Functional disability associated with disease and quality-of-life parameters in Chinese patients with rheumatoid arthritis

Ji, Juan; Zhang, Lijuan; Zhang, Qiuxiang; Yin, Rulan; Fu, Ting; Li, Liren; Gu, Zhifeng

doi:10.1186/s12955-017-0659-z

Cited by 45 publications

(43 citation statements)

References 38 publications

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“…Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by persistent joint inflammation, pain, and limited mobility [1][2][3]. Methotrexate, a synthetic disease-modifying antirheumatic drug (DMARD), is used as standard first-line treatment for RA [3,4].…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics, Pharmacodynamics, and Safety of Peficitinib (ASP015K) in Healthy Male Caucasian and Japanese Subjects

et al. 2020

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Background and Objective Peficitinib pharmacokinetics and pharmacodynamics have been characterized mainly in Caucasian subjects. This study investigated the pharmacokinetics, pharmacodynamics, safety, and tolerability of peficitinib in healthy Japanese subjects compared with Caucasian subjects. Methods In this single-center, randomized, double-blind, placebo-controlled study, a cohort of healthy Japanese (n = 24) and Caucasian (n = 24) men received a single oral dose of peficitinib (20, 60, or 200 mg) or placebo. Another cohort of Japanese men (n = 24) received peficitinib (10, 30, or 100 mg) or placebo twice daily for 7 days. Pharmacokinetic and pharmacodynamic parameters were assessed, and adverse events (AEs) monitored throughout. Results Dose proportionality of maximum plasma drug concentration (C max ) and area under the plasma concentration-time curve extrapolated to infinity (AUC inf ) was demonstrated for both ethnicities. The geometric mean ratio for dose-normalized C max was 45.7-98.8% higher and AUC inf was 33.8-66.4% higher in Japanese versus Caucasian subjects. Mean peak inhibition of STAT5 phosphorylation was higher in Japanese than Caucasian subjects for a given peficitinib dose, but inhibition was comparable across ethnicities for a given plasma peficitinib concentration. In the multiple-dose study, plasma peficitinib concentrations were similar on day 1 and day 7. All AEs were mild, and none resulted in study discontinuation. Conclusions Peficitinib was well tolerated at doses up to 200 mg daily for 7 days in healthy Japanese subjects. Doseproportional exposure was demonstrated across the single-dose range of 20-200 mg, with greater peficitinib exposure in Japanese compared with Caucasian subjects. The pharmacokinetic/pharmacodynamic relationships were considered comparable between these populations. ClinicalTrials.gov identifier NCT01225224.

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Section: Introductionmentioning

confidence: 99%

Pharmacokinetics, Pharmacodynamics, and Safety of Peficitinib (ASP015K) in Healthy Male Caucasian and Japanese Subjects

et al. 2020

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“…Rheumatoid arthritis (RA) is a chronic inflammatory disease that carries a significant burden for individuals and society [1][2][3]. It targets the joints, causing cartilage and bone damage; in many patients, progressive joint erosion is associated with physical disability and reduced quality of life [4,5]. Despite the available treatments, there remains a significant unmet therapeutic need in RA, with pain, physical and mental functioning and fatigue persisting at an unacceptable level [6].…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects with Normal and Impaired Renal Function

Miyatake

Shibata

et al. 2019

Clin Drug Investig

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Background and Objective This study measured and compared the exposure and safety of peficitinib (ASP015K), a novel oral Janus kinase inhibitor, in subjects with normal and impaired renal function after a single oral, clinically relevant peficitinib dose. Methods This was an open-label, parallel-group study conducted at two centres in Japan. Subjects with normal and mildly, moderately, or severely impaired renal function received a single oral dose of peficitinib (one 150 mg tablet) under fasting conditions in a hospital setting. Blood samples were collected prior to administration and up to 72 h post-dose for pharmacokinetic assessment. Safety was assessed up to 7 days post-dose. Results Peficitinib plasma concentration-time profiles were similar between those with normal and impaired renal function. In subjects with impaired renal function, area under the plasma concentration-time curve and maximum concentration were 0.8-to 1.1-fold those in subjects with no impairment. Two subjects (one in the normal group and one in the mildly impaired group) each experienced a treatment-emergent adverse event (TEAE). There were no serious TEAEs, deaths or TEAEs leading to treatment withdrawal. Conclusions Peficitinib exposure and TEAEs were similar in subjects with and without renal impairment after a single oral 150 mg dose. Based on these findings, it is not expected that peficitinib dose adjustment will be required in clinical practice, according to the degree of renal impairment. ClinicalTrials.gov identifier NCT02603497.

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“…Depression is believed to be a useful target for interventions aimed at improving subjective health and quality of life in patients with RA. Likewise, depression generally worsens outcomes of treatments, leading to increased pain, high disease activity, increased levels of functional disability, and reduced HRQoL . In RA, the association between depression and treatment outcomes such as pain, disease activity, functional disability and quality of life has not been widely explored.…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies reported there were 2‐4 times higher prevalence of depression in RA than the general population . Depressed patients with RA have poorer long‐term outcomes, including increased pain, high disease activity, increased levels of functional disability, and reduced health‐related quality of life (HRQoL) . Depression in patients with RA may therefore be a useful target for interventions aimed at improving subjective health and HRQoL.…”

Section: Introductionmentioning

confidence: 99%

Depression has an impact on disease activity and health‐related quality of life in rheumatoid arthritis: A systematic review and meta‐analysis

2019

Self Cite

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Objective The aim of this study was to explore the impact of depression on pain, disease activity, functional disability and quality of life in patients with rheumatoid arthritis (RA). Methods English (PubMed, the Cochrane Library, Web of Science and PsycINFO) and Chinese (Wan Fang Database and Chinese National Knowledge Infrastructure) databases were systematically and independently searched from their inception until 30 September, 2019. Studies evaluating the impact of depression on pain, disease activity, functional disability and quality of life with the use of the Short Form‐36 questionnaire (SF‐36) scoring system were included. Statistical analyses were performed with Revman5.3. Data were pooled using a fixed or random‐effects model according to heterogeneity. Results A total of 7 identified studies matched the inclusion criteria, reporting on a total of 1078 patients with RA in the analysis. The total Disease Activity Score in 28 joints was significantly higher in patients with depression than in patients without depression [standardized mean difference (SMD) =0.47, 95% CI 0.10‐0.85, P = .01]. All SF‐36 dimensions (physical function, role physical function, emotional role function, vitality, mental health, social function, body pain, general health, physical component scale, mental component scale) were lower in patients with depression than in groups without depression. Interestingly, the results of this meta‐analysis showed no significant difference between patients with and without depression in pain (SMD = 0.57, 95% CI − 0.03‐1.17, P = .06) and functional disability (SMD = 0.48, 95% CI − 0.03‐0.99, P = .43). Conclusion This meta‐analysis showed that RA patients with depression tended to have higher disease activity and lower quality of life than patients without depression.

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Functional disability associated with disease and quality-of-life parameters in Chinese patients with rheumatoid arthritis

Cited by 45 publications

References 38 publications

Pharmacokinetics, Pharmacodynamics, and Safety of Peficitinib (ASP015K) in Healthy Male Caucasian and Japanese Subjects

Pharmacokinetics, Pharmacodynamics, and Safety of Peficitinib (ASP015K) in Healthy Male Caucasian and Japanese Subjects

Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects with Normal and Impaired Renal Function

Depression has an impact on disease activity and health‐related quality of life in rheumatoid arthritis: A systematic review and meta‐analysis

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