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.
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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ABSTRACT: Participant dropouts can reduce the power of allergen immunotherapy clinical trials. Evaluation of the dropout rate and reasons for dropout are important not only in the planning of clinical studies but are also relevant for adherence to immunotherapy in daily clinical practice. A systematic review was carried out in order to establish the overall dropout rate among published double-blind, placebo-controlled randomized clinical trials of sublingual immunotherapy for respiratory allergic diseases. Dropouts were analysed in regards to allergen, formulation, treatment schedule, participant age, study size, number of centres and type of allergic disease. Relative dropout rates in placebo and active groups as well as reasons for dropout were also assessed. A total of 81 studies, comprising 9998 patients, were included. Dropout rates in sublingual immunotherapy controlled studies do not appear to be a major problem with a composite dropout percentage of 14% (95% CI:11.9–16). Furthermore, they are not different for active compared to placebo-treated participants. This lends support to the positive clinical outcomes seen in meta-analyses of these trials.Allergy 03/2014; · 5.88 Impact Factor
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ABSTRACT: We have prepared this document, "Sublingual Immunotherapy: World Allergy Organization Position Paper 2013 Update", according to the evidence-based criteria, revising and updating chapters of the originally published paper, "Sublingual Immunotherapy: World Allergy Organization Position Paper 2009", available at www.waojournal.org. Namely, these comprise: "Mechanisms of sublingual immunotherapy;" "Clinical efficacy of sublingual immunotherapy" - reporting all the data of all controlled trials published after 2009; "Safety of sublingual immunotherapy" - with the recently published Grading System for adverse reactions; "Impact of sublingual immunotherapy on the natural history of respiratory allergy" - with the relevant evidences published since 2009; "Efficacy of SLIT in children" - with detailed analysis of all the studies; "Definition of SLIT patient selection" - reporting the criteria for eligibility to sublingual immunotherapy; "The future of immunotherapy in the community care setting"; "Methodology of clinical trials according to the current scientific and regulatory standards"; and "Guideline development: from evidence-based medicine to patients' views" - including the evolution of the methods to make clinical recommendations.Additionally, we have added new chapters to cover a few emerging crucial topics: "Practical aspects of schedules and dosages and counseling for adherence" - which is crucial in clinical practice for all treatments; "Perspectives and new approaches" - including recombinant allergens, adjuvants, modified allergens, and the concept of validity of the single products. Furthermore, "Raising public awareness about sublingual immunotherapy", as a need for our patients, and strategies to increase awareness of allergen immunotherapy (AIT) among patients, the medical community, all healthcare stakeholders, and public opinion, are also reported in detail.World Allergy Organization Journal 03/2014; 7(1):6.
- The Journal of allergy and clinical immunology. 09/2014; 134(3):765-765.e2.