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Double-blind placebo-controlled study of sublingual immunotherapy with house dust mite extract (D.pt.) in children
1Klinik und Poliklinik für Kinderheilkunde, Universitts-Klinikum Carl Gustav Carus, Technischen Universität Dresden, Germany.
Insights
Sublingual immunotherapy with house dust mite extract was well tolerated in children over 12 months. However, no consistent clinical or immunological benefits were observed compared to placebo.
Area of Science:
- Allergy and Immunology
- Pediatric Pulmonology
Background:
- House dust mite allergy is a common trigger for asthma and rhinitis in children.
- Sublingual immunotherapy (SLIT) offers a potential alternative to subcutaneous immunotherapy (SCIT) for allergen-specific immunotherapy.
Purpose of the Study:
- To evaluate the safety and efficacy of sublingual-swallow immunotherapy (IT) with house dust mite extract in children.
- To compare a high cumulative dose of SLIT (570 micrograms Der p I) with placebo over 12 months.
Main Methods:
- A 12-month study involving 30 children aged 6-15 years.
- Participants received either active SLIT with house dust mite extract or placebo.
- Assessed safety through reported side effects and efficacy through clinical symptoms and immunological markers.
Main Results:
- One patient on active treatment withdrew due to weakness; minor local side effects were reported in both groups.
- Pulmonary symptoms improved in actively treated asthmatics, but bronchial reactivity and skin sensitivity did not.
- Specific IgE levels increased significantly in the active treatment group, while nasal sensitivity reduced in the placebo group.
Conclusions:
- Sublingual immunotherapy with a fivefold dose of house dust mite extract was well tolerated in children over 12 months.
- No consistent clinical or immunological benefit was demonstrated compared to placebo.
- Further research may be needed to optimize SLIT protocols for pediatric allergic diseases.
Unlabelled:
SAFETY and efficacy of sublingual (sublingual-swallow) immunotherapy (IT) with house dust mite extract were evaluated in 30 children (6-15 2/3 years of age) over the first 12 months of an ongoing study. The cumulative dose was 570 micrograms Der p I (five times that administered with subcutaneous therapy).
Safety:
One patient on active treatment dropped out after 8 weeks because of a subjective feeling of severe weakness, questionably induced by the therapy. Five patients on active therapy and one patient on placebo reported minor local side effects.
Efficacy:
Pulmonary symptoms were reduced after 12 months in actively treated asthmatics, but this was not consistent with the lack of improvement in bronchial reactivity, skin sensitivity and specific IgG and IgG4 against D.pt. in this group. In patients with rhinitis nasal sensitivity was reduced in the placebo group without concomitant improvement in the nasal symptom score. Specific IgE (D.pt. and D.f.) increased significantly more in the active treatment group after 3 and 12 months. We conclude that sublingual IT over 12 months with the fivefold Der p 1 dose of subcutaneous IT was well tolerated, but there was no consistent clinical or immunological benefit compared to placebo.