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SUBLINGUAL IMMUNOTHERAPY Giovanni Passalacqua

SUBLINGUAL IMMUNOTHERAPY Giovanni Passalacqua. Allergy & Respiratory Diseases Dept.Internal Medicine- University of Genoa ITALY. THE LITERATURE. 66 RDBPC TRIALS 8 RANDOMIZED OPEN TRIALS 6 COMPARATIVE (SLIT vs SCIT) 6 TRIALS IN OTHER DISEASES. 67%. 20. 10. grass. birch. parietaria.

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SUBLINGUAL IMMUNOTHERAPY Giovanni Passalacqua

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  1. SUBLINGUAL IMMUNOTHERAPY Giovanni Passalacqua Allergy & Respiratory Diseases Dept.Internal Medicine- University of Genoa ITALY

  2. THE LITERATURE 66 RDBPC TRIALS 8 RANDOMIZED OPEN TRIALS 6 COMPARATIVE (SLIT vs SCIT) 6 TRIALS IN OTHER DISEASES

  3. 67% 20 10 grass birch parietaria cat other ragweed HDM cypress

  4. TREATMENT DURATION Less or equal 6 months: 23 studies Less or equal 12 months: 15 studies More than 12 months: 20 studies PATIENTS ENROLLED < 20 : 4 studies < 50 : 21 studies < 100 : 16 studies < 150 : 11 studies > 150 : 8 studies

  5. 10 STUDIES WITH SAMPLE SIZE CALCULATION Durham 2006 De Blay, 2007 Dahl 2006 Pfaar 2008 Pham Ti 2007 Wahn 2009 Roder 2006 Ott 2009 Didier 2007 Bufe 2009 Skoner 2010 Cortellini 2010

  6. Sublingual immunotherapy with once-dailygrass allergen tablets: A randomized controlled trial in seasonal allergic rhinoconjunctivitis Durham SR, JACI 2006

  7. Prolonged preseasonal treatment with Grazax improves the clinical efficacy Calderon M et al, Allergy 2007

  8. Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis. Dahl et al, JACI 2006 VERSUS PLACEBO: SYMPTOM REDUCTION - 30% MEDICATION REDUCTION - 38% 634 PATIENTS !!!

  9. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis Wahn 2009 • VS PLACEBO • Symptoms • 28% (-39%) • Medications • - 24% (-48%)

  10. VS PLACEBO • Symptoms • 34% to –44%

  11. VS PLACEBO Symptoms -24% Medications - 34%

  12. 21 trials Sublingual immunotherapy for allergic rhinitis.Allergy, 2005. Wilson D., Torres Lima I, Durham S.

  13. Efficacy of sublingual immunotherapy in the treatment of allergic rhinitis in pediatric patients: Meta-analysis of randomized controlled trials. Martin Penagos, Enrico Compalati, Francesco Tarantini, Rodrigo Baena Cagnani, Jose Huerta Lopez, Giovanni Passalacqua and Giorgio Walter Canonica 2006

  14. Meta-analysis of the efficacy of sublingual immunotherapy in allergic asthma in pediatric patients, 3 to 18 years of age. M Penagos, G Passalacqua, E Compalati, C Baena-Cagnani, S Orozco, A Pedroza GW Canonica

  15. ARIA Update on immunotherapy SR Durham and G.Passalacqua JACI 2007 in press

  16. SCIT SLIT SLIT SLIT SCIT SLIT SLIT Meta analisi: sintomi A = adults C = children Specific immunotherapy for respiratory allergy: state of the art according to current meta-analyses. Compalati E et al, Ann Allergy Asthma Immunol 2009

  17. 49 (OUT OF 60) RDBPC TRIALS SUITABLE FOR POOLING: 2333 SLIT 2256 PLACEBO

  18. SYMPTOM SCORE

  19. MEDICATION SCORE

  20. Symptom Score Rhintis

  21. JACI 2010

  22. SLIT No fatal event reported since 1986

  23. Author, year Sex (age) Allergen (producer) Phase Onset Description Epinephrine De Groot, 2009 M (13) Grass (Grazax, ALK-Abellò) First dose 15 min Generalized urticaria, swelling of tongue NO De Groot, 2009 F (27) Grass (Grazax, ALK-Abellò) First dose 5 min Abdominal cramps, asthma, generalized itching, hypotension YES Blazowski, 2008 F (16) HDM (Staloral, Stallergenes) Maintenance overdose (60 drops) 10 min Hypotension-collapse, flushing, urticaria YES Eifan, 2008 F (11) dust mite + grass pollen mix (Stallergenes) Maintenance. 3 min Abdominal pain, chest pain, fever, nausea Not specified Dunski, 2006 F (31) Alternaria, cat, dog grass, ragweed, (Greer) 2nd day of updosing 5 min Angioedema, dizziness, dyspnea, generalized itching NO Antico, 2006 F (36) Latex End of rush buildup 10 min Asthma, generalized urticaria Not specified Anaphylaxis with SLIT

  24. Cox L, Linneman D, Nolte H, Weldon D, Finegold I, Nelson HS. Sublingual immunotherapy: A comprehensive review. J Allergy Clin Immunol 2006; 117: 1021-35 In 41 studies with information on the total number of AEs, 1047 adverse reactions in a total of 386,149 doses were identified (2.7 reactions/1,000 doses). In 49 studies with information on the number of patients, the AEs were 529 per 4378 patients (12%). In the trials that specified the severity of reaction, the occurrence of severe AE was 0.56 per 1,000 doses. Overall, 14 serious AEs probably related to the treatment were found.

  25. SLIT: POST MARKETING SURVEYS

  26. SINGLE ALLERGEN n (%) MULTI ALLERGENS n (%) Grass 140 (82) Grass + pariet 6 (2) Parietaria 4 (3) Grass+ olive 18 (7) Birch 14 (9) Grass + birch +alder+hazelnut 220 (87) Ragweed 4 (3) Grass + ragweed 9 (4) Olive - Grass + mugwort Birch+hazelnut +alder TOTAL 172 (100) 253 (100) THE SAFETY OF SUBLINGUAL IMMUNOTHERAPY WITH ONE OR MORE ALLERGENS IN CHILDREN Fabio Agostinis, Marcello Cottini, Carlo Lombardi, Giorgio Walter Canonica, Giovanni Passalacqua ,Allergy 2008 in press 415 children, 3-18 years, 272 male

  27. Coseasonal SLIT reduces the development of asthma in children with allergic rhinitis. Novembre E. et al, JACI 2004 NO ASTHMA ASTHMA 37 26 79 children Allergic rhinitis only Follow-up: 3 yrs 18 8 SLIT NO SLIT

  28. PREVENTIVE EFFECTS OF SUBLINGUAL IMMUNOTHERAPY IN CHILDHOOD. AN OPEN RANDOMIZED CONTROLLED STUDY MAURIZIO MAROGNA MD1 , D.TOMASSETTI1, A. BERNASCONI1, F.COLOMBO1, ALESSANDRO MASSOLO BS2, A. DI RIENZO BUSINCO4, GIORGIO W CANONICA MD3, GIOVANNI PASSALACQUA MD3 AND SALVATORE TRIPODI MD4 1Pneumology Unit, Cuasso al Monte, Macchi Hospital Foundation, Varese 2 Department of Animal Biology, University of Pavia, Pavia 3 Allergy & Respiratory Diseases,Department of Internal Medicine, Genoa University 4Pediatric Allergy Unit, S. Pertini Hospital, Rome AAAI 2008, 101: 261

  29. 14 dropout 144 SLIT 130 SLIT 216 PATIENTS 6 dropout 72 CONTROLS 66 CONT Diary card * * * * * * * * Visit * * Skin test * * MCh challenge Year 1 Year 2 Year 3 1 year BASELINE RANDOMIZED PHASE

  30. MONOSENSITIZED PATIENTS 70 *** 60 *** 50 40 % PATIENTS 30 20 10 baseline 3rd year SLIT PERSISTENT ASTHMA 70 60 *** 50 40 *** % PATIENTS 30 20 NS 10 baseline 3rd year CONTROLS

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