RECOMMENDATIONS FOR APPROPRIATE SLIT TRIALS
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1 RECOMMENDATIONS FOR APPROPRIATE SLIT TRIALS Giovanni Passalacqua Allergy & Respiratory Diseases Dept.Internal MedicineIRCCS S.Martino IST University of Genoa ITALY CHICAGO-WAO-2013
2 ISHIZAKA NOON UK CSM 1986 Randomized trials EMPIRICAL USE IgE ROMAGNANI Allergoids SLIT 1986 Th1/Th2 Peptides Mechanisms Recombinants WHO Pos Pap Liposomes Adjuvants DURHAM DNAITS ILIT EPIT 2012
3 Where does IT preferentially works? INFLAMMATION IgE REACTION Hymenoptera Allergy Seasonal rhinitis Food Allergy Atopic dermatitis Perennial rhinitis Asthma
4 Factors to be evaluate in SIT prescription IgE mediated disease Clear identification of the responsible allergen Severity and duration of symptoms Efficacy of pharmacological treatment Compliance Availability of standardized products demonstration of the efficacy
5 WHO Pos Pap. Therapeutical vaccines for allergic diseases Allergy 1998 Standards for practical allergen-specific immunotherapy. Allergy 2006 Allergen immunotherapy: A practice parameter second update JACI 2011
6 A Meta-analysis and Systematic reviews DBPC trials Randomize d Trials E.B.M. Evidence Based Medicine Cohort Studies Case series D Case Report, Ideas Editorials, Expert Opinion EBM Hierarchy
7 CERTAINTIES - EVIDENCE GREY AREAS UNMET NEEDS UNKNOWN
8 Tabella meta analisi
9 JACI 2013
10 JAMA, 2013
11 WAO POS PAP 2013
12 JACI 2011
13
14 Symptom Score Rhintis
15 JACI 2010
16 CERTAINTIES - EVIDENCE DOUBTFUL UNMET NEEDS UNKNOWN
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19 GRADE: Grading of Recommendation Assessment, Developing and Evaluation Quesito clinico (es. efficacia trattamento) ESAME LETTERATURA Valutazione della qualità della prova sperimentale Sicurezza Preferenza Costo RACCOMANDAZIONE FORTE RACCOMANDAZIONE DEBOLE
20 Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision Should subcutaneous specific immunotherapy be used for treatment of AR in adults without concomitant ASTHMA? Recommendation We suggest subcutaneous allergen specific immunotherapy in adults with seasonal AR (conditional recommendation moderate-quality evidence) and persistent AR caused by mites (conditional recommendation low-quality evidence). Should subcutaneous specific immunotherapy be used for treatment of in children without concomitant ASTHMA? Recommendation In children with, we suggest subcutaneous specific immunotherapy (conditional recommendation low-quality evidence).
21 Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision Should subcutaneous allergen-specific immunotherapy be used in patients with AR and concomitant asthma? Recommendation In patients with AR and asthma, we suggest subcutaneous specific immunotherapy for treatment of asthma (conditional recommendation moderate-quality evidence). Should sublingual allergen-specific immunotherapy be used in patients with AR and concomitant asthma? Recommendation In patients with AR and asthma, we suggest sublingual specific immunotherapy for treatment of asthma (conditional recommendation low-quality evidence).
22 JACI 2013
23 Curr Opin Allergy Clin Immunol 2012
24 Pham Ti, PAI 2007
25
26 March 2009
27 PROBLEMS: The majority of the trials were not designed and sized for asthma as primary outcome Heterogeneity of study designs, duration, dose and evaluation parameters. Few studies had functional parameters evaluated
28 Implications for clinical trials: If asthma is investigated, the trial should consider asthma as primary outcome Functional parameters (FEV1, VEMS, oscillometry) should be evaluated Patients should be symptomatic, or therapeutic control should be evaluated.
29 EIFAN
30
31 Implications for clinical trials: The optimal study design to compare SLIT and SCIT is the DB DD RPC fashion This is not currently feasible, due to economic limitations.
32
33 ANAPHYLAXES DUE TO SLIT AUTHOR Antico Dunsky Eifan Blazowski Rodriguez De Groot De Groot Buyukozurk Buyukozurk Rodriguez Rodriguez SEX M F F F M M F M M M F AGE ALLERG EPINEPH? Latex Mix N Mix N Mite Y Mite N Grass Y Grass Y Latex Y Y Latex Y Mite Y Mite
34
35 JACI 2013
36 Implications for clinical trials: Adverse events should be described, graded and classified in a standardized fashion Adverse events should be notified promptly, to monitoring authorities or manufacuturers
37 CERTAINTIES - EVIDENCE DOUBTFUL UNMET NEEDS UNKNOWN
38 UNSOLVED QUESTIONS Optimal maintenance regimen (continuous VS pre-coseasonal) Dose and extract standardization? Better drugs or SIT? Polysensitized? Optimal maintenance SLIT dose for other allergens
39
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45 METHODOLOGICAL ISSUES - HETEROGENEITY OF TRIALS - DOSES -PATIENTS SELECTION - PRIMARY OUTCOME/ANALYSIS - SAMPLE SIZE CALCULATION - ADHERENCE - REPORTING
46 Patients with symptoms out of the season
47 VS PLACEBO Symptoms -28% (-39%) Medications - 24% (-48%) Efficacy and safety of 5grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis Wahn 2009
48 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!!!
49 Sastre, Clin Exp Allergy 2010
50 GRASS Phl p 1 Phl p 5 Phl p 6 BIRCH Bet v 1 PARIETARIA Par j 1 Par j 2 Phl p 7 (profilin) Phl p 12 (CBP) Bet v 2 (profilin) Bet v 3 (CBP) Par j 3 (profilin)
51
52
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54 Senna GE, Lomabrdi C, Passalacqua G. JACI 2010
55
56 SCIT: 46 trials SLIT: 48 trials CONSORT: 1 trial Flowchart: 16 trials Dropouts: 12 trials Randomization: 16 trials CONSORT: 3 trial Flowchart: 20 trials Dropouts: 16 trials Randomization: 12 trials
57
58 CERTAINTIES - EVIDENCE DOUBTFUL UNMET NEEDS UNKNOWN
59 BIOMARKERS FOR RESPONDER (NON RESPONDER)?
60 JACI, Oct 09
61
62 THANK YOU! Contact us at WAO, Chicago, Dec 2013
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