The Journal of Allergy and Clinical Immunology
Volume 122, Issue 1 , Pages 44-48, July 2008

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

  • Maurizio G. Severino, MD

      Affiliations

    • Allergy Clinic, Nuovo Ospedale San Giovanni di Dio, Florence, Italy
    • ,
  • Gabriele Cortellini, MD

      Affiliations

    • Internal Medicine and Rheumatology, Rimini Hospital, Rimini, Italy
    • ,
  • Patrizia Bonadonna, MD

      Affiliations

    • Allergy Unit, Verona General Hospital, Verona, Italy
    • ,
  • Elisabetta Francescato, PhD

      Affiliations

    • Entomon SAS, Florence, Italy
    • ,
  • Ilaria Panzini, PhD

      Affiliations

    • Research and Innovation Unit, Rimini Hospital, Rimini, Italy
    • ,
  • Donatella Macchia, MD

      Affiliations

    • Allergy Clinic, Nuovo Ospedale San Giovanni di Dio, Florence, Italy
    • ,
  • Paolo Campi, MD

      Affiliations

    • Allergy Clinic, Nuovo Ospedale San Giovanni di Dio, Florence, Italy
    • ,
  • Igino Spadolini, MD

      Affiliations

    • Anallergo, Florence, Italy
    • ,
  • Walter G. Canonica, MD

      Affiliations

    • Allergy and Respiratory Diseases, University of Genoa, Genoa, Italy
    • ,
  • Giovanni Passalacqua, MD

      Affiliations

    • Allergy and Respiratory Diseases, University of Genoa, Genoa, Italy
    • Corresponding Author InformationReprint requests: Giovanni Passalacqua, MD, Allergy and Respiratory Diseases, Department of Internal Medicine, Padiglione Maragliano, L.go R. Benzi 10, 16132 Genoa, Italy.

Received 7 January 2008; received in revised form 10 March 2008; accepted 31 March 2008. published online 12 May 2008.

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.

Key words: Hymenoptera venom allergy, sublingual immunotherapy, large local reaction, sting challenge

Abbreviations used: HVA, Hymenoptera venom allergy, LLR, Large local reaction, SLIT, Sublingual immunotherapy, VIT, Venom immunotherapy

 

 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.

PII: S0091-6749(08)00617-9

doi:10.1016/j.jaci.2008.03.031

The Journal of Allergy and Clinical Immunology
Volume 122, Issue 1 , Pages 44-48, July 2008