“The value of pre- and co-seasonal sublingual immunotherapy in pollen-induced allergic rhinoconjunctivitis”

Clinical and Translational Allergy

Ulrich Wahn⁴  Hans-Jørgen Malling¹  Thomas B Casale²  Moises A Calderon³  Pascal Demoly⁵ 

[1] Allergy Clinic, Gentofte University Hospital, Copenhagen, Denmark;Internal Medicine, Morsani College of Medicine University of South Florida, Tampa, FL, Omaha, NE, USA;Section of Allergy and Clinical Immunology, Imperial College London-NHLI, Royal Brompton Hospital, London, UK;Department of Paediatric Pneumology and Immunology, Charité Virchow-Klinikum, Humboldt University, Berlin, Germany;Sorbonne Universités, UPMC Paris 06, UMR-S 1136 INSERM, IPLESP, Equipe EPAR, Paris, France

关键词: Grass;    Birch;    Pollen;    Sublingual immunotherapy;    Co-seasonal;    Pre-seasonal;    Allergic rhinitis;   

Others  :  1181594
DOI  :  10.1186/s13601-015-0061-z

 received in 2014-12-18, accepted in 2015-03-23,  发布年份 2015

【 摘 要 】

Allergen immunotherapy (AIT) is a guidelines-approved, disease-modifying treatment option for respiratory allergies, including allergic rhinitis (AR) induced by pollen. The various AIT regimens employed to date in pollen-induced AR can be classified as continuous (i.e. year-round) or discontinuous (i.e. pre-seasonal alone, co-seasonal alone or pre- and co-seasonal). Pre-and co-seasonal regimens are typically used for sublingual allergen immunotherapy (SLIT) and have economic and compliance advantages over perennial (year-round) regimens. However, these advantages must not come at the expensive of poor efficacy or safety. The results of recent double-blind, placebo-controlled, randomized clinical trials show that pre- and co-seasonal SLIT is safe and effective in patients with AR induced by grass pollen (treated with a tablet formulation) or by birch pollen (treated with a liquid formulation). Progress in SLIT has been made in defining the optimal dose of major allergen, the administration frequency (daily), the duration of pre-seasonal treatment (four months) and the number of treatment seasons (at least three). Post-marketing, “real-life” trials of pre- and co-seasonal birch or grass pollen SLIT regimens have confirmed the efficacy and safety observed in the clinical trials. In the treatment of pollen-induced AR, pre- and co-seasonal SLIT regimens appear to be at least as effective and safe as perennial SLIT regimens, and are associated with lower costs and good compliance. Good compliance may mean that pre- and co-seasonal SLIT regimens are inherently more effective and safer than perennial SLIT regimens. When considering the pre- and co-seasonal discontinuous regimen in particular, a 300 IR five-grass-pollen formulation is the only SLIT tablet with a clinical development programme having provided evidence of short-term, sustained and post-treatment efficacy.

【 授权许可】

   
2015 Demoly et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, et al.: Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 Update (in collaboration with the World Health Organization, GA2LEN and AllerGen). Allergy 2008, 63:S8-160.
• [2]Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, et al.: Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol 2010, 126:466-76.
• [3]Shaaban R, Zureik M, Soussan D, Neukirch C, Heinrich J, Sunyer J, et al.: Rhinitis and onset of asthma: a longitudinal population-based study. Lancet 2008, 372:1049-57.
• [4]Kessler RC, Almeida DM, Berglund P, Stang P: Pollen and mold exposure impairs the work performance of employees with allergic rhinitis. Ann Allergy Asthma Immunol 2001, 87:289-95.
• [5]Meltzer EO: Quality of life in adults and children with allergic rhinitis. J Allergy Clin Immunol 2001, 108:S45-53.
• [6]Léger D, Annesi-Maesano I, Carat F, Rugina M, Chanal I, Pribil C, et al.: Allergic rhinitis and its consequences on quality of sleep. An unexplored area. Arch Intern Med 2006, 166:1744-8.
• [7]Canonica GW, Bousquet J, Mullol J, Scadding GK, Virchow JC: A survey of the burden of allergic rhinitis in Europe. Allergy 2007, 62(Suppl 85):17-25.
• [8]Nathan RA: The burden of allergic rhinitis. Allergy Asthma Proc 2007, 28:3-9.
• [9]Valovirta E, Myrseth SE, Palkonen S: The voice of the patients: allergic rhinitis is not a trivial disease. Curr Opin Allergy Clin Immunol 2008, 8:1-9.
• [10]Meltzer EO, Bukstein DA: The economic impact of allergic rhinitis and current guidelines for treatment. Ann Allergy Asthma Immunol 2011, 106:S12-6.
• [11]Arbes SJ Jr, Gergen PJ, Elliott L, Zeldin DC: Prevalences of positive skin test responses to 10 common allergens in the US population: results from the third National Health and Nutrition Examination Survey. J Allergy Clin Immunol 2005, 116:377-83.
• [12]Bousquet PJ, Castelli C, Daures JP, Heinrich J, Hooper R, Sunyer J, et al.: Assessment of allergen sensitization in a general population-based survey (European Community Respiratory Health Survey I). Ann Epidemiol 2010, 20:797-803.
• [13]Smith M, Jäger S, Berger U, Sikoparija B, Hallsdottir M, Sauliene I, et al.: Geographic and temporal variations in pollen exposure across Europe. Allergy 2014, 69:913-23.
• [14]D’Amato G, Cecchi L, Bonini S, Nunes C, Annesi-Maesano I, Behrendt H, et al.: Allergenic pollen and pollen allergy in Europe. Allergy 2007, 62:976-90.
• [15]Shea KM, Truckner RT, Weber RW, Peden DB: Climate change and allergic disease. J Allergy Clin Immunol 2008, 122:443-53.
• [16]Ziska L, Knowlton K, Rogers C, Dalan D, Tierney N, Elder MA, et al.: Recent warming by latitude associated with increased length of ragweed pollen season in central North America. Proc Natl Acad Sci U S A 2011, 108:4248-51.
• [17]Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, et al.: The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunol 2008, 122(2):S1-84.
• [18]Ramirez LF, Urbinelli R, Allaert FA, Demoly P: Combining H1-antihistamines and nasal corticosteroids to treat allergic rhinitis in general practice. Allergy 2011, 66:1501-2.
• [19]Migueres M, Fontaine JF, Haddad T, Grosclaude M, Saint-Martin F, Bem David D, et al.: Characteristics of patients with respiratory allergy in France and factors influencing immunotherapy prescription: a prospective observational study (REALIS). Int J Immunopathol Pharmacol 2011, 24:387-400.
• [20]Canonica GW, Bousquet J, Casale T, Lockey RF, Baena-Cagnani CE, Pawankar R, et al.: Sub-lingual immunotherapy: World Allergy Organization Position Paper 2009. Allergy 2009, 64(Suppl 91):1-59.
• [21]Canonica GW, Cox L, Pawankar R, Baena-Cagnani CE, Blaiss M, Bonini S, et al.: Sublingual immunotherapy: World Allergy Organization position paper 2013 update. World Allergy Organ J 2014, 7:6. BioMed Central Full Text
• [22]Cox L, Nelson H, Lockey R, Calabria C, Chacko T, Finegold I, et al.: Allergen immunotherapy: a practice parameter third update. J Allergy Clin Immunol 2011, 127(Suppl):S1-55.
• [23]Viswanathan RK, Busse WW: Allergen immunotherapy in allergic respiratory diseases: from mechanisms to meta-analyses. Chest 2012, 141:1303-14.
• [24]Matricardi PM, Kuna P, Panetta V, Wahn U, Narkus A: Subcutaneous immunotherapy and pharmacotherapy in seasonal allergic rhinitis: a comparison based on meta-analyses. J Allergy Clin Immunol 2011, 128:791-9.
• [25]Devillier P, Dreyfus JF, Demoly P, Calderón MA: A meta-analysis of sublingual allergen immunotherapy and pharmacotherapy in pollen-induced seasonal allergic rhinoconjunctivitis. BMC Med 2014, 12:71. BioMed Central Full Text
• [26]Eng PA, Borer-Reinhold M, Heijnen IA, Gnehm HP: Twelve-year follow-up after discontinuation of preseasonal grass pollen immunotherapy in childhood. Allergy 2006, 61:198-201.
• [27]Burks AW, Calderon MA, Casale T, Cox L, Demoly P, Jutel M, et al.: Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus report. J Allergy Clin Immunol 2013, 131:1288-96.
• [28]Jacobsen L, Niggemann B, Dreborg S, Ferdousi HA, Halken S, Host A, et al.: Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-up on the PAT study. Allergy 2007, 62:943-8.
• [29]Calderon MA, Alves B, Jacobson M, Hurwitz B, Sheikh A, Durham S: Allergen injection immunotherapy for seasonal allergic rhinitis. Cochrane Database Syst Rev 2007., 1Article ID CD001936
• [30]Di Bona D, Plaia A, Scafidi V, Leto-Barone MS, Di Lorenzo G: Efficacy of sublingual immunotherapy with grass allergens for seasonal allergic rhinitis: a systematic review and meta-analysis. J Allergy Clin Immunol 2010, 126:558-66.
• [31]Calderon M, Mösges R, Hellmich M, Demoly P: Towards evidence-based medicine in specific grass pollen immunotherapy. Allergy 2010, 65:420-34.
• [32]Radulovic S, Wilson D, Calderon M, Durham S: Systematic reviews of sublingual immunotherapy (SLIT). Allergy 2011, 66:740-52.
• [33]Calderon MA, Penagos M, Sheikh A, Canonica GW, Durham S: Sublingual immunotherapy for treating allergic conjunctivitis. Cochrane Database Syst Rev 2011., 7Article ID CD007685
• [34]Calderon MA, Casale TB, Nelson HS, Demoly P: An evidence-based analysis of house dust mite allergen immunotherapy: a call for more rigorous clinical studies. J Allergy Clin Immunol 2013, 132:1322-36.
• [35]Lin SY, Erekosima N, Kim JM, Ramanathan M, Suarez-Cuervo C, Chelladurai Y, et al.: Sublingual immunotherapy for the treatment of allergic rhinoconjunctivitis and asthma: a systematic review. JAMA 2013, 309:1278-88.
• [36]Senna GE, Calderon M, Milani M: Allergy immunotherapy tablet: Grazax® for the treatment of grass pollen allergy. Expert Rev Clin Immunol 2011, 7:21-7.
• [37]Nelson H, Lehmann L, Blaiss MS: Treatment of seasonal allergic rhinoconjunctivitis with a once-daily SQ-standardized grass allergy immunotherapy tablet. Curr Med Res Opin 2012, 28:1043-51.
• [38]Lyseng-Williamson K: Sublingual five-grass pollen tablets (Oralair®): a guide to their use as allergen immunotherapy for grass pollen-induced allergic rhinoconjunctivitis. Drugs Ther Perspec 2014, 30:200-8.
• [39]Didier A, Wahn U, Horak F, Cox LS: Five-grass-pollen sublingual immunotherapy tablet for the treatment of grass-pollen-induced allergic rhinoconjunctivitis: 5 years of experience. Expert Rev Clin Immunol 2014, 10:1309-24.
• [40]Kannan JA, Epstein TG: Immunotherapy safety: what have we learned from surveillance surveys? Curr Allergy Asthma Rep 2013, 13:381-8.
• [41]Lockey RF, Benedict LM, Turkeltaub PC, Bukantz SC: Fatalities from immunotherapy (IT) and skin testing (ST). J Allergy Clin Immunol 1987, 79:660-77.
• [42]Bousquet J, Lockey R, Malling HJ, Alvarez-Cuesta E, Canonica GW, Chapman MD, et al.: Allergen immunotherapy: therapeutic vaccines for allergic diseases. World health organization. American academy of allergy, asthma and immunology. Ann Allergy Asthma Immunol 1998, 81:401-5.
• [43]Alvarez-Cuesta E, Bousquet J, Canonica GW, Durham SR, Malling HJ, Valovirta E, et al.: Standards for practical allergen-specific immunotherapy. Allergy 2006, 61(82):1-20.
• [44]Calderón MA, Simons FE, Malling HJ, Lockey RF, Moingeon P, Demoly P: Sublingual allergen immunotherapy: mode of action and its relationship with the safety profile. Allergy 2012, 67:302-11.
• [45]Lombardi C, Incorvaia C, Braga M, Senna G, Canonica GW, Passalacqua G: Administration regimens for sublingual immunotherapy to pollen allergens: what do we know? Allergy 2009, 64:849-54.
• [46]Palma-Carlos AG, Santos AS, Branco-Ferreira M, Pregal AL, Palma-Carlos ML, Bruno ME, et al.: Clinical efficacy and safety of preseasonal sublingual immunotherapy with grass pollen carbamylated allergoid in rhinitic patients. A double-blind, placebo-controlled study. Allergol Immun (Madr) 2006, 34:194-8.
• [47]Vervloet D, Birnbaum J, Laurent P, Hugues B, Fardeau MF, Massabie-Bouchat YP, et al.: Safety and efficacy of Juniperus ashei sublingual-swallow ultra-rush pollen immunotherapy in cypress rhinoconjunctivitis. A double-blind, placebo-controlled study. Int Arch Allergy Immunol 2007, 142:239-46.
• [48]Ott H, Sieber J, Brehler R, Fölster-Holst R, Kapp A, Klimek L, et al.: Efficacy of grass pollen sublingual immunotherapy for three consecutive seasons and after cessation of treatment: the ECRIT study. Allergy 2009, 64:1394-401.
• [49]Bufe A, Ziegler-Kirbach E, Stoeckmann E, Heidemann P, Gehlhar K, Holland-Letz T, et al.: Efficacy of sublingual swallow immunotherapy in children with severe grass pollen allergic symptoms: a double-blind placebo-controlled study. Allergy 2004, 59:498-504.
• [50]Sabate E: Adherence to long-term therapies: evidence for action. Available from: http://www.who.int/chp/knowledge/publications/adherence_report/en/ [Last accessed 22 January 2015]
• [51]Christensen AJ: Patient adherence to medical treatment regimens: bridging the gap between behavioral science and biomedicine. Yale University Press, Current Perspectives In Psychology. New Haven; 2004.
• [52]Didier A, Worm M, Horak F, Sussman G, de Beaumont O, Le Gall M, et al.: Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis. J Allergy Clin Immunol 2011, 128:559-66.
• [53]Didier A, Malling HJ, Worm M, Horak F, Sussman G, Melac M, et al.: Post-treatment efficacy of discontinuous treatment with 300IR 5-grass pollen sublingual tablet in adults with grass pollen-induced allergic rhinoconjunctivitis. Clin Exp Allergy 2013, 43:568-77.
• [54]Calderon MA, Birk AO, Andersen JS, Durham SR: Prolonged preseasonal treatment phase with Grazax sublingual immunotherapy increases clinical efficacy. Allergy 2007, 62:958-61.
• [55]Sieber J, De Geest S, Shah-Hosseini K, Mösges R: Medication persistence with long-term, specific grass pollen immunotherapy measured by prescription renewal rates. Curr Med Res Opin 2011, 27:855-61.
• [56]Worm M, Rak S, de Blay F, Malling HJ, Melac M, Cadic V, et al.: Sustained efficacy and safety of a 300IR daily dose of a sublingual solution of birch pollen allergen extract in adults with allergic rhinoconjunctivitis: results of a double-blind, placebo-controlled study. Clin Transl Aller 2014, 4:7. BioMed Central Full Text
• [57]Wahn U, Klimek L, Ploszczuk A, Adelt T, Sandner B, Trebas-Pietras E, et al.: High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: a double-blind, placebo-controlled study. J Allergy Clin Immunol 2012, 130:886-93.
• [58]Creticos PS, Esch RE, Couroux P, Gentile D, D’Angelo P, Whitlow B, et al.: Randomized, double-blind, placebo-controlled trial of standardized ragweed sublingual-liquid immunotherapy for allergic rhinoconjunctivitis. J Allergy Clin Immunol 2014, 133:751-8.
• [59]Hadler M, Karagiannis E, Shah-Hosseini K, Mösges R: Effectiveness and tolerability of a 2-year sublingual allergen immunotherapy (AIT) in routine medical practice in birch pollen allergic patients. Allergy: Eur J Allergy Clin Immunol 2013, 68(Suppl 97):483.
• [60]Hadler M, Schnitzer S, Schnitker J, Sieber J: Treatment satisfaction with sublingual immunotherapy in a real-life setting. World Aller Organ J 2012, 5(Suppl 2):S67.
• [61]Sieber J, Köberlein J, Mösges R: Sublingual immunotherapy in daily medical practice: effectiveness of different treatment schedules - IPD meta-analysis. Curr Med Res Opin 2010, 26:925-32.
• [62]Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Devillier P, Montagut A, et al.: Early onset of action of a 5-grass-pollen 300IRsublingual immunotherapy tablet evaluated in an allergen challenge chamber. J Allergy Clin Immunol 2009, 124:471-7.
• [63]Malling HJ, Montagut A, Melac M, Patriarca G, Panzner P, Seberova E, et al.: Efficacy and safety of 5-grass pollen sublingual immunotherapy tablets in patients with different clinical profiles of allergic rhinoconjunctivitis. Clin Exp Allergy 2009, 39:387-93.
• [64]Didier A, Malling HJ, Worm M, Horak F, Jäger S, Montagut A, et al.: Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5-grass pollen tablet for seasonal allergic rhinitis. J Allergy Clin Immunol 2007, 120:1338-45.
• [65]Committee for Medicinal Products for Human Use at the European Medicines Agency. Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases, Draft CHMP/EWP/18504/2006. London: 2008.
• [66]ORALAIR Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract Tablet for Sublingual Use: food and Drug Administration Allergenic Products Advisory Committee Briefing Document. Stallergenes S.A., 2013. Available from: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/UCM377851.pdf [Last accessed 22 January 2014]
• [67]Halken S, Agertoft L, Seidenberg J, Bauer CP, Payot F, Martin-Muñoz MF, et al.: Five-grass pollen 300IR SLIT tablets: efficacy and safety in children and adolescents. Pediatr Allergy Immunol 2010, 21:970-6.
• [68]Karagiannis E, Shah-Hosseini K, Hadler M, Mösges R: PD14 - Non-interventional 2-year study of sublingual immunotherapy in children and adolescents with allergic rhinoconjunctivitis caused by grass pollen. Clin Trans Aller 2014, 4(Suppl 1):14. BioMed Central Full Text
• [69]Antolin D, Valbuena T, Valls A, Garrido S, Blanco C, Garcia MA: One season of treatment with 5 grass pollen tablets in adults demonstrated a reduction in disease symptoms and impacts: findings of the SMILE study. Allergy: Eur J Allergy Clin Immunol 2013, 68(Suppl 97):479.
• [70]Eberle P, Brueck H, Gall R, Hadler M, Sieber J, Karagiannis E: An observational, real-life safety study of a 5-grass-pollen sublingual tablet in children and adolescents. Pediatr Allergy Immunol. 2014 Nov 7. doi:10.1111/pai.12298.
• [71]Quercia O, Bruno ME, Compalati E, Falagiani P, Mistrello G, Stefanini GF: Efficacy and safety of sublingual immunotherapy with grass monomeric allergoid: comparison between two different treatment regimens. Eur Ann Allergy Clin Immunol 2011, 43:176-83.
• [72]Wessel F, Chartier A, Meunier JP, Magnan A: Safety and tolerability of an SQ-standardized GRAss ALlergy immunotherapy tablet (GRAZAX®) in a real-life setting for three consecutive seasons - the GRAAL trial. Clin Drug Investig 2012, 32:451-63.
• [73]Calderón MA, Larenas D, Kleine-Tebbe J, Jacobsen L, Passalacqua G, Eng PA, et al.: European Academy of Allergy and Clinical Immunology task force report on ‘dose-response relationship in allergen-specific immunotherapy’. Allergy 2011, 66:1345-59.
• [74]Larenas-Linnemann D, Cox LS: Immunotherapy and Allergy Diagnostics Committee of the American Academy of Allergy, Asthma and Immunology: European allergen extract units and potency: review of available information. Ann Allergy Asthma Immunol 2008, 100:137-145.
• [75]Prescribing information for ORALAIR in the US. Available from: http://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=854c9772-63b9-44a3-a11e-77b29c59e91d&type=display [Last accessed 22 January 2015]
• [76]FDA Briefing Document. Biologic License Application (BLA) for Timothy Grass Pollen Allergen Extract Tablet for Sublingual Use. Available from: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/allergenicproductsadvisorycommittee/ucm378092.pdf [Last accessed 22 January 2015]
• [77]Durham SR, Yang WH, Pedersen MR, Johansen N, Rak S: Sublingual immunotherapy with once-daily grass allergen tablets: a randomized controlled trial in seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol 2006, 117:802-9.
• [78]Larenas-Linnemann D, Esch R, Plunkett G, Brown S, Maddox D, Barnes C, et al.: Maintenance dosing for sublingual immunotherapy by prominent European allergen manufacturers expressed in bioequivalent allergy units. Ann Allergy Asthma Immunol 2011, 107:448-58.
• [79]Westerhout KY, Verheggen BG, Schreder CH, Augustin M: Cost effectiveness analysis of immunotherapy in patients with grass pollen allergic rhinoconjunctivitis in Germany. J Med Econ 2012, 15:906-17.
• [80]Dranitsaris G, Ellis AK: Sublingual or subcutaneous immunotherapy for seasonal allergic rhinitis: an indirect analysis of efficacy, safety and cost. J Eval Clin Pract 2014, 20:225-38.