Trial reportInternational journal of clinical pharmacology and therapeutics2019
Population pharmacokinetics of tofacitinib in patients with psoriatic arthritis .
Trial report in International journal of clinical pharmacology and therapeutics, 2019. 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 12 papers.
What it found
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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.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor
Who cites it
12 citing papers in PubMed, 19 citations in OpenAlex.
- Pharmacokinetics, effectiveness, tolerability and effect on quality of life of open-label tofacitinib for the treatment of moderately active mucocutaneous manifestations of SLE: results of a 76-week phase II study.Lupus science & medicine · 2025Trial
- Exposure-Response Analysis of Tofacitinib in Active Psoriatic Arthritis: Results from Two Phase 3 Studies.Journal of clinical pharmacology · 2025Trial
- Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis.Clinical pharmacology in drug development · 2021Trial
- Population pharmacokinetics of tofacitinib in patients with active ankylosing spondylitis.International journal of 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
- Non-kinase off-target inhibitory activities of clinically-relevant kinase inhibitors.European journal of medicinal chemistry · 2024Review
- Tofacitinib pharmacokinetics in children and adolescents with juvenile idiopathic arthritis.CPT: pharmacometrics & systems pharmacology · 2024Article
- Knowledge, attitude, and practice of psoriatic arthritis among patients with psoriasis.Frontiers in medicine · 2024Article
- The JAK-STAT Signaling Pathway in Epilepsy.Current neuropharmacology · 2023Review
- Drug dosing in hospitalized obese patients with COVID-19.Critical care (London, England) · 2022Review
- Role of Janus Kinase Inhibitors in Therapy of Psoriasis.Journal of clinical medicine · 2021Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). This analysis characterized the pharmacokinetics (PK) of tofacitinib in adult patients with active PsA and evaluated the impact of covariates (baseline characteristics) on the disposition of tofacitinib. MATERIALS AND
methodsData were pooled from two phase 3 studies of tofacitinib of up to 12 months' duration in patients with active PsA (OPAL Broaden (NCT01877668); OPAL Beyond (NCT01882439)). This analysis included 650 tofacitinib-treated patients with 3,252 tofacitinib plasma concentration measurements. Tofacitinib PK was described using a one-compartment disposition model parameterized in terms of apparent oral clearance (CL/F) and apparent volume of distribution (V/F) with first-order absorption rate (Ka) and a lag time. Covariates evaluated were baseline age, baseline body weight, sex, race, ethnicity, baseline creatinine clearance (BCCL), and baseline C-reactive protein.
resultsThe estimates (95% confidence interval) of PK model parameters of a reference patient were CL/F: 20.4 (18.6, 21.8) L/h; V/F: 110 (108, 113) L; and Ka: 13.8 (12.1, 16.6)/h. Among the covariates, only BCCL led to clinically relevant changes in exposure; however, this was consistent with the known contribution of renal excretion to the total clearance of tofacitinib (~ 30%).
conclusionTofacitinib did not require dose modification or restrictions for age, body weight, sex, race, ethnicity, or baseline disease severity in patients with active PsA based on the magnitude of exposure relative to a reference patient. Dosing adjustments for renal impairment were derived from a separate phase 1 study.
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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.