Evidence map›Paper›PMID 40411119›Full record

ArticleBritish journal of clinical pharmacology2025

Population pharmacokinetic modelling of prednisolone in systemic lupus erythematosus patients: Analysis of exposure and disease activity.

Naïm Bouazza, Michaela Semeraro, Gabrielle Lui, Léo Froelicher-Bournaud, Laure Choupeaux, Jean-Marc Treluyer, Sihem Benaboud, Joelle Terzic, Eric Hachulla, Philippe Remy and 17 more

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03187743 nacompletednot on this map

Personalised Pharmacological Approach to the Tapering of Corticosteroid Doses in Systemic Lupus Patients Treated With Prednisone

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2018 to 2022Enrolled72ConditionsLupus Erythematosus, SystemicArmsBlood samples
NCT04202185 completednot on this map

Evaluation of a Cohort of Congenital Deep Deafness Patients and/or With Auditory Neuropathy, Looking for DFNB9

TypeobservationalSponsorAssistance Publique - Hôpitaux de ParisRan2020 to 2024Enrolled150ConditionsCongenital Profound Hearing LossArmsData collection, Genetic analysis
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Naïm BouazzaUniversité Paris Cité, Inserm, Pharmacologie et évaluations des thérapeutiques chez l'enfant et la femme enceinte, Paris, France.ORCID https://orcid.org/0000-0002-2158-1399
Michaela SemeraroUniversité Paris Cité, Inserm, Pharmacologie et évaluations des thérapeutiques chez l'enfant et la femme enceinte, Paris, France.
Gabrielle LuiUniversité Paris Cité, Inserm, Pharmacologie et évaluations des thérapeutiques chez l'enfant et la femme enceinte, Paris, France.
Léo Froelicher-BournaudUniversité Paris Cité, Inserm, Pharmacologie et évaluations des thérapeutiques chez l'enfant et la femme enceinte, Paris, France.
Laure ChoupeauxUnité de Recherche Clinique Necker Cochin, AP-HP, France.
Jean-Marc TreluyerUniversité Paris Cité, Inserm, Pharmacologie et évaluations des thérapeutiques chez l'enfant et la femme enceinte, Paris, France.ORCID https://orcid.org/0000-0002-2045-4742
Sihem BenaboudUniversité Paris Cité, Inserm, Pharmacologie et évaluations des thérapeutiques chez l'enfant et la femme enceinte, Paris, France.
Joelle TerzicNephrology Dialysis Transplantation Children's Unit, University Hospital Hautepierre, Strasbourg, France.
Eric HachullaUniv. Lille, Inserm, CHU Lille, Department of Internal Medicine and Clinical Immunology, Hôpital Claude Huriez, CERAINOM, U1286 - INFINITE - Institute for Translational Research in Inflammation, Lille, France.
Philippe RemyAssistance Publique des Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, Service de Néphrologie et Transplantation, Centre de Référence Maladie Rare «Syndrome Néphrotique Idiopathique», Fédération Hospitalo-Universitaire "Innovative Therapy for Immune Disorders", Créteil, France.
Jérôme HarambatPediatric Nephrology Unit, Reference Center for Rare Kidney Diseases, SORARE, Bordeaux University Hospital, Bordeaux, France.
Alexandre KarrasDepartment of Nephrology, Georges Pompidou European Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France; Université Paris Cité, Unité de Formation et de Recherche de Médecine, Paris, France.
Caroline Rousset-RouviereService de pédiatrie multidisciplinaire, Hôpital de la Timone, Assistance Publique-Hôpitaux de Marseille, Marseille, France.
Anne JolivotService de néphrologie, Hospices civils de Lyon, Hôpital Édouard Herriot, Lyon, France.
Zahir AmouraInternal Medicine Department 2, French National Referral Center for Rare Systemic Diseases and Histiocytoses, Sorbonne University, Assistance Publique-Hôpitaux de Paris, Pitié-Salpêtrière Hospital, Paris, France.
Eric DaugasService de Néphrologie, Assistance publique - Hôpitaux de Paris (AP-HP), Hôpital Bichat-Claude Bernard, Paris, France.
Aurélie HummelService de Néphrologie, Transplantation Adults, Hôpital Necker-Enfants Malades, Paris, France.
Rémi SalomonPediatric Nephrology, Inserm U1163, MARHEA Reference Center, Imagine Institute, Paris Cité University, Necker-Enfants Malades Hospital, APHP, Paris, France.
Jean-Christophe LegaDepartment of Internal and Vascular Medicine, Hospices Civils de Lyon, Lyon, France.
Stéphane DecramerDepartment of Pediatric Internal Medicine, Rheumatology and Nephrology, Toulouse University Hospital, Toulouse, France.
Alexandre BelotPediatric Rheumatology, Nephrology, Dermatology Department, CMR RAISE, Women-Mother-Child Hospital, Hospices Civils de Lyon, Bron, France.
Delphine GobertSorbonne Université, service de médecine interne, AP-HP, Hôpital universitaire Saint Antoine, Paris, France.
Nathalie Costedoat-ChalumeauCentre de référence maladies auto-immunes et systémiques rares de l'île de France, Cochin Hospital, Paris, France.
Stanislas FaguerDepartment of Nephrology and Organ Transplantation, University Hospital of Toulouse, French Intensive Care Renal Network, Toulouse, France.
Isabelle MelkiGeneral Paediatrics, Department of Infectious Disease and Internal Medicine, Robert Debré University Hospital, APHP, Nord-Université Paris Cité, Paris, France.
Noémie Jourde-ChicheDepartment of Nephrology, AP-, Marseille, HM, France.
Brigitte Bader-MeunierDepartment of Pediatric Immunology, Hematology and Rheumatology, Necker Hospital, AP-HP, National Reference Centre for Rheumatic and Autoimmune Diseases in Children, RAISE, Institut IMAGINE, Paris, France.

Funding

Programme Hospitalier de Recherche Clinique-PHRC 2017 (French Ministry of Health)
6 · The paper itself

Abstract

aimsPrednisone is a widely used glucocorticoid in the treatment of lupus, although its dosing is often determined empirically. Prednisolone, the active metabolite of prednisone, is found in its free form in the serum. The goal of this study was to develop a population pharmacokinetic model in patients with systemic lupus erythematosus (SLE) to forecast free prednisolone concentrations and its association with disease activity.

methodsA total of 66 active SLE patients (adults and children) were included, and followed up prospectively (242 observations available). Plasma prednisolone concentrations were assessed using liquid chromatography-mass spectrometry, and the data were analysed using Monolix software. The pharmacokinetic model was a one-compartment open model with absorption lag time representing the delay for both absorption and metabolism from inactive (prednisone) to active form (prednisolone). This model predicted free concentrations, which were then used to calculate total concentrations based on established binding constants.

resultsFree prednisolone clearance (CLu/F) and volume of distribution (Vu/F) were scaled allometrically to body weight. The typical population estimates (95% confidence interval) were 54 (48-62) L/h/70 kg and 235 (203-274) L/70 kg, respectively. Additionally, the bioavailability parameter was found to decrease non-linearly with the dose. Prednisolone cumulative exposure was not different between patients who responded at 3 months and those who did not.

conclusionsRobust pharmacokinetic targets are not yet clearly defined regarding toxicity or efficacy and are warranted in order to make a valuable contribution to prednisolone therapeutic drug monitoring in the context of SLE.

Indexed as

GlucocorticoidsLupus Erythematosus, SystemicModels, BiologicalPrednisoloneAdolescentAdultBiological AvailabilityChildFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesSeverity of Illness IndexYoung AdultGlucocorticoidsPrednisolonedisease activitypopulation pharmacokinetics

Identifiers

PMID40411119
PMCPMC12464645

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.