Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis

Background Peficitinib (ASP015K), a novel oral Janus kinase inhibitor, has demonstrated efficacy and safety in the treatment of patients with rheumatoid arthritis (RA). This study evaluated the effect of peficitinib on patient- and physician-reported outcomes in Asian patients with RA and an inadequ...

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Bibliographic Details
Published in:Arthritis research & therapy 2021-08, Vol.23 (1), p.1-221, Article 221
Main Authors: Tanaka, Yoshiya, Takeuchi, Tsutomu, Izutsu, Hiroyuki, Kaneko, Yuichiro, Kato, Daisuke, Fukuda, Musashi, Rokuda, Mitsuhiro, Schultz, Neil M.
Format: Article
Language:English
Subjects:
Absenteeism
Arthritis
ASP015K
Employment
Janus kinase (JAK)
Patient-reported outcomes (PROs)
Patients
Peficitinib
Productivity
Quality of life
Questionnaires
Rheumatoid arthritis
Work Productivity and Activity Impairment (WPAI) questionnaire
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Summary:Background Peficitinib (ASP015K), a novel oral Janus kinase inhibitor, has demonstrated efficacy and safety in the treatment of patients with rheumatoid arthritis (RA). This study evaluated the effect of peficitinib on patient- and physician-reported outcomes in Asian patients with RA and an inadequate response to prior disease-modifying antirheumatic drugs (DMARDs). Methods Patients from two randomized, placebo-controlled, double-blind, phase 3 trials (RAJ3 and RAJ4) received once-daily peficitinib 100 mg, peficitinib 150 mg, or placebo, alone or in combination with DMARDs (RAJ3), or in combination with methotrexate (RAJ4). Mean changes in Work Productivity and Activity Impairment (WPAI) questionnaire domain scores from baseline, and percentages of patients achieving minimal clinically important differences (MCIDs) for patient- and physician-reported outcomes (WPAI, Health Assessment Questionnaire – Disability Index [HAQ-DI], and Subject’s Global Assessment of Pain [SGAP]), and Physician’s Global Assessment of disease activity (PGA) were evaluated at weeks 4, 8, 12, and 12/early termination (ET). Results Data from 1025 patients were analyzed. At week 12/ET in both studies, patients who received peficitinib 100 mg or 150 mg reported significantly improved WPAI domain scores from baseline (except for absenteeism in RAJ4) compared with placebo (both doses, p
ISSN:1478-6362
1478-6354
1478-6362
DOI:10.1186/s13075-021-02590-z