Anti‐IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis New search for studies and content updated (no change to conclusions)

Abstract

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: 29 September 2017.

We searched two ongoing trial registries (Clinicaltrials.gov and the WHO trials platform). Date of latest search: 24 January 2018.

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.

Author(s)

Kana R Jat, Dinesh K Walia, Anju Khairwa

Abstract

Plain language summary

Use of anti‐IgE treatment for allergic bronchopulmonary aspergillosis in people with cystic fibrosis

Review question

We reviewed the evidence about the effect of anti‐IgE therapy for treating allergic bronchopulmonary aspergillosis in people with cystic fibrosis.

Background

Cystic fibrosis is a genetically inherited disease which is not uncommon in the Western World. Allergic bronchopulmonary aspergillosis is a lung disease caused by extreme sensitivity to aspergillus (a fungus) and may occur in 2% to 15% of people with cystic fibrosis. Corticosteroids and antifungal therapy are the mainstay of treatment for allergic bronchopulmonary aspergillosis, but lengthy or repeated use of corticosteroids may lead to serious side effects. Allergic bronchopulmonary aspergillosis occurs as a result of the action of IgE antibodies (a type of protein). A drug that acts against these IgE antibodies (anti‐IgE therapy), such as omalizumab, may be a possible treatment for allergic bronchopulmonary aspergillosis in people with cystic fibrosis. The drug is given as an injection below the skin every two to four weeks. The review aimed to show whether anti‐IgE therapy for allergic bronchopulmonary aspergillosis in people with cystic fibrosis is effective and to highlight any possible side effects.

Search date

The evidence is current to: 29 September 2017.

Study characteristics

We could only include one small study in the review (14 participants) and this was stopped early because not enough people agreed to join the study as volunteers. The study lasted six months and compared omalizumab (Xolair®) injections under the skin of the upper arm or the thigh to placebo injections (dummy treatment containing no active medication). Volunteers were given of 600 mg of omalizumab or placebo daily along with itraconazole (an antifungal drug) twice daily and oral corticosteroids, with a maximum daily dose of 400 mg.

Key results

The full results of the study were not published. Only limited results on side effects were published online. Six out of nine volunteers (66.67%) in the omalizumab group and one out of five volunteers (20%) in the placebo group reported one or more serious side effects.

Due to the lack of evidence, we are not able to make recommendations either in favour of, or against the use of, anti‐IgE (omalizumab) therapy in people with cystic fibrosis and allergic bronchopulmonary aspergillosis. More research into this treatment is needed.

Author(s)

Kana R Jat, Dinesh K Walia, Anju Khairwa

Reviewer's Conclusions

Authors' conclusions

Implications for practice

There is a lack of evidence for the efficacy and safety of anti‐IgE (omalizumab) therapy in people with CF and ABPA. It is not possible to make recommendations either in favour of, or against the use of, anti‐IgE (omalizumab) therapy in people with CF and ABPA.

Implications for research

There is a need for large prospective randomized controlled studies of anti‐IgE (omalizumab) therapy in people with CF and ABPA with both clinical and laboratory outcome measures such as steroid requirement, ABPA exacerbations and lung functions. Although RCTs are best to evaluate a new intervention, further RCTs are unlikely to be supported by the pharmaceutical industry given the failure to recruit a sufficient number of participants for the single identified study; any further studies will likely be investigator‐driven.

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