Utility of silver birch and house dust mite extracts derived from licensed sublingual tablets for nasal allergen challenge.
allergen immunotherapy
allergic rhinitis
birch pollen
house dust mite
nasal allergen challenge
Journal
Clinical and translational allergy
ISSN: 2045-7022
Titre abrégé: Clin Transl Allergy
Pays: England
ID NLM: 101576043
Informations de publication
Date de publication:
May 2024
May 2024
Historique:
revised:
16
04
2024
received:
27
12
2023
accepted:
25
04
2024
medline:
23
5
2024
pubmed:
23
5
2024
entrez:
23
5
2024
Statut:
ppublish
Résumé
Nasal allergen challenge (NAC) is used to investigate the effects of allergen exposure and assess treatment efficacy in allergic rhinitis (AR). This study aims to establish dose-responses to NAC using licensed silver birch (SB) pollen and house dust mite (HDM) sublingual tablets as sources of the allergen extracts in participants with AR. Sixteen volunteers with HDM-induced perennial AR and 15 volunteers with SB pollen-induced seasonal rhinitis underwent a graded up-dosing NAC with extracts derived from HDM allergen (Acarizax®) and SB (Itulazax®) tablets, respectively. Total nasal symptom score (TNSS, range 0-12) and peak nasal inspiratory flow (PNIF) were recorded before, at 10 min and at the end of the NAC. The dose of each allergen that provoked a TNSS of at least 7 ("provoking dose 7") in most allergic participants was identified. NACs using the "provoking dose 7" were performed on 5 non-allergic individuals to test for irritant effects. The "provoking dose 7" of HDM extract was used in a subgroup of two SB allergic, non-HDM allergic, volunteers, and vice versa for SB extract, to test for allergen specificity of the responses. Most patients experienced a TNSS of at least 7/12 at a median concentration of 1500 AU/mL for both SB pollen and HDM. The average decline in PNIF at this dose was 63.15% for SB and 63.99% for HDM. NACs using the 1500 AU/mL concentrations were performed on 5 non-allergic individuals with no symptomatic or PNIF response. 1500 AU/mL of HDM extract produced no symptoms in SB allergics nor 1500 AU/mL SB extract in HDM allergics. For both SB and HDM extracts, the optimal allergen dose for NAC to cause a moderate-severity response ("provoking dose 7/12") was 1500 AU/mL. Licensed sublingual allergen tablets provide a readily available and inexpensive source of SB and HDM extracts for use in future interventional studies in AR.
Sections du résumé
BACKGROUND
BACKGROUND
Nasal allergen challenge (NAC) is used to investigate the effects of allergen exposure and assess treatment efficacy in allergic rhinitis (AR). This study aims to establish dose-responses to NAC using licensed silver birch (SB) pollen and house dust mite (HDM) sublingual tablets as sources of the allergen extracts in participants with AR.
METHODS
METHODS
Sixteen volunteers with HDM-induced perennial AR and 15 volunteers with SB pollen-induced seasonal rhinitis underwent a graded up-dosing NAC with extracts derived from HDM allergen (Acarizax®) and SB (Itulazax®) tablets, respectively. Total nasal symptom score (TNSS, range 0-12) and peak nasal inspiratory flow (PNIF) were recorded before, at 10 min and at the end of the NAC. The dose of each allergen that provoked a TNSS of at least 7 ("provoking dose 7") in most allergic participants was identified. NACs using the "provoking dose 7" were performed on 5 non-allergic individuals to test for irritant effects. The "provoking dose 7" of HDM extract was used in a subgroup of two SB allergic, non-HDM allergic, volunteers, and vice versa for SB extract, to test for allergen specificity of the responses.
RESULTS
RESULTS
Most patients experienced a TNSS of at least 7/12 at a median concentration of 1500 AU/mL for both SB pollen and HDM. The average decline in PNIF at this dose was 63.15% for SB and 63.99% for HDM. NACs using the 1500 AU/mL concentrations were performed on 5 non-allergic individuals with no symptomatic or PNIF response. 1500 AU/mL of HDM extract produced no symptoms in SB allergics nor 1500 AU/mL SB extract in HDM allergics.
CONCLUSION
CONCLUSIONS
For both SB and HDM extracts, the optimal allergen dose for NAC to cause a moderate-severity response ("provoking dose 7/12") was 1500 AU/mL. Licensed sublingual allergen tablets provide a readily available and inexpensive source of SB and HDM extracts for use in future interventional studies in AR.
Types de publication
Journal Article
Langues
eng
Pagination
e12360Informations de copyright
© 2024 The Author(s). Clinical and Translational Allergy published by John Wiley & Sons Ltd on behalf of European Academy of Allergy and Clinical Immunology.
Références
Cho SH, Nanda A, Keswani A, et al. Nasal allergen challenge (NAC): practical aspects and applications from an EU/US perspective‐a work group report of the AAAAI rhinitis, rhinosinusitis and ocular allergy committee. J Allergy Clin Immunol. 2023;151(5):1215‐1222.e4. https://doi.org/10.1016/j.jaci.2023.02.014
Augé J, Vent J, Agache I, et al. EAACI position paper on the standardization of nasal allergen challenges. Allergy. 2018;73(8):1597‐1608. https://doi.org/10.1111/all.13416
Scadding GW, Calderon MA, Bellido V, et al. Optimisation of grass pollen nasal allergen challenge for assessment of clinical and immunological outcomes. J Immunol Methods. 2012;384(1‐2):25‐32. https://doi.org/10.1016/j.jim.2012.06.013
Scadding GW, Eifan A, Penagos M, et al. Local and systemic effects of cat allergen nasal provocation. Clin Exp Allergy. 2015;45(3):613‐623. https://doi.org/10.1111/cea.12434
Scadding GW, Eifan AO, Lao‐Araya M, et al. Effect of grass pollen immunotherapy on clinical and local immune response to nasal allergen challenge. Allergy. 2015;70(6):689‐696. https://doi.org/10.1111/all.12608
Scadding GW, Calderon MA, Shamji MH, et al. Effect of 2 years of treatment with sublingual grass pollen immunotherapy on nasal response to allergen challenge at 3 years among patients with moderate to severe seasonal allergic rhinitis. JAMA. 2017;317(6):615. https://doi.org/10.1001/jama.2016.21040
Fauquert JL, Alba‐Linero C, Gherasim A, et al. Organ‐specific allergen challenges in airway allergy: current utilities and future directions. Allergy. 2023;78(7):1794‐1809. https://doi.org/10.1111/all.15731
Eguiluz‐Gracia I, Testera‐Montes A, González M, et al. Safety and reproducibility of nasal allergen challenge. Allergy. 2019;74(6):1125‐1134. https://doi.org/10.1111/all.13728
Eifan AO, Fedina A, Durham SR, Scadding GW. Comparison of nasal allergen challenges with dissolved Timothy grass pollen tablets and aqueous extract. Allergy. 2021;76(5):1543‐1545. https://doi.org/10.1111/all.14590
Ohashi‐Doi K, Kito H, Du W, et al. Bioavailability of house dust mite allergens in sublingual allergy tablets is highly dependent on the formulation. Int Arch Allergy Immunol. 2017;174(1):26‐34. https://doi.org/10.1159/000479693
Lund K, Kito H, Skydtsgaard MB, Nakazawa H, Ohashi‐Doi K, Lawton S. The importance of tablet formulation on allergen release kinetics and efficiency: comparison of freeze‐dried and compressed grass pollen sublingual allergy immunotherapy tablet formulations. Clin Therapeut. 2019;41(4):742‐753. https://doi.org/10.1016/j.clinthera.2019.02.008
Yamamoto T, Ohashi‐Doi K, Matsuhara H, et al. Allergen release profiles of fast‐dissolving freeze‐dried orodispersible sublingual allergy immunotherapy tablets. Curr Ther Res. 2022;96:100678. https://doi.org/10.1016/j.curtheres.2022.100678
Popov TA, Passalacqua G, González‐Díaz SN, et al. Medical devices in allergy practice. World Allergy Organ J. 2020;13(10):100466. https://doi.org/10.1016/j.waojou.2020.100466
Scadding G, Hellings P, Alobid I, et al. Diagnostic tools in rhinology EAACI position paper. Clin Transl Allergy. 2011;1(1):2. https://doi.org/10.1186/2045‐7022‐1‐2
Nathan RA, Eccles R, Howarth PH, Steinsvåg SK, Togias A. Objective monitoring of nasal patency and nasal physiology in rhinitis. J Allergy Clin Immunol. 2005;115(3 Suppl 1):S442‐S459. https://doi.org/10.1016/j.jaci.2004.12.015
Bousquet J, Lebel B, Dhivert H, Bataille Y, Martinot B, Michel FB. Nasal challenge with pollen grains, skin‐prick tests and specific IgE in patients with grass pollen allergy. Clin Allergy. 1987;17(6):529‐536. https://doi.org/10.1111/j.1365‐2222.1987.tb02049.x
Lent AM, Harbeck R, Strand M, et al. Immunologic response to administration of standardized dog allergen extract at differing doses. J Allergy Clin Immunol. 2006;118(6):1249‐1256. https://doi.org/10.1016/j.jaci.2006.07.055
Pfaar O, Demoly P, Wijk RGV, et al. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI position paper. Allergy. 2014;69(7):854‐867. https://doi.org/10.1111/all.12383
Durham SR, Penagos M. Sublingual or subcutaneous immunotherapy for allergic rhinitis. J Allergy Clin Immunol. 2017;137(2):339‐349.e10. https://doi.org/10.1016/j.jaci.2015.12.1298
Kim K.‐S, Jang TY, Kim YH. Usefulness of Allerkin house dust mite extract for nasal provocation testing. Clin Exp Otorhinolaryngol. 2017;10(3):254‐258. https://doi.org/10.21053/ceo.2016.01137
Gherasim A, Dietsch F, Beck M, Domis N, de Blay F. Birch‐induced allergic rhinitis: results of exposure during nasal allergen challenge, environmental chamber, and pollen season. World Allergy Organ J. 2023;16(7):100801. https://doi.org/10.1016/j.waojou.2023.100801