References

1. 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 (ÖGAI), 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(8):282–319.
2. Roberts G, Pfaar O, Akdis CA, Ansotegui IJ, Durham SR, van Gerth Wijk R et al. EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis. Allergy 2018;73(4):765–98.
3. 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):1–52.
4. Halken S, Larenas-Linnemann D, Roberts G, Calderón MA, Angier E, Pfaar Oet al. EAACI guidelines on allergen immunotherapy: Prevention of allergy. Pediatr. Allergy Immunol. 2017;28(8):728–45.
5. 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(3):556–68.
6. Frankland AW. Preseasonal injection treatment in hay fever using aqueous extracts.Int. Arch. Allergy Immunol. 1965;28:1–11.
7. Dhami S, Kakourou A, Asamoah F, Agache I, Lau S, Jutel M et al.Allergen immunotherapy for allergic asthma: A systematic review and meta-analysis. Allergy 2017;72(12):1825–48.
8. Dhami S, Nurmatov U, Arasi S, Khan T, Asaria M, Zaman H et al. Allergen immunotherapy for allergic rhinoconjunctivitis: A systematic review and meta-analysis. Allergy 2017;72(11):1597–631.
9. Kim H-S, Lee S, Kim JH. Real-world Evidence versus Randomized Controlled Trial: Clinical Research Based on Electronic Medical Records. J Korean Med Sci 2018;33(34):e213.
10. Paoletti G, Di Bona D, Chu DK, Firinu D, Heffler E, Agache I et al.Allergen immunotherapy: The growing role of observational and randomized trial ”Real-World Evidence”. Allergy 2021;76(9):2663–72.
11. Flynn R, Plueschke K, Quinten C, Strassmann V, Duijnhoven RG, Gordillo-Marañon M et al. Marketing Authorization Applications Made to the European Medicines Agency in 2018-2019: What was the Contribution of Real-World Evidence? Clin Pharmacol Ther2022;111(1):90–7.
12. Shamji MH, Larson D, Eifan A, Scadding GW, Qin T, Lawson K et al.Differential induction of allergen-specific IgA responses following timothy grass subcutaneous and sublingual immunotherapy. J. Allergy Clin. Immunol. 2021;148(4):1061-1071.e11.
13. Aasbjerg K, Backer V, Lund G, Holm J, Nielsen NC, Holse M et al.Immunological comparison of allergen immunotherapy tablet treatment and subcutaneous immunotherapy against grass allergy. Clin. Exp. Allergy 2014;44(3):417–28.
14. Vogelberg C, Brüggenjürgen B, Richter H, Jutel M. House dust mite immunotherapy in Germany: Real-world adherence to a subcutaneous allergoid and a sublingual tablet. Allergo J. Int.2021;30(5):183–91.
15. Jutel M, Brüggenjürgen B, Richter H, Vogelberg C. Real-world evidence of subcutaneous allergoid immunotherapy in house dust mite-induced allergic rhinitis and asthma. Allergy2020;75(8):2046–54.
16. Schmitt J, Wüstenberg E, Küster D, Mücke V, Serup-Hansen N, Tesch F. The moderating role of allergy immunotherapy in asthma progression: Results of a population-based cohort study. Allergy 2020;75(3):596–602.
17. Vogelberg C, Brüggenjürgen B, Richter H, Jutel M. Real-World Adherence and Evidence of Subcutaneous and Sublingual Immunotherapy in Grass and Tree Pollen-Induced Allergic Rhinitis and Asthma. Patient Prefer Adherence 2020;14:817–27.
18. Devillier P, Molimard M, Ansolabehere X, Bardoulat I, Coulombel N, Maurel F et al. Immunotherapy with grass pollen tablets reduces medication dispensing for allergic rhinitis and asthma: A retrospective database study in France. Allergy 2019;74(7):1317–26.
19. Wahn U, Bachert C, Heinrich J, Richter H, Zielen S. Real-world benefits of allergen immunotherapy for birch pollen-associated allergic rhinitis and asthma. Allergy 2019;74(3):594–604.
20. Allam J-P, Andreasen JN, Mette J, Serup-Hansen N, Wüstenberg EG. Comparison of allergy immunotherapy medication persistence with a sublingual immunotherapy tablet versus subcutaneous immunotherapy in Germany.J. Allergy Clin. Immunol. 2018;141(5):1898-1901.e5.
21. Zielen S, Devillier P, Heinrich J, Richter H, Wahn U. Sublingual immunotherapy provides long-term relief in allergic rhinitis and reduces the risk of asthma: A retrospective, real-world database analysis.Allergy 2018;73(1):165–77.
22. Devillier P, Wahn U, Zielen S, Heinrich J. Grass pollen sublingual immunotherapy tablets provide long-term relief of grass pollen-associated allergic rhinitis and reduce the risk of asthma: Findings from a retrospective, real-world database subanalysis.Expert Rev Clin Immunol 2017;13(12):1199–206.
23. Sieber J, Geest S de, 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(4):855–61.
24. Kiel MA, Röder E, van Gerth Wijk R, Al MJ, Hop WCJ, Rutten-van Mölken MPMH. Real-life compliance and persistence among users of subcutaneous and sublingual allergen immunotherapy. J. Allergy Clin. Immunol.2013;132(2):353-60.e2.
25. Fritzsching B, Contoli M, Porsbjerg C, Buchs S, Larsen JR, Elliott Let al. Long-term real-world effectiveness of allergy immunotherapy in patients with allergic rhinitis and asthma: Results from the REACT study, a retrospective cohort study. Lancet Reg Health Eur 2022;13:100275.
26. Schmitt J, Schwarz K, Stadler E, Wüstenberg EG. Allergy immunotherapy for allergic rhinitis effectively prevents asthma: Results from a large retrospective cohort study. J. Allergy Clin. Immunol.2015;136(6):1511–6.
27. Oyinlola JO, Campbell J, Kousoulis AA. Is real world evidence influencing practice? A systematic review of CPRD research in NICE guidances.BMC Health Serv Res 2016;16:299.
28. Saturni S, Bellini F, Braido F, Paggiaro P, Sanduzzi A, Scichilone N et al. Randomized Controlled Trials and real life studies. Approaches and methodologies: A clinical point of view. Pulm. Pharmacol. Ther.2014;27(2):129–38.
29. Rawlins M. De Testimonio: on the evidence for decisions about the use of therapeutic interventions. Clin Med (Lond). 2008;8(6):579–588.
30. Elliott L, Fidler C, Ditchfield A, Stissing T. Hypoglycemia Event Rates: A Comparison Between Real-World Data and Randomized Controlled Trial Populations in Insulin-Treated Diabetes. Diabetes Ther2016;7(1):45–60.
31. Ankarfeldt MZ, Adalsteinsson E, Groenwold RH, Ali MS, Klungel OH. A systematic literature review on the efficacy-effectiveness gap: Comparison of randomized controlled trials and observational studies of glucose-lowering drugs. Clin Epidemiol. 2017;9:41–51.
32. Nordon C, Karcher H, Groenwold RHH, Ankarfeldt MZ, Pichler F, Chevrou-Severac Het al. The ”Efficacy-Effectiveness Gap”: Historical Background and Current Conceptualization. Value Health 2016;19(1):75–81.
33. Katona L, Bitter I, Czobor P. A meta-analysis of effectiveness of real-world studies of antipsychotics in schizophrenia: Are the results consistent with the findings of randomized controlled trials? Transl Psychiatry 2021;11(1):510.
34. Moran M, Nickens D, Adcock K, Bennetts M, Desscan A, Charnley N et al.Sunitinib for Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-Analysis of Real-World and Clinical Trials Data. Target Oncol 2019;14(4):405–16.
35. Framework for FDA’s real world evidence program [Internet]. Available from: https://www.fda.gov/media/120060/download.
36. Baumfeld Andre E, Reynolds R, Caubel P, Azoulay L, Dreyer NA. Trial designs using real-world data: The changing landscape of the regulatory approval process. Pharmacoepidemiol Drug Saf. 2020;29(10):1201–12.
37. Bozek A, Cudak A, Canonica GW. Long-term efficacy of injected allergen immunotherapy for treatment of grass pollen allergy in elderly patients with allergic rhinitis. Allergy Asthma Proc. 2020;41:271–7.
38. Bozek A, Foks A, Trzaska K, Canonica GW. Long-term effects of allergen sublingual immunotherapy. Adv Dermatol Allergol2020;37(6):943–7.
39. Durham SR, Emminger W, Kapp A, Monchy JGR de, 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(3):717-725.e5.
40. Didier A, Malling H-J, 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):12.
41. Valovirta E, Petersen TH, Piotrowska T, Laursen MK, Andersen JS, Sørensen HFet 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(2):529-538.e13.
42. Dominicus R. 3-years’ long-term effect of subcutaneous immunotherapy (SCIT) with a high-dose hypoallergenic 6-grass pollen preparation in adults.Allerg. Immunol. (Paris) 2012;44(3):135–40.
43. Passalacqua G, Bagnasco D. Real-life studies in allergen immunotherapy. Curr. Opin. Allergy Clin. Immunol. 2021;21:361–7.
44. Bachert C, Larche M, Bonini S, Canonica GW, Kundig T, Larenas-Linnemann Det al. Allergen immunotherapy on the way to product-based evaluation-a WAO statement. World Allergy Organ. J.2015;8(1):29–78.
45. Burden A, Roche N, Miglio C, Hillyer EV, Postma DS, Herings RM et al. An evaluation of exact matching and propensity score methods as applied in a comparative effectiveness study of inhaled corticosteroids in asthma.Pragmat Obs Res. 2017;8:15–30.
46. Kuss O, Blettner M, Börgermann J. Propensity Score - An Alternative Method of Analyzing Treatment Effects. Dtsch Arztebl Int.2016;113(35-36):597–603.
47. Worm M, Rak S, Samoliński B, Antila J, Höiby A-S, Kruse B et al.Efficacy and safety of birch pollen allergoid subcutaneous immunotherapy: A 2-year double-blind, placebo-controlled, randomized trial plus 1-year open-label extension. Clin. Exp. Allergy2019;49(4):516–25.
48. Zielen S, Kardos P, Madonini E. Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: A randomized controlled trial.J. Allergy Clin. Immunol. 2010;126(5):942–9.
49. Menditto E, Costa E, Midão L, Bosnic-Anticevich S, Novellino E, Bialek S et al. Adherence to treatment in allergic rhinitis using mobile technology. The MASK Study. Clin. Exp. Allergy2019;49(4):442–60.
50. Bédard A, Basagaña X, Anto JM, Garcia-Aymerich J, Devillier P, Arnavielhe S et al. Mobile technology offers novel insights into the control and treatment of allergic rhinitis: The MASK study. J. Allergy Clin. Immunol. 2019;144(1):135-143.e6.
51. Linneberg A, Dam Petersen K, Hahn-Pedersen J, Hammerby E, Serup-Hansen N, Boxall N. Burden of allergic respiratory disease: A systematic review.Clin Mol Allergy. 2016;14:12.
52. Brüggenjürgen B, Reinhold T. Cost-effectiveness of grass pollen subcutaneous immunotherapy (SCIT) compared to sublingual immunotherapy (SLIT) and symptomatic treatment in Austria, Spain, and Switzerland. J. Med. Econ. 2018;21(4):374–81.
53. Green W, Kleine-Tebbe J, Klimek L, Hahn-Pedersen J, Nørgaard Andreasen J, Taylor M. Cost-effectiveness of SQ(®) HDM SLIT-tablet in addition to pharmacotherapy for the treatment of house dust mite allergic rhinitis in Germany. Clinicoecon. Outcomes Res. 2017;9:77–84.
54. Reinhold T, Brüggenjürgen B. Cost-effectiveness of grass pollen SCIT compared with SLIT and symptomatic treatment. Allergo J. Int.2017;26(1):7–15.
55. Verheggen BG, Westerhout KY, Schreder CH, Augustin M. Health economic comparison of SLIT allergen and SCIT allergoid immunotherapy in patients with seasonal grass-allergic rhinoconjunctivitis in Germany. Clin. Transl. Allergy 2015;5(1):1.
56. 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(5):906–17.
57. Keiding H, Jørgensen KP. A cost-effectiveness analysis of immunotherapy with SQ allergen extract for patients with seasonal allergic rhinoconjunctivitis in selected European countries. Curr. Med. Res. Opin.2007;23(5):1113–20.
58. Brüggenjürgen B, Klimek L, Reinhold T. Real world effectiveness and cost consequences of grass pollen SCIT compared with SLIT and symptomatic treatment.Allergo J Int 2021;30(6):198–206.
59. Di Bona D, Bilancia M, Albanesi M, Caiaffa MF, Macchia L. Cost-effectiveness of grass pollen allergen immunotherapy in adults.Allergy 2020;75(9):2319–29.
60. Cox LS, Murphey A, Hankin C. The Cost-Effectiveness of Allergen Immunotherapy Compared with Pharmacotherapy for Treatment of Allergic Rhinitis and Asthma. Immunol Allergy Clin N Am 2020;40(1):69–85.