The VISYT trial: Venom Immunotherapy Safety and Tolerability with purified vs nonpurified extracts

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Abstract

Background:

Venom immunotherapy (VIT) is a highly effective treatment but can induce systemic adverse effects.

Objective:

To evaluate the safety and tolerability of VIT with purified and nonpurified extracts for treating yellow jacket and honeybee allergy.

Methods:

Ninety-four patients (mean age, 46 years) with a history of insect venom allergy were randomly allocated to undergo purified extract VIT (group A [44 patients]) or nonpurified extract VIT (group B [50 patients]). Fifty-six patients were allergic to yellow jacket venom (group A: 25; group B: 31) and 38 to honeybee (19 per group). The induction phase was performed using a 2- or 7-day ultrarush scheme. The maintenance phase lasted 11 weeks. Local and systemic reactions were recorded after each injection.

Results:

A total of 1,401 VIT injections were performed. Six systemic reactions were observed in 4 patients (honeybee-allergic patients only) (4% of patients; 0.4% of injections): 1 patient in group A (2%) and in 3 in group B (6%) (P = .57). Local extensive reactions were recorded after 5 injections in 4 patients (9%) in group A (2 yellow jacket– and 2 honeybee-allergic patients) and after 17 injections in 12 patients (24%) in group B (8 yellow jacket– and 4 honeybee-allergic patients) (P = .02). Total reactions (systemic and large local) numbered 6 in group A (0.9% of injections; 11% of patients) and 20 in group B (2.7% of injections; 30% of patients) (P = .001).

Conclusion:

In patients with honeybee or yellow jacket venom allergy, VIT with purified extracts has a significantly lower propensity toward severe local reactions compared with VIT with nonpurified extracts.

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