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Grass pollen sublingual immunotherapy treatment induces transcriptomic and metabolic changes due to AIT treatment

ABSTRACT: 47 patients were enrolled in a double-blind, placebo-controlled, multicenter trial using with GRAZAX® (Phleum pretense) during 2 years of therapy (T2). Immunological assays such as sIgE, sIgG4 and ISAC were carried out to the 31 patients who finished the trial. Additionally, serum and PBMCs samples from these samples were analyzed by metabolomics and transcriptomics, respectively. Based on their sensitization level, 22 patients were grouped in Mono and Poli groups, excluding epithelial allergic patients. Individuals were studied based on their treatment in Active and Placebo and their sensitization level. For metabolomics, samples were analyzed by Liquid and Gas Chromatography coupled to Mass Spectrometry (LC-MS and GC-MS, respectively).

ORGANISM(S): Human Homo Sapiens

TISSUE(S): Blood

DISEASE(S): Allergy

SUBMITTER: David Obeso Montero

PROVIDER: ST001369 | MetabolomicsWorkbench | Fri Mar 27 00:00:00 GMT 2020

REPOSITORIES: MetabolomicsWorkbench

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Project description:Lockwood2006 - AlzheimersDisease PBPK model A mathematical model to predict the effectiveness of CI-1017 (muscarinic agonist) for Alzheimer's disease by evaluating changes in ADAS-cog score. This model is described in the article: Application of clinical trial simulation to compare proof-of-concept study designs for drugs with a slow onset of effect; an example in Alzheimer's disease. Lockwood P, Ewy W, Hermann D, Holford N. Pharm. Res. 2006 Sep; 23(9): 2050-2059 Abstract: OBJECTIVE: Clinical trial simulation (CTS) was used to select a robust design to test the hypothesis that a new treatment was effective for Alzheimer's disease (AD). Typically, a parallel group, placebo controlled, 12-week trial in 200-400 AD patients would be used to establish drug effect relative to placebo (i.e., Ho: Drug Effect = 0). We evaluated if a crossover design would allow smaller and shorter duration trials. MATERIALS AND METHODS: A family of plausible drug and disease models describing the time course of the AD assessment scale (ADAS-Cog) was developed based on Phase I data and literature reports of other treatments for AD. The models included pharmacokinetic, pharmacodynamic, disease progression, and placebo components. Eight alternative trial designs were explored via simulation. One hundred replicates of each combination of drug and disease model and trial design were simulated. A 'positive trial' reflecting drug activity was declared considering both a dose trend test (p < 0.05) and pair-wise comparisons to placebo (p < 0.025). RESULTS: A 4 x 4 Latin Square design was predicted to have at least 80% power to detect activity across a range of drug and disease models. The trial design was subsequently implemented and the trial was completed. Based on the results of the actual trial, a conclusive decision about further development was taken. The crossover design provided enhanced power over a parallel group design due to the lower residual variability. CONCLUSION: CTS aided the decision to use a more efficient proof of concept trial design, leading to savings of up to US 4 M dollars in direct costs and a firm decision 8-12 months earlier than a 12-week parallel group trial. This model is hosted on BioModels Database and identified by: BIOMD0000000673. To cite BioModels Database, please use: Chelliah V et al. BioModels: ten-year anniversary. Nucl. Acids Res. 2015, 43(Database issue):D542-8. To the extent possible under law, all copyright and related or neighbouring rights to this encoded model have been dedicated to the public domain worldwide. Please refer to CC0 Public Domain Dedication for more information.

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Grass pollen sublingual immunotherapy treatment induces transcriptomic and metabolic changes due to AIT treatment

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