Allergy, Asthma & Respiratory Disease

The Korean Academy of Asthma, Allergy and Clinical Immunology (대한천식알레르기학회)
권호 표지
DOI QR코드

DOI QR Code

The Korean Academy of Asthma Allergy and Clinical Immunology guidelines for sublingual immunotherapy

대한천식알레르기학회 설하면역요법 진료지침

  • Gwanghui Ryu (Department of Otorhinolaryngology-Head and Neck Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Hye Mi Jee (Department of Pediatrics, CHA Bundang Medical Center, CHA University School of Medicine) ;
  • Hwa Young Lee (Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Sung-Yoon Kang (Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine) ;
  • Kyunghoon Kim (Department of Pediatrics, Seoul National University Bundang Hospital, Seoul National University College of Medicine) ;
  • Ju Hee Kim (Department of Pediatrics, Kyung Hee University School of Medicine) ;
  • Kyung Hee Park (Department of Internal Medicine, Yonsei University College of Medicine) ;
  • So-Young Park (Department of Internal Medicine, Chung-Ang University College of Medicine) ;
  • Myong Soon Sung (Department of Pediatrics, Soonchunhyang University Gumi Hospital) ;
  • Youngsoo Lee (Department of Allergy and Clinical Immunology, Ajou University School of Medicine) ;
  • Eun-Ae Yang (Department of Pediatrics, Daejeon St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Jin-Young Min (Department of Otorhinolaryngology-Head & Neck Surgery, Kyung Hee University Hospital, Kyung Hee University College of Medicine) ;
  • Eun Kyo Ha (Department of Pediatrics, Kangnam Sacred Heart Hospital, Hallym University College of Medicine) ;
  • Sang Min Lee (Division of Pulmonology and Allergy, Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine) ;
  • Yong Won Lee (Division of Allergy & Clinical Immunology, Department of Internal Medicine, Center for Health Policy Research, Catholic Kwandong University College of Medicine, International St. Mary's Hospital) ;
  • Eun Hee Chung (Department of Pediatrics, Chungnam National University School of Medicine) ;
  • Sun Hee Choi (Department of Pediatrics, Kyung Hee University Hospital at Gangdong) ;
  • Young-Il Koh (Department of Allergy and Clinical Immunology, Chonnam National University Hospital, Chonnam National University Medical School) ;
  • Seon Tae Kim (Department of Otolaryngology-Head & Neck Surgery, Gachon University Gil Medical Center, Gachon University College of Medicine) ;
  • Dong-Ho Nahm (Department of Allergy and Clinical Immunology, Ajou University School of Medicine) ;
  • Jung Won Park (Department of Internal Medicine, Yonsei University College of Medicine) ;
  • Jung Yeon Shim (Department of Pediatrics, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine) ;
  • Young Min An (Jang's Pediatrics) ;
  • Man Yong Han (Department of Pediatrics, CHA Bundang Medical Center, CHA University School of Medicine) ;
  • Jeong-Hee Choi (Department of Pulmonology and Allergy, Hallym University Dongtan Sacred Heart Hospital) ;
  • Yoo Seob Shin (Department of Allergy and Clinical Immunology, Ajou University School of Medicine) ;
  • Doo Hee Han (Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University College of Medicine) ;
  • Korean Academy of Asthma Allergy and Clinical Immunology (KAAACI) Allergen Immunotherapy and Allergen Working Group (Korean Academy of Asthma Allergy and Clinical Immunology (KAAACI))
  • 류광희 (성균관대학교 의과대학 삼성서울병원 이비인후과) ;
  • 지혜미 (차의과학대학교 분당차병원 소아청소년과) ;
  • 이화영 (가톨릭대학교 의과대학 서울성모병원 내과) ;
  • 강성윤 (가천대학교 의과대학 가천대길병원 호흡기알레르기내과) ;
  • 김경훈 (서울대학교 의과대학 분당서울대학교병원 소아청소년과) ;
  • 김주희 (경희대학교 의과대학 소아청소년과학교실) ;
  • 박경희 (연세대학교 의과대학 내과학교실) ;
  • 박소영 (중앙대학교 의과대학 내과학교실) ;
  • 성명순 (순천향대학교 구미병원 소아청소년과) ;
  • 이영수 (아주대학교 의과대학 알레르기내과학교실) ;
  • 양은애 (가톨릭대학교 의과대학 대전성모병원 소아청소년과) ;
  • 민진영 (경희대학교 의과대학 경희대학교병원 이비인후과) ;
  • 하은교 (한림대학교 의과대학 강남성심병원 소아청소년과) ;
  • 이상민 (가천대학교 의과대학 가천대길병원 호흡기알레르기내과) ;
  • 이용원 (가톨릭관동대학교 의과대학 국제성모병원 알레르기내과/의학산업연구센터) ;
  • 정은희 (충남대학교 의과대학 소아청소년과학교실) ;
  • 최선희 (경희대학교 강동병원 소아청소년과) ;
  • 고영일 (전남대학교 의과대학 전남대학교병원 알레르기내과) ;
  • 김선태 (가천대학교 의과대학 길병원 이비인후과) ;
  • 남동호 (아주대학교 의과대학 알레르기내과학교실) ;
  • 박중원 (연세대학교 의과대학 내과학교실) ;
  • 심정연 (성균관대학교 의과대학 강북삼성병원 소아청소년과) ;
  • 안영민 (장스 소아과) ;
  • 한만용 (차의과학대학교 분당차병원 소아청소년과) ;
  • 최정희 (한림대학교 동탄성심병원 호흡기알레르기내과) ;
  • 신유섭 (아주대학교 의과대학 알레르기내과학교실) ;
  • 한두희 (서울대학교 의과대학 이비인후과학교실) ;
  • 대한천식알레르기학회 면역요법/알레르겐연구팀 (대한천식알레르기학회)
  • Received : 2023.10.24
  • Accepted : 2024.02.27
  • Published : 2024.07.30
Download PDF
⟨ Previous Next ⟩

Abstract

Allergen immunotherapy (AIT) has been used for over a century and has been demonstrated to be effective in treating patients with various allergic diseases. AIT allergens can be administered through various routes, including subcutaneous, sublingual, intra-lymphatic, oral, or epicutaneous routes. Sublingual immunotherapy (SLIT) has recently gained clinical interest, and it is considered an alternative treatment for allergic rhinitis (AR) and asthma. This review provides an overview of the current evidence-based studies that address the use of SLIT for treating AR, including (1) mechanisms of action, (2) appropriate patient selection for SLIT, (3) the current available SLIT products in Korea, and (4) updated information on its efficacy and safety. Finally, this guideline aims to provide the clinician with practical considerations for SLIT.

Keywords

Acknowledgement

이 면역치료 진료지침은 대한천식알레르기학회의 연구비 지원을 받아서 제작되었습니다. 지침 제작에 참여하신 대한천식알레르기학회 면역요법/알레르겐연구팀의 모든 선생님들께 감사를 드립니다. 이 논문은 Allergy Asthma Immunol Res (AAIR) 잡지에 1차 출판된 논문(https://doi.org/10.4168/aair.2024.16.1.9)의 2차 출판물로 AAIR/AARD 잡지 편집장과 저자들의 2차 출판 허가를 받았습니다.

References

  1. Jutel M, Agache I, Bonini S, Burks AW, Calderon M, Canonica W, et al. International consensus on allergy immunotherapy. J Allergy Clin Immunol 2015;136:556-68.
  2. Noon L. Prophylactic inoculation against hay fever. Lancet 1911;177:1572-3.
  3. Freeman J. Further observations on the treatment of hay fever by hypodermic inoculations of pollen vaccine. Historical document. Ann Allergy 1960;18:427-34.
  4. Hur GY, Kim TB, Kim ST, Han MY, Nahm DH, Lee YW, et al. Allergy immunotherapy. Korean J Asthma Allergy Clin Immunol 2010;30:153-83.
  5. Balshem H, Helfand M, Schunemann HJ, Oxman AD, Kunz R, Brozek J, et al. GRADE guidelines: 3. Rating the quality of evidence. J Clin Epidemiol 2011;64:401-6.
  6. Lawrence MG, Steinke JW, Borish L. Basic science for the clinician: mechanisms of sublingual and subcutaneous immunotherapy. Ann Allergy Asthma Immunol 2016;117:138-42.
  7. Ozdemir C, Kucuksezer UC, Akdis M, Akdis CA. Mechanisms of aeroallergen immunotherapy: subcutaneous immunotherapy and sublingual immunotherapy. Immunol Allergy Clin North Am 2016;36:71-86.
  8. Mascarell L, Lombardi V, Louise A, Saint-Lu N, Chabre H, Moussu H, et al. Oral dendritic cells mediate antigen-specific tolerance by stimulating TH1 and regulatory CD4+ T cells. J Allergy Clin Immunol 2008;122:603-9.e5.
  9. Mascarell L, Saint-Lu N, Moussu H, Zimmer A, Louise A, Lone Y, et al. Oral macrophage-like cells play a key role in tolerance induction following sublingual immunotherapy of asthmatic mice. Mucosal Immunol 2011;4:638-47.
  10. Allam JP, Novak N, Fuchs C, Asen S, Berge S, Appel T, et al. Characterization of dendritic cells from human oral mucosa: a new Langerhans' cell type with high constitutive FcepsilonRI expression. J Allergy Clin Immunol 2003;112:141-8.
  11. Didier A, Malling HJ, Worm M, Horak F, Jager 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.
  12. Bergmann KC, Demoly P, Worm M, Fokkens WJ, Carrillo T, Tabar AI, et al. Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis. J Allergy Clin Immunol 2014;133:1608-14.e6.
  13. Roberts G, Pfaar O, Akdis CA, Ansotegui IJ, Durham SR, Gerth van Wijk R, et al. EAACI guidelines on allergen immunotherapy: allergic rhino-conjunctivitis. Allergy 2018;73:765-98.
  14. Pfaar O, Bachert C, Bufe A, Buhl R, Ebner C, Eng P, et al. Guideline on allergen-specific immunotherapy in IgE-mediated allergic diseases: S2k Guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the Society for Pediatric Allergy and Environmental Medicine (GPA), the Medical Association of German Allergologists (AeDA), the Austrian Society for Allergy and Immunology (OGAI), the Swiss Society for Allergy and Immunology (SGAI), the German Society of Dermatology (DDG), the German Society of Oto- Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), the German Society of Pediatrics and Adolescent Medicine (DGKJ), the Society for Pediatric Pneumology (GPP), the German Respiratory Society (DGP), the German Association of ENT Surgeons (BV-HNO), the Professional Federation of Paediatricians and Youth Doctors (BVKJ), the Federal Association of Pulmonologists (BDP) and the German Dermatologists Association (BVDD). Allergo J Int 2014;23:282-319.
  15. 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.
  16. 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.
  17. Korean Rhinologic Society. Allergic rhinitis update, 4th ed. Seoul (Korea): Korean Rhinologic Society; 2022.
  18. Korean Academy of Asthma, Allergy and Clinical Immunology. Korean guidelines for allergic rhinitis. Seoul (Korea): Korean Academy of Asthma, Allergy and Clinical Immunology; 2015.
  19. Guez S, Vatrinet C, Fadel R, Andre C. House-dust-mite sublingual-swallow immunotherapy (SLIT) in perennial rhinitis: a double-blind, placebo-controlled study. Allergy 2000;55:369-75.
  20. Hirsch T, Sahn M, Leupold W. Double-blind placebo-controlled study of sublingual immunotherapy with house dust mite extract (D.pt.) in children. Pediatr Allergy Immunol 1997;8:21-7.
  21. Marogna M, Spadolini I, Massolo A, Zanon P, Berra D, Chiodini E, et al. Effects of sublingual immunotherapy for multiple or single allergens in polysensitized patients. Ann Allergy Asthma Immunol 2007;98:274-80.
  22. Nolte H, Bernstein DI, Nelson HS, Kleine-Tebbe J, Sussman GL, Seitzberg D, et al. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol 2016;138:1631-8.
  23. 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. J Allergy Clin Immunol 2009;124:150-6.e1-5.
  24. Radulovic S, Calderon MA, Wilson D, Durham S. Sublingual immunotherapy for allergic rhinitis. Cochrane Database Syst Rev 2010;2010:CD002893.
  25. Wise SK, Lin SY, Toskala E, Orlandi RR, Akdis CA, Alt JA, et al. International consensus statement on allergy and rhinology: allergic rhinitis. Int Forum Allergy Rhinol 2018;8:108-352.
  26. Radulovic S, Wilson D, Calderon M, Durham S. Systematic reviews of sublingual immunotherapy (SLIT). Allergy 2011;66:740-52.
  27. Durham SR, Creticos PS, Nelson HS, Li Z, Kaur A, Meltzer EO, et al. Treatment effect of sublingual immunotherapy tablets and pharmacotherapies for seasonal and perennial allergic rhinitis: pooled analyses. J Allergy Clin Immunol 2016;138:1081-8.e4.
  28. Xian M, Feng M, Dong Y, Wei N, Su Q, Li J. Changes in CD4+CD25+ FoxP3+ regulatory T cells and serum cytokines in sublingual and subcutaneous immunotherapy in allergic rhinitis with or without asthma. Int Arch Allergy Immunol 2020;181:71-80.
  29. Tahamiler R, Saritzali G, Canakcioglu S, Ozcora E, Dirican A. Comparison of the long-term efficacy of subcutaneous and sublingual immunotherapies in perennial rhinitis. ORL J Otorhinolaryngol Relat Spec 2008;70:144-50.
  30. Kim JY, Jang MJ, Kim DY, Park SW, Han DH. Efficacy of subcutaneous and sublingual immunotherapy for house dust mite allergy: a network meta-analysis-based comparison. J Allergy Clin Immunol Pract 2021;9:4450-8.e6.
  31. Nelson H, Cartier S, Allen-Ramey F, Lawton S, Calderon MA. Network meta-analysis shows commercialized subcutaneous and sublingual grass products have comparable efficacy. J Allergy Clin Immunol Pract 2015;3:256-66.e3.
  32. Pfaar O, Demoly P, Gerth van Wijk R, Bonini S, Bousquet J, Canonica GW, et al. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Allergy 2014;69:854-67.
  33. Bousquet J, Bullinger M, Fayol C, Marquis P, Valentin B, Burtin B. Assessment of quality of life in patients with perennial allergic rhinitis with the French version of the SF-36 Health Status Questionnaire. J Allergy Clin Immunol 1994;94:182-8.
  34. Juniper EF, Guyatt GH. Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy 1991;21:77-83.
  35. Laforest L, Bousquet J, Pietri G, Sazonov Kocevar V, Yin D, Pacheco Y, et al. Quality of life during pollen season in patients with seasonal allergic rhinitis with or without asthma. Int Arch Allergy Immunol 2005;136:281-6.
  36. Barker-Tejeda TC, Bazire R, Obeso D, Mera-Berriatua L, Rosace D, Vazquez-Cortes S, et al. Exploring novel systemic biomarker approaches in grass-pollen sublingual immunotherapy using omics. Allergy 2021;76:1199-212.
  37. Heeringa JJ, McKenzie CI, Varese N, Hew M, Bakx A, Aui PM, et al. Induction of IgG(2) and IgG(4) B-cell memory following sublingual immunotherapy for ryegrass pollen allergy. Allergy 2020;75:1121-32.
  38. Di Lorenzo G, Mansueto P, Pacor ML, Rizzo M, Castello F, Martinelli N, et al. Evaluation of serum s-IgE/total IgE ratio in predicting clinical response to allergen-specific immunotherapy. J Allergy Clin Immunol 2009;123:1103-10, 1110.e1-4.
  39. Calderon MA, Vidal C, Rodriguez Del Rio P, Just J, Pfaar O, Tabar AI, et al. European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI): a real-life clinical assessment. Allergy 2017;72:462-72.
  40. Rodriguez Del Rio P, Vidal C, Just J, Tabar AI, Sanchez-Machin I, Eberle P, et al. The European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI): a paediatric assessment. Pediatr Allergy Immunol 2017;28:60-70.
  41. Calderon 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.
  42. Greenhawt M, Oppenheimer J, Nelson M, Nelson H, Lockey R, Lieberman P, et al. Sublingual immunotherapy: a focused allergen immunotherapy practice parameter update. Ann Allergy Asthma Immunol 2017;118:276-82.e2.
  43. Blaiss M, Maloney J, Nolte H, Gawchik S, Yao R, Skoner DP. Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents. J Allergy Clin Immunol 2011;127:64-71, 71.e1-4.
  44. Dahl R, Stender A, Rak S. Specific immunotherapy with SQ standardized grass allergen tablets in asthmatics with rhinoconjunctivitis. Allergy 2006;61:185-90.
  45. Mosbech H, Deckelmann R, de Blay F, Pastorello EA, Trebas-Pietras E, Andres LP, et al. Standardized quality (SQ) house dust mite sublingual immunotherapy tablet (ALK) reduces inhaled corticosteroid use while maintaining asthma control: a randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol 2014;134:568-75.e7.
  46. Didier A, Malling HJ, Worm M, Horak F, Sussman GL. Prolonged efficacy of the 300IR 5-grass pollen tablet up to 2 years after treatment cessation, as measured by a recommended daily combined score. Clin Transl Allergy 2015;5:12.
  47. Durham SR, Emminger W, Kapp A, Colombo G, de Monchy JG, Rak S, et al. Long-term clinical efficacy in grass pollen-induced rhinoconjunctivitis after treatment with SQ-standardized grass allergy immunotherapy tablet. J Allergy Clin Immunol 2010;125:131-8.e1-7.
  48. Durham SR, Emminger W, Kapp A, de Monchy JG, Rak S, Scadding GK, et al. SQ-standardized sublingual grass immunotherapy: confirmation of disease modification 2 years after 3 years of treatment in a randomized trial. J Allergy Clin Immunol 2012;129:717-25.e5.
  49. Valovirta E, Petersen TH, Piotrowska T, Laursen MK, Andersen JS, Sorensen HF, et al. Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy. J Allergy Clin Immunol 2018;141:529-38.e13.
  50. Okubo K, Masuyama K, Imai T, Okamiya K, Stage BS, Seitzberg D, et al. Efficacy and safety of the SQ house dust mite sublingual immunotherapy tablet in Japanese adults and adolescents with house dust mite-induced allergic rhinitis. J Allergy Clin Immunol 2017;139:1840-8.e10.
  51. Lin Z, Liu Q, Li T, Chen D, Chen D, Xu R. The effects of house dust mite sublingual immunotherapy in patients with allergic rhinitis according to duration. Int Forum Allergy Rhinol 2016;6:82-7.
  52. 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(1 Suppl):S1-55.
  53. Marogna M, Tomassetti D, Bernasconi A, Colombo F, Massolo A, Businco AD, et al. Preventive effects of sublingual immunotherapy in childhood: an open randomized controlled study. Ann Allergy Asthma Immunol 2008;101:206-11.
  54. Novembre E, Galli E, Landi F, Caffarelli C, Pifferi M, De Marco E, et al. Coseasonal sublingual immunotherapy reduces the development of asthma in children with allergic rhinoconjunctivitis. J Allergy Clin Immunol 2004;114:851-7.
  55. Marogna M, Spadolini I, Massolo A, Canonica GW, Passalacqua G. Long-lasting effects of sublingual immunotherapy according to its duration: a 15-year prospective study. J Allergy Clin Immunol 2010;126:969-75.
  56. Passalacqua G, Bagnasco D, Canonica GW. 30 years of sublingual immunotherapy. Allergy 2020;75:1107-20.
  57. Didier A, Malling HJ, Worm M, Horak F, Sussman G, Melac M, et al. Posttreatment 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.
  58. Lee HY, Lee SM, Kang SY, Kim K, Kim JH, Ryu G, et al. KAAACI guidelines for allergen immunotherapy. Allergy Asthma Immunol Res 2023;15:725-56.