scholarly journals Accelerated Dose Escalation with 3 Injections of an Aluminum Hydroxide-Adsorbed Allergoid Preparation of 6 Grasses Is Safe for Children and Adolescents with Moderate to Severe Allergic Rhinitis

2021 ◽  
pp. 1-11
Author(s):  
Xenia Bovermann ◽  
Isabell Ricklefs ◽  
Christian Vogelberg ◽  
Ludger Klimek ◽  
Matthias V. Kopp
Keyword(s):  
Allergic Rhinitis ◽  
Children And Adolescents ◽  
Aluminum Hydroxide ◽  
Dose Escalation ◽  
Grass Pollen ◽  
High Dose ◽  
Standard Group ◽  
Allergen Specific Immunotherapy ◽  
Strength Group ◽  
The One

A high-dose, accelerated escalation schedule during subcutaneous allergen-specific immunotherapy (AIT) is safe and well-tolerated in adults. However, there are no data in children and adolescents. The aim of the present trial was to assess safety and tolerability of an accelerated dose escalation schedule of an AIT with a grass pollen allergoid in children and adolescents with moderate to severe seasonal rhinoconjunctivitis in a multicenter, open-label, randomized phase II trial. The dose escalation scheme for patients in the One Strength Group included 3 injections with 1 strength B (10,000 TU/mL), whereas the dose escalation scheme for the Standard group included 7 injections with 2 strengths A (1,000 TU/mL) and B (10,000 TU/mL) of an allergoid grass pollen preparation. Overall, <i>n</i> = 50 children (<i>n</i> = 25 in each group; mean age 8.9 + 1.54 years) and <i>n</i> = 37 adolescents (<i>n</i> = 20 and <i>n</i> = 17; 14.2 + 1.62 years) were randomized. For all patients, the mean treatment duration was 59.4 days in the One Strength group and 88.6 days in the Standard group. Treatment-emergent adverse events (TEAEs) related to AIT were reported in 52 and 40% in children and 35 and 35.3% in adolescents, respectively. Systemic allergic reactions occurred in about 5% of our patients and were reported in more patients of the One Strength group (6.7 vs. 2.4%). All systemic reactions were classified as WAO Grade 1. Accelerated high-dose escalation with an aluminum hydroxide-adsorbed grass pollen allergoid can be initiated with a safety and tolerability profile comparable to the standard dose escalation schedule in children and adolescents with allergic rhinitis with or without asthma.

scholarly journals High dose vitamin D3 empowers effects of subcutaneous immunotherapy in a grass pollen-driven mouse model of asthma

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Laura Hesse ◽  
N. van Ieperen ◽  
Arjen H. Petersen ◽  
J. N. G. Oude Elberink ◽  
Antoon J. M. van Oosterhout ◽  
...  
Keyword(s):  
Mouse Model ◽  
Grass Pollen ◽  
Airway Hyperresponsiveness ◽  
Allergic Inflammation ◽  
Optimal Dose ◽  
Lavage Fluid ◽  
Subcutaneous Immunotherapy ◽  
High Dose ◽  
Allergen Specific Immunotherapy ◽  
Neutralizing Capacity

AbstractAllergen-specific immunotherapy (AIT) has the potential to provide long-term protection against allergic diseases. However, efficacy of AIT is suboptimal, while application of high doses allergen has safety concerns. The use of adjuvants, like 1,25(OH)2VitD3 (VitD3), can improve efficacy of AIT. We have previously shown that low dose VitD3 can enhance suppression of airway inflammation, but not airway hyperresponsiveness in a grass pollen (GP)-subcutaneous immunotherapy (SCIT) mouse model of allergic asthma. We here aim to determine the optimal dose and formulation of VitD3 for the GP SCIT. GP-sensitized BALBc/ByJ mice received three SCIT injections of VitD3-GP (30, 100, and 300 ng or placebo). Separately, synthetic lipids, SAINT, was added to the VitD3-GP-SCIT formulation (300 nmol) and control groups. Subsequently, mice were challenged with intranasal GP, and airway hyperresponsiveness, GP-specific IgE, -IgG1, and -IgG2a, ear-swelling responses (ESR), eosinophils in broncho-alveolar lavage fluid and lung were measured. VitD3 supplementation of GP-SCIT dose-dependently induced significantly enhanced suppression of spIgE, inflammation and hyperresponsiveness, while neutralizing capacity was improved and ESR were reduced. Addition of VitD3 further decreased Th2 cytokine responses and innate cytokines to allergens in lung tissue by GP-SCIT. However, addition of synthetic lipids to the allergen/VitD3 mixes had no additional effect on VitD3-GP-SCIT. We find a clear, dose dependent effect of VitD3 on GP-SCIT-mediated suppression of allergic inflammation and airway hyperresponsiveness. In contrast, addition of synthetic lipids to the allergen/VitD3 mix had no therapeutic effect. These studies underscore the relevance of VitD3 as an adjuvant to improve clinical efficacy of SCIT treatment regimens.

scholarly journals Real world effectiveness and cost consequences of grass pollen SCIT compared with SLIT and symptomatic treatment

2021 ◽  
Author(s):  
Bernd Brüggenjürgen ◽  
Ludger Klimek ◽  
Thomas Reinhold
Keyword(s):  
Allergic Rhinitis ◽  
Cost Effectiveness ◽  
Real World ◽  
Grass Pollen ◽  
Cost Effective ◽  
Symptomatic Treatment ◽  
Economic Modelling ◽  
Allergen Specific Immunotherapy ◽  
Life Years ◽  
Adherence Data

Abstract Purpose Real-world evidence (RWE) with regard to allergen-specific immunotherapy (AIT) adherence is increasingly available. Economic modelling has already shown AIT to be cost-effective in the treatment of allergic rhinitis compared with symptomatic treatment. However, analyzing sublingual (SLIT) and subcutaneous (SCIT) immunotherapeutic approaches based on RWE adherence data are not available for Germany. This analysis outlines the cost-effectiveness of SCIT compared with SLIT as well as a symptomatic treatment modality on the basis of recent RWE adherence data. Methods A Markov model, with predefined disease stages and a time period of 9 years, was adapted for this analysis. A 6-grass subcutaneous allergoid SCIT preparation and a 5-grass pollen SLIT tablet was employed as AIT administrations. Quality-adjusted life years (QALYs) were calculated based on symptom scores and used as the effectiveness variable. Total costs and cost effectiveness of SCIT, SLIT and symptomatic treatment (ST) were calculated. Model uncertainties were estimated by means of additional sensitivity analyses. Applied discount rate was 3%. Results Both SCIT and SLIT preparations proved superior compared to symptomatic treatment with regard to effectiveness. Although more expensive, AIT also proved to be cost-effective. A direct comparison of SCIT (Allergovit®) and SLIT (Oralair®) showed lower total costs for SCIT treatment over the study period of 9 years (SCIT 1779 € versus SLIT 2438 €) and improved effectiveness (SCIT 7.17 QALYs versus SLIT 7.11 QALYs). Conclusion AIT represents a cost-effective treatment option for patients with allergic rhinitis compared with symptomatic treatment. SCIT appeared to be dominant and cost-effective, due in particular to higher patient adherence and lower drug costs.

scholarly journals Atopic asthma: the role of allergen-specific immunotherapy

2015 ◽  
Vol 12 (6) ◽  
pp. 54-67
Author(s):  
N M Nenasheva
Keyword(s):  
Allergic Rhinitis ◽  
Atopic Dermatitis ◽  
Children And Adolescents ◽  
Systemic Therapy ◽  
Specific Immunotherapy ◽  
Atopic Asthma ◽  
Allergen Specific Immunotherapy ◽  
Asthma Phenotype ◽  
Adolescents And Adults

Bronchial asthma is a heterogeneous disease in terms of the phenotypes, but the majority of patients, both children and adolescents, and adults suffer from IgE-dependent (atopic) asthma. This asthma phenotype most often is associated with allergic rhinitis, which defines systemic therapy for both diseases. The allergen-specific immunotherapy (SIT) meets that approach best of all. SIT is viewed as a treatment not for a specific nosology (rhinitis, asthma or atopic dermatitis), but for an allergen. The epidemiology and the etiology of atopic asthma, role of SIT in treatment of asthma, efficacy, safety, and basic mechanisms are discussed in the article.

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