonal antibody to granulocyte–macrophage colony-stimulating factor (GM-CSF), in patients with rheumatoid arthritis (RA). Patients with active, moderate RA were enrolled in a randomised, multicentre, double-blind, placebo-controlled, dose-escalation trial of intravenous MOR103 (0.3, 1.0 or 1.5 mg/kg) once a week for 4 weeks, with follow-up to 16 weeks. The primary outcome was safety. Of the 96 randomised and treated subjects, 85 completed the trial (n=27, 24, 22 and 23 for pooled placebo and MOR103 0.3, 1.0 and 1.5 mg/kg, respectively). Treatment emergent adverse events (AEs) in the MOR103 groups were mild or moderate in intensity and generally reported at frequencies similar to those in the placebo group. The most common AE was nasopharyngitis. In two cases, AEs were classified as serious because of hospitalisation: paronychia in a placebo subject and pleurisy in a MOR103 0.3 mg/kg subject. Both patients recovered fully. In exploratory efficacy analyses, subjects in the MOR103 1.0 and 1.5 mg/kg groups showed significant improvements in Disease Activity Score-28 scores and joint counts and significantly higher European League Against Rheumatism response rates than subjects receiving placebo. MOR103 1.0 mg/kg was associated with the largest reductions in disease activity parameters. MOR103 was well tolerated and showed preliminary evidence of efficacy in patients with active RA. The data support further investigation of this monoclonal antibody to GM-CSF in RA patients and potentially in those with other immune-mediated inflammatory diseases. NCT01023256
登录
查看更多内容
DOI：
10.1084/jem.20071119
发表时间：
2008-09-29
期刊：
The Journal of experimental medicine
影响因子：
--
作者：
Sonderegger I;Iezzi G;Maier R;Schmitz N;Kurrer M;Kopf M
通讯作者：
Kopf M
影响因子：
27.4
作者：
Burmester, Gerd R.;Feist, Eugen;Magrini, Fabio
通讯作者：
Magrini, Fabio
影响因子：
27.4
作者：
van de Putte, LBA;Rau, R;Kupper, H
通讯作者：
Kupper, H
影响因子：
27.4
作者：
Plater-Zyberk, C.;Joosten, L. A. B.;van den Berg, W. B.
通讯作者：
van den Berg, W. B.
影响因子：
30.5
作者：
通讯作者：
--