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At least 73 records · Page 4Linked to original sources
PubMed2001

Safety of sublingual immunotherapy with monomeric allergoid in adults: multicenter post-marketing surveillance study.

BACKGROUND: Sublingual immunotherapy (SLIT) appears to be acceptably safe in clinical trials, but post-marketing data are needed to provide essential information. This study specifically evaluated the safety of commercial SLIT in adult patients in a post-marketing phase. METHODS: A total of 198 patients (83 male, 115 female, mean age 24.4 years) receiving SLIT for respiratory allergy were followed up for 3 years by a specific questionnaire for side-effects. SLIT (LAIS, Lofarma SpA, Milan, Italy), a monomeric allergoid in tablets, was administered, in association with drug therapy, pre- or pre-coseasonally for pollen and continuously for mites. The average duration was 12-36 months, and the total of doses was about 32 800. Side-effects were grouped as ocular, gastrointestinal, rhinitis, asthma, urticaria, edema of tongue/lips, and anaphylaxis. The severity was graded as low (no need for treatment or dose adjusting, no interference with activities), moderate (interference with activities/need for drugs/SLIT discontinuation), and severe (life-threatening/hospitalization/emergency care). RESULTS: Seventeen events corresponding to 7.5% of patients and 0.52 per 1000 doses were reported. Seven episodes of rhinitis (two in two patients), three of oral itching, and one of abdominal pain were self-limiting. Two cases of urticaria and two of abdominal pain/nausea were controlled by a temporary dose-adjustment, and one case of urticaria and conjunctivitis required oral antihistamines. Medical intervention was needed in six patients only during a 3-year period. CONCLUSION: The results of this study, performed in a real situation of clinical practice, confirm the satisfactory safety profile of SLIT.

Administration, Sublingual↗
PubMed2003

[Cluster-immunotherapy in seasonal allergic rhinitis: safety aspects of induction therapy with depot allergoids (Purethal)].

BACKGROUND: Specific immunotherapy (SIT) represents the only specific treatment that can be offered to allergic patients apart from allergen avoidance. SIT has been widely used in pollen allergic rhinitis. Clinical efficacy has been demonstrated in several controlled clinical trials and depends on the specific allergen the individual patient is sensitive to, the quality and total amount of allergen applied, and the SIT schedule. In classic SIT, gradually increasing dosages of the allergen extract are injected subcutaneously. Several dosage schedules for subcutaneous SIT can be applied. In Cluster-SIT, 2 - 3 injections per day of treatment are given once a week during induction treatment. PATIENTS: In this study, we investigated 64 patients (33 female, 31 male) from 18 to 54 years (26.9 +/- 5.1 years) in terms of side-effects of Cluster-SIT during induction treatment. RESULTS: The total amount of enlarged local reactions (> grade 1) was n = 77 or 15.2 % of all injections. Of these, 68 (88 %) were classified as immediate reactions, 8 (11 %) were late phase reactions and 1 (1 %) was immediate as well as late phase reaction. Of all enlarged local reactions, 48 (62 %) were grade 1 reactions, 13 (17 %) were grade 2 reactions, 13 (17 %) were grade 3 reactions and 1 (1 %) was a grade 4 reaction. The total amount of systemic reactions was n = 22 or 4.3 % of all injections. Of these, 19 (86 %) were classified as immediate reactions, 3 (14 %) were delayed reactions. Of all systemic reactions, 18 (82 %) were grade 1 reactions and 4 (18 %) grade 2 reactions. Grade 3 or grade 4 reactions did not occur. There were no differences in gender or age regarding the occurrence of side effects (all p > 0.05). CONCLUSIONS: Frequency and severity of adverse side effects in Cluster-SIT correspond to those in other dosage schedules. On behalf of security aspects, Cluster-SIT could become an interesting alternative dosage schedule for dose increase during SIT. Furthermore, in Cluster-SIT with allergoids, induction treatment can be carried out in two treatment days of approximately 2.5 hours each.

Adolescent↗
PubMed2006

Randomized double-blind controlled study with sublingual carbamylated allergoid immunotherapy in mild rhinitis due to mites.

BACKGROUND: The clinical efficacy of sublingual immunotherapy (SLIT) in mite allergy and in mild disease is still a matter of debate, thus we performed a long-term clinical trial. METHODS: The study was randomized, double-blind and placebo-controlled. After a 1-year assessment, 68 patients with mild rhinitis with/without asthma due to mites were randomized to drugs + placebo or drugs + SLIT for 2 years. Sublingual immunotherapy was given as soluble tablets of monomeric carbamylated allergoid. Clinical scores for asthma and rhinitis (0, absent to 3, severe) and drug consumption were assessed by diary card in the period November-February. Quality of life was assessed before and after each observation period and pharmaco-economy data were evaluated as well. RESULTS: Fifty-six patients completed the study. The rate of dropouts was similar in the two groups. No relevant side effect was reported. There was a significant reduction of total clinical scores (P < 0.05) in the active group vs placebo at the first year, but not at the second whereas nasal obstruction significantly improved in both years (P < 0.05). The reduction of drug intake score was significant only at the first year. No change was observed concerning most of the Short Form-36 items, because at baseline all patients displayed a normal profile. A significant change in SLIT group was seen for the item 'change in health status'. The need for extra visits was significantly lower in the active group (25%vs 43%). CONCLUSIONS: Sublingual immunotherapy was clinically effective and safe in mite-induced mild disease.

Administration, Sublingual↗
PubMed1985

Studies on allergen and allergoid preparations from purified timothy (Phleum pratense) pollen extracts. III. Comparative investigations by skin prick tests and nasal provocation tests.

The allergenic activities of allergen (GEN) and allergoid (GOID) preparations from partially purified timothy pollen extract were investigated in quantitative skin prick tests and nasal provocation tests. In skin prick test GOID yielded significantly less activity than GEN. Approximately 90 times more protein of GOID than of GEN was necessary to elicit wheals of the same mean size as 1 mg/ml histamine control solution (1 HEP). In nasal provocation the patients seemed to react differently with respect to their nasal sensitivity to GOID. One group of patients showed equal sensitivity to GOID and GEN, whereas the second group showed higher thresholds to GOID. These differences in nasal sensitivity to GOID could be of practical value to predict the optimal dosage schedule for the treatment of patients with GOID.

Adolescent↗
PubMed1991

Hyposensitization therapy of Parietaria-sensitive patients with a tyrosine adsorbed allergoid, Pollinex Parietaria (Bencard Parietaria).

Thirty patients suffering from allergy to Parietaria pollen were treated with either a new tyrosine-adsorbed allergoid of Parietaria judaica pollen (Pollinex Parietaria) or a commercially available alum-adsorbed extract (Alavac) as control. A reduced response to nasal provocation was seen in 7 out of 11 patients following treatment with Pollinex and 1 out of 10 after control treatment. 9 out of 11 and 3 out of 10, respectively, showed reduced skin test activity. Patients who received Pollinex tended to have fewer nasal symptoms during the pollen season. Pollinex induced larger increases in P. judaica-specific IgG antibody than did the control product. Side effects of therapy were similar between the two groups of patients. Pollinex Parietaria thus shows good potential for the control of allergy to Parietaria pollen.

Adult↗
PubMed1981

Influence of preseasonal treatment with L-tyrosine-adsorbed allergoids on IgE-mediated histamine release from basophils of children suffering from allergic diseases.

In 10 children suffering from allergic pollinosis and/or asthma, a preseasonal hyposensitization scheme with 3 weekly injections of a glutaraldehyde-modified, tyrosine-adsorbed grass-pollen allergen reduced the histamine release from basophils in response to increasing concentrations of antigen. The decrease in histamine release which occurred 1 week after the injection course was even maintained during the pollen season. The inhibition was only obtained when basophils were incubated with the serum of patients, but not with the serum of normals, indicating that blocking antibodies may have occurred. In contrast to what has been observed in the treated patients' group, 5 patients, who were not included in the hyposensitization scheme, showed identical histamine release curves during the whole investigation period. Specific IgE did not increase after the treatment course and shows the same behaviour as the untreated patients. Thus, as treatment with glutaraldehyde modified, tyrosine-adsorbed allergoids is safe to administer, requires only 3 injections, reduces histamine release from basophils by production of "blocking" antibodies, it appears to be a useful tool in the hyposensitization treatment.

Adsorption↗
PubMed1981

[Immunochemical characteristics of plant pollen allergoid].

Allergen from ragweed pollen was treated with formaldehyde to obtain allergoid. The preparation obtained loses to a significant extent its ability to react not only with allergic antibodies (reagins) of the patients but also with precipitins of sera from rabbits hyperimmunized with allergen. Immunoelectrophoresis in agarose allowed a conclusion that formaldehyde blocks up to 4--5 antigens possessing a higher positive electrophoretic charge. Electrophoresis in polyacrylamide gel has shown that concurrently there occur stabilization and enlargement of protein molecules.

Allergens↗
PubMed2006

Sublingual immunotherapy with Dermatophagoides monomeric allergoid down-regulates allergen-specific immunoglobulin E and increases both interferon-gamma- and interleukin-10-production.

BACKGROUND: The clinical efficacy and safety of sublingual immunotherapy (SLIT) for aeroallergens has been demonstrated in several trials, whereas the immunological changes induced by this treatment, which may account for the clinical improvement, are still unclear. OBJECTIVE: To investigate the effects of a successful SLIT on the in vitro allergen-driven T cell response and cytokine secretion as well as on the serum levels of chemokines and of IgE, IgG1 and IgG4 antibodies (Abs). MATERIALS AND METHODS: Twenty-five Dermatophagoides pteronyssinus (Dp)-sensitive patients with perennial rhinitic and/or rhinitic and asthmatic symptoms were randomized into two groups (13 untreated (UT) and 12 SLIT-treated) for a 1 year and half study. The proliferative response of peripheral blood mononuclear cell (PBMC) to purified Der p1 allergen, their cytokines (IFN-gamma, IL-4, IL-10 and TGF-beta) production and serum levels of chemokines associated with T helper type 1 (Th1) (CXCL10) or T helper type 2 (Th2) (CCL22) responses and of Dp-specific IgE, IgG1 and IgG4 Abs were evaluated before and after 6 months of treatment. RESULTS: SLIT induced a significant reduction of symptom medication scores after 6, 12 and 18 months of treatment in comparison with UT patients. SLIT-treated patients showed a significant decrease in serum levels of DP-specific IgE Abs, whereas total IgE, and specific IgG1 and IgG4 Abs remained unchanged. The proliferative response of allergen-specific T cells to Der p1 in vitro after 6 months of treatment was reduced, while no effect was observed on T cell proliferation to recall antigen (streptokinase). Moreover, Der p1-driven IFN-gamma and IL-10 were significantly increased in culture supernatants of PBMC from 6 month-treated patients in comparison with those detected at the beginning of therapy. CONCLUSIONS: These data suggest that the allergen-driven enhancement of IL-10- and IFN-gamma-producing T cells precedes and associates with SLIT-induced down-regulation of specific IgE, thus providing a rationale to explain the clinical benefit of SLIT in allergic patients.

Administration, Sublingual↗
PubMed2002

Immunophenotypic characterization of peripheral B cells. During short-term immunotherapy with tree pollen allergoid and the immunoadjuvant monophosphoryl lipid A.

The effects of immunotherapy (IT) on the activation and functions of B cells are not well described yet. We therefore measured the expression of several surface markers on peripheral B cells during short-term IT. Twelve patients with seasonal allergic rhinoconjunctivitis, sensitized to hazel, alder, and birch pollen proven by positive history, skin test, sIgE, and nasal provocation test, were included in the study. Eight patients received short-term IT with TA tree pollen and the immunoadjuvant monophosphoryl Lipid A; 4 patients received a placebo suspension containing 2% tyrosine. After separation of PBMCs, the expression of surface molecules on peripheral B cells were analyzed by flow cytometry before the start of IT, before the 3rd injection, at the end of IT, and after the pollen season. The expression of CD23, CD54, and HLA-DR-II on CD19+ B cells decreased during IT and then increased again after the pollen season. In the placebo group, the expression of CD23, CD54, and HLA-DR-II remained unchanged during the first three measurements. After the season, the expression of CD23, CD54 and HLA-DR-II increased in both groups. CD86 expression was decreased during treatment in both groups. Although CD86 expression increased in both groups after the season, the increase was more pronounced in the placebo group. No changes in the expression of CD32, CD40, and HLA-ABC-I were registered during the study. The results show that expression of CD23, CD54, and HLA-DR-II on peripheral B cells decreases during IT, which indicates reduced B-cell activation. Whether these effects are a result of direct allergen action on the B cells or whether they are mediated by T cells and their clinical relevance remains to be elucidated.

Adjuvants, Immunologic↗
PubMed1991

Pollinex Parietaria (Bencard Parietaria), a new allergoid for treatment of patients sensitive to Parietaria pollen.

Two matching groups each of eleven patients suffering from allergy to Parietaria pollen were treated either with tyrosine-adsorbed glutaraldehyde-modified extract of Parietaria judaica pollen (Bencard Parietaria/Pollinex Parietaria) or with alum-adsorbed pyridine-extract (Alavac). The side effects of therapy were similar in both groups and were mostly local in nature. Nasal symptoms were significantly less at the end of treatment in the group of patients treated with Pollinex. P. judaica-specific IgG levels were significantly higher in patients following treatment with Pollinex. The majority of patients in both groups showed reduced nasal and/or skin sensitivity following therapy as measured by provocation testing. The results indicate that Pollinex Parietaria is an effective vaccine for the treatment of immediate hypersensitivity to Parietaria pollen.

Adult↗
PubMed1986

[Immune response in therapy with allergens and allergoids].

We report on the patterns of specific IgE, IgG, and IgA antibodies during different kinds of hyposensitization. Whereas sIgE antibodies may even be influenced by environmental stimulants, the production of sIgG antibodies depends on the amount of antigens injected for therapy. There is some evidence that patients who do not reveal sIgG response have increased sIgA antibody titers, instead.

Allergens↗