Analysis of Safety, Risk Factors and Pretreatment Methods during Rush Hymenoptera Venom Immunotherapy

Abstract

Background: The safety profile of venom immunotherapy is a relevant issue. We evaluated the frequency of severe adverse events (SAE), associated risk factors, retrospective comparison of pretreatment protocols including solely H₁ receptor blockers and a combination of H₁ and H₂ receptor blockers during rush Hymenoptera venom immunotherapy. Methods: The study group comprised 118 patients. The treatment was initiated according to a 5-day rush protocol with the use of standardized venom allergens of either wasp or honeybee. Results: During the rush induction, side effects occurred in 18 patients (15.2%), whereas SAE were present in 7 patients (5.9%). Twelve out of 18 (66.6%) developed anaphylactic reactions on the fourth day of the rush protocol, with the majority of cases at a dose of 40 or 60 µg of the venom extract (p = 0.001). The frequency of SAE was also significantly higher on the fourth day than thereafter (p = 0.0001) as well as in patients allergic to bee venom (p = 0.049). All systemic side effects were more frequent in women (p = 0.0065). However, this relation was not true when SAE were consider (p = 0.11). A higher percentage of SAE was observed in the subjects pretreated with both H₁ and H₂ receptor antagonists than in those pretreated with H₁ blocker only (8.8 vs. 4.1%); however, the difference was not significant. Conclusions: Considerable severity of allergic adverse events requires particular attention to patients allergic to bee venom and during rush phase, especially when rapidly increasing doses are administered. Pretreatment with H₂ blockers is debatable and warrants further investigation.

The local and systemic side-effects of venom and inhaled-allergen subcutaneous immunotherapy

“…VIT SRs occurred during the dose-increase phase at a median dose of 46 µg (range 2-100 µg), which is comparable to the EAACI study where the median dose in the dose-increase phase was 30 µg (range 0.01-150 µg), and the Polish study where the majority of SRs in the dose-increase phase developed at a dose of 40 µg or 60 µg of the venom extract [14,16].…”

“…A Polish study observed SRs in 15.2% of patients during the 5-day rush induction phase of VIT, whereas severe adverse events were present in 5.9% patients. The risk factors were bee venom immunotherapy and female sex [16]. In a study in Spain it was concluded that immunotherapy is a safe treatment when EAACI guidelines are strictly followed [17].…”

Venom immunotherapy: clinical efficacy, safety and contraindications

“…Pre-treatment with antihistamines reduces the number and severity of large local reactions and mild systemic reactions such as urticaria and angio-edema. It is advised that antihistamines be administered 1 h before injection until the maintenance dose has been shown to be well tolerated [49]. Antihistamine pretreatment might also increase the efficacy of VIT [50].…”

Incidence and risk factors for subcutaneous immunotherapy anaphylaxis: the optimization of safety

“…Forty-two systemic reactions (0.6% of all injections) were documented in 39 patients (3.4%) [57]. On the other side, some studies involving fast venom immunotherapy regimens have found a lower incidence of systemic reaction than with conventional treatments [45], whereas the systemic reaction incidence was higher with other protocols [58].…”