BSACI Registry for Immunotherapy (BRIT): <i>Providing safe and effective immunotherapy for allergies and urticaria</i>

Khan, Sujoy; Krishna, Mamidipudi Thirumala; Michaelis, Louise J.; Dawson, Tom C.; Marriage, Deborah; Thursby-Pelham, Anna; Özyiğit, Leyla Pur; Jones, Carla; Regent, Lynne; Erlewyn-Lajeunesse, Michel

doi:10.1111/cea.13887

Cited by 4 publications

(5 citation statements)

References 9 publications

(16 reference statements)

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“…The role of registries as a robust, real‐world data gathering tool has been highlighted recently 11 . BRIT, a UK‐based prospective registry, has reported outcomes from the UK National Health System on the efficacy and safety of AIT and other immunomodulatory treatments for chronic spontaneous urticaria, reflecting real‐life clinical practice 12,13 . In contrast, ADER encompasses a wider picture, mirroring how AIT works in 8 different centers in real life with all the expected heterogeneity, making this registry a valuable additional resource of real world evidence.…”

Section: Discussionmentioning

confidence: 99%

“…11 BRIT, a UK-based prospective registry, has reported outcomes from the UK National Health System on the efficacy and safety of AIT and other immunomodulatory treatments for chronic spontaneous urticaria, reflecting real-life clinical practice. 12,13 In contrast, ADER encompasses a wider picture, mirroring how AIT works in 8 different centers in real life with all the expected heterogeneity, making this registry a valuable additional resource of real world evidence. Considering that ADER is focused on AIT safety, our results cover the full spectrum of AE characteristics and describe in detail all AE occurred during AIT treatment.…”

Section: Discussionmentioning

confidence: 99%

“…[4][5][6][7][8] Even though few observational studies and RCTs have evaluated adverse events (AE) due to AIT, there is a need for systematically and prospectively documenting these AE, in the context of an AIT registry. [9][10][11][12][13] Such a registry (Allergen Immunotherapy Adverse Reactions Registry -ADER) has been established with the support of the European Academy of Allergy and Clinical Immunology. 14 Moreover, it is important to identify and highlight factors that may increase the risk of AE.…”

Section: Introductionmentioning

confidence: 99%

“…It has been shown that allergen immunotherapy in children is well‐tolerated, but there are still concerns regarding safety 4–8 . Even though few observational studies and RCTs have evaluated adverse events (AE) due to AIT, there is a need for systematically and prospectively documenting these AE, in the context of an AIT registry 9–13 . Such a registry (Allergen Immunotherapy Adverse Reactions Registry ‐ ADER) has been established with the support of the European Academy of Allergy and Clinical Immunology 14 .…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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

Asllani,

Mitsias,

Konstantinou

et al. 2023

Clinical & Translational All

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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

Asllani,

Mitsias,

Konstantinou

et al. 2023

Clinical & Translational All

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“…Variability in clinical practice can introduce confounding factors that are hard to control for in the analysis. 101 Several AIT registries have been developed to provide consistent, high-quality RWD, such as the British Society for Allergy and Clinical Immunology-BSACI Registry for ImmunoTherapy (BRIT) 102 and the OmaBASE registry, 103 or Danish National Health Service Prescription Database and Statistics Denmark Database. 104 These registries are helping to further our understanding of the safety and efficacy of AIT and biologicals for allergies and urticaria in real-world settings.…”

Section: Molecular Allergy Diagnosticsmentioning

confidence: 99%

Hot topics in allergen immunotherapy, 2023: Current status and future perspective

Zemelka‐Wiacek,

Agache,

Akdis

et al. 2023

Allergy

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The importance of allergen immunotherapy (AIT) is multifaceted, encompassing both clinical and quality‐of‐life improvements and cost‐effectiveness in the long term. Key mechanisms of allergen tolerance induced by AIT include changes in memory type allergen‐specific T‐ and B‐cell responses towards a regulatory phenotype with decreased Type 2 responses, suppression of allergen‐specific IgE and increased IgG1 and IgG4, decreased mast cell and eosinophil numbers in allergic tissues and increased activation thresholds. The potential of novel patient enrolment strategies for AIT is taking into account recent advances in biomarkers discoveries, molecular allergy diagnostics and mobile health applications contributing to a personalized approach enhancement that can increase AIT efficacy and compliance. Artificial intelligence can help manage and interpret complex and heterogeneous data, including big data from omics and non‐omics research, potentially predict disease subtypes, identify biomarkers and monitor patient responses to AIT. Novel AIT preparations, such as synthetic compounds, innovative carrier systems and adjuvants, are also of great promise. Advances in clinical trial models, including adaptive, complex and hybrid designs as well as real‐world evidence, allow more flexibility and cost reduction. The analyses of AIT cost‐effectiveness show a clear long‐term advantage compared to pharmacotherapy. Important research questions, such as defining clinical endpoints, biomarkers of patient selection and efficacy, mechanisms and the modulation of the placebo effect and alternatives to conventional field trials, including allergen exposure chamber studies are still to be elucidated. This review demonstrates that AIT is still in its growth phase and shows immense development prospects.

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

Julijana,

Dimitrios,

George

et al. 2024

Allergy

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BackgroundRegistries 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.MethodsThe 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.ResultsA 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.ConclusionIn 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.

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BSACI Registry for Immunotherapy (BRIT): Providing safe and effective immunotherapy for allergies and urticaria

Cited by 4 publications

References 9 publications

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

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

Hot topics in allergen immunotherapy, 2023: Current status and future perspective

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

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