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: 2.43). 02/2012; 157(3):288-98. DOI: 10.1159/000327566
Source: PubMed

ABSTRACT 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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    • "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.
    01/2014; 1(1):30–37. DOI:10.1016/j.alergo.2014.03.002
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    • "There are few published DBPC trials that evaluated efficacy of HDM-SLIT on AR in children with contradictory results [18e22]. Recently, Yuksel et al compared head to head the efficacy of SCIT and SLIT in HDM-allergic children and reported that SCIT significantly reduced rhinitis symptoms compared to SLIT and placebo, with no difference between SLIT and placebo [23]. It might be argued that most of the studies reported previosly included patients with multiallergen and other comorbidities such as asthma, hence effectivity of SLIT to treat perennial AR could be obscured. "
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    ABSTRACT: Although sublingual immunotherapy (SLIT) has been demonstrated to be a safe and efficient treatment in children with seasonal allergic rhinitis (AR), there is little evidence on the efficacy of SLIT with house-dust-mite (HDM) extract in children with isolated perennial AR. We sought to assess the clinical efficacy and safety of HDM-SLIT in children with isolated allergic rhinitis-conjunctivitis mono-sensitized to HDM without asthma symptoms. Twenty-two children (aged 5-10 years) with perennial AR and conjunctivitis symptoms mono-sensitized to Dermatophagoides pteronyssinus and Dermatophagoides farinae were enrolled. During a 2 months run-in period, symptom and medication scores, lung functions, bronchial hyperreactivity, nasal provocation and skin prick tests were evaluated. Subjects were randomized to active or placebo using a double-blind method. A total of eighteen subjects were randomised to receive either active SLIT or placebo for 12 months. Daily symptom and medication scores, baseline lung functions, bronchial hyperreactivity, nasal provocation and skin prick tests were recorded and re-evaluated at the end of treatment. After one year of treatment, no significant differences were detected in the between groups and within group comparisons based on total rhinitis symptom/medication scores (p > 0.05). Skin reactivity to Dermatophagoides pteronyssinus was significantly reduced in HDM-SLIT compared to placebo group (p = 0.018). A significant reduction in nasal sensitivity was observed in SLIT group after one year treatment when compared to baseline (p = 0.04). Total conjunctivitis symptoms were reduced significantly in both active and lacebo group at the end of treatment compared to baseline. The proportion of patients with non-specific bronchial hyperreactivity increased to almost 3-fold in placebo group compared to baseline. HDM-SLIT was not superior to placebo in reducing isolated rhinoconjunctivitis symptoms within 12 months of treatment. However, HDM-SLIT has a modulating effect on allergen-specific nasal and skin reactivity in isolated perennial AR children. The trial was registered at number, ACTRN12613000315718.
    Respiratory medicine 07/2013; 107(9). DOI:10.1016/j.rmed.2013.06.021 · 2.92 Impact Factor
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    ABSTRACT: Immunoglobulin E-mediated allergies affect more than 25% of the population. Allergen exposure induces a variety of symptoms in allergic patients, which include rhinitis, conjunctivitis, asthma, dermatitis, food allergy and life-threatening systemic anaphylaxis. At present, allergen-specific immunotherapy (SIT), which is based on the administration of the disease-causing allergens, is the only disease-modifying treatment for allergy. Current therapeutic allergy vaccines are still prepared from relatively poorly defined allergen extracts. However, with the availability of the structures of the most common allergen molecules, it has become possible to produce well-defined recombinant and synthetic allergy vaccines that allow specific targeting of the mechanisms of allergic disease. Here we provide a summary of the development and mechanisms of SIT, and then review new forms of therapeutic vaccines that are based on recombinant and synthetic molecules. Finally, we discuss possible allergen-specific strategies for prevention of allergic disease.
    Journal of Internal Medicine 05/2012; 272(2):144-57. DOI:10.1111/j.1365-2796.2012.02556.x · 5.79 Impact Factor
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