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P4 data, Journal: Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. (Pubmed Central) - Jul 22, 2024 P2, P2/3, The 300IR house dust mite (HDM) sublingual immunotherapy (SLIT) tablet is approved for treatment of HDM-induced allergic rhinitis (AR)...4 severe laryngopharyngeal reactions (2 requiring adrenaline/epinephrine) and 1 moderate eczema considered serious rapidly resolved with medications; no anaphylaxis was reported...Safety data from RCTs and more than 7 years of real-life experience confirmed the favorable safety profile of 300IR HDM-SLIT tablet in patients across different regions, regardless of age and asthma status. NCT00674700; Retrospectively registered 06 May 2008.NCT01199133; Retrospectively registered 09 September 2010.NCT01527188; Retrospectively registered 01 February 2012.NCT02443805; Registered 29 April 2015/EudraCT 2014-004223-46; Registered 16 September 2015.jRCT2080221872/JapicCTI-121917; Registered 01 August 2012.jRCT2080222929/JapicCTI-15298; Registered 04 August 2015.
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LILRA5 and CCL25 as candidate predictive biomarkers of AIT efficacy (Palma) - May 25, 2024 - Abstract #EAACI2024EAACI_2956; Background Allergen immunotherapy (AIT) is recognised as a safe and efficacious treatment for type I respiratory allergies...When focusing on polysensitised patients with asthma, we observed an improvement in ROC analyses with area under curves reaching 0.84 and 0.7 for LILRA5 and CCL25, respectively. Conclusion Altogether, our findings clearly identify that the levels of LILRA5 and CCL25 in the blood before AIT serve as a reflection of the patient's inflammatory status, thus offering insights into the potential clinical responses expected during house dust mite immunotherapy.
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Prospective, pilot, phase 1 study of iPUMP (Innovation Hub) - Apr 21, 2024 - Abstract #EAACI2024EAACI_1760; It is easy to use and the functions in the connected device and app. can be consulted by patients to monitor their own compliance.
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Journal: Impact of COVID-19 in allergen immunotherapy: An Italian survey. (Pubmed Central) - Sep 18, 2022 The results show that Italian physicians (N=66) did not consider that the COVID-19 pandemic presented an added risk to patients with allergic asthma or rhinitis receiving AIT. Although most treatments continued, there were reduced rates of AIT therapy initiations and sublingual AIT was favored over subcutaneous AIT.
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Review, Journal: Update about Oralair® as a treatment for grass pollen allergic rhinitis. (Pubmed Central) - Jul 24, 2022 Effectiveness has been substantiated in subsequent observational studies with sustained efficacy following treatment cessation and a favorable level of adherence, quality of life, benefit, and satisfaction for the patients. Supportive evidence for a benefit in reducing the risk or delaying the development of allergic asthma is emerging.
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Clinical, Journal, IO biomarker: Coordinated IgG2 and IgE responses as a marker of allergen immunotherapy efficacy. (Pubmed Central) - Apr 22, 2022 We provide evidence for coordinated serum immune responses upon AIT in HDM-allergic subjects exhibiting high clinical benefit when compared with low responders. Assessing HDM-specific IgE, IgG2 and IgG4 in serum could be used as follow-up combined markers to support decision as to AIT continuation and/or adaptation.
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Preclinical, Journal: Bet v 1 contiguous overlapping peptides anchored to virosomes with TLR4 agonist enhance immunotherapy efficacy in mice. (Pubmed Central) - Jan 15, 2022 Whereas sublingual allergen immunotherapy (AIT) is routinely performed without any adjuvant or delivery system, there is a strong scientific rationale to better target the allergen(s) to oral dendritic cells known to support regulatory immune responses by using appropriate presentation platforms...We report herein for the first time on the capacity of a novel and safe presentation platform, i.e. virosomes with membrane-integrated TLR4 agonist, to improve dramatically sublingual AIT efficacy in a murine model due to its intrinsic dual properties of targeting and stimulating to further promote anti-allergic immune responses. As such, our study paves the ground for further clinical development of this allergen presentation platform for patients suffering from respiratory allergies.
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Clinical, P3 data, Journal: A 300°IR sublingual tablet is an effective, safe treatment for house-dust-mite-induced allergic rhinitis: an international, double-blind, placebo-controlled, randomized Phase III clinical trial. (Pubmed Central) - Sep 24, 2021 P3 The 300°IR sublingual HDM tablet is an effective, safe treatment for HDM-induced AR. (NCT02443805, EudraCT 2014-004223-46) CLINICAL IMPLICATIONS: A 300 index of reactivity sublingual tablet formulation of Dermatophagoides pteronyssinus:Dermatophagoides farinae extract is a safe, effective treatment for moderate-to-severe house-dust-mite-induced allergic rhinitis.
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Journal: Personalized medicine and allergen immunotherapy: the beginning of a new era? (Pubmed Central) - Jul 9, 2021 AIT also broadens the field of possibilities for healthcare professionals and patients, by allowing to choose the galenic formulation according to patient preferences and on the basis of their clinical history, adapting the product composition to the patient's sensitization profiles and the underlying biological mechanisms identified at the diagnostic stage, while guaranteeing quality of the prescribed product as the production of allergens and allergoids is today more regulated than in the past years. In the management of AIT, it is also possible to involve patients in decisions throughout their care pathway thanks to multiple services, offering personalized follow-up and support, to ensure the highest treatment efficacy levels, and recalling medication intake, medical appointments and prescription renewals.
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Review, Journal, IO biomarker: Personalized Medicine for allergy treatment: allergen immunotherapy still a unique and unmatched model. (Pubmed Central) - May 15, 2021 The stakes of PM in allergic patients are molecular diagnostics, to detect specific IgE to single allergen molecules and to distinguish the causative molecules from those merely cross-reactive, pursuit of patient's treatable traits addressing genetic, phenotypic and psychosocial features, and omics, such as proteomics, epi-genomics, metabolomics and breathomics, to forecast patient's responsiveness to therapies, to detect biomarker and mediators, and verify the disease control. This new approach has already improved the precision of allergy diagnosis and is likely to significantly increase, through the higher performance achieved with the personalized treatment, the effectiveness of allergen immunotherapy by enhancing its already known and unique characteristics of treatment that acts on the causes.
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