Sublingual immunotherapy for large local reactions caused by honeybee sting: a double-blind, placebo-controlled trial.
BACKGROUND
Sublingual immunotherapy (SLIT) proved effective and safe in respiratory allergy, and thus its use in hymenoptera allergy can be hypothesized.


OBJECTIVE
We sought to assess, in a proof-of-concept study, whether SLIT might potentially be beneficial in hymenoptera allergy. The sting challenge in large local reactions (LLRs) was used to test this hypothesis.


METHODS
We performed a randomized, double-blind, placebo-controlled study involving patients with LLRs who were monosensitized to honeybee. After the baseline sting challenge, they were randomized to either SLIT or placebo for 6 months. The treatment (Anallergo, Florence, Italy) involved a 6-week build-up period, followed by maintenance with 525 microg of venom monthly. The sting challenge was repeated after 6 months.


RESULTS
Thirty patients (18 male patients; mean age, 44.5 years) were enrolled, and 26 completed the study, with 1 dropout in the active group and 3 dropouts in the placebo group. In the active group the median of the peak maximal diameter of the LLRs decreased from 20.5 to 8.5 cm (P = .014), whereas no change was seen in the placebo group (23.0 vs 20.5 cm, P = not significant). The diameter was reduced more than 50% in 57% of patients. One case of generalized urticaria occurred in a placebo-treated patient at sting challenge. No adverse event caused by SLIT was reported.


CONCLUSIONS
Honeybee SLIT significantly reduced the extent of LLRs, and its safety profile was good. Although LLRs are not an indication for immunotherapy, this proof-of-concept study suggests that SLIT in hymenoptera allergy deserves further investigation. Trials involving systemic reactions and dose-ranging studies are needed.
Severino
Maurizio G
MG
Allergy Clinic, Nuovo Ospedale San Giovanni di Dio, Florence, Italy.
Cortellini
Gabriele
G
Bonadonna
Patrizia
P
Francescato
Elisabetta
E
Panzini
Ilaria
I
Macchia
Donatella
D
Campi
Paolo
P
Spadolini
Igino
I
Canonica
Walter G
WG
Passalacqua
Giovanni
G
D000286:Administration, Sublingual; D000328:Adult; D000818:Animals; D001514:Bee Venoms / Q000008:administration & dosage / Q000276:immunology*; D001516:Bees; D003888:Desensitization, Immunologic / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000276:immunology / Q000628:therapy*; D007299:Insect Bites and Stings / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D010919:Placebos
D001514:Bee Venoms; D010919:Placebos