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ALLERGEN-SPECIFIC IMMUNOTHERAPY IN CHILDREN. STANDARDIZING THE EFFICACY EVALUATION APPROACHES

https://doi.org/10.15690/pf.v12i2.1280

Abstract

The article is concerned with the issue of a standardized approach to determining the effectiveness of allergen-specific therapy (AST) in children. AST has a special role in treating allergy: only this method can induce clinical and immunological tolerance to the cause-significant allergen; is safe enough and highly effective; reduces the duration of acute conditions; reduces the necessity for both basic therapy medicines and additional symptomatic therapy; is capable of preventing the progression of allergic diseases by reducing the sensibility spectre and the formation of bronchial asthma in those suffering from allegic rhinitis; improves the control over the disease and has a positive effect on the patient’s and his family quality of life. At the moment evaluating the effectiveness of medical technologies is one of the most important tasks in medicine while the effectiveness and safety of any medical intervention should be obtained in accordance with the requirements of evidence-based medicine. In order to determine the effectiveness of AST in children, a combined clinical and pharmaceutical evaluation should be performed and as a secons point — determine the patient’s life quality and also evaluate the gravity of symptoms according to the visual analogue scale, and to count the number of days with the symptoms and without them. 

 

 

About the Authors

E. A. Vishneva
Scientific Center of Children’s Health, Russia
Russian Federation


L. S. Namazova-Baranova
Scientific Center of Children’s Health, Russia
Russian Federation


A. A. Alekseeva
Scientific Center of Children’s Health, Russia
Russian Federation


K. E. Efendieva
Scientific Center of Children’s Health, Russia
Russian Federation


Yu. G. Levina
Scientific Center of Children’s Health, Russia
Russian Federation


A. Yu. Tomilova
Scientific Center of Children’s Health, Russia
Russian Federation


N. I. Voznesenskaya
Scientific Center of Children’s Health, Russia
Russian Federation


K. S. Volkov
Scientific Center of Children’s Health, Russia
Russian Federation


V. A. Barannik
Scientific Center of Children’s Health, Russia
Russian Federation


O. I. Muradova
Scientific Center of Children’s Health, Russia
Russian Federation


L. R. Selimzyanova
Scientific Center of Children’s Health, Russia
Russian Federation


E. A. Dobrynina
Scientific Center of Children’s Health, Russia
Russian Federation


E. A. Promyslova
Scientific Center of Children’s Health, Russia
Russian Federation


References

1. Global atlas of allergy. Editors: Cezmi A. Akdis, Ioana Agache. Published by the European Academy of Allergy and Clinical Immunology. 2014. 388 p.

2. Ant K., Pearce N., Anderson H.R., Ellwood P., Montefort S., Shah J. Global map of the prevalence of symptoms of rhinoconjunctivitis in children. The International Study of Asthma and Allergies in Childhood ISAAC Phase Three. Allergy. 2009; 64: 123–148.

3. Allergiya u detei: ot teorii — k praktike. Pod red. L.S. Namazovoi-Baranovoi [Allergies in Children: from Theory - to Practice. Ed. by L.S. Namazova-Baranova]. Moscow, Soyuz pediatrov Rossii, 2010–2011. 668 p.

4. Roberts G., Xatzipsalti M., Borrego L.M., Custovic A., Halken S., Hellings P.W., Papadopoulos N.G., Rotiroti G., Scadding G., Timmermans F., Valovirta E. Paediatric rhinitis: position paper of the European Academy of Allergy and Clinical Immunology. Allergy. 2013; 68: 1102–1116.

5. Vishneva E.A., Namazova-Baranova L.S., Alekseeva A.A., Efendieva K.E., Levina Yu.G., Voznesenskaya N.I., Tomilova A.Yu., Muradova O.I., Selimzyanova L.R., Promyslova E.A. Modern principles of treatment of allergic rhinitis in children. Pediatricheskaya farmakologiya = Pediatric pharmacology. 2014; 11 (1): 6−14.

6. Kurbacheva O.M., Pavlova K.S., Kozulina I.E. Allergen immunotherapy: history, methods and opportunities. Meditsinskii sovet = Medical recommendation. 2013; 3−2: 10−19.

7. Federal'nye klinicheskie rekomendatsii po provedeniyu allergenspetsificheskoi immunoterapii (Federal clinical recommendations for allergen immunotherapy). RAAKI, 2013. 14 p. Available at: http://www.raaci.ru/ClinRec/7.ASIT.pdf

8. Pfaar O., Demoly P., Gerth van Wijk R., Bonini S., Bousquet J., Canonica G.W., Durham S.R., Jacobsen L., Malling H.J., Mosges R., Papadopoulos N.G., Rak S., Rodriguez del Rio P., Valovirta E., Wahn U., Calderon M.A. Recommendations for the standardization of clinical outcomes used in allergen immunotherapy trials for allergic rhinoconjunctivitis: an EAACI Position Paper. Allergy. 2014; 69: 854–867.

9. Bousquet J., Khaltaev N., Cruz A.A., Denburg J., Fokkens W.J., 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 (Suppl. 86): 8–160.

10. European Medicines Agency. (CHMP). Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases. Committee for Medicinal Products for Human Use. 2008.

11. Canonica G.W., Baena-Cagnani C.E., Bousquet J., Bousquet P.J., Lockey R.F., Malling H.J. et al. 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: 317–324.

12. Clark J., Schall R. Assessment of combined symptom and medication scores for rhinoconjunctivitis immunotherapy clinical trials. Allergy. 2007; 62: 1023–1028.

13. Wilson A.M., O’Byrne P.M., Parameswaran K. Leukotriene receptor antagonists for allergic rhinitis: a systematic review and meta-analysis. Am J Med. 2004; 116: 338–344.

14. 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: 182–188.

15. 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: 281–286.

16. Juniper E.F., Guyatt G.H. Development and testing of a new measure of health status for clinical trials in rhinoconjunctivitis. Clin Exp Allergy. 1991; 21: 77–83.

17. Juniper E.F., Thompson A.K., Ferrie P.J., Roberts J.N. Validation of the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire. J Allergy Clin Immunol. 1999; 104: 364–369.

18. Juniper E.F., Thompson A.K., Ferrie P.J., Roberts J.N. Development and validation of the mini Rhinoconjunctivitis Quality of Life Questionnaire. Clin Exp Allergy. 2000; 30: 132–140.

19. Juniper E.F., Howland W.C., Roberts N.B., Thompson A.K., King D.R. Measuring quality of life in children with rhinoconjunctivitis. J Allergy Clin Immunol. 1998; 101: 163–170.

20. Juniper E.F., Guyatt G.H., Dolovich J. Assessment of quality of life in adolescents with allergic rhinoconjunctivitis: development and testing of a questionnaire for clinical trials. J Allergy Clin Immunol. 1994; 93: 413–423.

21. Baiardini I., Pasquali M., Giardini A., Specchia C., Passalacqua G., Venturi S. et al. Rhinasthma: a new specific QoL questionnaire for patients with rhinitis and asthma. Allergy. 2003; 58: 289–294.

22. Sieber J., Gross A., Shah-Hosseini K., Mosges R. The RHINASTHMA GAV scores without SLIT, at the beginning and at the end of seasonal SLIT. Asian Pac J Allergy Immunol. 2010; 28: 232–236.

23. Braido F., Baiardini I., Stagi E., Scichilone N., Rossi O., Lombardi C. et al. Rhin Asthma patient perspective: a short daily asthma and rhinitis QoL assessment. Allergy. 2012; 67: 1443–1450.

24. Bousquet P.J., Combescure C., Klossek J.M., Daures J.P., Bousquet J. Change in visual analog scale score in a pragmatic randomized cluster trial of allergic rhinitis. J Allergy Clin Immunol. 2009; 123: 1349–1354.

25. Langley G.B., Sheppeard H. The visual analogue scale: its use in pain measurement. Rheumatol Int. 1985; 5: 145–148.

26. Demoly P., Bousquet P.J., Mesbah K., Bousquet J., Devillier P. Visual analogue scale in patients treated for allergic rhinitis: an observational prospective study in primary care: asthma and rhinitis. Clin Exp Allergy. 2013; 43: 881–888.

27. Worm M. «Well days» after sublingual immunotherapy with a high-dose 6-grass pollen preparation. Allergy. 2009; 64: 1104–1105.

28. 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, placebocontrolled study. J Allergy Clin Immunol. 2012; 130: 886–893.

29. Durham S.R., Yang W.H., Pedersen M.R., 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: 802–809.

30. Dahl R., Stender A., Rak S. Specific immunotherapy with SQ standardized grass allergen tablets in asthmatics with rhinoconjunctivitis. Allergy. 2006; 61: 185–190.

31. Dahl R., Kapp A., Colombo G., de Monchy J.G., Rak S., Emminger W. et al. Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2006; 118: 434–440.

32. Bufe A., Eberle P., Franke-Beckmann E., Funck J., Kimmig M., Klimek L. et al. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. J Allergy Clin Immunol. 2009; 123: 167–173.

33. Didier A., Malling H.J., 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: 1338–1345.

34. Durham S.R., Birk A.O., Andersen J.S. Days with severe symptoms: an additional efficacy endpoint in immunotherapy trials. Allergy. 2011; 66: 120–123.

35. Durham S.R., Emminger W., Kapp A., de Monchy J.G., Rak S., Scadding G.K. 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: 717–725.

36. Justicia J.L., Cardona V., Guardia P., Ojeda P., Olaguibel J.M., Vega J.M. et al. Validation of the first treatment-specific questionnaire for the assessment of patient satisfaction with allergen-specific immunotherapy in allergic patients: the ESPIA questionnaire. J Allergy Clin Immunol. 2013; 131: 1539–1546.

37. Franzke N., Schafer I., Jost K., Blome C., Rustenbach S.J., Reich K. et al. A new instrument for the assessment of patientdefined benefit in the treatment of allergic rhinitis. Allergy. 2011; 66: 665–670.

38. Nogueira-Silva L., Martins S.V., Cruz-Correia R., Azevedo L.F., Morais-Almeida M., Bugalho-Almeida A. et al. Control of allergic rhinitis and asthma test ― a formal approach to the development of a measuring tool. Respir Res. 2009; 10: 52.

39. Fonseca J.A., Nogueira-Silva L., Morais-Almeida M., Sa-Sousa A., Azevedo L.F., Ferreira J. et al. Control of Allergic Rhinitis and Asthma Test (CARAT) can be used to assess individual patients over time. Clin Transl Allergy. 2012; 2: 16.

40. Nathan R.A., Dalal A.A., Stanford R.H., Meltzer E.O., Schatz M., Derebery J. et al. Qualitative Development of the Rhinitis Control Assessment Test (RCAT), an Instrument for Evaluating Rhinitis Symptom Control. Patient. 2010; 3: 91–99.

41. Demoly P., Jankowski R., Chassany O., Bessah Y., Allaert F.A. Validation of a self-questionnaire for assessing the control of allergic rhinitis. Clin Exp Allergy. 2011; 41: 860–868.

42. Dreborg S., Frew A. Allergen standardization and skin tests. EAACI Position paper. Allergy. 1993; 48 (Suppl. 44): 49–82.

43. Malling H.-J., Weeke B. Immunotherapy. Position Paper of the European Academy of Allergology and Clinical Immunology (EAACI). Allergy. 1993; 48 (Suppl. 14): 9–35.

44. Francis J.N., James L.K., Paraskevopoulos G., Wong C., Calderon M.A., Durham S.R. et al. Grass pollen immunotherapy: IL-10 induction and suppression of late responses precedes IgG4 inhibitory antibody activity. J Allergy Clin Immunol. 2008; 121: 1120–1125.

45. Des Roches A., Paradis L., Knani J., Hejjaoui A., Dhivert H., Chanez P. et al. Immunotherapy with a standardized Dermatophagoides pteronyssinus extract. V. Duration of the efficacy of immunotherapy after its cessation. Allergy. 1996; 51: 430–433.

46. Bousquet J., Maasch H., Martinot B., Hejjaoui A., Wahl R., Michel F.B. 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: 439–446.

47. Horst M., Hejjaoui A., Horst V., Michel F.B., Bousquet J. Double-blind, placebo-controlled rush immunotherapy with a standardized Alternaria extract. J Allergy Clin Immunol. 1990; 85: 460–472.

48. Corrigan C.J., Kettner J., Doemer C., Cromwell O., Narkus A. Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid. Allergy. 2005; 60: 801–807.

49. Frew A.J., Powell R.J., Corrigan C.J., Durham S.R. Efficacy and safety of specific immunotherapy with SQ allergen extract in treatment-resistant seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2006; 117: 319–325.

50. Kuna P., Kaczmarek J., Kupczyk M. Efficacy and safety of immunotherapy for allergies to Alternaria alternata in children. J Allergy Clin Immunol. 2011; 127: 502–508.

51. Moller C., Dreborg S., Ferdousi H.A., Halken S., Host A., Jacobsen L. et al. Pollen immunotherapy reduces the development of asthma in children with seasonal rhinoconjunctivitis (the PAT-study). J Allergy Clin Immunol. 2002; 109: 251–256.

52. DuBuske L.M., Frew A.J., Horak F., Keith P.K., Corrigan C.J., Aberer W. et al. Ultrashort-specific immunotherapy successfully treats seasonal allergic rhinoconjunctivitis to grass pollen. Allergy Asthma Proc. 2011; 32: 239–247.

53. Pfaar O., Urry Z., Robinson D.S., Sager A., Richards D., Hawrylowicz C.M. et al. A randomized placebo-controlled trial of rush preseasonal depigmented polymerized grass pollen immunotherapy. Allergy. 2012; 67: 272–279.

54. Pfaar O., Kleine-Tebbe J., Hormann K., Klimek L. Allergen-specific immunotherapy: which outcome measures are useful in monitoring clinical trials? Immunol Allergy Clin North Am. 2011; 31: 289–309.


Review

For citations:


Vishneva E.A., Namazova-Baranova L.S., Alekseeva A.A., Efendieva K.E., Levina Yu.G., Tomilova A.Yu., Voznesenskaya N.I., Volkov K.S., Barannik V.A., Muradova O.I., Selimzyanova L.R., Dobrynina E.A., Promyslova E.A. ALLERGEN-SPECIFIC IMMUNOTHERAPY IN CHILDREN. STANDARDIZING THE EFFICACY EVALUATION APPROACHES. Pediatric pharmacology. 2015;12(2):173-179. https://doi.org/10.15690/pf.v12i2.1280

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