[Analysis of the safety and associated risk factors of rush immunotherapy in 316 patients with allergic rhinitis].

Abstract

Objective: To assess the safety and to identify risk factors associated with systemic adverse effects (SAEs) during the dose-escalation phase of rush immunotherapy (RIT) in patients with allergic rhinitis (AR). Methods: A retrospective analysis was conducted in 316 house dust mite-allergic patients diagnosed with AR who underwent RIT at the Second Affiliated Hospital of Nanchang University between February 2012 and August 2024, including 206 males and 110 females aging from 5 to 58 years old. The number of patients experiencing SAEs, the frequency of SAE incidents, and the severity grades of SAEs during the dose-escalation phase were analyzed. Associations between SAE occurrence and 19 potential factors, including demographic characteristics, serological parameters, and pulmonary function parameters, were investigated. Data were analyzed using IBM SPSS Statistics version 26.0. Results: Among the 316 patients, 4 358 RIT injections were administered during the dose-escalation phase. SAEs occurred in 45 patients (14.24%, 45/316), accounting for 57 distinct SAE incidents. The SAE incidence rate per injection was 1.31%. Of the 57 SAEs, 34 (59.65%) were Grade Ⅰ, 5 (8.77%) were Grade Ⅱ, and 18 (31.58%) were Grade Ⅲ. No Grade Ⅳ or Ⅴ SAEs were observed. SAE occurrence demonstrated significant associations with: age (Z=-2.73, P=0.006), body mass index (BMI; t=4.08, P<0.001), skin prick test reaction intensity (χ²=10.34, P=0.006), eosinophil count (Z=-2.19, P=0.028), eosinophil percentage (Z=-2.59, P=0.010), forced expiratory volume in one second (FEV₁; Z=-2.04, P=0.042), peak expiratory flow (PEF; Z=-2.44, P=0.015). Multivariate logistic regression analysis identified BMI as an independent risk factor for SAEs (OR=0.86; 95%CI: 0.75-0.99; P=0.034). Conclusions: During the RIT dose-escalation phase for house dust mite-allergic AR patients, the incidence of SAEs was approximately 1.31% per injection. SAEs were predominantly mild (Grade Ⅰ), consistent with a favorable overall safety profile. BMI was identified as a statistically significant risk factor for SAE occurrence.