Intralymphatic Immunotherapy (ILIT) With Bee Venom Allergens: A Clinical Proof-of-Concept Study and the Very First...

Area of Science:

• Immunology
• Allergy Treatment
• Pharmacology

Background:

• Subcutaneous venom immunotherapy (VIT) is effective for bee venom allergy but has drawbacks like long treatment times, high costs, and adverse events (AEs).
• There is a need for shorter, safer, and more cost-effective treatment alternatives for bee venom allergy.

Purpose of the Study:

• To evaluate the safety, immunogenicity, and efficacy of bee venom intralymphatic immunotherapy (ILIT).

Main Methods:

• A pilot study involved 12 patients receiving bee venom ILIT over three sessions.
• A subsequent randomized multicenter study included 67 patients randomized to receive 10- or 20-μg doses of bee venom ILIT over four sessions.
• Clinical endpoints assessed included specific IgE and IgG levels and protection following a bee sting challenge.

Main Results:

• The pilot study reported no serious AEs and showed increased allergen-specific IgG1, with 7 of 8 patients protected after a sting challenge.
• The multicenter study observed increased allergen-specific IgG and IgE, with higher doses correlating with greater increases.
• Despite some protection observed, serious AEs occurred post-sting challenge, and no correlation was found between antibody levels and sting protection.

Conclusions:

• While a pilot study suggested safety and efficacy, a randomized study revealed significant AEs post-challenge, indicating insufficient immunological protection with bee venom ILIT.
• Differences in bee venom allergen extracts used in the studies (approved vs. non-approved formulations) may have influenced outcomes.
• Further investigation using approved formulations is necessary to definitively establish the safety and efficacy of bee venom ILIT.