Publications by authors named "Elena Gras Colomer"
Patient care and control of inflammatory disorders, such as psoriasis, can be improved by model-informed precision dosing (MIPD) techniques based on population pharmacokinetic/pharmacodynamic (PK/PD) models. Clinical dose selection decisions based on MIPD strategies need to take account of the uncertainty associated with the individual PK/PD model parameters, which is determined by the quantity of individual observational data collected in clinical practice. The aim of this study was to propose an approach for personalized dosage regimens of secukinumab (SCK) in 22 Spanish patients with plaque psoriasis, whose severity level was considered moderate to severe, taking into account the uncertainty associated with individual parameters in a population-based PK/PD model.
View Article and Find Full Text PDFBackground/objectives: Implementing model-informed precision dosing (MIPD) strategies guided by population pharmacokinetic/pharmacodynamic (PK/PD) models could enhance the management of inflammatory diseases such as psoriasis. However, the extent of individual experimental data gathered during MIPD significantly influences the uncertainty in estimating individual PK/PD parameters, affecting clinical dose selection decisions.
Methods: This study proposes a methodology to individualize ustekinumab (UTK) dosing strategies for 23 Spanish patients with moderate to severe chronic plaque psoriasis.
Background: Patient-reported outcome measures (PROMs) and patient-reported experiences measures (PREMs) are crucial for understanding the impact of GD on quality of life and patient's perceptions on care, but also to guide decision-making processes. Nevertheless, no specific PREMs in GD have been published, neither PROMs for Spanish GD patients have been developed.
Methods: Two project coordinators selected key-points to be included in a PROMs/PREMs questionnaire, and the scientific committee and a group of expert patients contributed to the initial draft.
Background And Objective: Patient activation is a concept that refers to the willingness to manage one's health and medical care. To assess it, a patient activation measure (PAM) has been developed and validated. Several studies report low activation in patients with chronic diseases.
View Article and Find Full Text PDFLysosomal storage disorders (LSDs) constitute a large group of rare, multisystemic, inherited disorders of metabolism, characterized by defects in lysosomal enzymes, accessory proteins, membrane transporters or trafficking proteins. Pompe disease (PD) is produced by mutations in the acid alpha-glucosidase (GAA) lysosomal enzyme. This enzymatic deficiency leads to the aberrant accumulation of glycogen in the lysosome.
View Article and Find Full Text PDFAims: The aims of this work are (i) to characterize the absorption properties of orally administered formulations at different dose levels, and (ii) to evaluate the impact of entero-hepatic circulation on the time-course of amiodarone (AM) in rats in order to optimize the development of new oral (OR) formulations.
Methods: Intravenous (IV) formulation consisted on a solution of a commercial injectable of AM chlorhydrate. OR formulations included the IV commercial formulation (Trangorex®) (Solution I), an aqueous supramicellar solution of AM chlorhydrate with Polysorbate at 5% (Solution II) and a suspension from Trangorex® tablets (Tablet).
Article Synopsis
- The emergence of biological therapies, particularly monoclonal antibodies (mAb), has significantly changed how psoriasis is treated, but these therapies have complex pharmacokinetics (PK) and pharmacodynamics (PD).
- This study reviews 22 articles on population PK/PD models for various mAb in psoriasis, including TNF-α and IL inhibitors, and summarizes clinical trials and structural models used.
- Key findings highlight that body weight and immunogenicity impact drug clearance, and the absence of consensus in PK/PD relationships emphasizes the importance of therapeutic drug monitoring (TDM) for determining proper dosages in psoriasis treatment.
Quantitative assessment of the exposure-efficacy relationship of glucocerebrosidase using Markovian elements in Gaucher patients treated with enzyme replacement therapy.
Br J Clin Pharmacol
June 2022
Aims: The aims of this study are (i) to develop a population pharmacokinetic model of enzyme activity in Gaucher-type 1 (GD1) patients after intravenous administration of enzyme replacement therapy (ERT), and (ii) to establish an exposure-efficacy relationship for bone marrow infiltration to propose dose adjustments according to patient covariate values.
Methods: A prospective follow-up, semi-experimental multi-centre study was conducted in four hospitals to evaluate the pharmacokinetics, efficacy and safety of ERT in GD1 patients. Twenty-five individuals with 266 glucocerebrosidase (GCase) observations in plasma and leukocytes and 14 individuals with 68 Spanish magnetic resonance imaging (S-MRI) observations were enrolled.
Background: Intravenous admixtures of dexketoprofen-trometamol and paracetamol are frequently used in clinical practice due to synergism obtained administering both drugs concomitantly. Physicochemical stability of binary admixture containing both drugs is currently unknown.
Objective: To determine physicochemical stability of binary admixture containing dexketoprofen-trometamol 50 mg and paracetamol 1000 mg in a low-density polyethylene bottle at different storage conditions of light and temperature for advanced preparation.
Article Synopsis
- A study evaluated the link between glucocerebrosidase enzyme activity and clinical response in Gaucher disease type I patients undergoing enzyme replacement therapy (ERT) to help personalize treatment dosages.
- The researchers measured enzyme activity at two points: shortly after ERT infusion and during the infusion to assess how well the drug was working in the body.
- Findings indicated that enzyme activity levels were good predictors of clinical response, suggesting that monitoring these markers could enhance treatment effectiveness for Gaucher disease patients.
Background: Enzyme replacement therapy (ERT) is currently the standard treatment for patients with Gaucher disease type I (GD1), but the pharmacokinetics have hardly been studied. This study aimed to quantify in vivo enzyme activity in peripheral leukocytes from patients receiving long-term treatment with imiglucerase or velaglucerase for GD1, and set out to assess the process of enzymatic uptake by peripheral leukocytes.
Methods: A prospective semi-experimental study was conducted.
Background: Patient registries (PRs) are important tools for public-health surveillance and rare-disease research. The purpose of this study is to identify the most important criteria for the creation of a rare-disease PR that could be used by public-health authorities to develop health policies.
Methods: A consensus-development Delphi study was used, with participants selected for their expertize in rare diseases and registries.