ABSTRACT
The recommendation to use sublingual-swallow immunotherapy (SLIT) in children and adults with allergic rhinitis has been established over the past decade. Recently, ultra-rush titration of SLIT has become more and more common, raising concerns about its safety in children with asthma. Fifty-four children with asthma and adolescents aged 614 with documented allergic disease because of tree pollen (birch and possibly alder and/or hazel) from 14 study centers in Germany participated in a randomized, double-blind, and placebo-controlled study. Twenty-seven were randomized to receive SLIT with standardized birch pollen allergen extract and the other 27 to receive placebo. An ultra-rush high-dose SLIT titration regimen reaching the maintenance dose of 300 index of reactivity (IR) within 90 min (3090150300 IR) was used. The difference in mean PFR changes during ultra-rush titration between SLIT and placebo was not significant (p = 0.056). A 95% probability that SLIT does not decrease PFR during ultra-rush titration was demonstrated. Neither anaphylactic shock nor else serious systemic reactions to the study drug occurred. No serious adverse event assessed by the investigator as related to study drug treatment was reported.
Subject(s)
Asthma/immunology , Asthma/therapy , Desensitization, Immunologic , Rhinitis, Allergic, Seasonal/immunology , Rhinitis, Allergic, Seasonal/therapy , Administration, Sublingual , Adolescent , Allergens/administration & dosage , Allergens/adverse effects , Asthma/complications , Child , Drug Dosage Calculations , Feasibility Studies , Female , Humans , Male , Pollen/adverse effects , Respiratory Function Tests , Rhinitis, Allergic, Seasonal/complications , Trees/immunologyABSTRACT
BACKGROUND: Specific immunotherapy (IT) is an effective treatment for rhinitis and asthma caused by aeroallergens sensitization. Sublingual IT (SLIT) was introduced to solve the problem of systemic reactions to subcutaneous IT (SCIT) and developed to represent an actual treatment option. It is now generally accepted that allergen doses much higher than those administered by SCIT must be used to achieve clinical efficacy on allergic symptoms. OBJECTIVE: To evaluate the characteristics of Staloral, an allergen extract produced by Stallergenes (Antony, France) in terms of practical administration, efficacy, safety and mechanism of action. METHODS: Data were obtained from 20 double-blind, placebo-controlled studies using Staloral in patients sensitized to pollens and house-dust mites, and also from open studies concerning practical administration and the mechanism of action. RESULTS/CONCLUSION: Efficacy and safety of Staloral, as demonstrated by the revision of the studies, which used doses up to 1125 times those administered with SCIT, are very satisfactory and confer to this allergen extract optimal characteristics for treating patients with seasonal allergies due to pollens or with perennial symptoms induced by dust mites. The main mechanism of action is the interaction with dendritic cells of the oral mucosa and the subsequent tolerance induced in T cells.
