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Allergen-specific immunotherapy

Allergen-specific immunotherapy

Allergen-specific immunotherapy is a potentially disease-modifying therapy that is effective for the treatment of allergic rhinitis/conjunctivitis, allergic asthma and stinging insect hypersensitivity. However, despite its proven efficacy in these conditions, it is frequently underutilized in Canada. The decision to proceed with allergen-specific immunotherapy should be made on a case-by-case basis, taking into account individual patient factors, such as the degree to which symptoms can be reduced by avoidance measures and pharmacological therapy, the amount and type of medication required to control symptoms, the adverse effects of pharmacological treatment, and patient preferences. Since this form of therapy carries a risk of anaphylactic reactions, it should only be prescribed by physicians who are adequately trained in the treatment of allergic conditions. Furthermore, for subcutaneous therapy, injections must be given under medical supervision in clinics that are equipped to manage anaphylaxis. In this article, the authors review the indications and contraindications, patient selection criteria, and details regarding the administration, safety and efficacy of allergen-specific immunotherapy.
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EAACI: A European Declaration on Immunotherapy. Designing the future of allergen specific immunotherapy

EAACI: A European Declaration on Immunotherapy. Designing the future of allergen specific immunotherapy

Allergen specific immunotherapy has been found to be effective in reducing symptoms of allergic rhinitis and al- lergic asthma and improving the quality of life of allergy sufferers. It also results in reduced use of symptom re- lieving medications. Allergen specific immunotherapy has the potential for important longer-term benefits, even after cessation of the treatment. In patients with al- lergy to insect venom or food allergy, allergen specific immunotherapy is able to prevent life-threatening reac- tions. Different routes for allergen specific immunother- apy have been evaluated, such as the subcutaneous, sublingual, oral, nasal, bronchial, and intra-lymphatic, the first two of these routes being the most commonly used in clinical practice today. The most common aller- gens used in clinical practice are aero-allergens for sea- sonal and perennial allergy; more recently, latex and food allergens have been evaluated in clinical trial with promising results to be confirmed [54].
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Clinical Efficacy of Allergen Specific Immunotherapy (ASIT) in Allergic Rhinitis

Clinical Efficacy of Allergen Specific Immunotherapy (ASIT) in Allergic Rhinitis

Though efficacy of Allergen Specific Immunotherapy (ASIT) has been proved in many studies, reports about success in clinical practice and under field conditions in alleviating the suffering or decreasing the morbidity in patients of Aller- gic Rhinitis are few. 260 patients of Allergic Rhinitis without coexisting diseases were included. Skin prick test was done on all patients. ASIT was initiated with common inhalant indoor allergens as per standard protocol and patients were assessed at the start and at 2 m, 6 m and 18 months of ASIT. ASIT was able to significantly reduce the symptom score in all the three groups namely sneezing, rhinorrhoea and nasal itching (p < 0.001). Concurrently it was also able to produce a significant reduction in the usage of concomitant drug intake (p < 0.001) thereby implying a decrease in morbidity. When assessed regarding clinical efficacy, ASIT was found to be satisfactory or highly effective in more than 75% patients. ASIT has got a role in clinical practice in polysensitized patients in field conditions. This is based on the evidence that besides decrease in hypersensitivity/symptoms, it also has an effect on minimizing the necessity of taking drugs to relieve the symptoms, which has strong implications of economics and toxicity, while treating patients.
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Combination of specific allergen and probiotics induces specific regulatory B cells and enhances specific immunotherapy effect on allergic rhinitis

Combination of specific allergen and probiotics induces specific regulatory B cells and enhances specific immunotherapy effect on allergic rhinitis

The therapeutic efficacy of allergen specific immunotherapy (SIT) on allergic diseases is to be improved. Probiotics can regulate immune response. This study aims to promote the effect of SIT on allergic rhinitis (AR) by co-administration with Clostridium butyricum (Cb). In this study, patients with AR sensitized to mite allergens were enrolled to this study, and treated with SIT or/and Cb. The therapeutic efficacy was evaluated by the total nasal symptom scores (NSS), medication scores, serum specific IgE levels and T helper (Th)2 cytokine levels. The improvement of immune regulation in the AR patients was assessed by immunologic approaches. The results showed that treating AR patients with SIT alone markedly reduced NSS and medication scores; but did not alter the serum specific IgE, Th2 cytokines and skin prick test (SPT) index. The clinical symptoms on AR in SIT group relapsed one month after stopping SIT. Co-administration of Cb significantly enhanced the efficacy of SIT on AR as shown by suppression of NSS, medication scores, serum specific IgE, Th2 cytokines and SPT index; the regulatory B cell frequency was also markedly increased. Such an effect on AR was maintained throughout the observation period even after stopping the treatment. Butyrate blocked the activation of histone deacetylase-1, the downstream activities of epsilon chain promoter activation, and the IgE production in the antigen specific B cells. On the other hand, butyrate induced the IL-10 expression in B cells with a premise of the B cell receptor activation by specific antigens. In conclusion, administration with Cb can markedly enhance the efficacy of SIT on AR.
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Allergen-specific immunotherapy provides immediate, long-term and preventive clinical effects in children and adults: the effects of immunotherapy can be categorised by level of benefit -the centenary of allergen specific subcutaneous immunotherapy

Allergen-specific immunotherapy provides immediate, long-term and preventive clinical effects in children and adults: the effects of immunotherapy can be categorised by level of benefit -the centenary of allergen specific subcutaneous immunotherapy

Allergen specific immunotherapy is the only treatment that interferes with the basic pathophysiological mechanisms of the allergic disease and thereby carries the potential for changes in the long-term prognosis of respiratory allergy. SIT should be recognised not only as first-line therapeutic treatment for allergic rhinocon- junctivitis but also as secondary preventive treatment for respiratory allergic diseases. Together with the long term clinical experience available, SIT is an important treatment for prevention of asthma in patients with allergic rhinitis and it makes asthma control easier to accomplish. Immunotherapy seems to reduce the devel- opment of new allergic sensitivities as measured by skin prick test as well as specific IgE measurements, and long term follow-up on immunotherapy studies demon- strate that specific immunotherapy with modern phar- maceutically standardised allergen extracts shows persistent long term effect on clinical symptoms after termination of treatment and long-term, preventive effect on later development of asthma in children with seasonal rhinoconjunctivitis. These are important added benefits to the immediate clinical effect which is com- parable to other treatment options and has shown to progressively improve during treatment periods. It is so far the only treatment for allergic diseases which has shown to be able to prevent worsening of disease and development of asthma. In these years, a number of large ongoing clinical studies with the primary purpose of establishing the EMA guideline documentation needed for registration of pharmaceutical products will certainly add further to our basic knowledge about the potential immunological modifications and long-term options. This is of great importance for the optimization of the future treatment of the increasing number of patients suffering from respiratory allergic diseases.
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Specific immunotherapy in Albanian patients with anaphylaxis to hymenoptera venoms

Specific immunotherapy in Albanian patients with anaphylaxis to hymenoptera venoms

In summary, the present study describes the first investi- gation on the use of specific immunotherapy in a develop- ing country such as Albania and proves that this treatment option may also be used in non-industrialized countries with an adverse reaction profile similar to western coun- tries.

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Clinical practice recommendations for allergen-specific immunotherapy in children: the Italian consensus report

Clinical practice recommendations for allergen-specific immunotherapy in children: the Italian consensus report

The severity of the disease, the effectiveness and the advantages of the treatment for the allergic children rep- resent relevant criteria to decide if carrying on or dis- continuing AIT. The causes underlying a poor or absent improvement of symptoms usually may be: 1) incorrect identification and treatment of the clinically relevant al- lergens; 2) inadequate dose of allergen administered to the patient; 3) too short duration of the therapy; and 4) poor adherence to treatment. As opposite, once assessed the effect of immunotherapy, the treatment should be continued for not less than 3 years. The duration of the treatment may be prolonged (5 years or more), depend- ing on the clinical response of subjects. Many patients experience a prolonged remission of symptoms after dis- continuation of AIT [52–55] whereas others may have a relapse of clinical manifestations. Currently, there are no specific laboratory tests or biomarker that can distin- guish patients who will relapse from those who would have a prolonged clinical remission after discontinuing AIT [56]. Therefore, the duration of AIT should be de- cided by the pediatric allergist on an individual basis Table 3 Indications for allergen-specific immunotherapy (AIT)
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Specific immunotherapy by the sublingual route for respiratory allergy

Specific immunotherapy by the sublingual route for respiratory allergy

The management of respiratory allergy relies upon, when possible, allergen avoidance, drug treatment, and allergen-specific immunotherapy (SIT) [3]. SIT is the practice of administering gradually increasing doses of the specific causative allergen to reduce the clinical reactivity of allergic subjects. SIT has central importance because of its ability to modify the natural history of the disease and to extend its effectiveness also after treat- ment withdrawal, provided it is administered for an ade- quate duration [4]. The subcutaneous route has been for decades the traditional route of administration, but in recent years the sublingual route emerged as an actual treatment option [5]. The main reason to introduce sub- lingual immunotherapy (SLIT) was the safety problems with subcutaneous immunotherapy (SCIT), which may include systemic reactions, sometimes severe and, though very rarely, even fatal [6].
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Role of interleukin 10 in specific immunotherapy

Role of interleukin 10 in specific immunotherapy

Although specific immunotherapy (SIT) is applied fre- quently in allergy to hymenoptera venom, the mechanisms by which clinical improvement is achieved in allergic patients re- main to be elucidated. Stimulation of IgG4 antibodies and a decline of the IgE/IgG4 anti-PLA antibody ratio (15–20) were claimed to be responsible for successful SIT. Also, the genera- tion of IgE downregulating CD8 1 T cells and reduced numbers of mediator-secreting mast cells and eosinophils (21–25) were found in SIT. Moreover, successful SIT of allergic rhinitis was shown to be associated with decreased numbers of Th2 and in- creased IFN- g –producing cells (26). A shift from a Th2 cyto- kine pattern toward increased IFN- g production in SIT of al- lergy to BV, Lol p, and Der p (26–29) indicated an important involvement of cytokine-producing CD4 1 T cells. However, the induction of an anergic state in peripheral T cells, which is characterized by suppressed proliferative and cytokine re- sponses against the major allergen(s), appeared to be a pivotal step in SIT (30).
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Influence of subcutaneous specific immunotherapy on drug costs in children sufferingfrom allergic asthma

Influence of subcutaneous specific immunotherapy on drug costs in children sufferingfrom allergic asthma

2006 which represents the time of the highest exposure to house dust mites. Data from patient diaries during the baseline year build a sound and reliable basis of an individual patient status prior to the start of treatment. After achieving asthma control, patients were randomized into an intervention group, receiving a subcutaneous specific immunotherapy with house dust mite allergoid Acaroid® in addition to standard asthma medication, or into a control group with standard asthma medication alone. The patients were compared during a mean follow up period of 3 years. The study including the present health economic analysis, was approved by an ethics committee in accordance to the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements.
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Allergen-specific immunotherapy

Allergen-specific immunotherapy

Immunotherapy has been shown to be effective against allergic asthma caused by grass, ragweed, house dust mites, cat and alternaria [6,12]. A Cochrane review of 75 randomized controlled trials examining the use of aller- gen-specific immunotherapy in asthma management con- firmed its efficacy in reducing asthma symptom scores and medication requirements, and improving airway hyperre- sponsiveness [1]. Similar benefits have been noted with sublingual immunotherapy [13], which is expected to be approved in Canada in the near future. Evidence also sug- gests that allergen-specific immunotherapy may prevent the onset of asthma in atopic individuals [14,15]. One study in children with grass and/or birch pollen allergy found that only 26% of subjects treated with immunother- apy developed asthma 3 years after completion of treat- ment compared to 45% who were not treated with immunotherapy [15]. Allergen-specific immunotherapy may also modify the progression of established asthma in children. A study published in the 1960s found that 70% of treated children no longer had asthma 4 years after completing immunotherapy compared to 19% of untreated control subjects, and these results were sustained up to 16 years of age [16]. However, there is no current evidence that immunotherapy influences the evolution of estab- lished asthma in adults.
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Prospective adherence to specific immunotherapy in Europe (PASTE) survey protocol

Prospective adherence to specific immunotherapy in Europe (PASTE) survey protocol

In addition, the SurveyMonkey® facility uses advanced technology for Internet security. To use this tool, as ad- ministrator, a unique user name and password must be entered. SurveyMonkey® issues a session “cookie” only to record encrypted authentication information for the dur- ation of a specific session. Once the user accesses se- cured areas, the Secure Sockets Layer (SSL) technology protects user information using both server authentica- tion and data encryption, ensuring that user data is safe, secure, and available only to authorised persons. Survey- Monkey® is PCI-DSS compliant [47].
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The perception of allergen-specific immunotherapy among pediatricians in the primary care setting

The perception of allergen-specific immunotherapy among pediatricians in the primary care setting

In the pediatric age range, allergic diseases represent a special problem, with specific aspects, that include their possible evolution (allergic march) [4 – 6], the problems related to the long-term pharmacotherapy, the compli- ance (which is in charge of caregivers), the objective dif- ficulties in correctly deliver inhaled drugs. In addition, the quality of life of the children themselves and of their parents (drug treatment, emergency unit visits, impaired school performance and absenteeism), is usually affected [7, 8]. Thus, an early and correct diagnosis and an ad- equate therapeutic management of allergic respiratory diseases in children are strongly desirable [9].
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Clinical Efficacy of Allergen Specific Immunotherapy from Patient and Physician Perspectives

Clinical Efficacy of Allergen Specific Immunotherapy from Patient and Physician Perspectives

were only from internal medicine and pediatrics. This is the reason why the number of patients receiving SLIT was small in our study. Secondly, we could not compare the efficacy and safety of AIT between AIT products or administration meth- ods. The questionnaire developed by an expert panel of the allergen and immunotherapy workgroup of the KAAACI was inadequate for these purposes. Our workgroup is planning to compare AIT products in future studies. However, the strengths of the present study are that data were collected in real-life settings and that relevant data based on current guidelines were provided for the management of patients re- Table 2. Effects of AIT according to Age Groups
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Allergen-Specific Immunotherapy for Pediatric Asthma and Rhinoconjunctivitis: A Systematic Review

Allergen-Specific Immunotherapy for Pediatric Asthma and Rhinoconjunctivitis: A Systematic Review

Allergen-speci fi c immunotherapy (SIT) is frequently used to treat asthma and allergic rhinitis and may modify the course of the disease. SIT is typically recommended for children whose as- thma and allergic rhinitis symptoms cannot be adequately controlled with medication or environmental changes. The US Food and Drug Administration has approved the use of allergen ex- tracts for subcutaneous immunother- apy (SCIT) to treat allergic rhinitis and allergic asthma. Considerable interest has developed in using sublingual im- munotherapy (SLIT), which is currently prescribed off-label in the United States. SLIT involves placement of the allergen under the tongue for local absorption, to desensitize the allergic individual over a period of months to years; this method has gained favor in Europe, 3 where
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Self adjuvanting nanoemulsion targeting dendritic cell receptor Clec9A enables antigen specific immunotherapy

Self adjuvanting nanoemulsion targeting dendritic cell receptor Clec9A enables antigen specific immunotherapy

Our findings indicate that the Clec9A-targeting vaccination platform can efficiently exploit the immunogenicity of the unique epitopes expressed by oncogenic viruses or generated by somat- ic mutations, which represent the most potent antigens for cancer immunotherapy. Indeed, HPV16 synthetic long peptides used with- in conventional vaccination approaches induced strong antitumor immunity and clinical responses in patients with HPV16-driven car- cinomas (50–52). More recently, neoantigen vaccines in the form of RNA polyepitopes or based on the use of synthetic long peptides administered with adjuvant were shown to elicit robust specific T cell responses to advanced melanoma, with potential clinical ben- efits (53, 54). The ability of the TNE vaccination platform to deliver tumor antigens directly to cross-presenting Clec9A + DCs in vivo and
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Allergen-Specific Immunotherapy in the Treatment of Pediatric Asthma: A Systematic Review

Allergen-Specific Immunotherapy in the Treatment of Pediatric Asthma: A Systematic Review

Two reviewers extracted data and assessed risk of bias (ROB). Efficacy outcomes that were graded per our protocol included the following: asthma symptoms as reported by asthma control composite scores, QoL, medication use, health care use, and pulmonary physiology (forced expiratory volume in 1 second [FEV 1 ]). Safety outcomes included anaphylaxis, local effects, systemic effects, and deaths. Details regarding immunotherapy including allergen, formulation, dose, and treatment duration were extracted.

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Basophil sensitivity through CD63 or CD203c is a functional measure for specific immunotherapy

Basophil sensitivity through CD63 or CD203c is a functional measure for specific immunotherapy

Increase in basophil sensitivity during the up dosing phase of SCIT may be limited by factors in plasma The effect of the up-dosing phase of subcutaneous immunotherapy on basophil up regulation of CD63 and CD203c (figure 1) was evaluated by fitting a sigmoid curve to data points obtained with a 7-step logarithmic dilution series of V. vespula allergen and blood of wasp allergic patients drawn at each of visits 1, 2, 3, 4, 7 and maintenance visit, if that did not coincide with visit 7. From this curve at each visit, the concentration of aller- gen resulting in half-maximal CD63 activation was determined (figure 1e). It is termed LC50. When nor- malised to the baseline visit, the LC50 was normally dis- tributed. When plotted against visit, it increased significantly from the first to the third week of immu- notherapy (visit 1 - 3; p = 0, 0098, visit 2 - 3 p = 0, 0259, visit 3 - 4 p = 0, 0274, visit 3-maint p = 0, 0095 for all in a mixed linear model, p = 0,029 for CD63, p = 0,015 for CD203c, n = 18), and tended toward baseline levels beyond that (figure 2a).
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Novel birch pollen specific immunotherapy formulation based on contiguous overlapping peptides

Novel birch pollen specific immunotherapy formulation based on contiguous overlapping peptides

intradermally with multi-T cell epitope preparations [16]. They did not induce immediate-type reactions but late re- spiratory symptoms including dyspnea, which occurred a few hours after the injections [39,40]. Long synthetic pep- tides overlapping by 5 to 20 amino acids (COPs), as ap- plied in the current study, were initially developed from PLA2, the major bee venom allergen [17,18]. PLA2 hyper- sensitive volunteers did not react to intradermal tests with PLA2 derived long synthetic peptides. A phase I clinical trial in bee venom hypersensitive patients was safe and in- duced only transient late allergic reactions (sensation of heat in two volunteers) and was immunogenic, namely in- ducing a significant rise in PLA2 specific IgG4 [20]. In the present study, the same approach was applied to Bet v 1, the dominant allergen from birch pollen, a very common respiratory allergy in Northern Europe. Three sets of pep- tides were obtained, two consisting in three overlapping peptides T1-T2-T3 and T6-T7-T8, another in two overlap- ping peptides T4-T5. Their sequences were derived from the most representative Bet v 1 isoform, rBet v 1.01A. The interest of COPs relies in part in their capacity to cover all potential T cell epitopes known to be spread all along the Bet v 1 molecule [24], as previously observed also with Table 2 AN002 clinical trial: volunteers ’ characteristics
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Phase I clinical trial of HER2 specific immunotherapy with concomitant HER2 kinase inhibtion

Phase I clinical trial of HER2 specific immunotherapy with concomitant HER2 kinase inhibtion

pretreated population with multiple sites of metastasis who had progressive disease on trastuzumab and prior lapatinib compares favorably with other clinical data. For example, although there is insufficient data in the literature regarding the outcome of patients refractory to both drugs, among patients who have progressive dis- ease while receiving trastuzumab therapy, overall survi- val has ranged from 10 - 19 months [29-31]. In the EGF104900 study, which randomized patients who had progressed on trastuzumab to either lapatinib alone or lapatinib in combination with trastuzumab, PFS of 8 weeks and OS of 39 weeks (or 273 days) was reported for the lapatinib only arm [31]. It has also been observed in some immunotherapy studies, that OS is improved despite a lack of effect on PFS suggesting that delayed effects of the vaccine might have led us to prematurely discontinue immunization. Future studies should permit a greater extent of progression (such as 50% growth) in asymptomatic progression as has been suggested in the literature [32].
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