Abstract
BACKGROUND: Research on the combination of biologics with rush immunotherapy (RIT) remains scarce, particularly regarding safety and efficacy data in pediatric and hypersensitive populations undergoing rapid desensitization or concurrent biologic therapy. Furthermore, regarding RIT, it remains unclear which patients can effectively reduce the occurrence of adverse reactions when combined with biologics, and which patients fail to achieve such a reduction with this combination therapy. METHODS: This retrospective study analyzed 202 patients with mite-induced allergic asthma (2018-2024) receiving RIT alone (n = 133) or omalizumab-pretreated RIT (RIT + Omb-pre, n = 69). Stratified analyses were conducted based on age, mite sIgE levels, total IgE(T-IgE) levels, and sIgE to T-IgE ratios. Outcomes included systemic adverse reaction (SR) rates, RIT completion rates, improvements in clinical parameters following omalizumab intervention, and 1-year follow-up efficacy across subgroups. RESULTS: Both regimens were well tolerated, with no grade ≥3 SRs observed. Compared to RIT alone, RIT + Omb-pre significantly reduced SR incidence (p < 0.05) and showed a trend toward higher target peak concentration completion rates (p = 0.054). Age-stratified analysis revealed higher SR risks in children/teenager patients vs. adults. Subgroup analyses further demonstrated that SR incidence correlated positively with mite sIgE levels and sIgE/T-IgE ratio (p < 0.05), but not with T-IgE. Patients with low-risk biomarkers (sIgE grades 1-2 and sIgE/T-IgE <10%) exhibited minimal SR incidence unaffected by omalizumab, whereas high-risk subgroups (sIgE grades 3-6 and sIgE/T-IgE ≥10%) showed significantly elevated SR incidence, which was markedly mitigated by omalizumab (p < 0.05).Subgroup with sIgE/T-IgE ratios >16% achieved substantially greater improvements in ACQ scores and daily medication burden compared to those with ratios <16% during the 12-month intervention. Furthermore, this study reaffirmed the age-dependent efficacy correlation, with pediatric patients demonstrating superior therapeutic outcomes to adult patients. CONCLUSIONS: Regarding the safety of dust mite rush immunotherapy for allergic asthma, Omalizumab significantly reduces the incidence of SRs in high-risk populations (sIgE grades 3-6 and sIgE/T-IgE ≥10%), whereas it demonstrates limited efficacy in low-risk subgroups (sIgE grades 1-2 and sIgE/T-IgE <10%).