Information paper

Monoclonal antibody therapy for severe asthma

Four monoclonal antibody therapies (benralizumab, mepolizumab, dupilumab and omalizumab) are available in Australia for the treatment of severe asthma in patients whose asthma is uncontrolled despite optimised standard treatment.

This information paper is an evidence-based resource for primary care health professionals to help explain the latest treatment options for patients with severe asthma.

Key Points

  • Monoclonal antibody therapy is an add-on treatment option for reducing severe flare-ups and improving symptom control in patients with severe allergic or eosinophilic asthma whose asthma is uncontrolled despite treatment with high-dose inhaled corticosteroids and long-acting beta2 agonists.
  • These therapies target inflammatory pathways that activate type 2 immune responses leading to airway inflammation.
  • Patients using these treatments must keep taking their inhaled corticosteroid-containing preventers.
  • Four agents are available in Australia: benralizumab, mepolizumab, dupilumab and omalizumab.
  • These monoclonal antibody therapies are subsidised by the Pharmaceutical Benefits Scheme (PBS) for patients in specialist care who meet strict criteria.
  • After treatment has been initiated by a specialist, ongoing maintenance doses can be administered in primary care, or by the patient or carer, under specialist supervision.
  • Monoclonal antibody therapies currently available in Australia for severe asthma are generally well tolerated. Injection site reactions are among the most common adverse events. Systemic reactions, including anaphylaxis, are rare but can occur.
  • Like all patients with asthma, those using monoclonal antibody therapies need an up-to-date written asthma action plan.


  • When asthma is poorly controlled, first check for common causes (e.g. incorrect inhaler technique and suboptimal adherence, comorbidities, self-management difficulties) and correct these.
  • For patients with uncontrolled asthma who might benefit from monoclonal antibody therapy, refer for specialist assessment as soon as possible to expedite access through PBS. Unless the diagnosis of severe asthma was made by a multidisciplinary severe asthma clinic team, the patient must be under the care of the same specialist for at least 6 months before becoming eligible for PBS subsidy.
  • Arrange specialist referral if any of the following apply, despite treatment with a moderate or high dose of inhaled corticosteroid and long-acting beta2 agonist combination therapy: poor symptom control persists, the patient has been prescribed two or more short courses of oral corticosteroids for flare-ups in the past year, or you are considering long-term maintenance oral corticosteroids for asthma.
  • Advise patients who have been prescribed a monoclonal antibody therapy that they should keep taking their inhaled corticosteroid-containing preventer. Continue to check adherence and inhaler technique regularly and at every opportunity.
  • Ensure that patients understand that they must attend all scheduled specialist visits to remain eligible for access to monoclonal antibody therapy through the PBS.
  • When administering monoclonal antibody therapies, carefully follow instructions for storing, preparing and administering doses.
  • Ensure that each patient has an up-to-date written asthma action plan: review it at least yearly or whenever the medication regimen is changed. Remind patients taking monoclonal antibody therapy to follow their written asthma action plan when symptoms worsen.


This information paper was prepared in consultation with the following health professionals:

  • Ms Ceri Banks, clinical research nurse consultant
  • Professor Connie Katelaris AM, allergist and clinical immunologist
  • Professor Helen Reddel, respiratory physician
  • Adjunct Associate Professor Debbie Rigby, consultant clinical pharmacist
  • Dr Joel Ten, general practitioner
  • Professor Peter Wark, respiratory physician

Contributors to the 2018 edition also included:

  • Professor Vanessa McDonald, clinical academic nurse consultant
  • Dr Victoria Smith, general practitioner

This update was co-funded by GSK Australia and Sanofi Australia. Apart from providing a financial grant, GSK and Sanofi have not been involved in the development, recommendation, review or editing of this publication. The first (2018) edition of this information paper was developed with support from GSK Australia.

Recommended citation

National Asthma Council Australia. Monoclonal antibody therapy for severe asthma. National Asthma Council Australia; Melbourne: 2021.


Although all care has been taken, this information paper is a general guide only, which is not a substitute for assessment of appropriate courses of treatment on a case-by-case basis. The National Asthma Council Australia expressly disclaims all responsibility (including for negligence) for any loss, damage or personal injury resulting from reliance on the information contained herein.

 © 2021

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