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Immunotherapy

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  • 1. WHAT YOU SHOULD HAVE READ BUT….2010
    • immunotherapy
    University of Verona, Italy Attilio Boner
  • 2. sottocutanea
  • 3. A prospective Italian survey on the safety of subcutaneous immunotherapy for respiratory allergy Schiappoli Clinical & Experimental Allergy 2009;39:1569 % OF SISTEMIC REACTION
    • 11 Italian allergy departments recorded the clinical characteristics of sistemic reactions (SRs) due to immunotherapy.
    • 1738 patients (age range 5-71).
    • A total of 60785 injections.
    6 – 5 – 4 – 3 – 2 – 1 – 0 PATIENTS COURSES 3.28 % 4.7 % 1.56/1000 injections
  • 4. A prospective Italian survey on the safety of subcutaneous immunotherapy for respiratory allergy Schiappoli Clinical & Experimental Allergy 2009;39:1569 % OF SISTEMIC REACTION
    • 11 Italian allergy departments recorded the clinical characteristics of sistemic reactions (SRs) due to immunotherapy.
    • 1738 patients (age range 5-71).
    • A total of 60785 injections.
    6 – 5 – 4 – 3 – 2 – 1 – 0 PATIENTS COURSES 3.28 % 4.7 % 1.56/1000 injections 25 patients experienced more than 1 adverse event
  • 5. A prospective Italian survey on the safety of subcutaneous immunotherapy for respiratory allergy Schiappoli Clinical & Experimental Allergy 2009;39:1569 80.7% Odds ratio (left axis, triangles) and Relative risk (right axis, circles) for the association between the single allergens and systemic reactions. Odds ratio (left axis, triangles) and Relative risk (right axis, circles) for the association between the manufacturers and systemic reactions.
  • 6. BACKGROUND Although previous immunotherapy studies have demonstrated that a local reaction does not predict a systemic reaction, no study has investigated whether a local reaction predicts a local reaction. OBJECTIVE To determine whether a local reaction predicts a local reaction at the next immunotherapy injection. The LOCAL Study: Local reactions do not predict local reactions in allergen immunotherapy Calabria JACI 2009;124:739
  • 7. The LOCAL Study: Local reactions do not predict local reactions in allergen immunotherapy Calabria JACI 2009;124:739
    • 360 patients received a total of 9678 injections.
    % PATIENTS WITH 80 – 70 – 60 – 50 – 40 – 30 – 20 – 10 – 0 AT LEAST 1 LOCAL REACTION A LOCAL REACTION LARGES THAN THE PATIENT’S PALM 78.3% 7.5%
  • 8. % OF A SECOND LOCAL REACTION FOLLOWING THE FIRST 30 – 20 - 10 - 0 27.2% The LOCAL Study: Local reactions do not predict local reactions in allergen immunotherapy Calabria JACI 2009;124:739
    • 360 patients received a total of 9678 injections.
  • 9.
    • 360 patients received a total of 9678 injections.
    % OF A SECOND LOCAL REACTION FOLLOWING THE FIRST 30 – 20 - 10 - 0 27.2% In a clinic that does not dose-adjust for local reactions, local reactions do not predict local reactions at the next immunotherapy injection. The LOCAL Study: Local reactions do not predict local reactions in allergen immunotherapy Calabria JACI 2009;124:739
  • 10. sublingual
  • 11. House Dust Mite Sublingual Immunotherapy: The Role for Transforming Growth Factor–β and Functional Regulatory T Cells O'Hehir AJRCCM 2009:180:936
    • A 12-month sublingual HDM immunotherapy (Stallergenes).
    • 30 HDM-allergic subjects
    Rhinitis Symptom Score
  • 12. House Dust Mite Sublingual Immunotherapy: The Role for Transforming Growth Factor–β and Functional Regulatory T Cells O'Hehir AJRCCM 2009:180:936
    • A 12-month sublingual HDM immunotherapy (Stallergenes).
    • 30 HDM-allergic subjects
    Total Asthma Score
  • 13. House Dust Mite Sublingual Immunotherapy: The Role for Transforming Growth Factor–β and Functional Regulatory T Cells O'Hehir AJRCCM 2009:180:936
    • A 12-month sublingual HDM immunotherapy (Stallergenes).
    • 30 HDM-allergic subjects
    IL-5 pg/mL
  • 14. House Dust Mite Sublingual Immunotherapy: The Role for Transforming Growth Factor–β and Functional Regulatory T Cells O'Hehir AJRCCM 2009:180:936
    • A 12-month sublingual HDM immunotherapy (Stallergenes).
    • 30 HDM-allergic subjects
    IL-5 pg/mL TGF-β mediates the immunological suppression seen early in clinically effective sublingual HDM immunotherapy in addition to an increase in Tregs with suppressor function.
  • 15. Early onset of action of a 5-grass-pollen 300-IR sublingual immunotherapy tablet evaluated in an allergen challenge chamber Horak JACI 2009;124:471
    • Sublingual immunotherapy (SLIT) tablet (Stallergènes SA).
    • Allergen challenge chamber (ACC).
    • Onset of action and efficacy of 300-IR.
    • Average rhinoconjunctivitis total symptom score (ARTSS).
    Study design
  • 16. Early onset of action of a 5-grass-pollen 300-IR sublingual immunotherapy tablet evaluated in an allergen challenge chamber Horak JACI 2009;124:471
    • Sublingual immunotherapy (SLIT) tablet (Stallergènes SA).
    • Allergen challenge chamber (ACC).
    • Onset of action and efficacy of 300-IR.
    • Average rhinoconjunctivitis total symptom score (ARTSS).
    Mean ARTTSS at baseline and at each challenge
  • 17. Early onset of action of a 5-grass-pollen 300-IR sublingual immunotherapy tablet evaluated in an allergen challenge chamber Horak JACI 2009;124:471
    • Sublingual immunotherapy (SLIT) tablet (Stallergènes SA).
    • Allergen challenge chamber (ACC).
    • Onset of action and efficacy of 300-IR.
    • Average rhinoconjunctivitis total symptom score (ARTSS).
    Mean ARTTSS at baseline and at each challenge The 300-IR 5-grass-pollen SLIT tablets had a significant effect on rhinoconjunctivitis symptoms (vs placebo) from the first month of treatment onward.
  • 18. Early onset of action of a 5-grass-pollen 300-IR sublingual immunotherapy tablet evaluated in an allergen challenge chamber Horak JACI 2009;124:471 Immunotherapy  The investigational product was a 300-IR 5-grass-pollen SLIT tablet, (orchard, meadow, perennial rye, sweet vernal, and timothy grasses; Stallergènes SA) taken once daily. The IR is a measure of the biologic potency of an allergen extract assessed based on skin reactivity. The dosage of the 300-IR tablet corresponded to approximately 20 μg of group 5 major allergens. Patients were told to take the sublingual pollen extract or placebo tablets once a day before eating or drinking and, preferably, at the same time of day throughout the 4-month treatment period. The patients were further instructed to leave the tablet under the tongue and not to swallow until the tablet had completely dissolved. Treatment was taken daily at the dose of 300 IR from day 1 and for 4 months.
  • 19. Sublingual immunotherapy for allergic respiratory diseases: An evaluation of meta-analyses Nieto JACI 2009;124:157 Background: Five published meta-analyses (MAs) seem to prove the efficacy of sublingual immunotherapy in allergic asthma and rhinoconjunctivitis. Objective: We aimed to assess the consistency, magnitude, and robustness of the results of these MAs. Methods: The data reported in the MAs were checked with the data reported in the original studies. Funnel plots were performed to test for potential publication bias, and the trim-and-fill method was used to assess and correct the estimate of the effects if asymmetry was present.
  • 20. Sublingual immunotherapy for allergic respiratory diseases: An evaluation of meta-analyses Nieto JACI 2009;124:157 Results: The 5 MAs included 43 studies; 17 were used in more than one MA. There were discrepancies among the MAs in the data reported from the same original studies: the MAs reported different estimates for the same outcome or the same estimates for different outcomes in 16 of those 17 studies. The MAs evaluated 15 main outcomes, 10 of which showed benefits that reached statistical significance. Funnel plots showed asymmetry in 7 outcomes, and correction by using the trim-and-fill method led to a decrease in their effect estimates and even to a loss of statistical significance in 4 of the previously significant outcomes.
  • 21. Sublingual immunotherapy for allergic respiratory diseases: An evaluation of meta-analyses Nieto JACI 2009;124:157 Conclusion: Because of discrepancies, inconsistencies, and lack of robustness, the MAs on sublingual immunotherapy do not provide enough evidence to support its current routine management in patients with allergic asthma or rhinoconjunctivitis. Sensitivity to potential publication bias should be tested and reported in all MAs.
  • 22.
    • Food allergy desensitisation
    • L’ho messe nella food allergy!!!!
  • 23. Future possibilities
  • 24. Epicutaneous allergen administration as a novel method of allergen-specific immunotherapy Senti JACI 2009;124:997
    • 37 a dult patients with positive skin prick and nasal provocation tests to grass pollen.
    • Allergen (n = 21) or placebo (n = 16).
    The patch consisted of a 3 × 5 cm polyethylene pouch that was filled with grass pollen extract in Vaseline. The side of the pouch that faced the skin was perforated. The pouch was held onto the skin by a self-adhesive tape.
  • 25. Epicutaneous allergen administration as a novel method of allergen-specific immunotherapy Senti JACI 2009;124:997 Visit/time Intervention/analysis February-March 2006 Newspaper advertisement and telephone interviews Visit 1 (March-April 2006) NPT, application of first patch March-May 2006 Weekly application of next 3 patches by the patients at home Visit 2 (April-May 2006) Application of patch, skin inspection for erythema and edema, recording of adverse events and medication April-September 2006 Weekly recording of symptoms, weekly application of 8 patches by the patients at home
  • 26. Epicutaneous allergen administration as a novel method of allergen-specific immunotherapy Senti JACI 2009;124:997 Visit/time Intervention/analysis Visit 3 NPT, recording of i mprovement/deterioration (September-October 2006) on a visual analog scale, recording of adverse events and medication Visit 4 (April 2007) NPT April-September 2007 Weekly recording of symptoms Visit 5 NPT, recording of i mprovement/deterioration (October-December 2007) on a visual analog scale, recording of medication
  • 27. Epicutaneous allergen administration as a novel method of allergen-specific immunotherapy Senti JACI 2009;124:997 Local eczema reactions Patient-recorded hay fever symptoms. Patients receiving verum (filled boxes) reported better improvement than placebo patients ( open boxes; 2006, P  = .02; 2007, P = .005). Box plots show median; 10th, 25th, 75th, and 90th percentiles; and outliers.
  • 28. Epicutaneous allergen administration as a novel method of allergen-specific immunotherapy Senti JACI 2009;124:997 Local eczema reactions Patient-recorded hay fever symptoms. Patients receiving verum (filled boxes) reported better improvement than placebo patients ( open boxes; 2006, P  = .02; 2007, P = .005). Box plots show median; 10th, 25th, 75th, and 90th percentiles; and outliers. Epicutaneous allergen immunotherapy is a promising strategy to treat allergies and merits further investigation.

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