对于患有季节性变应性鼻结膜炎合并季节性变应性哮喘的患者，奥马珠单抗与特异性免疫疗法联合使用优于单纯免疫疗法。

Combination of omalizumab and specific immunotherapy is superior to immunotherapy in patients with seasonal allergic rhinoconjunctivitis and co-morbid seasonal allergic asthma.

作者信息

Kopp M V, Hamelmann E, Zielen S, Kamin W, Bergmann K-C, Sieder C, Stenglein S, Seyfried S, Wahn U

机构信息

Zentrum für Kinder- und Jugendmedizin, University of Freiburg, Freiburg, Germany.

出版信息

Clin Exp Allergy. 2009 Feb;39(2):271-9. doi: 10.1111/j.1365-2222.2008.03121.x. Epub 2008 Oct 30.

DOI:10.1111/j.1365-2222.2008.03121.x

PMID:19016798

Abstract

BACKGROUND

The treatment of allergic asthma by specific immunotherapy (SIT) is hampered by potential side-effects.

OBJECTIVE

The aim of this study was to study the effect of omalizumab, a monoclonal anti-IgE antibody, in combination with SIT in patients with seasonal allergic rhinoconjunctivitis (SAR) and co-morbid seasonal allergic asthma (SAA) incompletely controlled by conventional pharmacotherapy.

METHODS

A randomized, double-blind, placebo-controlled, multi-centre trial was performed to assess the efficacy and safety of omalizumab (Xolair) vs. placebo in combination with depigmented SIT (Depigoid) during the grass pollen season. Omalizumab or placebo was started 2 weeks before SIT; the whole treatment lasted 18 weeks. Primary endpoint was daily 'symptom load', the sum of daily scores for symptom severity and rescue medication use.

RESULTS

A total of 140 patients (age 11-46 years) were randomized; and a total of 130 finished the study. Combination therapy reduced the symptom load by 39% (P=0.0464, Wilcoxon test) over SIT monotherapy. This difference was mainly due to reduced symptom severity (P=0.0044), while rescue medication use did not change significantly. Combination therapy also improved asthma control (Asthma Control Questionnaire, P=0.0295) and quality of life in the case of asthma (Asthma Quality of Life Questionnaire, P=0.0293) and rhinoconjunctivitis (Rhinoconjunctivitis Quality of Life Questionnaire, P=0.0537). Numbers of patients with 'excellent or good' treatment efficacy according to ratings of investigators (75.0% vs. 36.9%) or patients (78.5% vs. 46.1%) were markedly higher in the combination group than under SIT alone.

CONCLUSION

Combination of omalizumab with SIT for treatment of patients with SAR and co-morbid SAA was safe and reduced the symptom load in a statistically significant and clinically meaningful manner.

摘要

背景

特异性免疫疗法（SIT）治疗过敏性哮喘受到潜在副作用的阻碍。

目的

本研究旨在探讨奥马珠单抗（一种抗IgE单克隆抗体）联合SIT治疗季节性变应性鼻结膜炎（SAR）合并季节性变应性哮喘（SAA）且常规药物治疗控制不佳患者的效果。

方法

进行一项随机、双盲、安慰剂对照、多中心试验，以评估在草花粉季节奥马珠单抗（Xolair）与安慰剂联合脱色SIT（Depigoid）的疗效和安全性。奥马珠单抗或安慰剂在SIT前2周开始使用；整个治疗持续18周。主要终点是每日“症状负荷”，即症状严重程度和急救药物使用的每日评分总和。

结果

共140例患者（年龄11 - 46岁）被随机分组；共130例完成研究。联合治疗比单独SIT治疗使症状负荷降低了39%（P = 0.0464，Wilcoxon检验）。这种差异主要是由于症状严重程度降低（P = 0.0044），而急救药物使用无显著变化。联合治疗还改善了哮喘控制（哮喘控制问卷，P = 0.0295）以及哮喘（哮喘生活质量问卷，P = 0.0293）和鼻结膜炎（鼻结膜炎生活质量问卷，P = 0.0537）情况下的生活质量。根据研究者评分（75.0%对36.9%）或患者评分（78.5%对46.1%），联合治疗组“治疗效果优秀或良好”的患者数量明显高于单独SIT治疗组。