Allergen immunotherapy: The growing role of observational and randomized trial “Real‐World Evidence”

Abstract

Background: Although there is a considerable body of knowledge about allergen immunotherapy (AIT), there is a lack of data on the reliability of real-world evidence (RWE) in AIT, and consequently, a lack of information on how AIT effectively works in real life. Methods:To address the current unmet need for an appraisal of the quality of RWE in AIT, the European Academy of Allergy and Clinical Immunology Methodology Committee recently initiated a systematic review of observational studies of AIT, which will use the RELEVANT tool and the Grading of Recommendations Assessment, Development and Evaluation approach (GRADE) to rate the quality of the evidence base as a whole. The next step will be to develop a broadly applicable, pragmatic "real-world" database using systematic data collection. Based on the current RWE base, and perspectives and recommendations of authorities and scientific societies, aGlobally, SLIT appears to be the most common route of administration of AIT, as demonstrated by an analysis of the worldwide market hierarchy of RWE in AIT is proposed, which places pragmatic trials and registry data at the positions of highest level of evidence. Key Results:There is a need to establish more AIT registries that collect data in a cohesive way, using standardized protocols.Conclusions: This will provide an essential source of real-world data that can be easily shared, promoting evidence-based research and quality improvement in study design and clinical decision-making.

Allergen immunotherapy for respiratory allergy: Quality appraisal of observational comparative effectiveness studies using the REal Life Evidence AssessmeNt Tool. An EAACI methodology committee analysis

“…This will help in providing reliable information that can hardly be obtained from RCTs, such as the duration of benefit after AIT discontinuation, treatment persistence, and adherence. In light of this, establishing AIT registries, with the aim of collecting data in a cohesive way, using standardized protocols will provide an essential source of RWE to promote evidence‐based research and quality improvement in study design and clinical decision‐making 40 …”

“…In light of this, establishing AIT registries, with the aim of collecting data in a cohesive way, using standardized protocols will provide an essential source of RWE to promote evidence-based research and quality improvement in study design and clinical decision-making. 40…”

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

“…4 The report also shows how national registry data can provide high-quality evidence of 'realworld' clinical effectiveness of immunomodulatory therapies as highlighted by the European Academy of Allergy and Clinical Immunology (EAACI). 5…”

“…In this editorial, we aim to describe the BRIT registry and highlight the publication of its first report 4 . The report also shows how national registry data can provide high‐quality evidence of ‘real‐world’ clinical effectiveness of immunomodulatory therapies as highlighted by the European Academy of Allergy and Clinical Immunology (EAACI) 5 …”

Real-world evidence: Methods for assessing long-term health and effectiveness of allergy immunotherapy

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Recently, scientific societies and regulatory authorities have stressed the need for more robust real-world evidence (RWE) in allergic respiratory disease. [1][2][3][4] Despite the importance of complementing randomized clinical trials (RCTs) with high-quality RWE, and although a relative increase in the numbers of RWE studies (RWSs) in allergy immunotherapy (AIT) has been seen in recent years, the number of RWSs conducted in AIT is still limited 4 (Fig 1). The highest level of evidence is suggested if coexisting RCTs and observational studies provide consistent findings.

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