Steroid-sparing effects with allergen-specific immunotherapy in children with asthma: A randomized controlled trial
Asthma control is now recognized as the main goal of asthma therapy. Guidelines recommend finding the lowest effective dose of inhaled corticosteroids in children with persistent asthma.
The aim of this study was to investigate the efficacy of an allergen-specific immunotherapy with a high-dose hypoallergenic mite preparation (allergoid) as steroid-sparing agent in children with allergic asthma.
Sixty-five children with asthma (Global Initiative for Asthma treatment levels II and III; 6-17 years old), after reaching asthma control with inhaled steroids during a 5-month baseline period, were randomized for subcutaneous mite allergoid immunotherapy (SCIT) plus fluticasone propionate (FP) or FP therapy alone for 2 years. During 2 subsequent 5-month winter periods, steroid therapy was adjusted according to predefined dose steps, determining and comparing the changes in FP dosages and the lowest FP dose sufficient to maintain asthma control. Immunologic and functional investigations were also carried out.
Children treated with house dust mite SCIT plus FP were able to significantly reduce the FP dose by more steps (P < .05), compared with the control group on FP alone. The mean daily dose in the immunotherapy group decreased from 330.3 μg in the baseline period to 151.5 μg after 2 treatment years, whereas in the control group the dose decreased from 290.6 μg to 206.3 μg. Compared with the control group, significant improvement was also observed in morning peak expiratory flow (P = .0315). Significantly increased levels of specific IgG(1) (P = .0001) and IgG(4) (P < .0001) were also observed.
Adding a mite allergoid SCIT to pharmacologic treatment is an effective and safe strategy to reduce corticosteroid doses while maintaining disease control in children with mite-induced allergic asthma.
Available from: Piotr Kuna
- "Allergy immunotherapy (AIT) addresses the underlying cause of allergy through immunomodulation, and thus treats both manifestations of respiratory allergic disease. Subcutaneous immunotherapy (SCIT) has been shown to reduce the use of inhaled corticosteroid (ICS) in adults and children with house dust mite (HDM) related asthma  . Further, a trial with 3 years of standardized SCIT treatment , suggested a preventive effect on development of asthma in children with seasonal rhinitis [8e10]. "
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In a double-blind, placebo-controlled trial (EudraCT identifier: 2006-001795-20), the standardised quality (SQ) house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet (ALK, Denmark) was investigated.
The trial included 604 subjects, ≥14 years, with mild-moderate HDM allergic asthma. Subjects were randomised 1:1:1:1 to 1, 3 or 6 SQ-HDM or placebo once daily. The primary endpoint was reduction in inhaled corticosteroid (ICS) after one year. ICS reduction, asthma quality of life questionnaire (AQLQ) and asthma control questionnaire (ACQ) score was analysed post hoc in a subgroup with daily ICS use of 400-800μg and ACQ score of 1-1.5, corresponding to partly controlled asthma (N=108).
The trial met its primary endpoint. In the subgroup, the difference between placebo and 6 SQ-HDM in change from baseline in daily ICS use was 327μg (p<0.0001), while it was 0.52 (p=0.010) for AQLQ. The treatment effect on ICS reduction and AQLQ was increased for the subgroup versus the residual population (ICS reduction: p<0.001); AQLQ: p=0.044).
In this subgroup, including only patients with partly controlled asthma, the benefit of 1 year of treatment with SQ HDM SLIT-tablet was significantly higher than for the less severe full population, both in terms of increased asthma control and improved quality of life.
Respiratory Medicine 10/2014; 108(10). DOI:10.1016/j.rmed.2014.07.017 · 3.09 Impact Factor
Available from: Salvatore Tripodi
- "macrolides)  help controlling asthma but allergen-specific immunotherapy (SIT) is the only treatment potentially changing the natural history of the allergic component of moderate asthma, with a potential long lasting exacerbation-preventing effect and corticosteroid-sparing effect . However, due to the difficulty in carrying out placebo controlled trials, efficacy of SIT, especially in its subcutaneous version (SCIT), has been so far demonstrated in children by a few trials only [96-98]. "
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ABSTRACT: The epidemic of childhood allergic disorders has been associated to the decline of infectious disease. However, exposure to many triggers (airborne viruses, tobacco smoke, pollution, indoor allergens, etc.) contribute to the disease. Breast feeding practices, nutrition, dietary and obesity also play a multifaceted role in shaping the observed worldwide trends of childhood allergies. Guidelines for treatment are available, but their implementation is suboptimal. Then developed countries are slowing learning integrating the development of suitable guidelines with implementation plans. Awareness, psychosocial and family factors strongly influence asthma and food allergy control. Moreover, monitoring tools are necessary to facilitate self-management. By taking into consideration these and many other pragmatic aspects, national public health programs to control the allergic epidemic have been successful in reducing its impact and trace the need for future research in the area.
Italian Journal of Pediatrics 12/2013; 39(1):80. DOI:10.1186/1824-7288-39-80 · 1.52 Impact Factor
Available from: Susanne Thum-Oltmer
- "The ICS dosages in both groups during the third treatment year were described elsewhere . For details on inclusion and exclusion criteria and detailed statistical methods see the publication of Zielen et al. 2010 . "
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ABSTRACT: Subcutaneous specific immunotherapy (SCIT) is an effective treatment attenuating the progression of allergic asthma. To date, there is a lack of studies investigating the economic consequences of SCIT on health care expenditures.
A health-economic piggy-back analysis of SCIT was conducted based on a RCT that enrolled 65 children and adolescents with allergic asthma. Patients were allocated into two groups: A group receiving SCIT with a high-dose hypoallergenic house dust mite preparation plus asthma medication and a control group receiving only asthma medication. For both groups asthma control was achieved before the start of the SCIT treatment and was maintained during the study. Both, costs and cost-effectiveness of SCIT with the high-dose hypoallergenic house dust mite preparation were investigated based on total medication costs, incremental medication costs and treatment effects (measured as lung function), respectively. A bootstrap analysis was performed to validate the results.
A steady decline in medication costs could be observed in the SCIT group one year after treatment start compared to the control group. This cost trend became statistically significant 3 years after SCIT started. The calculated potential savings in the SCIT group correlated with an improved lung function. The distribution of the bootstrap results revealed that the probability of SCIT having a superior effectiveness compared to the control group is around 90%.
SCIT with a high-dose hypoallergenic preparation received by children and adolescents suffering from mite induced allergic asthma reduces the allergic medication intake and has cost-saving effects. Additional costs associated with SCIT may be completely compensated by drug cost savings 4 years after end of SCIT. Additionally, SCIT is superior compared to routine care as measured by the lung function that improved in SCIT-treated patients. Trial registration: (EudraCT no. 2004 -- 003892 -- 35).
09/2013; 3(1):30. DOI:10.1186/2045-7022-3-30
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