2022
DOI: 10.1097/aci.0000000000000808
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Update on the use of allergen challenge chambers in immunotherapy: clinical implications

Abstract: Purpose of reviewThis review aims to reflect on and discuss recent evidence of applicability of allergen exposure chambers (AEC) for allergen immunotherapy studies, especially focussing on validation of AECs, technical documentation and future perspectives. Recent findingsPublications covered by this review summarize the historical background, current status of research use and validation of AEC systems. It describes identified unmet needs regarding comparability of AEC systems, reproducibility of clinical ass… Show more

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Cited by 6 publications
(7 citation statements)
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“…Several confounders impact clinical trials in AIT development programs, such as false reporting of PROMs, imputation of missing data or the role of natural (non‐standardized) allergen exposure impacting the outcome of a (field‐) trial 116 . Allergen provocation under standardized conditions in so‐called allergen exposure chambers (AECs) may overcome methodological flaws 127 . Still, to date, this technology is not clinically validated to replace ‘classical’ field trials under natural exposure, as emphasized by EMA in the aforementioned guideline 128 .…”
Section: Methods In Ait Development Programs: Current Standards and F...mentioning
confidence: 99%
See 1 more Smart Citation
“…Several confounders impact clinical trials in AIT development programs, such as false reporting of PROMs, imputation of missing data or the role of natural (non‐standardized) allergen exposure impacting the outcome of a (field‐) trial 116 . Allergen provocation under standardized conditions in so‐called allergen exposure chambers (AECs) may overcome methodological flaws 127 . Still, to date, this technology is not clinically validated to replace ‘classical’ field trials under natural exposure, as emphasized by EMA in the aforementioned guideline 128 .…”
Section: Methods In Ait Development Programs: Current Standards and F...mentioning
confidence: 99%
“…116 Allergen provocation under standardized conditions in so-called allergen exposure chambers (AECs) may overcome methodological flaws. 127 Still, to date, this technology is not clinically validated to replace 'classical' field trials under natural exposure, as emphasized by EMA in the aforementioned guideline. 128 However, an EAACI task force comprising worldwide clinicians, AEC providers and delegates from regulatory authorities has provided overviews of the similarities and differences of current AEC facilities with the aim of further harmonization.…”
Section: Me Thods In Ait De Velopment Prog R Ams: Current S Tandards ...mentioning
confidence: 99%
“…Comparable clinical scores were achieved in a study conducted by ECC with an allergen dose similar to environmental exposure. For AIT, further validation of the treatment effect size as assessed in the EEC challenges is needed to relate it to effect sizes found under natural exposure in field trials [ 80 , 81 , 82 ].…”
Section: Biomarkers For Aitmentioning
confidence: 99%
“…79,[81][82][83][85][86][87][88][89][90] AIT: Allergen immunotherapy, CCR3: C-C chemokine receptor type 3, ECP: Eosinophilic cationic protein, ELIFAB: Enzyme-linked immunosorbent-facilitated antigen-binding assay, DAO: Diamine oxidase, IgE-BF: IgE-blocking factor, FAB: facilitated antigen binding, IFN-γ: Interferon-gamma, ILCs: Innate lymphoid cells, SPT: Skin prick tests, TARC: thymus and activation regulated protein, TGF-β: Transforming growth factor-beta.…”
mentioning
confidence: 99%
“… 14 For the performance of pivotal immunotherapy trials, regulatory authorities require harmonization of clinical assessments and documentation between clinical outcomes obtained using EECs versus environmental exposure. 15 …”
Section: Introductionmentioning
confidence: 99%