» Articles » PMID: 39092213

The Evidence for Commercial House Dust Mite Immunotherapy Products: A pragmatic Systematic Review with Narrative Synthesis

Overview
Date 2024 Aug 2
PMID 39092213
Authors
Affiliations
Soon will be listed here.
Abstract

House dust mite (HDM) allergen immunotherapy (AIT) has an established role in the treatment of perennial allergic rhinitis (AR) and allergic asthma (AA) triggered by HDM sensitization. We aimed to identify all double-blind, randomized, placebo-controlled trials of HDM AIT for the treatment of AR and AA in humans and to summarize the evidence for AIT products that are currently manufactured and available for clinical use. A total of 56 eligible double-blind, randomized, placebo-controlled trials of HDM AIT for the treatment of AA and/or AR in humans fit the inclusion criteria and investigated a total of 14 commercial AIT products; together, the 56 studies enrolled a total of 14,619 patients. Of the 56 studies, 39 studies investigated the current manufacturer-recommended maintenance dose (MRMD) of the product, and 17 investigated other doses. We identified 39 studies (12,539 patients randomized) for 8 sublingual immunotherapy (SLIT) products and 17 studies (2,080 patients randomized) for subcutaneous immunotherapy products. For AR, 3 products, the ALK 12 standardized-quality (SQ-HDM) SLIT tablet, the ALK 6 SQ-HDM tablet, and the SG 300 index of reactivity SLIT tablet, had both dose-finding studies (DFSs) and phase III definitive studies (DSs) to demonstrate efficacy of the MRMD of the product. For AA, 2 products, the ALK 12 SQ-HDM SLIT tablet and the ALK 6 SQ-HDM tablet, had both DFSs and DSs for the MRMD. No subcutaneous immunotherapy product had a paired DFS and DS supporting the MRMD. A total of 30 studies of products no longer commercially manufactured were excluded. This study will help to inform clinical care and product selection for the treatment of HDM-induced AR and AA.

Citing Articles

Optimization of Basophil Activation Test in the Diagnosis and Qualification for Allergen-Specific Immunotherapy in Children with Respiratory Allergy to the House Dust Mite .

Spiewak R, Gregorius A, Ostrowski G, Czarnobilska E Int J Mol Sci. 2024; 25(18).

PMID: 39337447 PMC: 11432158. DOI: 10.3390/ijms25189959.

References
1.
Bonertz A, Tripathi A, Zimmer J, Reeb C, Kaul S, Bridgewater J . A regulator's view on AIT clinical trials in the United States and Europe: Why successful studies fail to support licensure. J Allergy Clin Immunol. 2022; 149(3):812-818. DOI: 10.1016/j.jaci.2022.01.004. View

2.
Pakkasela J, Ilmarinen P, Honkamaki J, Tuomisto L, Andersen H, Piirila P . Age-specific incidence of allergic and non-allergic asthma. BMC Pulm Med. 2020; 20(1):9. PMC: 6954552. DOI: 10.1186/s12890-019-1040-2. View

3.
Pfaar O, Gerth van Wijk R, Klimek L, Bousquet J, Creticos P . Clinical trials in allergen immunotherapy in the age group of children and adolescents: current concepts and future needs. Clin Transl Allergy. 2020; 10:11. PMC: 7181492. DOI: 10.1186/s13601-020-00314-1. View

4.
Mahler V, Esch R, Kleine-Tebbe J, Lavery W, Plunkett G, Vieths S . Understanding differences in allergen immunotherapy products and practices in North America and Europe. J Allergy Clin Immunol. 2019; 143(3):813-828. DOI: 10.1016/j.jaci.2019.01.024. View

5.
Bousquet J, Scheinmann P, Guinnepain M, PERRIN-FAYOLLE M, Sauvaget J, Tonnel A . Sublingual-swallow immunotherapy (SLIT) in patients with asthma due to house-dust mites: a double-blind, placebo-controlled study. Allergy. 1999; 54(3):249-60. DOI: 10.1034/j.1398-9995.1999.00916.x. View