Allergen immunotherapy adverse events in adults with respiratory allergies-data from ADER: An EAACI task force report

Julijana Asllani^{1

2}, Dimitrios Mitsias³, George Konstantinou⁴, Etleva Qirko⁵, Mirela Hitaj⁶, Sybi Musollari⁷, George Christoff⁸, Silviya Novakova⁹, Michael Makris¹⁰, Mira Radulovic Pevec¹¹, Branko Pevec¹¹, Adriana Muntean^{12

13}, Vesna Tomic-Spiric^{14

15}, Rajica Stosovic^{14

15}, Mitja Kosnik¹⁶, Dilsad Mungan¹⁷, Todor A Popov¹⁸, Moises Calderon¹⁹, Nikolaos G Papadopoulos^{3

20}; ADER Study Group

Collaborators, Affiliations

Collaborators

ADER Study Group:
Gerta Sinani, Eris Mesonjesi, Esmeralda Shehu, Etleva Qirko, Anila Nano, Valbona Martini, Enkelejda Gjata, Aferdita Sinani, Jana Sinani, Sybi Musollari, Alketa Bakiri, Diana Qama, Erjola Piluri, Fatmira Xhixha, Gilda Xhoxhi, Mirela Hitaj, Mehmet Hoxha, Alfred Priftanji, Dimitrov Zlatko, George Christoff, Silviya Novakova, Katya Noleva, Plamen Yakovliev, Ted Popov, Mirjana Turkalj, Damir Erceg, Asja Stipic, Mira Radulovic Pevec, Branko Pevec, Sanja Popovic, Nikos Papadopoulos, Michalis Makris, George Konstantinou, Dimitris Mitsias, Xenophon Aggelidis, Christina Ciobanum, Ioana Agache, Florin Dan Popescu, Irina Bukur, Ierima Augustin, Deleanu Dianna, Adriana Muntean, Irena Nedelea, Radu Balan, Vesna Tomic-Spiric, Rajica Stosovic, Mirjana Bogic, Dragana Tadic, Alexandra Plavsic, Mitja Kosnik, Zeynep Mısırlıgil, Mungan Dislad, Moises A Z Calderon

Affiliations

¹ Faculty of Medicine, University of Medicine, Tirana, Albania.
² Allergy and Asthma Medical Clinic, Tirana, Albania.
³ Allergy Department 2nd Pediatric Clinic, University of Athens, Athens, Greece.
⁴ Department of Allergy and Clinical Immunology, 424 General Military Training Hospital, Thessaloniki, Greece.
⁵ University Hospital Center "Mother Teresa", Tirana, Albania.
⁶ Ambulatory Polyclinic of Specialties, Tirana, Albania.
⁷ Musollari Allergy Clinic, Tirana, Albania.
⁸ Medical University-Sofia, Faculty of Public Health, Sofia, Bulgaria.
⁹ Internal Consulting Department, Allergy Unit University hospital "Sv. Georgi", Plovdiv, Bulgaria.
¹⁰ Immunotherapy Outpatient Clinic, Allergy Unit, 2nd Department Dermatology and Venereology, National and Kapodistrian University of Athens, University General Hospital 'Attikon', Athens, Greece.
¹¹ Clinic for Lung Diseases Jordanovac, University Hospital Centre Zagreb, Zagreb, Croatia.
¹² Immunology and Allergology Department, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
¹³ Allergology and Immunology Ambulatory, Professor Doctor Octavian Fodor Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.
¹⁴ Clinic of Allergology and Immunology, University Clinical Center of Serbia, Belgrade, Serbia.
¹⁵ Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
¹⁶ University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.
¹⁷ Department of Allergy and Immunology, Ankara University School of Medicine, Ankara, Turkey.
¹⁸ University Hospital "Sv Ivan Rilski", Sofia, Bulgaria.
¹⁹ Section of Allergy and Clinical Immunology, Imperial College London-NHLI, London, UK.
²⁰ Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, UK.

PMID: 39175252
DOI: 10.1111/all.16286

Multicenter Study

Allergen immunotherapy adverse events in adults with respiratory allergies-data from ADER: An EAACI task force report

Julijana Asllani et al. Allergy. 2025 Mar.

. 2025 Mar;80(3):775-784.

doi: 10.1111/all.16286. Epub 2024 Aug 22.

Authors

Collaborators

ADER Study Group:
Gerta Sinani, Eris Mesonjesi, Esmeralda Shehu, Etleva Qirko, Anila Nano, Valbona Martini, Enkelejda Gjata, Aferdita Sinani, Jana Sinani, Sybi Musollari, Alketa Bakiri, Diana Qama, Erjola Piluri, Fatmira Xhixha, Gilda Xhoxhi, Mirela Hitaj, Mehmet Hoxha, Alfred Priftanji, Dimitrov Zlatko, George Christoff, Silviya Novakova, Katya Noleva, Plamen Yakovliev, Ted Popov, Mirjana Turkalj, Damir Erceg, Asja Stipic, Mira Radulovic Pevec, Branko Pevec, Sanja Popovic, Nikos Papadopoulos, Michalis Makris, George Konstantinou, Dimitris Mitsias, Xenophon Aggelidis, Christina Ciobanum, Ioana Agache, Florin Dan Popescu, Irina Bukur, Ierima Augustin, Deleanu Dianna, Adriana Muntean, Irena Nedelea, Radu Balan, Vesna Tomic-Spiric, Rajica Stosovic, Mirjana Bogic, Dragana Tadic, Alexandra Plavsic, Mitja Kosnik, Zeynep Mısırlıgil, Mungan Dislad, Moises A Z Calderon

Affiliations

¹ Faculty of Medicine, University of Medicine, Tirana, Albania.
² Allergy and Asthma Medical Clinic, Tirana, Albania.
³ Allergy Department 2nd Pediatric Clinic, University of Athens, Athens, Greece.
⁴ Department of Allergy and Clinical Immunology, 424 General Military Training Hospital, Thessaloniki, Greece.
⁵ University Hospital Center "Mother Teresa", Tirana, Albania.
⁶ Ambulatory Polyclinic of Specialties, Tirana, Albania.
⁷ Musollari Allergy Clinic, Tirana, Albania.
⁸ Medical University-Sofia, Faculty of Public Health, Sofia, Bulgaria.
⁹ Internal Consulting Department, Allergy Unit University hospital "Sv. Georgi", Plovdiv, Bulgaria.
¹⁰ Immunotherapy Outpatient Clinic, Allergy Unit, 2nd Department Dermatology and Venereology, National and Kapodistrian University of Athens, University General Hospital 'Attikon', Athens, Greece.
¹¹ Clinic for Lung Diseases Jordanovac, University Hospital Centre Zagreb, Zagreb, Croatia.
¹² Immunology and Allergology Department, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
¹³ Allergology and Immunology Ambulatory, Professor Doctor Octavian Fodor Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.
¹⁴ Clinic of Allergology and Immunology, University Clinical Center of Serbia, Belgrade, Serbia.
¹⁵ Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
¹⁶ University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.
¹⁷ Department of Allergy and Immunology, Ankara University School of Medicine, Ankara, Turkey.
¹⁸ University Hospital "Sv Ivan Rilski", Sofia, Bulgaria.
¹⁹ Section of Allergy and Clinical Immunology, Imperial College London-NHLI, London, UK.
²⁰ Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, UK.

PMID: 39175252
DOI: 10.1111/all.16286

Abstract

Background: Registries can yield important insights on allergen immunotherapy (AIT) outcomes in daily clinical practice. However, systematic recordings of adverse events (AE) due to AIT in real-life are lacking.

Methods: The Allergen Immunotherapy Adverse Events Registry (ADER) is a prospective, multicenter registry on real-life AIT safety. Data on adults (>18 years old) with respiratory allergies receiving AIT with mites, pollens, epithelia, and/or molds were retrieved and analyzed from ADER. The frequency, characteristics and risk factors of AE were investigated. The MedDRA terminology was used to record AE.

Results: A total of 1545 individuals with a mean age of 33 ± 10 years receiving 1815 AIT courses (n = 1060 sublingual (SLIT); n = 755 subcutaneous (SCIT)) in centers from eight countries were included. Patients had allergic rhinitis (65%) or, asthma only (3.7%) or rhinitis with asthma (31.2%). Grass was the most frequent specific sensitizer (60.7%), followed by mites (45.5%), birch pollen (20.6%), epithelia (16.1%), and molds (8%). There were 296 AE recorded in 115 patients (7.4%). A higher frequency of AE occurred during up-dosing (59%) compared to maintenance. Severe reactions were rare (0.2%), all in the context of SCIT. After 6 weeks of maintenance only one moderate AE was recorded. The most frequently reported symptoms were from the respiratory system and the skin. Having asthma, doing SCIT, AIT with mugwort, cat, or birch were associated with higher risk for AE while the use of allergoids induced lower risk.

Conclusion: In real life clinical practice, AIT-associated AE occur in a minority of patients, while severe reactions are rare. The presence of asthma and use of SCIT are risk factors, while the use of modified allergens lowers the risk.

Keywords: adverse reactions; allergen immunotherapy; real‐world data; risk factors; safety.

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References

REFERENCES

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1. Dhami S, Kakourou A, Asamoah F, et al. Allergen immunotherapy for allergic asthma: a systematic review and meta‐analysis. Allergy. 2017;72(12):1825‐1848. doi:10.1111/all.13208
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Allergen immunotherapy adverse events in adults with respiratory allergies-data from ADER: An EAACI task force report

Collaborators

Affiliations

Allergen immunotherapy adverse events in adults with respiratory allergies-data from ADER: An EAACI task force report

Authors

Collaborators

Affiliations

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