Effectiveness and safety of allergen immunotherapy in autoimmune diseases: a real-world retrospective analysis

Dominika Ochab; Piotr Lacwik; Kacper Packi; Beata Kręcisz; Maciej Kupczyk; Cezary Pałczyński

doi:10.5114/pja.2026.160808

eISSN: 2391-6052
ISSN: 2353-3854

Alergologia Polska - Polish Journal of Allergology

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abstract:

Effectiveness and safety of allergen immunotherapy in autoimmune diseases: a real-world retrospective analysis

Dominika Ochab

^{1, 2}

,

Piotr Lacwik

^{1, 2}

,

Kacper Packi

^{3, 4, 5}

,

Beata Kręcisz

¹

,

Maciej Kupczyk

⁶

,

Cezary Pałczyński

^{1, 2}

Collegium Medicum, Jan Kochanowski University, Kielce, Poland
Clinical Division of Lung Diseases and Allergology, Holy Cross Centre for Lung Disease, Czerwona Góra, Poland
Department of Nucleic Acid Biochemistry, Medical University of Lodz, Poland
AllerGen Center of Personalized Medicine, Piotrków Trybunalski, Poland
Władysław Biegański Collegium Medicum, Jan Długosz University, Częstochowa, Poland
Department of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Poland

DOI: https://doi.org/10.5114/pja.2026.160808

Online publish date: 2026/04/23

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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.

keywords:

Effectiveness and safety of allergen immunotherapy in autoimmune diseases: a real-world retrospective analysis

Dominika Ochab 1, 2 , Piotr Lacwik 1, 2 , Kacper Packi 3, 4, 5 , Beata Kręcisz 1 , Maciej Kupczyk 6 , Cezary Pałczyński 1, 2

safety, treatment effectiveness, autoimmune disease, venom immunotherapy, allergen immunotherapy, real-world study

Dominika Ochab

^{1, 2}

,

Piotr Lacwik

^{1, 2}

,

Kacper Packi

^{3, 4, 5}

,

Beata Kręcisz

¹

,

Maciej Kupczyk

⁶

,

Cezary Pałczyński

^{1, 2}