Australian Asthma Handbook
The National Guidelines for Health Professionals
Australian Asthma Handbook
The National Guidelines for Health Professionals
Do not advise parents that allergen immunotherapy will control asthma symptoms in children sensitised to common aeroallergens.
The potential benefits, risk of adverse effects, cost, and treatment protocol should be carefully explained to parents considering allergen immunotherapy.
Recommendation type: Consensus recommendation
Specific allergen immunotherapy involves administration of allergen extracts in precisely calculated doses to induce desensitization and/or tolerance. There are two approaches: subcutaneous immunotherapy and sublingual immunotherapy.
The Australasian Society of Clinical Immunology and Allergy advises that specific-allergen immunotherapy can be considered when indicated in children 5 years and over, based on practical considerations and clinical trial evidence, but not an absolute limitation.[ASCIA 2024]
In most patients sensitised to aeroallergens, allergen immunotherapy reduces, but does not eliminate, allergic reactions.[ASCIA 2024]
The role of allergen immunotherapy in clinical asthma management is not well established.[Kappen 2023]
Subcutaneous allergen immunotherapy: Few clinical trial of subcutaneous allergen immunotherapy to house dust mite have been conducted only in children, or have reported results for children separately.[Agache 2019] A 2020 systematic review of allergen immunotherapy in children (≤18 years) with asthma reported that subcutaneous allergen immunotherapy reduced ICS requirement (moderate strength of evidence), and improved asthma-related quality of life and lung function (low strength of evidence).[Rice 2018]
Asthma, especially severe or uncontrolled asthma, has been identified as a major risk factor for severe and fatal adverse reactions to subcutaneous allergen immunotherapy.[Epstein 2021]
Subcutaneous immunotherapy should only be prescribed and administered by practitioners with training and experience in allergy testing and in the formulation and administration of subcutaneous immunotherapy. Standardized extracts should be used, where available.
Sublingual allergen immunotherapy: There is limited evidence demonstrating effects of sublingual allergen immunotherapy on asthma exacerbations and quality of life.[Fortescue 2020] A 2020 Cochrane review of 66 trials of sublingual immunotherapy for allergic rhinitis in adults and children, in which at least 80% of participants also had allergic asthma, concluded that addition of sublingual allergen immunotherapy to asthma treatment may reduce the risk of asthma exacerbation requiring OCS or healthcare visits (low strength of evidence).[Fortescue 2020] However, results for children <12 years were not be reported separately.[Fortescue 2020]
Ragweed sublingual immunotherapy reduced asthma symptoms, SABA use, and nocturnal awakenings during peak ragweed season, compared with placebo, in a randomised clinical trial in children 5 to 17 years with ragweed pollen-induced allergic rhinitis and asthma. [Nolte 2020]
Sublingual allergen immunotherapy for patients with asthma sensitised to house dust mite is better supported in adults than children.[Wonsa 2022] A 2022 systematic review reported that the single included study in children with mild-to-moderate asthma found that house dust mite sublingual allergen immunotherapy had no benefit.[Wonsa 2022]
The rate of serious adverse events associated with sublingual allergen immunotherapy in randomised clinical trials (all ages) has been estimated at ≤1%.[Fortescue 2020]
Agache I, Lau S, Akdis CA, et al. EAACI guidelines on allergen immunotherapy: house dust mite-driven allergic asthma. Allergy 2019; 74: 855-873.
Australian Register of Therapeutic Goods (ARTG) [webpage]. https://www.tga.gov.au/resources/artg
ASCIA. Allergen Immunotherapy FAQ – Availability and Regulation [webpage]. [Updated July 2023] Australasian Society of Clinical Immunology and Allergy, 2023.
ASCIA. Aeroallergen immunotherapy (AIT): a guide for clinical immunology/allergy specialists. ASCIA, 2024.
Australian Product Information – Actair (mixture of American (D Farinae) and European (D Pteronyssinus) house dust mite allergen extracts) sublingual tablets. [Revised 10 January 2024]. Therapeutic Goods Administration (www.ebs.tga.gov.au)
Australian Product Information – Alustal house dust mites extract (American (D. farinae) and European (D. pteronyssinus) house dust mite allergen extracts). [Revised 16 October 2024] Therapeutic Goods Administration (www.ebs.tga.gov.au)
Australian Product Information – Alustal L pollen extract of five grasses (Dactylis glomerata/ Poa pratensis/ Lolium perenne/ Anthoxanthum odoratum/Phleum pratense pollen extracts) [Revised 16 October 2024] Therapeutic Goods Administration (www.ebs.tga.gov.au)
Australian Product Information – Grazax (Phleum pratense) subingual tablets. [Revised 3 November 2021] Therapeutic Goods Administration (www.ebs.tga.gov.au)
Australian Product Information – Oralair (allergen pollen extract of 5 grasses) tablets. [Revised 17 May 2023] Therapeutic Goods Administration (www.ebs.tga.gov.au)
Epstein TG, Murphy-Berendts K, Liss GM, et al. Risk factors for fatal and nonfatal reactions to immunotherapy (2008-2018): postinjection monitoring and severe asthma. Ann Allergy Asthma Immunol 2021; 127: 64-69.e61.
Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev 2020; 9: CD011293.
Kappen J, Diamant Z, Agache I, et al. Standardization of clinical outcomes used in allergen immunotherapy in allergic asthma: An EAACI position paper. Allergy 2023; 78: 2835-2850.
Rice JL, Diette GB, Suarez-Cuervo C, et al. Allergen-specific immunotherapy in the treatment of pediatric asthma: A systematic review. Pediatrics 2018; 141: e20173833.
Wongsa C, Phinyo P, Sompornrattanaphan M, et al. Efficacy and safety of house dust mite sublingual immunotherapy tablet in allergic asthma: a systematic review of randomized controlled trials. J Allergy Clin Immunol Pract 2022; 10: 1342-1355.e24.
ASCIA’s Allergen immunotherapy e-training for health professionals
ASCIA’s list of TGA-approved allergen immunotherapy products
ASCIA’s treatment plans for sublingual immunotherapy and subcutaneous immunotherapy
The Australian Register of Therapeutic Goods lists a wide range of allergen preparations for sublingual or subcutaneous immunotherapy. [ARTG, ASCIA 2023] Availability of allergen immunotherapy products is limited by supply shortages and approval processes. [ASCIA 2023]
A sublingual immunotherapy commercial preparation of house dust mite allergens is approved by TGA for the treatment of children aged ≥5 years diagnosed with house dust mite allergy. [Australian PI Actair]
A subcutaneous allergen immunotherapy children commercial preparation of house dust mite allergens is approved by TGA for the treatment of children with dust mite allergy manifesting as perennial rhinitis, conjunctivitis, rhinoconjunctivitis with or without associated asthma.[Australian PI Alustal 2024]
Sublingual immunotherapy commercial preparations of grass pollen allergens are approved by TGA for the treatment of grass pollen allergic rhinitis with or without conjunctivitis in children ≥5 years.[Australian PI Oralair 2023, Australian PI Grazax 2021)]
A subcutaneous immunotherapy commercial preparation of grass pollen allergens is approved by TGA for the treatment of children with grass pollen allergy manifesting as perennial rhinitis, conjunctivitis, rhinoconjunctivitis with or without associated asthma.[Australian PI Alustal 2024]
