Novartis Pharmaceuticals Corp, East Hanover, NJ 07936-1080, USA.
J Allergy Clin Immunol. 2010 Feb;125(2):383-9. doi: 10.1016/j.jaci.2009.11.022.
Although specific immunotherapy is a valuable treatment option for patients with allergic asthma, the potential for systemic allergic reactions has limited its use, especially for patients with symptomatic disease.
To evaluate omalizumab's effect on the tolerability of specific immunotherapy in patients with symptomatic persistent asthma not adequately controlled with inhaled corticosteroids.
This multicenter, double-blind, parallel-group study randomized patients to treatment with omalizumab or placebo, after which they received specific immunotherapy to at least 1 of 3 perennial aeroallergens (cat, dog, and house dust mite) according to a 4-week, 18-injection cluster regimen, followed by 7 weeks of maintenance therapy. The primary efficacy variable, a systemic allergic reaction after immunotherapy, was analyzed by using the Cochrane-Mantel-Haenszel test.
A total of 248 randomized patients (126 omalizumab, 122 placebo) received at least 1 dose of immunotherapy and were evaluated for efficacy. Patients receiving omalizumab experienced significantly fewer systemic allergic reactions to immunotherapy than those receiving placebo (17/126 [13.5%] vs 32/122 [26.2%]; P = .017; 95% CI, 2.91% to 22.56%) and had fewer respiratory-related (grade 3) systemic allergic reactions (6 vs 24, respectively). Grade 4 reactions were reported in 2 patients in each group. More omalizumab patients were able to reach the target maintenance immunotherapy dose (110 [87.3%] vs 88 [72.1%], respectively; P = .004).
Use of omalizumab in patients whose asthma was symptomatic despite use of inhaled corticosteroids was associated with fewer systemic allergic reactions to specific immunotherapy and enabled more patients to achieve the target immunotherapy maintenance dose.
尽管特异性免疫疗法是治疗过敏性哮喘患者的一种有价值的治疗选择，但全身性过敏反应的可能性限制了其应用，特别是对有症状疾病的患者。
评估奥马珠单抗对吸入性皮质类固醇治疗未能充分控制的有症状持续性哮喘患者特异性免疫疗法耐受性的影响。
这是一项多中心、双盲、平行分组研究，将患者随机分为奥马珠单抗治疗组或安慰剂治疗组，然后根据 4 周 18 次注射簇方案对至少 1 种 3 种常年气传过敏原（猫、狗和屋尘螨）进行特异性免疫治疗，随后进行 7 周的维持治疗。采用 Cochrane-Mantel-Haenszel 检验对免疫治疗后全身性过敏反应这一主要疗效变量进行分析。
共 248 例随机患者（奥马珠单抗 126 例，安慰剂 122 例）至少接受了 1 次免疫治疗并进行了疗效评估。接受奥马珠单抗治疗的患者发生免疫治疗后全身性过敏反应的比例明显低于接受安慰剂治疗的患者（17/126 [13.5%] vs 32/122 [26.2%]；P =.017；95%CI，2.91%至 22.56%），且发生与呼吸相关的（3 级）全身性过敏反应的患者比例也较低（分别为 6 例和 24 例）。两组各有 2 例患者报告了 4 级反应。更多的奥马珠单抗患者能够达到目标维持免疫治疗剂量（分别为 110 [87.3%]和 88 [72.1%]；P =.004）。
对于吸入性皮质类固醇治疗后仍有症状的哮喘患者，使用奥马珠单抗与特异性免疫治疗后全身性过敏反应发生率较低相关，并使更多患者达到目标免疫治疗维持剂量。
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