A Multicentre Randomised Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of Birch Pollen Allergens

The aim of this clinical trial is to show safety and efficacy of the allergoid preparation of birch pollen allergens in the treatment of birch allergic patients in a representative number of patients.

开始日期2005-06-01

申办/合作机构

Allergopharma GmbH & Co. KG

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100 项与 Birch pollen allergoid (Allergopharma) 相关的转化医学

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项与 Birch pollen allergoid (Allergopharma) 相关的文献（医药）

2019-12-01·Immunotherapy4区 · 医学

Year-Round Treatment Initiation for a 6-Grasses Pollen Allergoid in Specific Immunotherapy of Allergic Rhinoconjunctivitis and Asthma

4区 · 医学

Article

作者: Rosewich, Martin ; Zielen, Stefan ; Mahler, Vera

Aim: Allergen immunotherapy (AIT) is an effective treatment for allergic diseases. We investigate whether treatment-initiation during the pollen season is safe. Methods: RCT-IIIb-trial of 6-grass-pollen-allergoid (Allergovit®) in grass pollen-allergic patients (18–65 years) with moderate–severe rhinitis/rhinoconjunctivitis (± controlled asthma), randomized 2:1 to treatment-initiation during (Group-A) versus outside the pollen season (Group-B). Results: Of 240 patients (32.8 ± 9.9 years, 19.5% asthma) treated, 84.9% (Group-A) and 86.6% (Group-B) reached maintenance dose without delay. Treatment-emergent adverse events occurred in 108 (68.4%/Group-A) and 41 patients (56.2%/Group-B) leading to premature trial-termination in 11 patients (7%/A) versus 3 (4.1%/B). Across groups, physicians (for 190 patients; 85.2%) and patients (192; 86.1%) rated the tolerability as ‘very good’–‘good’. Phleum pratense-specific IgG4 increased in both groups (p < 0.0001). Conclusion: Year-round allergen immunotherapy-initiation with this preparation is safe.

2018-01-01·Allergologie select

Subcutaneous specific immunotherapy: Economic implications from the perspective of statutory health insurance – a population-based cost-effectiveness estimation

Review

作者: Reinhold, T ; Brüggenjürgen, B ; Willich, S

BACKGROUNDSpecific immunotherapy is the only potentially curative therapy in patients with allergic rhinitis (AR) and allergic asthma (AA). The present study examined the effects of subcutaneous immunotherapy (SCIT) on the financial situation of the German statutory health insurance systems and measures the impact on AR/AA prevalence during the next decades. A further objective was to identify possible SCIT-treatment strategies in order to reach an efficient SCIT-use.METHODSTaking population projections of the German Statistical Federal Office, the number of expected new cases (AR, AA) was calculated until 2050. Based on assumptions about the proportion of patients who received SCIT in the future, age cohorts run through a model-calculation based on Markov chains. Data on effectiveness were extracted from published literature. For determining the cost situation of SCIT pharmacies we used selling prices for Allergovit^®. All future costs are discounted at a mean rate of 2%. The model calculation was supplemented by a Delphi panel.RESULTSBased on the current situation, a total annual economic burden of 540 million Euros is to be expected for care of about yearly 6 million patients with AR and AA in Germany between 2011 and 2050. Several scenarios have shown that the use of SCIT seems to be associated with cost savings from the perspective of statutory health insurances, when SCIT is offered to a larger amount of patients with moderate to severe symptoms. That would result in reduced number of expensive patients who suffer from AA. The best effects on the future number of diseased patients could be achieved, however, if SCIT additionally would be applied to patients in earlier stages of disease. Due to the large number of patients receiving SCIT in such a scenario, the initial costs would not completely compensated by cost savings. Nevertheless, the additional costs of 300 to 350 Euros per additionally healed patient seem to be justifiable.CONCLUSIONFrom the perspective of the SHI, SCIT is a useful strategic option for preventing the progression of allergic diseases. Particularly with increased use in early disease stages, the number of healed patients is high. Potential cost savings may result from increased treatment rates in patients with advanced disease stages.

2017-02-01·Allergo Journal International

Cost-effectiveness of grass pollen SCIT compared with SLIT and symptomatic treatment

Article

作者: Reinhold, Thomas ; Brüggenjürgen, Bernd

BACKGROUNDWhereas specific immunotherapy (SIT) has already been shown to be cost-effective in the treatment of allergic rhinitis compared with symptomatic treatment, only a small number of investigations have compared sublingual (SLIT) and subcutaneous (SCIT) immunotherapeutic approaches. This analysis discusses the cost-effectiveness of SCIT compared with SLIT and a symptomatic treatment modality. At the same time, particular attention is paid to preparation-specific characteristics.METHODSThe investigation is based on a previously published health economic model calculation. A Markov model, with predefined disease stages and a time period of 9 years, formed the basis of the analysis. The data on specific SCIT (Allergovit®) and SLIT (Oralair®) preparations required for the calculation were adjusted for the present analysis. Quality-adjusted life years (QALYs) based on symptom scores were calculated as the endpoint for effectiveness. Furthermore, the total costs and cost effectiveness of SCIT were determined. Model uncertainties were estimated by means of additional sensitivity analyses.RESULTSWith regard to effectiveness, both the SCIT and SLIT preparations proved superior compared to symptomatic treatment. Although more expensive, SIT seem to be cost-effective. A direct comparison of SCIT (Allergovit®) and SLIT (Oralair®) showed lower total costs for SCIT treatment over the study period (SCIT 1159 € versus SLIT 1322 €) and improved effectiveness (SCIT 7.112 QALYs versus SLIT 7.060 QALYs).DISCUSSIONSIT represents a cost-effective treatment option for patients with allergic rhinitis compared with symptomatic treatment. The comparison of SCIT (Allergovit®) and SLIT (Oralair®) showed SCIT to be predominant and cost-effective, due in particular to somewhat greater patient compliance and lower drug costs. It also became evident that, as far as possible, product-specific model variables are required for an economic evaluation of SIT treatment.

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