ArticleClinical pharmacokinetics2022
Population Pharmacokinetics of Abrocitinib in Healthy Individuals and Patients with Psoriasis or Atopic Dermatitis.
Article in Clinical pharmacokinetics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 11 registered trials, which are not on this map. Cited by 8 papers.
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.
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.
A Phase 1, Within Cohort, Randomized, Double Blind, Third-Party Open, Placebo-Controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-04965842 In Healthy Western and Japanese Subjects
A Phase 1, Open Label, Single Dose 3 Way Crossover Study to Evaluate the Bioavailability of a Solid Dose Formulation of PF 04965842 Relative to a Suspension Formulation Under Fasting Conditions and the Effect of Food on the Bioavailability of the Solid Dosage Formulation of Pf 04965842 in Healthy Subjects
A Phase 2, Randomized, Double-blind, Placebo-controlled Study To Evaluate Safety And Efficacy Of Pf-04965842 In Subjects With Moderate To Severe Psoriasis
A phase 2b randomized, double-blind, placebo-controlled, parallel, multicenter, dose-ranging, study to evaluate the efficacy and safety profile of pf-04965842 in subjects with moderate to severe atopic dermatitis
A phase 3 randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate the efficacy and safety of pf-04965842 monotherapy in subjects aged 12 years and older, with moderate to severe atopic dermatitis
A phase 1, randomized, placebo-and positive-controlled crossover study to determine the effect of single-dose pf-04965842 on qtc interval in healthy volunteers
A phase 3 randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate the efficacy and safety of pf-04965842 monotherapy in subjects aged 12 years and older, with moderate to severe atopic dermatitis
A phase 1, non-randomized, open-label, single-dose study to compare the pharmacokinetics, safety and tolerability of pf-04965842 in adult subjects with mild and moderate hepatic impairment relative to subjects with normal hepatic function
A phase 1, open-label, randomized, fixed-sequence, parallel-cohort study to estimate the effect of fluvoxamine or fluconazole, on the pharmacokinetics, safety and tolerability of a single dose of pf-04965842 in healthy subjects
A phase 1, open-label, fixed-sequence study to estimate the effect of repeat-dose rifampin on the pharmacokinetics of pf-04965842 in healthy subjects
A phase 1, open-label, fixed-sequence study to assess single dose and multiple dose pharmacokinetics of pf-04965842 and its metabolites, and the effect of repeat-dose probenecid on the single dose pharmacokinetics of pf-04965842 and its metabolites in healthy participants
Who cites it
8 citing papers in PubMed, 20 citations in OpenAlex.
- Population pharmacokinetic-pharmacodynamic modelling of platelet time-courses following administration of abrocitinib.British journal of clinical pharmacology · 2022Trial
- Therapeutic Drug Monitoring for Precision Dosing of Janus Kinase Inhibitors: Protocol for a Prospective Observational Study.JMIR research protocols · 2025Article
- Plant-based zinc nanoflowers assisted molecularly imprinted polymer for the design of an electrochemical sensor for selective determination of abrocitinib.Mikrochimica acta · 2024Article
- Targeted Systemic Therapies for Adults with Atopic Dermatitis: Selecting from Biologics and JAK Inhibitors.American journal of clinical dermatology · 2024Review
- Case report: Treatment of psoriasiform dermatitis in patients with malignancy.Frontiers in medicine · 2024Article
- Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development.Clinical pharmacokinetics · 2023Article
- Efficacy and Safety of JAK1 Inhibitor Abrocitinib in Atopic Dermatitis.Pharmaceutics · 2023Review
- Population Pharmacokinetic/Pharmacodynamic Modeling of the Effect of Abrocitinib on QT Intervals in Healthy Volunteers.Clinical pharmacology in drug development · 2022Article
Corrections and comments
- Erratum issued
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectiveAbrocitinib is a Janus kinase 1 inhibitor in development for the treatment of atopic dermatitis (AD). This work characterized orally administered abrocitinib population pharmacokinetics in healthy individuals, patients with psoriasis, and patients with AD and the effects of covariates on abrocitinib exposure.
methodsAbrocitinib concentration measurements (n = 6206) from 995 individuals from 11 clinical trials (seven phase I, two phase II, and two phase III) were analyzed, and a non-linear mixed-effects model was developed. Simulations of abrocitinib dose proportionality and steady-state accumulation of maximal plasma drug concentration (C
resultsA two-compartment model with parallel zero- and first-order absorption, time-dependent bioavailability, and time- and dose-dependent clearance best described abrocitinib pharmacokinetics. Abrocitinib coadministration with rifampin resulted in lower exposure, whereas Asian/other race coadministration with fluconazole and fluvoxamine, inflammatory skin conditions (psoriasis/AD), and hepatic impairment resulted in higher exposure. After differences in body weight are accounted for, Asian participants demonstrated a 1.43- and 1.48-fold increase in C
conclusionsA population pharmacokinetics model was developed for abrocitinib that can be used to predict abrocitinib steady-state exposure in the presence of drug-drug interaction effects or intrinsic patient factors. Key covariates in the study population accounting for variability in abrocitinib exposures are Asian race and adolescent age, although these factors are not clinically meaningful. CLINICAL TRIAL NUMBERS: NCT01835197, NCT02163161, NCT02201524, NCT02780167, NCT03349060, NCT03575871, NCT03634345, NCT03637790, NCT03626415, NCT03386279, NCT03937258.
Indexed as
Identifiers
What OpenQuestion holds
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.