Clinical efficacy of sublingual immunotherapy tablets for allergic rhinitis is unlikely to be derived from in vitro allergen-release data
| Autor: | Laurent Mascarell, Pascal Demoly, Ulrich Wahn, Efstrathios Karagiannis, Catherine Bos, Giovanni Passalacqua, Philippe Devillier, Giorgio Walter Canonica, Thomas B. Casale |
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| Přispěvatelé: | Gestionnaire, Hal Sorbonne Université, Department of Internal Medicine [Milan, Italy], Humanitas University [Milan] (Hunimed)-Research Hospital ICH [Milan, Italy], Laboratoire de recherche sur les mécanismes moléculaires et pharmacologiques de l’obstruction bronchique (LOBIP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Hôpital Foch [Suresnes], Department of Internal Medicine [Tampa, FL, USA] (Division of Allergy/Immunology ), University of South Florida [Tampa] (USF), Département pneumologie et addictologie [Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Arnaud de Villeneuve, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Sorbonne Université (SU), Hôpital Arnaud de Villeneuve [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Département de Médecine Interne [Antony, France], Stallergenes Greer (France, Antony), Istituti di Ricovero e Cura a Carattere Scientifico (IRCCS), Università degli studi di Genova = University of Genoa (UniGe), Department of Paediatric Pneumology and Immunology [Berlin, Germany], Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Genoa (UNIGE) |
| Rok vydání: | 2019 |
| Předmět: |
safety
0301 basic medicine efficacy Immunology dissolution formulation grass pollen Pharmacology medicine.disease_cause 03 medical and health sciences 0302 clinical medicine Allergen Grass pollen Immunology and Allergy Medicine Potency Sublingual immunotherapy Clinical efficacy [SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology dissolution Administration allergic rhinitis efficacy formulation grass pollen safety sublingual immunotherapy tablet 030203 arthritis & rheumatology allergic rhinitis business.industry [SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy Slit In vitro 3. Good health Bioavailability 030104 developmental biology sublingual immunotherapy tablet Administration in vitro dissolution [SDV.IMM.IMM] Life Sciences [q-bio]/Immunology/Immunotherapy business [SDV.IMM.ALL] Life Sciences [q-bio]/Immunology/Allergology |
| Zdroj: | Expert Review of Clinical Immunology Expert Review of Clinical Immunology, In press, Epub ahead of print. ⟨10.1080/1744666X.2019.1649597⟩ Expert Review of Clinical Immunology, Expert Reviews (formerly Future Drugs), In press, Epub ahead of print. ⟨10.1080/1744666X.2019.1649597⟩ |
| ISSN: | 1744-8409 1744-666X |
| DOI: | 10.1080/1744666x.2019.1649597 |
| Popis: | International audience; Introduction: Allergen bioavailability underpins the efficacy and safety of SLIT tablets. Three product-related factors are likely to influence this: tablet potency, formulation and sublingual holding time.Areas covered: Tablet formulation determines the rate and extent of solubilized allergen release. Using validated in vitro dissolution assays, the two licensed grass pollen SLIT tablets are shown to release ≥85% of their total allergenic activity within several minutes. Sublingual holding time affects the contact duration between solubilized allergens and sublingual tissue. Maximal uptake of allergens by sublingual tissue requires ~5 minutes, with little uptake occurring within the first minute. A higher potency tablet with longer sublingual holding time would provide higher bioavailability, while faster rates of allergen release in vitro are unlikely to translate to a greater increase in bioavailability. Differences in dissolution times cannot serve as a surrogate of in vivo bioavailability, and are not related to differences in efficacy at the marketed tablet dosages. Rapid in vitro dissolution is likely not a key requirement for inducing a potent immune response.Expert opinion: In vitro dissolution cannot predict the clinical efficacy of SLIT tablets but could be important in immune tolerance and safety. In addition, a discontinuous administration regimen may have benefits for adherence and cost without compromising efficacy. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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