Allergen Immunotherapy: Biomarkers and Clinical Outcome Measures

References

• Bousquet J, Khaltaev N, Cruz AA, et al. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001;108:S147–S334.
   PubMed Web of Science ®Google Scholar
• Nurmatov U, Dhami S, Arasi S, et al. Allergen immunotherapy for allergic rhinoconjunctivitis: a systematic overview of systematic reviews. Clin Transl Allergy. 2017;7(1):24. doi:10.1186/s13601-017-0159-6
   Web of Science ®Google Scholar
• Dhami S, Zaman H, Varga EM, et al. Allergen immunotherapy for insect venom allergy: a systematic review and meta-analysis. Allergy. 2017;72(3):342–365. doi:10.1111/all.13077
   PubMed Web of Science ®Google Scholar
• Frankland AW, Augustin R. Prophylaxis of summer hay-fever and asthma: a controlled trial comparing crude grass-pollen extracts with the isolated main protein component. Lancet. 1954;263(6821):1055–1057. doi:10.1016/S0140-6736(54)91620-7
   Google Scholar
• Frati F, Incorvaia C, Lombardi C, Senna G. Allergen immunotherapy: 100years, but it does not look like. Eur Ann Clin Immunol. 2012;44:99–106.
   Google Scholar
• Pfaar O, Demoly P. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI position paper. Allergy. 2014;69:854–867.
   PubMed Web of Science ®Google Scholar
• Bousquet PJ, Brozek J, Bachert C, et al. The CONSORT statement checklist in allergen-specific immunotherapy: a GA2LEN paper. Allergy. 2009;64(12):1737–1745. doi:10.1111/j.1398-9995.2009.02232.x
   PubMed Web of Science ®Google Scholar
• Roberts G, Pfaar O, Akdis CA, Ansotegui IJ, Durham SR. EAACI guidelines on allergen immunotherapy: allergic rhinoconjunctivitis. Allergy. 2018;73:765–798.
   PubMed Web of Science ®Google Scholar
• Senti G, von Moos S, Tay F, et al. Epicutaneous allergen-specific immunotherapy ameliorates grass pollen-induced rhinoconjunctivitis: a double-blind, placebo-controlled dose escalation study. J Allergy Clin Immunol. 2012;129(1):128–135. doi:10.1016/j.jaci.2011.08.036
   PubMed Web of Science ®Google Scholar
• Witten M, Malling HJ, Blom L, Poulsen BC, Poulsen LK. Is intralymphatic immunotherapy ready for clinical use in patients with grass pollen allergy? J Allergy Clin Immunol. 2013;132(5):1248–1252. doi:10.1016/j.jaci.2013.07.033
   PubMed Web of Science ®Google Scholar
• Matricardi PM, Dramburg S, Alvarez-Perea A, Antonin-Amerigo D, Apfelbacher C. The role of mobile health technologies in allergy care: an EAACI position paper. Allergy. 2020;75(2):259–272. doi:10.1111/all.13953
   PubMed Web of Science ®Google Scholar
• Pfaar O, Kleine-Tebbe J, Hörmann K, Klimek L. Allergen-specific immunotherapy: which outcome measures are useful in monitoring clinical trials? Immunol Allergy Clin North Am. 2011;31(2):289–309. doi:10.1016/j.iac.2011.02.004
   Web of Science ®Google Scholar
• Kouser L, Kappen J, Walton RP, Shamji MH. Update on biomarkers to monitor clinical efficacy response during and post treatment in allergen immunotherapy. Curr Treat Options Allergy. 2017;4(1):43–53. doi:10.1007/s40521-017-0117-5
   PubMedGoogle Scholar
• Atkinson AJ, Colburn WA, DeGruttola VG, DeMets DL, Downing GJ, Hoth DF. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther. 2001;69:89–95.
   PubMed Web of Science ®Google Scholar
• EMA-Committee for medical products for human use. Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases. London, Doc. Ref. CHMP/EWP/18504/2006. 2008.
   Google Scholar
• Akdis M, Akdis C. Mechanisms of allergen-specific immunotherapy: multiple suppressor factors at work in immune tolerance to allergens. J Allergy Clin Immunol. 2014;133(3):621–631. doi:10.1016/j.jaci.2013.12.1088
   PubMed Web of Science ®Google Scholar
• Shamji MH, Kappen JH, Akdis M, et al. Biomarkers for monitoring clinical efficacy of allergen immunotherapy for allergin rhinoconjunctivitis and allergic asthma: an EAACI position paper. Allergy. 2017;72(8):1156–1173. doi:10.1111/all.13138
   PubMed Web of Science ®Google Scholar
• Di Lorenzo PA, Mansueto P, Pacor ML, et al. Evaluation of serum s-IgE/total IgE ratio in predicting clinical response to allergen specific immunotherapy. J Allergy Clin Immunol. 2009;123(5):1103–1110. doi:10.1016/j.jaci.2009.02.012
   Web of Science ®Google Scholar
• Jutel M, Jaeger L, Suck R, Meyer H, Math D, Fiebig H. Allergen-specific immunotherapy with recombinant grass pollen allergens. J Allergy Clin Immunol. 2005;116(3):608–613. doi:10.1016/j.jaci.2005.06.004
   PubMed Web of Science ®Google Scholar
• Shamji MH, Ljørring C, Francis JN, et al. Functional rather than immunoreactive levels of IgG4 correlate closely with clinical response to grass pollen immunotherapy. Allergy. 2012;67(2):217–226. doi:10.1111/j.1398-9995.2011.02745.x
   PubMed Web of Science ®Google Scholar
• Gomez E, Fernandez TD, Dona I, et al. Initial immunological changes as predictors for house dust mite immunotherapy response. Clin Exp Allergy. 2015;45(10):1542–1553. doi:10.1111/cea.12578
   Web of Science ®Google Scholar
• Gehlar K, Schlaak M, Becker WM, Bufe A. Monitoring allergen immunotherapy of pollen-allergic patients: the ratio of allergen-specific IgG4 to IgG1 correlates with clinical outcome. Clin Exp Allergy. 1999;29(4):497–506. doi:10.1046/j.1365-2222.1999.00525.x
   Web of Science ®Google Scholar
• James LK, Shamji MH, Walker SM, et al. Long-term tolerance after allergen immunotherapy is accompanied by selective persistence of blocking antibodies. J Allergy Clin Immunol. 2011;127(2):509–516. doi:10.1016/j.jaci.2010.12.1080
   PubMed Web of Science ®Google Scholar
• James LK, Till SJ. Potential mechanisms for IgG4 inhibition of immediate hypersensitivity reactions. Curr Allergy Asthma Rep. 2016;16(3):23. doi:10.1007/s11882-016-0600-2
   PubMed Web of Science ®Google Scholar
• Baron-Bodo V, Horiot S, Lautrette A, et al. Heterogeneity of antibody responses among clinical responders during grass pollen sublingual immunotherapy. Clin Exp Allergy. 2013;43(12):1362–1373. doi:10.1111/cea.12187
   Web of Science ®Google Scholar
• Zenner HP, Baumgarten C, Rasp G, Kunkel G, Hauswald B, Ring J. Short-term immunotherapy: a prospective, randomized, double-blind, placebo-controlled multicenter study of molecular standardized grass and rye allergens in patients with grass pollen-induced rhinitis. J Allergy Clin Immunol. 1997;100(1):23–29. doi:10.1016/S0091-6749(97)70190-8
   Web of Science ®Google Scholar
• Van Neerven RJJ, Knol EF, Ejraes A, Wrtzen PA. IgE-mediated allergen presentation and blocking antibodies: regulation of T-cell activation in allergy. Int Arch Allergy Immunol. 2006;141(2):119–129. doi:10.1159/000094714
   Web of Science ®Google Scholar
• Wurtzen PA, Lund G, Lund K, Arvidsson M, Rak S, Ipsen H. A double-blind placebo-controlled birch allergy vaccination study II: correlation between inhibition of IgE binding, histamine release and facilitated allergen presentation. Clin Exp Allergy. 2008;38(8):1290–1301. doi:10.1111/j.1365-2222.2008.03020.x
   Web of Science ®Google Scholar
• Petersen AB, Gudmann P, Mikvang-Gronager P, et al. Performance evaluation of a specific IgE assay developed for the ADVIA centaur immunoassay system. Clin Biochem. 2004;37(10):882–892. doi:10.1016/j.clinbiochem.2004.06.010
   Web of Science ®Google Scholar
• Shamji MH, Wilcock LK, Wachholz PA, et al. The IgE-facilitated allergen binding (FAB assay): validation of a novel flow-cytometric based method for the detection of inhibitory antibody responses. J Immunol Methods. 2006;317(1–2):71–79. doi:10.1016/j.jim.2006.09.004
   PubMed Web of Science ®Google Scholar
• Gueguen C, Bouley J, Moussu H, et al. Changes in markers associated with dendritic cells driving the differentiation of either TH2 cells or regulatory T cells correlate with clinical benefit during allergen immunotherapy. J Allergy Clin Immunol. 2016;137(2):545–558. doi:10.1016/j.jaci.2015.09.015
   PubMed Web of Science ®Google Scholar
• Kjellman NIM, Lanner A. Hyposensitization in childhood hay fever. A comparison of refined and whole timothy extracts. Allergy. 1980;35(4):323–334. doi:10.1111/j.1398-9995.1980.tb01774.x
   Web of Science ®Google Scholar
• Østerballe O. Immunotherapy in hay fever with two major allergens 19,25 and partially purified extract of timothy grass pollen. Allergy. 1980;35(6):473–489. doi:10.1111/j.1398-9995.1980.tb01795.x
   Web of Science ®Google Scholar
• Bousquet J, Maasch H, Martinot B, Hejjaoui A, Wahl R, Michel FB. Double-blind, placebo-controlled immunotherapy with mixed grass-pollen allergoids. II. comparison between parameters assessing the efficacy of immunotherapy. J Allergy Clin Immunol. 1988;82(3):439–446. doi:10.1016/0091-6749(88)90017-6
   Web of Science ®Google Scholar
• Sun W, Pan L, Yu Q. The skin prick test response after allergen immunotherapy in different levels of tIgE children with mite sensitive asthma/rhinitis in south China. Hum Vaccin Immunother. 2018;14(10):2510–2515. doi:10.1080/21645515.2018.1482171
   PubMed Web of Science ®Google Scholar
• Bowton DL, Fasano MB, Bass DA. Skin sensitivity to allergen does not accurately predict airway response to allergen. Ann Allergy Asthma Immunol. 1998;80(2):207–1143. doi:10.1016/S1081-1206(10)62957-2
   Web of Science ®Google Scholar
• Agache I, Bilò BM, Braunstahl G-J, et al. In vivo diagnosis of allergic diseases-allergen provocation tests. Allergy. 2015;70(4):355–365. doi:10.1111/all.12586
   PubMed Web of Science ®Google Scholar
• Campo P, Barrionuevo E, Eguiluz I, Salas M, Torres J, Rondón C. Nasal provocation tests with allergens: just a research tool or suitable for everyday clinical practice? Curr Treat Options Allergy. 2017;4(1):98–109. doi:10.1007/s40521-017-0118-4
   Google Scholar
• Richelmann H, Epple B, Gropper G. Comparison of conjunctival and nasal provocation test in allergen rhinitis to house dust mite. Int Arch Allergy Immunol. 2003;130(1):51–59. doi:10.1159/000068369
   Web of Science ®Google Scholar
• Larson D, Patel P, Salapatek AM, et al. Nasal allergen challenge and environmental exposure chamber challenge: a randomized trial comparing clinical and biological responses to cat allergen. J Allergy Clin Immunol. 2020;145(6):1585–1597. doi:10.1016/j.jaci.2020.02.024
   PubMed Web of Science ®Google Scholar
• Day JH, Briscoe M, Widlitz MD. Cetirizine, loratadine, or placebo in subjects with seasonal allergic rhinitis: effects after controlled ragweed pollen challenge in an environmental exposure unit. J Allergy Clin Immunol. 1998;101(5):638–645. doi:10.1016/S0091-6749(98)70172-1
   Web of Science ®Google Scholar
• Day JH, Briosce MP, Rafeiro E, Ellis AK, Pettersson E, Åkerlund A. Onset of action of intranasal budesonide (Rhinocort aqua) in seasonal allergic rhinitis studied in a controlled exposure model. J Allergy Clin Immunol. 2000;105(3):489–494. doi:10.1067/mai.2000.104550
   PubMed Web of Science ®Google Scholar
• Horak F, Zieglmayer P, Zieglmayer R, et al. Early onset of action of a 5-grass-pollen 300-IR sublingual immunotherapy tablet evaluated in an allergen challenge champer. J Allergy Clin Immunol. 2009;124(3):471–477. doi:10.1016/j.jaci.2009.06.006
   PubMed Web of Science ®Google Scholar
• Pfaar O, Alvaro M, Cardona V, Hamelmann E, Mösges R, Kleine-Tebbe J. Clinical trials in allergen immunotherapy: current concepts and future needs. Allergy. 2018;73(9):1775–1783. doi:10.1111/all.13429
   Web of Science ®Google Scholar
• Mokkink LB, Terwee CB, Knol DL, et al. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol. 2010;10(1):22. doi:10.1186/1471-2288-10-22
   PubMed Web of Science ®Google Scholar
• U.S. Department of Health and Human Services, FDA Food and Drug Evaluation and Research (CDER). Guidance for Industry. Allergic Rhinitis: Clinical Development Programs for Drug Products. Draft Guidance. 2000.
   Google Scholar
• Amar SM, Harbeck RJ, Sills M, Silveira LJ, O’ Brien H, Nelson HS. Response to sublingual immunotherapy with grass pollen extract: monotherapy versus combination in a multiallergen extract. Allergy Clin Immunol. 2009;124(1):150–156. doi:10.1016/j.jaci.2009.04.037
   Google Scholar
• Pitsios C, Dietis N. Ways to increase adherence to allergen immunotherapy. Curr Med Res Opin. 2019;35(6):1027–1031. doi:10.1080/03007995.2018.1552044
   PubMed Web of Science ®Google Scholar
• Halken S, Larenas-Linnemann D, Roberts G, et al. EAACI guidelines on allergen immunotherapy: prevention of allergy. Pediatr Allergy Immunol. 2017;28(8):728–745. doi:10.1111/pai.12807
   PubMed Web of Science ®Google Scholar
• Tosca MA, Del Barba P, Licari A, Ciprandi G, Asthma Rhinitis Control Study Group. The measurement of asthma and allergic rhinitis control in children and adolescents. Children (Basil). 2020;7(5):43. doi:10.3390/children7050043
   Google Scholar
• Canonica GW, Baena-Cagnani CE, Bousquet J, Bousquet PJ, Lockey RF, Malling HJ. Recommendations for standardization of clinical trials with allergen specific immunotherapy for respiratory allergy. A statement of a world allergy organization (WAO) taskforce. Allergy. 2007;62(3):317–324. doi:10.1111/j.1398-9995.2006.01312.x
   PubMed Web of Science ®Google Scholar
• Bousquet J, Hellings PW, Agache I, et al. ARIA 2016: care pathways implementing emerging technologies for predictive medicine in rhinitis and asthma across the life cycle. Clin Transl Allergy. 2016;6:47.
   PubMed Web of Science ®Google Scholar
• Bousquet PJ, Combescure C, Klossek JM, Daures JP, Bousquet J. Change in visual analogue score in a pragmatic randomized cluster trial of allergic rhinitis. J Allergy Clin Immunol. 2009;123(6):1349–1354. doi:10.1016/j.jaci.2009.02.033
   PubMed Web of Science ®Google Scholar
• Juniper EF, Guyatt GH. Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy. 1991;21(1):77–83. doi:10.1111/j.1365-2222.1991.tb00807.x
   PubMed Web of Science ®Google Scholar
• Juniper EF, Thompson AK, Ferrie PJ, Roberts JN. Validation of a standardised version of the rhinoconjunctivitis quality of life questionnaire. J Allergy Clin Immunol. 1999;104(2):364–369. doi:10.1016/S0091-6749(99)70380-5
   PubMed Web of Science ®Google Scholar
• Juniper EF, Howland WC, Roberts NB, Thompson AK, King DR. Measuring quality of life in children with rhinoconjunctivitis. J Allergy Clin Immunol. 1998;101(2):163–170. doi:10.1016/S0091-6749(98)70380-X
   Web of Science ®Google Scholar
• Brazier JE, Harper R, Jones NM, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992;305(6846):160–164. doi:10.1136/bmj.305.6846.160
   PubMed Web of Science ®Google Scholar
• Baiardini I, Pasquali M, Giardini A, et al. Rhinasthma: a new specific QoL questionnaire for patients with rhinitis and asthma. Allergy. 2003;58(4):289–294. doi:10.1034/j.1398-9995.2003.00079.x
   PubMed Web of Science ®Google Scholar
• Eifan AO, Akkoc T, Yildiz A, et al. Clinical efficacy and immunological mechanisms of sublingual and subcutaneous immunotherapy in asthmatic/rhinitis children sensitized to house dust mite: an open randomized controlled trial. Clin Exp Allergy. 2010;40(6):922–932. doi:10.1111/j.1365-2222.2009.03448.x
   Web of Science ®Google Scholar