Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis
Omalizumab pretreatment decreases acute reactions after rush immunotherapy for ragweed-induced seasonal allergic rhinitis
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DOI：
10.1016/j.jaci.2005.09.036
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发表时间：
2006-01-01
影响因子：
14.2
通讯作者：
Deniz, Y
中科院分区：
文献类型：
--
作者：
Casale, TB;Busse, WW;Deniz, Y
背景：快速免疫疗法(RIT)是标准免疫疗法的一种有吸引力的替代疗法。目的：我们假设人源化的抗IgE单抗奥马珠单抗能有效地提高RIT的安全性和有效性。方法：成年豚草变应性鼻炎患者参加3中心、4臂、双盲、平行分组、安慰剂对照试验。患者接受9周的奥马珠单抗(0.016 mg/kg/Ig E[IU/mL]/mo)或安慰剂治疗，然后是1d的抢救(最大剂量为1.2~4.0mU/g)或安慰剂免疫治疗，然后是12周的奥马珠单抗或安慰剂加免疫治疗。在免疫治疗患者中，豚草特异性免疫球蛋白水平增加11倍，而在奥马珠单抗患者中，游离IgE水平下降10倍。接受奥马珠单抗加免疫治疗的患者比仅接受免疫治疗的患者不良事件更少。对接受免疫治疗的小组进行的HOE后分析表明，添加奥马珠单抗可将RIT引起的过敏反应风险降低5倍(优势比为0.17；P=0.026)。在意向治疗的基础上，在豚草季节，同时接受奥马珠单抗和免疫治疗的患者的严重程度评分与仅接受免疫治疗的患者相比有显著改善(0.69比0.86；P=0.044)。结论：奥马珠单抗预治疗提高了RIT治疗豚草变应性鼻炎的安全性。此外，奥马珠单抗和过敏原免疫疗法的联合治疗可能是一种有效的策略，使过敏性疾病患者能够更安全、更有效地进行更快速、更高剂量的过敏原免疫疗法。
Background: Rush immunotherapy (RIT) presents an attractive alternative to standard immunotherapy. However, RIT carries a much greater risk of acute allergic reactions, including anaphylaxis.Objectives: We hypothesized that omalizumab, a humanized monoclonal anti-IgE antibody, would be effective in enhancing both safety and efficacy of RIT.Methods: Adult patients with ragweed allergic rhinitis were enrolled in a 3-center, 4-arm, double-blind, parallel-group, placebo-controlled trial. Patients received either 9 weeks of omalizumab (0.016 mg/kg/IgE [IU/mL]/mo) or placebo, followed by 1-day rush (maximal dose 1.2-4.0 mu g Amb a 1) or placebo immunotherapy, then 12 weeks of omalizumab or placebo plus immunotherapy.Results: Of the 159 patients enrolled, 123 completed all treatments. Ragweed-specific IgG levels increased > 11-fold in immunotherapy patients, and free IgE levels declined > 10-fold in omalizumab patients. Patients receiving omalizumab plus immunotherapy had fewer adverse events than those receiving immunotherapy alone. Post hoe analysis of groups receiving immunotherapy demonstrated that addition of omalizumab resulted in a 5-fold decrease in risk of anaphylaxis caused by RIT (odds ratio, 0.17; P = .026). On an intent-to-treat basis, patients receiving both omalizumab and immunotherapy showed a significant improvement in severity scores during the ragweed season compared with those receiving immunotherapy alone (0.69 vs 0.86; P = .044).Conclusion: Omalizumab pretreatment enhances the safety of RIT for ragweed allergic rhinitis. Furthermore, combined therapy with omalizumab and allergen immunotherapy may be an effective strategy to permit more rapid and higher doses of allergen immunotherapy to be given more safely and with greater efficacy to patients with allergic diseases.