Nagakura T, Ogino S, Okubo K, Sato N, Takahashi M, Ishikawa T
The Allergy and Internal Medicine, Yoga Allergy Clinic, Tokyo, Japan.
Clin Exp Allergy. 2008 Feb;38(2):329-37. doi: 10.1111/j.1365-2222.2007.02894.x. Epub 2007 Dec 7.
Seasonal allergic rhinitis (SAR) induced by Japanese cedar pollens is a major problem in Japan. Omalizumab, a humanized monoclonal anti-IgE antibody, improves symptoms associated with SAR, but a comparative study with an anti-allergy drug has not yet been conducted.
To compare the efficacy and safety of omalizumab with suplatast tosilate, a selective T-helper type 2 (Th2) cytokine inhibitor, in patients with Japanese cedar pollen-induced SAR.
A randomized, double-blind, double-dummy study was conducted in 308 Japanese patients with a history of moderate-to-severe SAR who showed a CAP-RAST value (> or =2+) specifically to Japanese cedar pollens. Patients were treated for 12 weeks with omalizumab plus placebo of suplatast tosilate or suplatast tosilate plus placebo of omalizumab.
The mean daily nasal symptom medication scores (sum of the daily nasal symptom severity score and daily nasal rescue medication score) were significantly lower in the omalizumab group than in the suplatast tosilate group during three evaluation periods (P<0.001). The omalizumab group also had significantly lower mean daily nasal severity scores, each of the mean daily nasal and ocular symptom severity scores (sneezing, runny nose, stuffy nose, itchy nose, itchy eyes, watery eyes, and red eyes). Omalizumab reduced rescue medication requirements, and the proportion of days with any rescue medication use in the omalizumab group was significantly lower. Serum-free IgE levels markedly decreased in the omalizumab group and it was associated with clinical efficacy. The adverse reaction profiles were similar between the two groups. The overall incidence of injection site reactions was higher in the omalizumab group than in the suplatast tosilate group, but all these events were of mild degree. No anti-omalizumab antibodies were detected.
Omalizumab showed significantly greater improvements than suplatast tosilate in the treatment of SAR induced by Japanese cedar pollens.
日本雪松花粉引起的季节性变应性鼻炎（SAR）是日本的一个主要问题。奥马珠单抗，一种人源化抗IgE单克隆抗体，可改善与SAR相关的症状，但尚未与抗过敏药物进行比较研究。
比较奥马珠单抗与选择性2型辅助性T细胞（Th2）细胞因子抑制剂甲苯磺酸舒普拉泰在日本雪松花粉诱导的SAR患者中的疗效和安全性。
对308例有中重度SAR病史且对日本雪松花粉特异性CAP-RAST值（≥2+）的日本患者进行了一项随机、双盲、双模拟研究。患者接受奥马珠单抗加甲苯磺酸舒普拉泰安慰剂或甲苯磺酸舒普拉泰加奥马珠单抗安慰剂治疗12周。
在三个评估期内，奥马珠单抗组的每日鼻腔症状用药评分（每日鼻腔症状严重程度评分与每日鼻腔急救用药评分之和）显著低于甲苯磺酸舒普拉泰组（P<0.001）。奥马珠单抗组的每日鼻腔严重程度平均评分、每日鼻腔和眼部症状严重程度平均评分（打喷嚏、流鼻涕、鼻塞、鼻痒、眼痒、流泪和眼红）也显著较低。奥马珠单抗减少了急救用药需求，奥马珠单抗组使用任何急救药物的天数比例显著更低。奥马珠单抗组血清游离IgE水平显著降低，且与临床疗效相关。两组的不良反应情况相似。奥马珠单抗组注射部位反应的总体发生率高于甲苯磺酸舒普拉泰组，但所有这些事件均为轻度。未检测到抗奥马珠单抗抗体。
在治疗日本雪松花粉诱导的SAR方面，奥马珠单抗比甲苯磺酸舒普拉泰显示出显著更大的改善。
