Farmacoriflessioni
L’immunoterapia sublinguale puň sostituire quella iniettiva nel trattamento delle malattie allergiche respiratorie?
CAN SUBLINGUAL IMMUNOTHERAPY SUBSTITUTE SUBCUTANEOUS INJECTIVE IMMUNOTHERAPY FOR THE TREATMENT OF RESPIRATORY ALLERGIC DISEASES?
DANIELE RADZIK
UO di Pediatria, Ospedale di Castelfranco Veneto (TV)
Febbraio 2006 - pagg. 104 -110
Abstract
Subcutaneous injective immunotherapy (SCIT) has been used for almost 100 years for the treatment of respiratory allergic diseases, with many data available on this topic. SCIT remains however rather controversial because, even if its effects persist after its discontinuation, there is no evidence that the natural history of the disease could be modified in adulthood. Moreover SCIT does not provide any additional clinical advantage when associated to a correct pharmacological treatment. Therefore the decision to start this type of therapy should be taken evaluating the risk-cost/benefit ratio of each single patient. In order to provide a more comfortable use and enhanced safety, sublingual immunotherapy (SLIT) was recently developed and is now commonly adopted, although its clinical efficacy in particular in comparison to SCIT is not fully established. To tackle this issue, all randomized controlled trials comparing SLIT vs SCIT were reviewed. Three trials conducted in adult populations were identified and they demonstrated the equivalence of SLIT vs. SCIT. However, only one trial had appropriate randomization while the other 2 had uncertain treatment allocation. Hence, the validity of the results is questionable given the significant methodological biases found.
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Bibliografia
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28. Mungan D, Misirligil Z, Gurbuz L. Comparison of the efficacy of subcutaneous and sublingual immunotherapy in mite sensitive patients with rhinitis and asthma: a placebo controlled study. Ann Allergy Asthma Immunol 1999;82:485-90.
29. Quirino T, Iemoli E, Siciliani E, Parmiani S. Sublingual vs injective immunotherapy in grass pollen allergic patients: a double blind double dummy study. Clin Exp Allergy 1996; 26:1253-61.
30. Bernardis P, Agnoletto M, Puccinelli P, Parmiani S, Pozzan M. Injective vs sublingual immunotherapy in Alternaria tenuis allergic patients. J Invest Allergol Clin Immunol 1996; 6:55-62.
31. Ongari S, Domeneghetti P, Parmiani S. Comparison among drugs, injective IT and sublingual IT in grass allergic patients. Allergy 1995;50:358.
32. Piazza I, Bizzarro N. Humoral response to subcutaneous, oral and nasal immunotherapy for allergic rhinitis due to Dermatophagoides pteronyssinus. Ann Allergy 1993;71:461-9.
33. Altman DG, Schultz F. Concealing treatment allocation in randomised trials. BMJ 2001;323:446-7.
34. Mills JL. Data torturing. N Engl J Med 1993;329:1196-9.
35. Roberts C, Torgerson D. Randomisation methods in controlled trials. BMJ 1998;317: 1301-10.
36. Schulz KF, Chalmers I, Hayes RJ. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatement effects in controlled trials. JAMA 1995; 273:408-12.
2. Till SJ, Francis JN, Nouri-Aria K, Durham SR. Mechanism of immunotherapy. J Allergy Clin Immunol 2004;113(6):1025-34.
3. Moller C, Dreborg S, Ferdousi HA, Halken S, Host A, Jacobsen L. Pollen immunotherapy reduces the development of asthma in children with seasonal rhinoconjunctivitis (the PAT Study). J Allergy Clin Immunol 2002; 109: 251-6.
4. Des-Roches A, Paradis L, Menardo JL, Bouges S, Daures JP, Bousquet J. Immunotherapy with a standardized Dermatophagoides pteronyssinus extract. Specific immunotherapy prevent the onset of new sensitizations in children. J Allergy Clin Immunol 1997;99:450-3.
5. Pajno GB, Barberio G, De Luca F, Morabito L, Parmiani S. Prevention of new sensitizations in asthmatic children monosensitized to house dust mite by specific immunotherapy. A sixyear follow-up study. Clin Exp Allergy 2001; 31:1392-7.
6. Des-Roches A, Paradis L, Knani J, Hejjaoui A, Dhivert H, Chanez P. Immunotherapy with a standardized Dermatophagoides pteronyssinus extract. Duration of the efficacy of immunotherapy after its cessation. Allergy 1996; 51:430-3.
7. Durham SR, Walker SM, Varga EM, Jacobson MR, O’Brien F, Noble W. Long term clinical efficacy of grass-pollen immunotherapy. N Engl J Med 1999;341:468-75.
8. Bousquet J, Lockey R, Malling H-J. WHO position paper. Allergen immunotherapy: therapeutic vaccines for allergic diseases. Allergy 1998;53(Suppl.44):1-42.
9. Bousquet J, van Cauwenberge P, Khaltaev N, Aria Workshop Group, World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol 2001;108 (Suppl.5);S147-S334.
10. Centro Studi Assobiomedica. Il vaccino antiallergico (l’immunoterapia allergene specifica). Secondo aggiornamento, numero 18; settembre 2004.
11. Limb SL, Brown KC, Wood RA, et al. Adult asthma severity in individuals with a history of childhood asthma. J Allergy Clin Immunol 2005;115(1):61-6.
12. Calvo M, Marin F, Grob K, et al. Ten-year follow-up in pediatric patients with allergic bronchial asthma: evaluation of specific immunotherapy. J Investig Allergol Clin Immunol 1994;4(3):126-31.
13. Adkinson NF, Eggleston PA, Eney D, et al. A controlled trial of immunotherapy for asthma in allergic children. N Engl J Med 1997;336 (5):324:31.
14. Pajno GB, Vita D, Parmiani S, Caminiti L, La Grutta S, Barberio G. Impact of sublingual immunotherapy on seasonal asthma and skin reactivity in children allergic to Parietaria pollen treated with inhaled fluticasone propionate. Clin Exp Allergy 2003;33(12):1641-7.
15. Hedlin G, Wille S, Browaldh L, et al. Immunotherapy in children with allergic asthma: effect on bronchial hyperreactivity and pharmacotherapy. J Allergy Clin Immunol 1999; 103(4):609-14.
16. Maestrelli P, Zanolla L, Pozzan M, Fabbri LM. Effect of specific immunotherapy added to pharmacologic treatment and allergen avoidance in asthmatic patients allergic to house dust mite. J Allergy Clin Immunol 2004;113 (4):643-9.
17. Passalacqua G, Canonica GW. Sublingual or injection immunotherapy: the final answer? Allergy 2004;59:37-8.
18. WHO Position Paper. Allergen immunotherapy: therapeutic vaccines for allergic diseases. Allergy 1998;53(suppl):1-42.
19. Gidaro GB, Marcucci F, Sensi L, Incorvaia C, Frati F, Ciprandi G. The safety of sublingualswallow immunotherapy: an analysis of published studies. Clin Exp Allergy 2005;35 (5):565- 71.
20. Miceli Sopo S, Macchiaolo M, Zorzi G, Tripodi S. Sublingual immunotherapy in asthma and rhinoconjunctivitis: systematic review of paediatric literature. Arch Dis Child 2004;89 (7):620-4.
21. Wilson DR, Torres LI, Durnham SR. Sublingual immunotherapy for allergic rhinitis. Cochrane Database Syst Rev 2003;(2):CD 002893.
22. Reider N. Sublingual immunotherapy for allergic rhinoconjunctivitis: the seeming and the real. Int Arch Allergy Immunol 2005;137: 181-6.
23. Frati F, Sensi L, Di Cara G, Incorvaia C, Marcucci F. Immunoterapia sublinguale: dal meccanismo d’azione alle evidenze cliniche. Pneumologia Pediatrica 2005;18:33-6.
24. Frati F, Sensi L, Di Cara G, Incorvaia C, Marcucci F. L’immunoterapia sublinguale: efficacia, sicurezza e meccanismo d’azione. Area Pediatrica 2005;9(6):8-12.
25. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel- group randomised trials. Lancet 2001; 357:1191-4.
26. Guyatt G, Rennis D (Eds). User’s guide to the medical literature. A manual for evidencebased medical practice. The Evidence-Based Medicine Working Group, JAMA and Archives Journal, American Medical Association, 2002.
27. Khinchi MS, Poulsen LK, Carat F, André C, Hansen AB, Malling HJ. Clinical efficacy of sublingual and subcutaneous birch pollen allergen- specific immunotherapy: a randomized, placebo-controlled, double-dummy study. Allergy 2004;59:45-53.
28. Mungan D, Misirligil Z, Gurbuz L. Comparison of the efficacy of subcutaneous and sublingual immunotherapy in mite sensitive patients with rhinitis and asthma: a placebo controlled study. Ann Allergy Asthma Immunol 1999;82:485-90.
29. Quirino T, Iemoli E, Siciliani E, Parmiani S. Sublingual vs injective immunotherapy in grass pollen allergic patients: a double blind double dummy study. Clin Exp Allergy 1996; 26:1253-61.
30. Bernardis P, Agnoletto M, Puccinelli P, Parmiani S, Pozzan M. Injective vs sublingual immunotherapy in Alternaria tenuis allergic patients. J Invest Allergol Clin Immunol 1996; 6:55-62.
31. Ongari S, Domeneghetti P, Parmiani S. Comparison among drugs, injective IT and sublingual IT in grass allergic patients. Allergy 1995;50:358.
32. Piazza I, Bizzarro N. Humoral response to subcutaneous, oral and nasal immunotherapy for allergic rhinitis due to Dermatophagoides pteronyssinus. Ann Allergy 1993;71:461-9.
33. Altman DG, Schultz F. Concealing treatment allocation in randomised trials. BMJ 2001;323:446-7.
34. Mills JL. Data torturing. N Engl J Med 1993;329:1196-9.
35. Roberts C, Torgerson D. Randomisation methods in controlled trials. BMJ 1998;317: 1301-10.
36. Schulz KF, Chalmers I, Hayes RJ. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatement effects in controlled trials. JAMA 1995; 273:408-12.