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. 2021 Sep 22;9(9):CD010288.
doi: 10.1002/14651858.CD010288.pub5.

Anti-IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis

Kana R Jat  1 , Dinesh K Walia  2 , Anju Khairwa  3
Affiliations

Anti-IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis

Kana R Jat et al. Cochrane Database Syst Rev. .

Abstract

Background: Cystic fibrosis is an autosomal recessive multisystem disorder with an approximate prevalence of 1 in 3500 live births. Allergic bronchopulmonary aspergillosis is a lung disease caused by aspergillus-induced hypersensitivity with a prevalence of 2% to 15% in people with cystic fibrosis. The mainstay of treatment includes corticosteroids and itraconazole. The treatment with corticosteroids for prolonged periods of time, or repeatedly for exacerbations of allergic bronchopulmonary aspergillosis, may lead to many adverse effects. The monoclonal anti-IgE antibody, omalizumab, has improved asthma control in severely allergic asthmatics. The drug is given as a subcutaneous injection every two to four weeks. Since allergic bronchopulmonary aspergillosis is also a condition resulting from hypersensitivity to specific allergens, as in asthma, it may be a candidate for therapy using anti-IgE antibodies. Therefore, anti-IgE therapy, using agents like omalizumab, may be a potential therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis. This is an updated version of the review.

Objectives: To evaluate the efficacy and adverse effects of anti-IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis.

Search methods: We searched the Cochrane Cystic Fibrosis Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched the reference lists of relevant articles and reviews. Last search: 09 September 2021. We searched two ongoing trial registries (Clinicaltrials.gov and the WHO trials platform). Date of latest search: 16 August 2021.

Selection criteria: Randomized and quasi-randomized controlled trials comparing anti-IgE therapy to placebo or other therapies for allergic bronchopulmonary aspergillosis in people with cystic fibrosis.

Data collection and analysis: Two review authors independently extracted data and assessed the risk of bias in the included study. They planned to perform data analysis using Review Manager.

Main results: Only one study enrolling 14 participants was eligible for inclusion in the review. The double-blind study compared a daily dose of 600 mg omalizumab or placebo along with twice daily itraconazole and oral corticosteroids, with a maximum daily dose of 400 mg. Treatment lasted six months but the study was terminated prematurely and complete data were not available. We contacted the study investigator and were told that the study was terminated due to the inability to recruit participants into the study despite all reasonable attempts. One or more serious side effects were encountered in six out of nine (66.67%) and one out of five (20%) participants in omalizumab group and placebo group respectively.

Authors' conclusions: There is lack of evidence for the efficacy and safety of anti-IgE (omalizumab) therapy in people with cystic fibrosis and allergic bronchopulmonary aspergillosis. There is a need for large prospective randomized controlled studies of anti-IgE therapy in people with cystic fibrosis and allergic bronchopulmonary aspergillosis with both clinical and laboratory outcome measures such as steroid requirement, allergic bronchopulmonary aspergillosis exacerbations and lung function.

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Conflict of interest statement

All authors: none known.

Figures

1
1
Study flow diagram.
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2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

NCT00787917 {published data only}
    1. EUCTR2007-006648-23-IT. An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab (Xolair) in cystic fibrosis complicated by allergic bronchopulmonary aspergillosis - ND. www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2007-006648-23-IT (date first registered 22 May 2009). [CFGD REGISTER: PI253b]
    1. NCT00787917. An exploratory study to assess multiple doses of omalizumab in patients with cystic fibrosis complicated by acute bronchopulmonary aspergillosis (ABPA). clinicaltrials.gov/ct2/show/NCT00787917 (date first posted 10 November 2008). [CFGD REGISTER: PI253a]

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References to other published versions of this review

Jat 2013
    1. Jat KR, Walia DK, Khairwa A. Anti-IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No: CD010288. [DOI: 10.1002/14651858.CD010288.pub2] - DOI - PubMed
Jat 2015
    1. Jat KR, Walia DK, Khairwa A. Anti-IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2015, Issue 11. Art. No: CD010288. [DOI: 10.1002/14651858.CD010288.pub3] - DOI - PubMed
Jat 2018
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