Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria
Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria
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DOI：
10.1056/nejmoa1215372
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发表时间：
2013-03-07
影响因子：
158.5
通讯作者：
Casale, Thomas
中科院分区：
文献类型：
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作者：
Maurer, Marcus;Rosen, Karin;Casale, Thomas
许多慢性特发性荨麻疹（也称为慢性自发性荨麻疹）患者对H-1抗组胺药治疗没有反应，即使在高剂量下也是如此。在2期试验中，omalizumab，一种IgE单克隆抗体，目标IgE和影响肥大细胞和嗜碱性粒细胞的功能，已显示出疗效，在这样的patients.METHODSIn这3期，多中心，随机，双盲研究，我们评估了omalizumab的疗效和安全性，中度至重度慢性特发性荨麻疹患者谁仍然有症状，尽管H-1-抗组胺治疗（许可剂量）。我们将323名患者随机分配接受三次皮下注射，间隔4周，剂量为75 mg，150 mg或300 mg或安慰剂，随后是16周的观察期。主要疗效结果是每周瘙痒严重程度评分（范围从0到21，评分越高表明瘙痒越严重）相对于基线的变化。在所有四个研究组中，基线每周瘙痒严重程度评分约为14。第12周时，安慰剂组每周瘙痒严重程度评分较基线的平均（+/- SD）变化为-5.1 +/- 5.6，75 mg组为-5.9 +/- 6.5（P = 0.46），150 mg组为-8.1 +/- 6.4（P = 0.001），300 mg组为-9.8 +/- 6.0（P
BACKGROUNDMany patients with chronic idiopathic urticaria (also called chronic spontaneous urticaria) do not have a response to therapy with H-1-antihistamines, even at high doses. In phase 2 trials, omalizumab, an IgE monoclonal antibody that targets IgE and affects mast-cell and basophil function, has shown efficacy in such patients.METHODSIn this phase 3, multicenter, randomized, double-blind study, we evaluated the efficacy and safety of omalizumab in patients with moderate-to-severe chronic idiopathic urticaria who remained symptomatic despite H-1-antihistamine therapy (licensed doses). We randomly assigned 323 patients to receive three subcutaneous injections, spaced 4 weeks apart, of omalizumab at doses of 75 mg, 150 mg, or 300 mg or placebo, followed by a 16-week observation period. The primary efficacy outcome was the change from baseline in a weekly itch-severity score (ranging from 0 to 21, with higher scores indicating more severe itching).RESULTSThe baseline weekly itch-severity score was approximately 14 in all four study groups. At week 12, the mean (+/- SD) change from baseline in the weekly itch-severity score was -5.1 +/- 5.6 in the placebo group, -5.9 +/- 6.5 in the 75-mg group (P = 0.46), -8.1 +/- 6.4 in the 150-mg group (P = 0.001), and -9.8 +/- 6.0 in the 300-mg group (P