A double-blind randomized placebo-controlled trial with short-term beta-glucuronidase therapy in children with chronic rhinoconjunctivitis and/or asthma due to dust mite allergy.
BACKGROUND
Enzyme potentiated desensitization, in which beta-glucuronidase (BG) is administered with low doses of mixed allergens, was proposed in the 1970s for specific immunotherapy. The BG currently commercially available in a purified and standardized preparation devoid of any allergen has been suggested as a regulator in the allergic immune response, acting on the cytokine-network of type 2 helper T cells. A double-blind trial with a single-dose of BG proved effective in preventing symptoms in adult patients with rhinoconjunctivitis due to grass pollens.


OBJECTIVE
The aim of this randomized double-blind placebo-controlled trial was to confirm the safety and effectiveness of double-dose intradermal BG immunotherapy in preventing symptoms in children suffering from chronic rhinoconjunctivitis and/or asthma due to dust mite.


METHODS
We randomized 125 children with dust-mite related chronic rhinoconjunctivitis and/or asthma to the BG treated group (67) or the placebo group (58). All patients were screened before treatment (TO), at BG or placebo administration (T1 and T3), and at 3 and 9 months after T1 (T2 and T4). Drug intake and bronchial, nasal and ocular symptoms were recorded in a diary.


RESULTS
Patients in both groups completed the study and BG treatment was well tolerated without side effects. Significant differences in symptoms were observed, in particular for conjunctivitis (P= .008). The total drug intake for allergic symptoms was significantly lower in the treated group than in the placebo group (P<. 01).


CONCLUSIONS
BG immunotherapy is efficacious, safe, and well tolerated in allergic children. Moreover, good compliance with the administration of 2 doses per year and the lack of significant side effects makes the benefit/risk ratio of this treatment particularly favorable.
Galli
E
E
Research Center San Pietro, Fatebenefratelli Hospital, AfaR, Rome, Italy. galli.elena@fbfrm.it
Bassi
M S
MS
Mora
E
E
Martelli
M
M
Gianni
S
S
Auricchio
G
G
Arabito
E
E
Rossi
P
P
D000293:Adolescent; D000818:Animals; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D005966:Glucuronidase / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006967:Hypersensitivity / Q000188:drug therapy*; D008297:Male; D010349:Patient Compliance; D039981:Pyroglyphidae / Q000276:immunology*; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*
D018926:Anti-Allergic Agents; D005966:Glucuronidase