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. 2025 Sep 19:18:1311-1326.
doi: 10.2147/JAA.S546044. eCollection 2025.

Safety and Effectiveness of Allergen Immunotherapy in Patients with Severe Allergic Asthma

Ana I Tabar  1 , Julio Delgado-Romero  2 , Eloína González-Mancebo  3 , Javier Domínguez-Ortega  4 , Lorena Soto-Retes  5 ; Asthma and Immunotherapy Group of the SEAIC
Affiliations

Safety and Effectiveness of Allergen Immunotherapy in Patients with Severe Allergic Asthma

Ana I Tabar et al. J Asthma Allergy. .

Abstract

Objective: Allergen immunotherapy (AIT) is an established treatment for mild to moderate allergic asthma. However, limited data are available regarding its safety and efficacy in patients with severe asthma. This study aimed to gather real-world evidence (RWE) on the safety and effectiveness of AIT in individuals with severe asthma caused by sensitization to at least 1 allergen, who were either currently undergoing AIT or had received it within the past five years.

Methods: A retrospective study was conducted in Spain, including patients aged ≥6 years with severe asthma (Spanish Guideline for Asthma Management [GEMA] steps 5-6 and Global Initiative for Asthma [GINA] step 5) sensitized to at least 1 allergen who had received AIT within the previous 5 years, to evaluate safety and effectiveness.

Results: The study included 93 patients (54.8% female) with a median age of 40.3 years, including 5 under 14. A total of 16 systemic reactions (SRs) were reported in 8 patients (8.6%), mostly immediate (13/16) and occurring during the initiation phase (12/16), all in patients receiving subcutaneous immunotherapy. Most SRs were mild to moderate, except for 2 severe reactions in 1 patient. Only 3 patients discontinued treatment. Significant improvements in both FeNO and FEV1 (%) were observed after 6 and 12 months of AIT, respectively. Quality of Life (through mini-AQLQ) scores improved at 1, 2 and 3 years after initiation of AIT compared to baseline. The number of patients who did not require rescue medication for asthma was significantly higher after starting AIT than before treatment. AIT was also associated with a 75.8% reduction in the number of emergency visits.

Conclusion: This study confirms the safety and effectiveness of AIT in patients with well-controlled severe asthma in routine clinical practice. Additional prospective real-world studies are needed to better understand the efficacy of AIT in severe asthma.

Keywords: allergen immunotherapy; allergic asthma; real-world evidence; safety; severe asthma.

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Conflict of interest statement

AIT has received consultancy and speaking honoraria from Allergy Therapeutics, ALK-Abelló, Diater, Glaxo, Inmunotek, InnoUp, ITAI, LETI Pharma, Probelte, and Roxall. She has participated in research projects sponsored by Allergy Therapeutics, ALK-Abelló, Diater, Inmunotek, InnoUp, and Roxall. She also reports payment from RTC2019-006977-1 (Retos-Colaboración 2019 del Ministerio de Ciencia e Innovación). IP 2020-2024 paid to her institution. JDR has received speaker honoraria from AstraZeneca, Bial, Chiesi, GlaxoSmithKline, and Sanofi, as well as research grants from AstraZeneca within the past three years. He has also received meeting travel assistance from Sanofi and Menarini. EGM has received consultancy and/or speaking fees from Allergy Therapeutics, ALK-Abelló, AstraZeneca, Diater, Faes Pharma, Gebro, GlaxoSmithKline, Sanofi, Inmunotek, LETI Pharma, Novartis, Roxall, and Stallergenes Greer. She has also participated in research projects sponsored by Allergy Therapeutics, ASAC, LETI Pharma, and Roxall. JDO has received consulting and speaking fees over the past three years from ALK-Abelló, AstraZeneca, Chiesi, GlaxoSmithKline, LETI Pharma, Novartis, Mundipharma, Sanofi, and TEVA. Over the past three years, LSR has received honoraria for speaking at meetings sponsored by Allergy Therapeutics, Sanofi, AstraZeneca, Stallergenes-Greer, and GlaxoSmithKline. She also reports payment for manuscript preparation from LETI Pharma. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Variables associated with the occurrence of systemic reactions. (A) Use of rescue treatment with short-acting beta agonists (SABA) or inhaled corticosteroids (ICS)/long-acting beta agonists (ICS/LABA) (p = 0.048; Fisher’s exact test). (B) Asthma control (p = 0.004)*. The number of positive patients out of the total number of patients analyzed in each group is indicated within the histogram bars.
Figure 2
Figure 2
Effect of allergen immunotherapy (AIT) in the use of biologic treatments in the study population. A total of 15 patients were initially receiving concomitant biologic treatments, 14 of them omalizumab and only 1 mepolizumab. After 5 years of AIT, all patients were free of biologics.
Figure 3
Figure 3
Effect of allergen immunotherapy (AIT) on the number of emergency room visits. The figure shows the total number of visits in the year before versus after initiation of AIT. A reduction of 75.8% in the total number of visits was observed, from 62 visits before the start of AIT to 15 visits after the start of AIT. The number of visits is indicated within the histogram bars.
See this image and copyright information in PMC

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