Effect of One-Year Subcutaneous and Sublingual Immunotherapy on Clinical and Laboratory Parameters in Children with Rhinitis and Asthma: A Randomized, Placebo-Controlled, Double-Blind, Double-Dummy Study

Clinic of Pediatric Allergy and Immunology, Children's Hospital of Gaziantep, Gaziantep, Turkey.
International Archives of Allergy and Immunology (Impact Factor: 2.67). 02/2012; 157(3):288-98. DOI: 10.1159/000327566
Source: PubMed


It has been reported that both sublingual (SLIT) and subcutaneous (SCIT) allergen-specific immunotherapy have clinical efficacy, yet there are rather few comparative placebo studies of children. We aimed to investigate the clinical and immunological efficacy of mite-specific SLIT and SCIT versus a placebo in rhinitis and asthma in children.
The outcomes of this 1-year, randomized, placebo-controlled, double-blind, double-dummy study were symptom and medication scores, visual analog scores (VAS), titrated skin prick tests, nasal and bronchial allergen provocation doses, serum house dust mite-specific immunglobulin E (HDM-sIgE), sIgG4, IL-10 and IFN-γ levels.
Clinical and laboratory parameters were evaluated in 30 patients. SCIT significantly diminished symptom and medication scores for rhinitis and asthma (p = 0.03 and p = 0.05 for rhinitis; p = 0.01 and p = 0.05 for asthma) and VAS. SLIT also reduced VAS, symptoms associated with rhinitis and asthma as well as medication usage for rhinitis, but this reduction was not significant when compared with the placebo. Skin reactivitiy to HDM and HDM-sIgE levels was reduced significantly in both immunotherapy groups. Serum IL-10 levels and nasal provocative doses increased significantly with both SCIT and SLIT. Nasal eosinophil increments after nasal challenge decreased with two treatment modes, but bronchial provocative doses and sputum eosinophil increments after bronchial challenge were reduced only with SCIT. In both treatment arms, there was no change in IFN-γ levels. Serum sIgG4 levels increased significantly only in the SCIT group.
Based on the limited number of patients at the end of the 1-year immunotherapy, the clinical efficacy of SCIT on rhinitis and asthma symptoms was more evident when compared with the placebo.

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Available from: Seval Guneser Kendirli, Mar 03, 2015
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    • "The effects on lung function were not consistent among trials. Also, more recent studies on efficacy of subcutaneous immunotherapy in asthma show similar treatment effect [19•, 20]. The most recent meta-analysis of the effectiveness of SCIT in the treatment of allergic rhinitis and asthma up to May 2013 concluded that SCIT reduces asthma symptoms and asthma medication usage. "
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    ABSTRACT: Opinion statement Current asthma therapies can effectively control symptoms and the on-going inflammatory process; however, they do not affect the underlying, dysregulated immune response. Thus, they are limited to blunting the progression of the disease, which relapses on ceasing the treatment. Allergen-specific immunotherapy (AIT) is the only etiology-based treatment capable of disease modification. Recent evidence provided a plausible explanation for its multiple mechanisms inducing both rapid desensitization and long-term allergen-specific immune tolerance, as well as the suppression of allergic inflammation in the affected tissues. Although the current guideline documents give both subcutaneous (SCIT) and sublingual (SLIT) immunotherapy a conditional recommendation in allergic asthma due to the moderate and low quality of evidence, respectively, a growing body of evidence from double-blind, placebo-controlled studies shows that both SLIT and SCIT are effective in reducing symptom scores and medication use, improving quality of life, and inducing favorable changes in specific immunologic markers. Due to the very limited evidence from head-to-head comparative studies and variability of the end-point used in different studies, it is currently not possible to assess superiority of either route of vaccine administration.
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    • "The 2010 revision of the allergic rhinitis and its impact on asthma (ARIA) guidelines recommends SLIT for children with allergic rhinitis due to pollen but, because of poor evidence, SLIT was not recommended for use in children with allergic rhinitis caused by HDM [14]. Subsequent studies have reported a non-significant reduction in symptoms of allergic rhinitis and asthma in children with HDM allergies treated with SLIT compared to placebo [15,16]. "
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    ABSTRACT: Allergen immunotherapy is a recognised intervention in patients with allergies not responding to standard pharmacotherapy or in whom pharmacotherapy is contraindicated. We describe the sublingual immunotherapy (SLIT) regimens used in children and adolescents with house dust mite (HDM) respiratory allergies in France and assess the efficacy and safety of this treatment. This was a sub-analysis of paediatric patients included in a previous retrospective, observational, multicentre study. Inclusion criteria were: age 5–17 years; respiratory allergy and proven sensitisation to HDM; at least 2 years follow-up after SLIT initiation. The following data were recorded at SLIT initiation: clinical characteristics; sensitisation profile; concomitant symptomatic medications; details of SLIT protocol. During follow-up and at the end of treatment the following data were recorded: any changes to SLIT treatment; any changes to symptomatic medications; symptom progression; adverse events. SLIT efficacy, patient compliance and satisfaction, and safety were assessed. 736 paediatric patients were included in this analysis. Most patients (95.5%) had allergic rhinitis, which was moderate to severe persistent in 62.8%. Allergic asthma was present in 64.0% and was mild to moderate persistent in 52.7% of these patients. The majority of patients had rhinitis with asthma (59.5%). Three-hundred and seventy five (62.3%) patients were polysensitised. Compliance was good in 86.5% of patients and SLIT was effective in 83.8%. Symptoms of rhinitis and asthma were improved in 64.6% and 64.3% of patients, respectively. A decrease in symptomatic medication was observed following SLIT initiation in patients with rhinitis and/or asthma. SLIT was well tolerated with mainly local reactions reported. HDM SLIT appears to be effective in children and adolescents with rhinitis and/or asthma due to HDM allergens, with no tolerability issues and similar benefits as in adults.
    Full-text · Article · Apr 2014
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    • "SLIT została uznana za skuteczną metodę leczenia alergicznego nieżytu nosa, spojówek i astmy przez międzynarodowe panele specjalistów, w tym przez grupę ARIA. Pilotażowe badania przeprowadzone metodą randomizacji i podwójnie ślepej próby z zastosowaniem placebo (randomised, double blind, placebo controlled; RDBPC) porównujące obie formy immunoterapii wskazują na przewagę SCIT nad SLIT w zmniejszeniu objawów astmy i alergicznego nieżytu nosa, porównywalny wpływ obu metod leczenia na parametry immunologiczne (sIgE, IL-10) i zapalenie górnych dróg oddechowych oraz przewagę SCIT nad SLIT w odniesieniu do zapalenia w dolnych drogach oddechowych ocenianego na podstawie testów prowokacyjnych [18]. Brak obecnie podstaw do rekomendacji SLIT w alergii pokarmowej, co zgodne jest także ze stanowiskiem European Medicine Agency (EMA) [80]. "
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    ABSTRACT: SLIT (sublingual immunotherapy) is a therapeutic method aiming at producing allergen-specific tolerance of the immune system to a gradually increasing dose of an allergen that is administered sublingually. SLIT initiates similar immune mechanisms as does subcutaneous immunotherapy (SCIT). The aim of the study at this position is to update the current knowledge on sublingual immunotherapy. Randomized double-blind, placebo-controlled (RDBPC) studies that compared both immunotherapy forms point to an advantage of SCIT over SLIT in decreasing symptoms of asthma and allergic rhinitis, a comparable effect of both the methods on immune parameters (sIgE, IL-10) and upper respiratory tract inflammations and an advantage of SCIT over SLIT with respect to lower respiratory tract inflammations as based on provocation tests. At present, there are no grounds for recommending SLIT in food allergy. In view of the high safety profile and absence of anxiety-provoking infections, SLIT may be the method that is more often selected in children as compared to adults. On the other hand, immune mechanisms and results of clinical trials provide an argument for preferential employment of SCIT in adults. It should be borne in mind, however, that SLIT is effective if a good quality vaccine with a high allergen dose, is employed for at least three years. National and international reports indicate the necessity of conducting further clinical trials, especially including a direct comparison between SCIT and SLIT with respect to effectiveness and safety.
    Full-text · Article · Mar 2014
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