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Sublingual immunotherapy for large local reactions caused by honeybee sting: A double-blind, placebo-controlled trial

https://doi.org/10.1016/j.jaci.2008.03.031Get rights and content

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 μg 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.

Conclusion

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.

Section snippets

Study design

The study was designed as a randomized, double-blind, placebo-controlled, 2-parallel group. The enrolled volunteers, all with HVA caused by honeybee venom with LLRs only, were randomized to receive either SLIT or placebo for 6 months. The extent of LLRs was assessed before randomization and after 6 months by means of a standardized sting challenge. Safety and tolerability were evaluated, and specific IgE and IgG antibodies were measured. The study was approved by the reference ethical

Results

Thirty adult subjects (18 male subjects; mean age, 44.5 years) fulfilling the inclusion criteria were enrolled and signed the informed consent form. None of them had a history of systemic reactions, and all were monosensitized to honeybee venom. The patients were randomized to either SLIT or placebo, and their demographic characteristics were similar at enrollment, as summarized in Table II. Four patients did not complete the study procedures. In fact, 1 subject from the active group and 3

Discussion

Today, SLIT is gaining an increasing approval within the medical community as more and more experimental data are published. The good safety profile and the ease of use of SLIT have prompted the investigation of new indications other than allergic rhinitis and asthma. In fact, in the recent literature some studies proposed the possible use of SLIT in conditions such as atopic dermatitis,14 food allergy,15 or latex allergy.16 Despite this, no attempt has been made thus far to use SLIT in HVA,

References (28)

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The sublingual immunotherapy and matched placebo were kindly provided by Anallergo S.p.A, Florence, Italy.

Disclosure of potential conflict of interest: E. Francescato is employed by Entomon SAS. I. Spadolini owns stock in and is employed by Anallergo. The rest of the authors have declared that they have no conflict of interest.

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