Trial reportCPT: pharmacometrics & systems pharmacology2017
Dose/Exposure-Response Modeling to Support Dosing Recommendation for Phase III Development of Baricitinib in Patients with Rheumatoid Arthritis.
Trial report in CPT: pharmacometrics & systems pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed.
- A Population Pharmacokinetic and Exposure-Response Analysis for Baricitinib in Pediatric Patients with Atopic Dermatitis.Clinical pharmacokinetics · 2026Trial
- A population pharmacokinetic model using allometric scaling for baricitinib in patients with juvenile idiopathic arthritis.CPT: pharmacometrics & systems pharmacology · 2024Trial
- Pharmacokinetics, Safety, and Tolerability of Single- and Multiple-Dose Once-Daily Baricitinib in Healthy Chinese Subjects: A Randomized Placebo-Controlled Study.Clinical pharmacology in drug development · 2020Trial
- Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study.Annals of the rheumatic diseases · 2019Trial
- JAK Inhibitors for Crohn's Disease: A Systematic Review and Dose-Response Network Meta-Analysis of Efficacy and Safety.JGH open : an open access journal of gastroenterology and hepatology · 2026Review
- Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib.Clinical pharmacology and therapeutics · 2026Article
- Therapeutic Drug Monitoring for Precision Dosing of Janus Kinase Inhibitors: Protocol for a Prospective Observational Study.JMIR research protocols · 2025Article
- The effect of baricitinib on pSTAT3 levels in IL-6- or IL-15-stimulated PBMCs isolated from patients with SLE.Frontiers in immunology · 2025Article
- Recent Advances in Understanding the Pathogenesis of Rheumatoid Arthritis: New Treatment Strategies.Cells · 2021Review
- JAK selectivity and the implications for clinical inhibition of pharmacodynamic cytokine signalling by filgotinib, upadacitinib, tofacitinib and baricitinib.Annals of the rheumatic diseases · 2021Article
- Authors' Reply to Moura et al.: "Safety of Janus Kinase Inhibitors in Older Patients: A Focus on the Thromboembolic Risk".Drugs & aging · 2021Article
- Factors contributing to discrepant estimated glomerular filtration values measured by creatinine and cystatin C in patients with rheumatoid arthritis.Scientific reports · 2021Observational
- Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis.Pharmacology research & perspectives · 2021Article
- JAK-Inhibitors for the Treatment of Rheumatoid Arthritis: A Focus on the Present and an Outlook on the Future.Biomolecules · 2020Review
- A Hydrophilic Interaction Liquid Chromatography-Tandem Mass Spectrometry Quantitative Method for Determination of Baricitinib in Plasma, and Its Application in a Pharmacokinetic Study in Rats.Molecules (Basel, Switzerland) · 2020Article
- Baricitinib for the treatment of rheumatoid arthritis.Reumatologia · 2020Review
- Comparison of baricitinib, upadacitinib, and tofacitinib mediated regulation of cytokine signaling in human leukocyte subpopulations.Arthritis research & therapy · 2019Article
- Cardiovascular Safety During Treatment With Baricitinib in Rheumatoid Arthritis.Arthritis & rheumatology (Hoboken, N.J.) · 2019Article
- Baricitinib: A Review in Rheumatoid Arthritis.Drugs · 2018Review
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Baricitinib is an oral inhibitor of Janus kinases (JAKs), selective for JAK1 and 2. It demonstrated dose-dependent efficacy in patients with moderate-to-severe rheumatoid arthritis (RA) in a phase IIb study up to 24 weeks. Population pharmacokinetic/pharmacodynamic (PopPK/PD) models were developed to characterize concentration-time profiles and dose/exposure-response (D/E-R) relationships for the key efficacy (proportion of patients achieving American College of Rheumatology 20%, 50%, or 70% response rate) and safety endpoints (incidence of anemia) for the phase IIb study. The modeling suggested that 4 mg q.d. was likely to offer the optimum risk/benefit balance, whereas 2 mg q.d. had the potential for adequate efficacy. In addition, at the same total daily dose, a twice-daily regimen is not expected to provide an advantage over q.d. dosing for the efficacy or safety endpoints. The model-based simulations formed the rationale for key aspects of dosing, such as dose levels and dosing frequency for phase III development.
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