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Mistrello G, Canonica GW. Absorption and distribution kinetics of the major immunotherapy with allergen in powder in atopic patients sensitive to Parietaria I. Ann Allergy. 1986 Nov;57(5):363-6. PubMed PMID: 3777536.
Parietaria judaica allergen (Par j 1) administered by noninjectable routes in officinalis pollen. J Investig Allergol Clin Immunol. 1995 May-Jun;5(3):126-32. 93: Del Prete GF, De Carli M, Mastromauro C, Biagiotti R, Macchia D, Falagiani P, 107: Brunello F, Falagiani P, Genchi C. Enzyme immunoassay (ELISA) for the
healthy human beings. J Allergy Clin Immunol. 1997 Jul;100(1):122-9. PubMed PMID: PubMed PMID: 7582157. Ricci M, Romagnani S. Purified protein derivative of Mycobacterium tuberculosis detection of specific IgG antibodies to Toxocara canis ES antigens. Boll Ist
9257796. and excretory-secretory antigen(s) of Toxocara canis expand in vitro human T Sieroter Milan. 1986;65(1):54-60. Erratum in: Boll Ist Sieroter Milan
80: Panzani RC, Falagiani P, Riva G, Delord Y, Mercier P. Screening for atopy in cells with stable and opposite (type 1 T helper or type 2 T helper) profile of 1986;65(5):following 445. PubMed PMID: 3718679.
66: Asero R, Mistrello G, Roncarolo D, Antoniotti P, Falagiani P. a coffee processing factory. Allergol Immunopathol (Madr). 1995 cytokine production. J Clin Invest. 1991 Jul;88(1):346-50. PubMed PMID: 1829097;
Exercise-induced egg anaphylaxis. Allergy. 1997 Jun;52(6):687-9. PubMed PMID: Jan-Feb;23(1):29-34. PubMed PMID: 7631592. PubMed Central PMCID: PMC296040. 08: Genchi C, Tinelli M, Brunello F, Falagiani P. Serodiagnosis of ocular
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67: Asero R, Mistrello G, Falagiani P. Oral allergy syndrome from pork. Allergy. Evaluation of allergenic potency by REAST inhibition. A new tool for the G, Sondergaard I. Allergenic fragments in Parietaria judaica pollen extract. J 109: Falagiani P, Cavallone E, Nali M, Rindone B, Tollari S, Crespi G. Aqueous
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12. The first specific sublingual immuntherapy
with allergoids available as tablets & drops
The Idea:
To combine the advantages of
allergoids together with the
sublingual route into a better
effective and more safe
Immunotherapy
13. Chemical modification of
residual peripheral
aminoacid-sequences
Reduced IgE binding affinity
Maintained
conformation
for T-cell-binding
14. The first specific sublingual immuntherapy
with allergoids available as tablets & drops
Sublingual Allergoides Allergens
the modified molecule resists to The unmodified molecule is destroyed
enzymatic coupling and remains intact. by the attack of enzymes.
15. The first specific sublingual immuntherapy
with allergoids available as tablets & drops
The novel approach
Monomerization
(Monoid)
Allergen extracts are chemically transformed, the
Carbamylation, to replace parts of the protein
components, and to maintain the molecular dimensions.
16. Characterization of the sublingual
carbamylated allergoid (Monoid)
1-Reduction of the Allergenicity
2-Maintenance of the Antigenicity
3-Maintenance of the Molecular Dimension
4-Resistance against Enzymatic Digestion
5-Absence of Toxicity
17. Concept Overview
Allergenicit Proteine Enzymatic
Allergen Type Antigenity
y Structure Protection
Modified,
Reduced complex
Monoid Maintained Shown
(targeted) („Segments
cut“)
Native Allergen Maintained Maintained Nativ, complex Not shown
Reduced
Reduced
Allergoid (Not Polymerized Not shown
(targeted)
targeted)
18. Route of action in the oromucosal and
gastrointestinal system
APC Lymphozytes
oral Lymphatic
mucosa system
Allergoid systemic clinical
SLIT circulation results
gastrointestinal capillaries
mucosa
20. Clin Exp Allergy 2001, 31; 54-60
Pharmacokinetics of an allergen and a monomeric
allergoid for oromucosal immunotherapy
in allergic volunteers
Bagnasco M, Passalacqua G, Villa G, Augeri C, Flamigni G, Borini E,
Falagiani P, Mistrello G, Canonica GW, Mariani G..
Clinical Immunology Service, DIMI, Genoa, Italy
Objective
To study the pharmacokinetics
in allergic volunteers
of allergoid sublingual immunotherapy
in oromucosal tablets
21. Clin Exp Allergy 2001, 31; 54-60
Pharmacokinetics of an allergen and a monomeric
allergoid for oromucosal immunotherapy
in allergic volunteers
Bagnasco M, Passalacqua G, Villa G, Augeri C, Flamigni G, Borini E,
Falagiani P, Mistrello G, Canonica GW, Mariani G..
Clinical Immunology Service, DIMI, Genoa, Italy
Methods
Radiolabelled monomeric allergoid and native allergen, administered to 8
allergic pts and 1 non atopic, were detected by scintigraphic acquisitions.
Plasma radioactivity was measured at different intervals.
Results
The increased resistance to gastrointestinal enzymatic degradation can explain
the high absorption of the monomeric allergoid and its appearance in the
bloodstream.
The local persistence of the monomeric allergoid and allergen may involve the
mucosal immunity in the mechanism of action of antiallergic vaccination.
22. Clin Exp Allergy 2001, 31; 54-60
Pharmacokinetics of an allergen and a monomeric
allergoid for oromucosal immunotherapy
in allergic volunteers
M. Bagnasco et al.
Clinical Immunology Service, DIMI, Genoa, Italy
5-
Sublingual allergoids
Plasmatic Radioactivity
in form of tablets
3-
Native Allergens
in liquid solution
1- Native Allergens
in form of tablets
I I I I
1 2 5 Hrs after application 15
ALLERGO Kinetics
23. Clin Exp Allergy 2001, 31; 54-60
Pharmacokinetics of an allergen and a monomeric
allergoid for oromucosal immunotherapy
in allergic volunteers
M. Bagnasco et al.
Clinical Immunology Service, DIMI, Genoa, Italy
Conclusions
Systemic absorption
Mucosal immunity involvement
24. Clin Exp Allergy 2006, 36; 261-272
Sublingual immunotherapy in Dermatophagoides monomeric
allergoid down-regulates allergen-specific immunoglobulin E
and increases both interferon- and interleukin-10-production.
Cosmi L, Santarlasci V, Angeli R, Liotta F, Maggi L, Frosali F, Rossi O,
Falagiani P, Riva G, Romagnani S, Annunziato F, Maggi E.
Center of Research, Transfer, High Education “DENOthe”, University Firenze, Italy
Objective
To show the immunological effects of a sublingual carbamylated allergoid.
Methods
25 pts: with rhinitis / asthma to Der p1, positive to
anamnesis, prick, RAST, SNPT and MCH.
Protocol: double blind vs placebo. 1,5 years of treatment.
Treated group: 12 Lais Der p1
Placebo group: 13
25. Clin Exp Allergy 2006, 36; 261-272
Sublingual immunotherapy in Dermatophagoides monomeric
allergoid down-regulates allergen-specific immunoglobulin E
and increases both interferon- and interleukin-10-production.
L. Cosmi et al.
Center of Research, Transfer, High Education “DENOthe”, University Firenze, Italy
Results
the sublingual allergoid increases the
production of the cytokines IL-10 & IFN-
26. Clin Exp Allergy 2006, 36; 261-272
Sublingual immunotherapy in Dermatophagoides monomeric
allergoid down-regulates allergen-specific immunoglobulin E
and increases both interferon- and interleukin-10-production.
L. Cosmi et al.
Center of Research, Transfer, High Education “DENOthe”, University Firenze, Italy
Results
the sublingual allergoid reduces the
production of spezific IgE
27. Clin Exp Allergy 2006, 36; 261-272
Sublingual immunotherapy in Dermatophagoides monomeric
allergoid down-regulates allergen-specific immunoglobulin E
and increases both interferon- and interleukin-10-production.
L. Cosmi et al.
Center of Research, Transfer, High Education “DENOthe”, University Firenze, Italy
Conclusion
Clear immunological effects have been shown under
treatment with a sublingual carbamylated allergoid.
29. Results from recent
(DBPC) Trials
Sublingual Allergoids
efficacy (subjective data)
• Reduction of symptoms of asthma
• Reduction of symptoms of rhinoconjunctivitis
• Reduction of symptomatic medication
30. Results from recent
(DBPC) Trials
Sublingual allergoids
efficacy (objective data)
Efficacy was assessed using objective measurements:
• increase of the provocative dose
specifically in nasal provocation test
unspecifically with Metacholine
31. Results from recent
(DBPC) Trials
Sublingual allergoids
Safety
The safety of treatment is supported by
numerous published clinical studies.
The sublingual allergoid, the Monoid, has
demonstrated its safety also in patients with
Oral Allergy Syndrome (OAS).
32. Results from recent
(DBPC) Trials
Sublingual allergoids
Tolerability
Tolerability is supported by data from numerous
clinical trials
33. Results from recent
(DBPC) Trials
Sublingual allergoids
Compliance
Compliance, adherence with the treatment is excellent as
demonstrated by:
•Pill count in clinical trials.
•Repetitive prescription in real life studies.
35. Allergy, 2000: 55: 1-6
Preseasonal local allergoid immunotherapy to grass pollen
in children: a double-blind, placebo-controlled, randomized
trial
C.Caffarelli, L.G.Sensi, F.Marcucci, G.Cavagni
Paediatric Departments of Parma, Perugia and Sassuolo, Italy
Material & methods
48 pts: 8 yrs mean age, Rhinoconjunctivitis/Asthma
to Grass. DBPC study. Positive anamnesis,
SPT and RAST. ECP, symptoms, drug score
and Compliance recorded.
Protocol: preseasonal scheduling.
IT treated: 24 Lais Grass.
Drug treated: 20 (4 drop out).
36. Allergy, 2000: 55: 1-6
Preseasonal local allergoid immunotherapy to grass pollen
in children: a double-blind, placebo-controlled, randomized
trial
C.Caffarelli, L.G.Sensi, F.Marcucci, G.Cavagni
Paediatric Departments of Parma, Perugia and Sassuolo, Italy
Results
Statistically significant differences in
Allergoid SLIT treated group:
Reduced symptom & medication scores in pollen season
Good compliance.
No differences in placebo group.
37. Allergy, 2000: 55: 1-6
Preseasonal local allergoid immunotherapy to grass pollen
in children: a double-blind, placebo-controlled, randomized
trial
C.Caffarelli, L.G.Sensi, F.Marcucci, G.Cavagni
Paediatric Departments of Parma, Perugia and Sassuolo, Italy
15 - p<0.05
score
10 - NS
NS
5- p<0.05
NS
I I I I I
Symptome Symptome Symptome Symptome Rescue medication
NASAL OCULAR BRONCHIAL TOTAL
Reduction of total symptom score
during treatment with sublingual allergoids vs Placebo
During the grass pollen season.
38. Allergy, 2000: 55: 1-6
Preseasonal local allergoid immunotherapy to grass pollen
in children: a double-blind, placebo-controlled, randomized
trial
C.Caffarelli, L.G.Sensi, F.Marcucci, G.Cavagni
Paediatric Departments of Parma, Perugia and Sassuolo, Italy
Conclusions
The preseasonal course with Lais Grass
as Allergoid SLIT:
is effective in the reduction of respiratory
symptoms of children,
in particular asthma, within 3,5 months
39. Allergol et Immunopathol 2006; 34 (5): 194 – 198.
Clinical efficacy and safety of preseasonal sublingual
immunotherapy with gras pollen carbamylated allergoid in
rhinitic patients. A double-blind, placebo-controlled study.
Palma-Carlos AG, Santos AS, Branco-Ferreira M, Pregal AL,
Palma-Carlos ML, Bruno ME, Falagiani P, Riva G.
Clinical Allergy Immunology Center. CAIC. Lisbon, Portugal
Material & Methods
33 pts: with rhinitis / asthma to Phl p5, positive to
anamnesis, prick, RAST, SNPT and MCH.
Protocol: double blind vs placebo
Treated group: 17 Lais 3-Gras Mix
Placebo group: 16
40. Allergol et Immunopathol 2006; 34 (5): 194 – 198.
Clinical efficacy and safety of preseasonal sublingual
immunotherapy with gras pollen carbamylated allergoid in
rhinitic patients. A double-blind, placebo-controlled study.
Palma-Carlos AG, Santos AS, Branco-Ferreira M, Pregal AL,
Palma-Carlos ML, Bruno ME, Falagiani P, Riva G.
Clinical Allergy Immunology Center. CAIC. Lisbon, Portugal
Design
41. Allergol et Immunopathol 2006; 34 (5): 194 – 198.
Clinical efficacy and safety of preseasonal sublingual
immunotherapy with gras pollen carbamylated allergoid in
rhinitic patients. A double-blind, placebo-controlled study.
Palma-Carlos AG, Santos AS, Branco-Ferreira M, Pregal AL,
Palma-Carlos ML, Bruno ME, Falagiani P, Riva G.
Clinical Allergy Immunology Center. CAIC. Lisbon, Portugal
Improvement of the nasal provocation test
Results Reduction of rhinoconjunctivitis symptoms
42. Allergol et Immunopathol 2006; 34 (5): 194 – 198.
Clinical efficacy and safety of preseasonal sublingual
immunotherapy with gras pollen carbamylated allergoid in
rhinitic patients. A double-blind, placebo-controlled study.
A.G. Palma-Carlos, A.S. Santos, M. Branco-Ferreira, A.L. Pregal
Clinical Allergy Immunology Center. CAIC. Lisbon, Portugal
Reduction of steroid consumption
Results
43. Allergol et Immunopathol 2006; 34 (5): 194 – 198.
Clinical efficacy and safety of preseasonal sublingual
immunotherapy with gras pollen carbamylated allergoid in
rhinitic patients. A double-blind, placebo-controlled study.
A.G. Palma-Carlos, A.S. Santos, M. Branco-Ferreira, A.L. Pregal
Clinical Allergy Immunology Center. CAIC. Lisbon, Portugal
Conclusions
SLIT in gras allergic patients is effective and reduces
single symptoms between 40 - 60 %
and
co-medication (steroids) vs. placebo up to 80%
(at pollen peak)
44. Invest Allergol Clin Immunol, May-June 1998 Vol 8 (3)
Efficacy and safety of oral immunotherapy in respiratory
allergy to Parietaria judaica pollen.
A double blind study
R.Ariano*, R.C.Panzani** and C.Augeri*
*Allergy Dept., Bordighera, Italy
**Lab. De Recherches, Marseille, France
Material & methods
30 pts: with rhinitis / asthma to Par j, positive to
anamnesis, prick, RAST, SNPT and MCH.
Protocol: double blind vs placebo. Dec.92 to Jul.95.
Treated group: 15 Lais Par j (1 drop out).
Placebo group: 15
45. Invest Allergol Clin Immunol, May-June 1998 Vol 8 (3)
Efficacy and safety of oral immunotherapy in respiratory
allergy to Parietaria judaica pollen.
A double blind study
R.Ariano*, R.C.Panzani** and C.Augeri*
*Allergy Dept., Bordighera, Italy
**Lab. De Recherches, Marseille, France
Results
Statistically significant differences in the
Allergoid SLIT treated group:
Reduced symptoms score (in particular during pollen season).
Reduced medication score.
Increased threshold dose with Allerkin Test.
Increased threshold dose with Methacholine Lofarma.
No differences in placebo group.
46. Invest Allergol Clin Immunol, May-June 1998 Vol 8 (3)
Efficacy and safety of oral immunotherapy in respiratory
allergy to Parietaria judaica pollen.
A double blind study
R.Ariano*, R.C.Panzani** and C.Augeri*
*Allergy Dept., Bordighera, Italy
**Lab. De Recherches, Marseille, France
Conclusions
Hyposensitization with Parietaria pollen as
Allergoid SLIT
is a safe and efficaceous vaccine
which may be used in children and adults.
47. The Lancet Vol.351 Feb 28, 1998
Randomised controlled trial of local allergoid
immunotherapy on allergic inflammation in
house dust mite - induced rhinoconjunctivitis
G. Passalacqua et al.
Clinical Immunology Service, DIMI, Genoa, Italy
Material & methods
20 pts: per. rhinoconjunctivitis to Der, positive to
anamnesis, prick, RAST and SCPT.
Inflammatory-cells and ICAM-1 and
serum inflam. markers (ECP) recorded.
Protocol: double blind vs placebo. Apr.94 to Mar.96.
Treated group: 10 Lais Der p&f.
Placebo group: 10 (1 drop out).
48. The Lancet Vol.351 Feb 28, 1998
Randomised controlled trial of local allergoid
immunotherapy on allergic inflammation in
house dust mite - induced rhinoconjunctivitis
G. Passalacqua et al.
Clinical Immunology Service, DIMI, Genoa, Italy
Results
Statistically significant differences in
The monomeric Allergoid SLIT group:
Reduced symptom & medication scores.
Reduced inflammatory infiltration and ICAM-1 expression.
Reduced MPI, the Minimal Persistent Inflammation.
No differences in placebo group.
49. The Lancet Vol.351 Feb 28, 1998
Randomised controlled trial of local allergoid
immunotherapy on allergic inflammation in
house dust mite - induced rhinoconjunctivitis
G. Passalacqua et al.
Clinical Immunology Service, DIMI, Genoa, Italy
NEUTROFILE
EOSINOFILE
ICAM 1
0.001
3- p<0.001 3- 10 -
0.001
NS
NS
1- NS
1- 5-
I I I I I I
T0 24 Months T0 24 Months T0 24 Months
Reduction of inflammation
After 24 months of treatment with sublingual allergoids vs Placebo
Demonstrated by conjunctival provocation test
50. The Lancet Vol.351 Feb 28, 1998
Randomised controlled trial of local allergoid
immunotherapy on allergic inflammation in
house dust mite - induced rhinoconjunctivitis
G. Passalacqua et al.
Clinical Immunology Service, DIMI, Genoa, Italy
Conclusions
Hyposensitization with Dermatophagoides
as Allergoid SLIT:
l reduces the allergic inflammation
l is safe and clinically effective.
51.
52. Giornale Italiano di All e Imm Clin, 2000: 10: S-1
Allergen Specific Oromucosal Immunotherapy: Efficacy and
Safety of a Clustered Scheme of
Treatment for Parietaria Respiratory Allergy
S.D’Agostino, A.D’Agostino, G.Riva. A.Tiri
Napoli, Medical Dept Lofarma S.p.A.Italy
Material & methods
39 pts: Rhinoconjunctivitis / Asthma (50%) to Par.
Positive anamnesis, SPT, PFT and SNPT.
Serum inflam. markers (ECP) recorded.
Symptoms & Drug Score, QoL.
Protocol: clustered treatment according to Data Sheet.
IT treated: 27 Lais Par.
Drug treated: 12 (3 drop out).
53. Giornale Italiano di All e Imm Clin, 2000: 10: S-1
Allergen Specific Oromucosal Immunotherapy: Efficacy and
Safety of a Clustered Scheme of
Treatment for Parietaria Respiratory Allergy
S.D’Agostino, A.D’Agostino, G.Riva. A.Tiri
Napoli, Medical Dept Lofarma S.p.A.Italy
Results
Statistically significant differences in
Allergoid SLIT treated group:
Reduced symptom & medication scores.
Improved Quality of Life, assessed by questionnaire.
Good compliance, over 80% .
No differences in placebo group.
54. Giornale Italiano di All e Imm Clin, 2000: 10: S-1
Allergen Specific Oromucosal Immunotherapy: Efficacy and
Safety of a Clustered Scheme of
Treatment for Parietaria Respiratory Allergy
S.D’Agostino, A.D’Agostino, G.Riva. A.Tiri
Napoli, Medical Dept Lofarma S.p.A.Italy
Conclusions
The Clustered Treatment with Parietaria as
Allergoid SLIT:
l is a suitable treatment when it is too
late to start a conventional scheduling
l is well tolerated and safe.
55. Giorn it Allergol Immunol Clin 2002; 12:221-226
Safety of Ultra Rush (two hours) Sublingual
Swallow Immunotherapy in Allergic Patients
R.E. Rossi, G.Monasterolo*
Allergy Unit, National Health Service, Savigliano, Italy
*Laboratorio Analisi Osp. SS.Trinità, Fossano, Italy
Objective
To study the safety of ultra
rush SLIT with four commercial
products in allergic patients.
56. Giorn it Allergol Immunol Clin 2002; 12:221-226
Safety of Ultra Rush (two hours) Sublingual
Swallow Immunotherapy in Allergic Patients
R.E. Rossi, G.Monasterolo*
Allergy Unit, National Health Service, Savigliano, Italy
*Laboratorio Analisi Osp. SS.Trinità, Fossano, Italy
Material & Methods
Ninety-one allergic patients with rhino-conjunctivitis
and/or asthma.
Prospective observational, 36 months follow-up study.
Maintenance phase from Dec 2001 to Mar 2002.
Subdivided in three groups, one was administered the
sublingual allergoid, the others, injective I.T. and drugs.
57. Giorn it Allergol Immunol Clin 2002; 12:221-226
Safety of Ultra Rush (two hours) Sublingual
Swallow Immunotherapy in Allergic Patients
R.E. Rossi, G.Monasterolo*
Allergy Unit, National Health Service, Savigliano, Italy
*Laboratorio Analisi Osp. SS.Trinità, Fossano, Italy
Results
One adverse event, after 300 IR/ml,
disappeared when adjusted at 30 IR.
No adverse events were noted after
administration of the allergoid SLIT.
58.
59.
60.
61. Int Journ of Immunopathology and Pharmacology, 16, 3;, 277-282
Specific Immunotherapy of allergic disease:
A three years prospective observational study
A. Arena*, E. Barbatano°, E. Gammeri* et al.
*ASL 5, Messina, °Pneumologia, Catania, Italy
Objective
To evaluate the efficacy, tolerability
and adherence to treatment of
allergoid sublingual immunotherapy
(I.T.), in comparison with injective
I.T. and drugs.
62. Int Journ of Immunopathology and Pharmacology, 16, 3;, 277-282
Specific Immunotherapy of allergic disease:
A three years perspective observational study
A. Arena*, E. Barbatano°, E. Gammeri* et al.
*ASL 5, Messina, °Pneumologia, Catania, Italy
Material & Methods
One hundred and ten allergic patients with rhino-
conjunctivitis and/or asthma.
Subdivided in three groups, one was administered the
sublingual allergoid, the others injective I.T. and drugs.
Prospective, observational, 36 months follow-up study.
Allergens: pollens and House Dust Mite.
63. Int Journ of Immunopathology and Pharmacology, 16, 3;, 277-282
Specific Immunotherapy of allergic disease:
A three years perspective observational study
A. Arena*, E. Barbatano°, E. Gammeri* et al.
*ASL 5, Messina, °Pneumologia, Catania, Italy
Results
Sublingual allergoid I.T. was
considered by patients and doctors to
be better than the other two therapies
(p<0.0001) as far as efficacy,
tolerability and patient’s compliance
concern.
64. Int Journ of Immunopathology and Pharmacology, 16, 3;, 277-282
Specific Immunotherapy of allergic disease:
A three years perspective observational study
A. Arena*, E. Barbatano°, E. Gammeri* et al.
*ASL 5, Messina, °Pneumologia, Catania, Italy
Conclusions
Allergoid Sublingual I.T. was
positively appreciated by both
patients and physicians for its
simplicity of use, good efficacy and
the high degree of safety offered.
65.
66. SLIT with monomeric allergoid
• Effective in rhinoconjunctivitis and asthma
• Impeccable safety also in risk populations
• Perfectly tolerable in adults and children
• Outstanding compliance and adherence
• Internationally accepted by
– The Paul Ehrlich Institute