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Intervention Review

Anti-IgE for chronic asthma in adults and children

  1. Samantha Walker1,*,
  2. Michele Monteil2,
  3. Kieran Phelan3,
  4. Toby J Lasserson4,
  5. E. Haydn Walters5

Editorial Group: Cochrane Airways Group

Published Online: 19 APR 2006

Assessed as up-to-date: 20 FEB 2006

DOI: 10.1002/14651858.CD003559.pub3


How to Cite

Walker S, Monteil M, Phelan K, Lasserson TJ, Walters EH. Anti-IgE for chronic asthma in adults and children. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD003559. DOI: 10.1002/14651858.CD003559.pub3.

Author Information

  1. 1

    National Respiratory Training Centre, Warwick, UK

  2. 2

    Faculty of Medical Sciences, Department of ParaClinical Sciences, St Augustine, Trinidad and Tobago

  3. 3

    Cincinnati Children's Hospital Medical Center, Health Policy & Clinical Effectiveness, Cincinnati, Ohio, USA

  4. 4

    St George's, University of London, Community Health Sciences, London, UK

  5. 5

    University of Tasmania Medical School, Discipline of Medicine, Hobart, Tasmania, Australia

*Samantha Walker, National Respiratory Training Centre, The Athenaeum, 10 Church Street, Warwick, CV34 4AB, UK. s.walker@educationforhealth.org.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 19 APR 2006

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Omalizumab is a recombinant humanised monoclonal antibody directed against immunoglobulin E (anti-IgE) to inhibit the immune system's response to allergen exposure. Omalizumab is directed against the binding site of IgE for its high affinity Fc receptor. It prevents free serum IgE from attaching to mast cells and other effector cells and prevents IgE mediated inflammatory changes.

Objectives

To determine the efficacy of anti-IgE compared with placebo in patients with allergic asthma

Search methods

We searched the Cochrane Airways Group Asthma trials register for potentially relevant studies (February 2006).

Selection criteria

Randomised controlled trials examining anti-IgE administered in any manner for any duration. Trials with co-interventions were included as long as they were the same in each arm.

Data collection and analysis

Two reviewers independently assessed study quality and extracted and entered data. Three modes of administration were identified from the published literature (inhaled, intravenous and subcutaneous injection). Subgroup analysis was performed by asthma severity. Data were extracted from published and unpublished sources.

Main results

Fourteen trials (15 group comparisons) were included in the review, contributing a total of 3143 mild to severe allergic asthmatic participants with high levels of IgE. Treatment with intravenous and subcutaneous Omalizumab significantly reduced free IgE compared with placebo. Omalizumab led to a significant reduction in inhaled steroid (ICS) consumption compared with placebo (-119 mcg/day (95% CI -154 to -83, three trials)). There were significant increases in the number of participants who were able to reduce ICS by over 50% (odds ratio (OR) 2.50, 95% confidence interval (CI) 2.02 to 3.10 (four trials)); or completely withdraw their daily ICS intake (OR 2.50 (95%CI 2.00 to 3.13; four trials)). Participants treated with Omalizumab were less likely to suffer an asthma exacerbation with treatment as an adjunct to ICS (OR 0.52, 95%CI 0.41 to 0.65, five trials), or as an ICS tapering agent (OR 0.47, 95% CI 0.37 to 0.60, four trials).

Authors' conclusions

Omalizumab was significantly more effective than placebo at increasing the numbers of patients who were able to reduce or withdraw their inhaled steroids, but the clinical value of the reduction in steroid consumption has be considered in the light of the high cost of Omalizumab. The impressive placebo effects observed in control groups bring into question the true effect of Omalizumab. Omalizumab was effective in reducing asthma exacerbations as an adjunctive therapy to inhaled steroids, and during steroid tapering phases of clinical trials. Omalizumab was generally well tolerated, although there were more injection site reactions with Omalizumab. Patient and physician assessments of the drug were positive. Further assessment in paediatric populations is necessary, as is direct double-dummy comparison with ICS.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Anti-Immunoglobulin E (Omalizumab/Xolair) for chronic asthma in adults and children

Allergic people produce Immunoglobulin E (IgE) when exposed to environmental allergens, and IgE binds to mast cells in the airways. Acute exposure to the allergen causes mast cells to release chemicals (such as histamine) causing itching, sneezing, blocked nose, wheezing, shortness of breath and cough. This review of trials found that anti-IgE, a treatment developed to remove IgE from the circulation, led to a reduction, and in some cases, withdrawal of regular inhaled steroid use and a reduction in asthma exacerbations. Compared with placebo, effects were relatively modest. Side effects were few and mild-moderate in the short term; longer term evaluation is needed. Patient and physician assessment of the effectiveness of therapy were positive.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

抗免疫球蛋白E (AntiIgE)應用在成人及兒童慢性氣喘

Omalizumab是一種直接對抗免疫球蛋白E的合成的人類單株抗體,用來抑制接觸過敏原後的免疫系統反應。Omalizumab是直接接在免疫球蛋白E 上對Fc受體高親和力的結合位置上,它可防止血清中的游離免疫球蛋白E 連接至肥大細胞(mast cells) 及其他作用細胞,間接防止免疫球蛋白E 主導的發炎反應發生

目標

比較抗免疫球蛋白E 與安慰劑對過敏性氣喘的效果

搜尋策略

搜尋the Cochrane Airways Group Asthma trials register,找出可能相關的研究(2006年2月)

選擇標準

所有給予抗免疫球蛋白E (不論何種方式或時間長短)的隨機對照實驗。只要實驗的各組有相同設計,與其他治療結合的實驗也包括在內

資料收集與分析

兩位評論者各自評估研究等級,並摘選及輸入資料。發表的文獻中有3種給予方式(吸入、靜脈注射、及皮下注射)。依照氣喘嚴重度來做子群分析。摘選的資料來源包括已發表及未發表的文章

主要結論

此篇回顧包含14個試驗(15組的比較),共有3143位輕度到重度過敏性氣喘且含高量免疫球蛋白E 的參與者。用靜脈注射及皮下注射法給予Omalizumab治療者比給予安慰劑者,有明顯減少游離免疫球蛋白E 的量。Omalizumab比安慰劑可明顯減少吸入性類固醇的用量(−119 mcg/day (95% CI −154 to −83, 3個實驗))。減少吸入性類固醇用量超過50%的病人數目有明顯增加(勝算比(OR)2.5,95%信賴區間(CI)2.02到3.10,4個實驗)),或完全停用吸入性類固醇(OR 2.50 (95%CI 2.00 to 3.13; 4個實驗))。把Omalizumab用來輔助吸入性類固醇治療時,病患較不可能有氣喘惡化的情形(OR 0.52, 95%CI 0.41 to 0.65, 5個實驗),或在吸入性類固醇減量時期用Omalizumab,也可避免氣喘惡化(OR 0.47, 95% CI 0.37 to 0.60,4個實驗)

作者結論

Omalizumab明顯比安慰劑有效,它讓越來越多病患可減少或停用吸入性類固醇,但鑑於高價的Omalizumab,須考慮減少類固醇用量的臨床價值。從對照組中可觀察到明顯的安慰劑效應,因此對Omalizumab的真正效果有些疑問。臨床實驗中用Omalizumab輔助吸入性類固醇的治療,或用在類固醇減量時期,在減少氣喘惡化方面很有效。雖然Omalizumab在注射處的反應較常見,但可被ㄧ般病患適應良好。病患及醫師對於此藥物的評價都是正面的。在兒童族群上需要更進一步評估,可直接用來與吸入性類固醇比較

翻譯人

本摘要由高雄長庚醫院陳乃菁翻譯

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌

總結

過敏的人在接觸環境過敏原後會產生免疫球蛋白E (IgE) ,而免疫球蛋白E 會與呼吸道中的肥大細胞結合。急性暴露至過敏原會使肥大細胞釋放化學物質(例如組織胺),造成鼻子癢、打噴嚏、鼻塞、氣喘、呼吸急促及咳嗽的症狀。此篇實驗的回顧發現抗免疫球蛋白E,一種研發來移除循環中免疫球蛋白E 的治療,可使常規吸入性類固醇的用量減少,甚至在一些病例中可停用吸入性類固醇,並且讓氣喘惡化的情形減少。與安慰劑比較時,其效果相對地不明顯。短期內副作用很少,且屬輕微到中度的,需長時間的評估。病患及醫師對此治療的效果評價都是正面的