Introduction

Autoimmune diseases (AID) are associated with immune dysregulation, raising concerns about the safety and effectiveness of allergen immunotherapy (AIT) and venom immunotherapy (VIT). Patients with AID are frequently excluded from clinical trials, and current guidelines remain cautious despite limited real-world evidence. The aim of this study was to evaluate and compare the safety and clinical effectiveness of AIT and VIT in patients with and without AID.

Material and methods

We retrospectively reviewed patients treated with AIT or VIT between 2014 and 2024 at a tertiary allergy center. AID diagnoses were confirmed via specialist records. Treatment effectiveness was defined as documented patient-reported improvement – reduction of allergy medication (AIT) or tolerance of field stings (VIT). Safety was based on reported adverse events. Group comparisons used the c2 test or Fisher’s exact test.

Results

In the AIT group, clinical improvement was observed in 51.4% of AID vs. 38.9% of non-AID patients (p = 0.2012). Adverse events occurred in 27.0% and 38.9% (p = 0.163). In the VIT group, 86.7% of AID and 88.7% of non-AID patients tolerated field stings without systemic reactions (p = 0.6847). Using a stricter definition (no local or systemic reactions), rates were 60.0% vs. 57.6% (p = 0.8571). Adverse events occurred in 56.1% and 54.7% (p = 0.8683).

Conclusions

In this real-world cohort, both AIT and VIT were found to be safe and effective in patients with stable AID. The presence of autoimmune comorbidities did not significantly affect clinical outcomes. These findings challenge longstanding concerns and support the use of immunotherapy in appropriately selected patients with AID.