Adverse events in children and adolescents undergoing allergen immunotherapy for respiratory allergies-Report from the Allergen Immunotherapy Adverse Events Registry (ADER), a European Academy of Allergy and Clinical Immunology taskforce

Julijana Asllani; Dimitrios Mitsias; George Konstantinou; Eris Mesonjesi; Fatmira Xhixha; Esmeralda Shehu; George Christoff; Katia Noleva; Michael Makris; Xenofon Aggelidis; Mirjana Turkalj; Erceg Damir; Ioana Agache; Vesna Tomic-Spiric; Rajica Stosovic; Zeynep Misirligil; Mitja Kosnik; Todor A Popov; Moises Calderon; Nikolaos G Papadopoulos; ADER study group

doi:10.1002/clt2.12250

Adverse events in children and adolescents undergoing allergen immunotherapy for respiratory allergies-Report from the Allergen Immunotherapy Adverse Events Registry (ADER), a European Academy of Allergy and Clinical Immunology taskforce

Clin Transl Allergy. 2023 Jun;13(6):e12250. doi: 10.1002/clt2.12250.

Authors

Julijana Asllani^{1

2}, Dimitrios Mitsias³, George Konstantinou⁴, Eris Mesonjesi⁵, Fatmira Xhixha⁶, Esmeralda Shehu⁷, George Christoff⁸, Katia Noleva⁹, Michael Makris¹⁰, Xenofon Aggelidis¹⁰, Mirjana Turkalj^{11

12

13}, Erceg Damir^{11

12

13}, Ioana Agache¹⁴, Vesna Tomic-Spiric^{15

16}, Rajica Stosovic^{15

16}, Zeynep Misirligil¹⁷, Mitja Kosnik¹⁸, Todor A Popov¹⁹, Moises Calderon²⁰, Nikolaos G Papadopoulos^{3

21}; ADER study group

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 Pevec, Branko Pevec, Sanja Popovic-Grle, Nikos Papadopoulos, Michael Makris, George Konstantinou, Dimitrios Mitsias, Xenofon Aggelidis, Christina Ciobanum, Ioana Agache, Florin Dan Popescu, Irina Bukur, Ierima Augustin, Deleanu Dianna, Adriana Muntean, Vesna Tomic-Spiric, Rajica Stosovic, Mirjana Bogic, Dragana Tadic, Aleksandra Plavsic, Mitja Kosnik, Zeynep Mısırlıgil, Dilsad Mungan, Moises A Z Calderon

Affiliations

¹ 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, Nr. 3, Tirana, Albania.
⁷ Internal Medicine Department, Durres Regional Hospital, Durres, Albania.
⁸ Medical University-Sofia, Faculty of Public Health, Sofia, Bulgaria.
⁹ ET Dr. K. Noleva IPSMP, Sofia, 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 Srebrnjak Children's Hospital, Zagreb, Croatia.
¹² Medical School Catholic University of Croatia, Zagreb, Croatia.
¹³ Medical School University J.J. Strossmayer, Osijek, Croatia.
¹⁴ Faculty of Medicine, Transylvania University, Brasov, Romania.
¹⁵ Clinic of Allergology and Immunology, University Clinical Center of Serbia, Belgrade, Serbia.
¹⁶ Faculty of Medicine, University of Belgrade, Belgrade, Serbia.
¹⁷ İstinye University, Faculty of Medicine, Ankara Liv Hospital, Ankara, Turkey.
¹⁸ University Clinic of Respiratory and Allergic Diseases, Golnik, Slovenia.
¹⁹ University Hospital "Sv Ivan Rilski", Sofia, Bulgaria.
²⁰ Section of Allergy and Clinical Immunology, Imperial College London-NHLI, London, UK.
²¹ Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Manchester, UK.

Abstract

Background: Although it has been shown that allergen immunotherapy (AIT) is well-tolerated in children, systematic and prospective surveillance of AIT safety in real life settings is needed.

Methods: The multinational Allergen Immunotherapy Adverse Events Registry (ADER) was designed to address AIT safety in real life clinical practice. Data on children ≤18 years old with respiratory allergies undergoing AIT were retrieved. Patient- and AIT-related features were collected and analyzed. The characteristics of adverse events (AE) and risk factors were evaluated.

Results: A total of 851 patients, 11.3 ± 3.4 years old, with rhinitis only (47.6%); asthma and rhinitis (44.5%); asthma (7.9%), receiving 998 AIT courses were analyzed. Sublingual immunotherapy (SLIT) accounted for 51% of the courses. In 84.5% of patients only one AIT treatment was prescribed. Pollen was the most frequent sensitizer (57.1%), followed by mites (53.4%), molds (18.2%) and epithelia (16.7%). Local and systemic AEs were reported in 85 patients (9.9%). Most AEs (83.1%) were mild and occurred in <30 min (87%). Respiratory and cutaneous symptoms were more frequent. Only 4 patients (0.47%) had severe AE (none after 6 weeks of maintenance). The risk of AE was higher in patients undergoing SCIT.

Conclusions: AIT is safe and well tolerated in children and adolescents with respiratory allergies in real-life clinical practice. Though SCIT is more prone to AE compared to SLIT, overall severe reactions are rare and occur during build-up and early maintenance.

Keywords: adverse events; allergen immunotherapy; real-life settings; risk factors.

Abstract

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