A pooled safety analysis of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis treated over a median of 2 years.

Published on May 4, 2021in Modern Rheumatology2.113
· DOI :10.1080/14397595.2020.1836789
Tsutomu Takeuchi84
Estimated H-index: 84
(Keio: Keio University),
Yoshiya Tanaka92
Estimated H-index: 92
+ 4 AuthorsDaisuke Kato (Astellas Pharma)
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Abstract
To evaluate the safety of peficitinib for the treatment of rheumatoid arthritis (RA) in Asian patients. Safety data from one Phase 2b, two Phase 3, and one open-label long-term extension study [dat...
References41
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#1Amir EmamifarH-Index: 9
#2Søren HessH-Index: 18
Last. Peter Thye-RønnH-Index: 9
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Background: Giant cell arteritis (GCA) is the most frequent systemic vasculitis after the age of 50 years old. Recent interest in the processes of immune and vascular aging have been proposed as a disease risk factor. Data on the impact of age at diagnosis of GCA on the clinical course of the disease are scarce Objectives: To assess the role of age at diagnosis of GCA on the risk and time to relapse Methods: Centres participating in the Italian Society of Rheumatology Vasculitis Study Group retr...
183 CitationsSource
#1Tsutomu Takeuchi (Keio: Keio University)H-Index: 84
#2Yoshiya Tanaka (University of Occupational and Environmental Health Japan)H-Index: 92
Last. Emi Yamada (Astellas Pharma)H-Index: 3
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BACKGROUND: Peficitinib (ASP015K), a novel oral Janus kinase inhibitor, has demonstrated efficacy and safety for the treatment of rheumatoid arthritis (RA) in randomized, controlled trials of up to 52 weeks' duration. However, safety and effectiveness after long-term treatment have not been assessed. METHODS: This was an interim analysis of an ongoing open-label, multicenter extension study in RA patients who completed phase 2b (RAJ1; 12 weeks) and phase 3 (RAJ3 and RAJ4; 52 weeks) peficitinib s...
10 CitationsSource
#1Masayoshi HarigaiH-Index: 44
#2Tsutomu Takeuchi (Keio: Keio University)H-Index: 84
Last. Yoshiya TanakaH-Index: 92
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AbstractObjectives: Baricitinib is a selective oral inhibitor of JAK1/JAK2 for patients with moderately-to-severely active rheumatoid arthritis (RA). Baricitinib’s safety profile in Japanese patients was evaluated using six studies (five Ph2/Ph3 trials, one long-term extension study through 01 September 2016) from an integrated database (nine RA studies).Methods: Incidence rates (IRs) or exposure-adjusted IRs (EAIRs) of adverse events (AEs) per 100 patient-years (PY) were calculated using data w...
21 CitationsSource
#1Ying Chou Chen (CGU: Chang Gung University)H-Index: 1
#2Dae Hyun Yoo (Hanyang University)H-Index: 22
Last. Yoshiya Tanaka (University of Occupational and Environmental Health Japan)H-Index: 92
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AIM: We evaluated the safety of baricitinib in an East Asian (EA) patient population with moderate-to-severely active rheumatoid arthritis (RA), through an integrated sub-analysis of data from the overall baricitinib RA clinical program. METHODS: Data from EA patients who received any dose of baricitinib from five completed studies (1 Phase 2, 4 Phase 3) and an ongoing long-term extension study were pooled up to 1 September, 2016. Exposure-adjusted incidence rates (EAIR) and incidence rates (IRs...
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#1Sean T. Duggan (Springer Science+Business Media)H-Index: 18
#2Susan J. Keam (Springer Science+Business Media)H-Index: 15
Upadacitinib (Rinvoq™), an orally-administered Janus kinase 1 (JAK-1) inhibitor, is being developed by AbbVie for the treatment of rheumatoid arthritis. In August 2019, based on positive results from multinational phase III trials conducted in patients with rheumatoid arthritis, upadacitinib received marketing approval in the USA for the treatment of moderately to severely active rheumatoid arthritis and an inadequate response or intolerance to methotrexate. This article summarizes the milestone...
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#1Tsutomu Takeuchi (Keio: Keio University)H-Index: 84
#2Yoshiya Tanaka (University of Occupational and Environmental Health Japan)H-Index: 92
Last. Désirée van der Heijde (LUMC: Leiden University Medical Center)H-Index: 122
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Objective To evaluate the efficacy and safety of the oral Janus kinase (JAK) inhibitor peficitinib versus placebo in Japanese patients with rheumatoid arthritis (RA). Methods In this multicentre, double-blind, parallel-group, placebo-controlled phase III study, patients with RA and inadequate response to methotrexate (MTX) were randomised 1:1:1 to placebo, peficitinib 100 mg once daily or peficitinib 150 mg once daily with MTX for 52 weeks. Based on baseline randomisation, at week 12, non-respon...
39 CitationsSource
#1Yoshiya Tanaka (University of Occupational and Environmental Health Japan)H-Index: 92
#2Tsutomu Takeuchi (Keio: Keio University)H-Index: 84
Last. Emi Yamada (Astellas Pharma)H-Index: 3
view all 16 authors...
Objectives To investigate the efficacy and safety of peficitinib, an oral Janus kinase inhibitor, in patients with rheumatoid arthritis (RA). Methods In this double-blind phase III study, patients with RA and an inadequate response to prior disease-modifying anti-rheumatic drugs (DMARDs) were randomised to peficitinib 100 mg once daily, peficitinib 150 mg once daily, placebo or open-label etanercept for 52 weeks’ treatment; placebo-treated patients were switched at week 12 to peficitinib 100 or ...
44 CitationsSource
#1Huifang Liang (AbbVie)H-Index: 1
#2Raghava Danwada (AbbVie)H-Index: 1
Last. Syed S. Islam (AbbVie)H-Index: 2
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Objectives To assess incidence rates (IRs) of VTE in patients with rheumatoid arthritis (RA) on different DMARDs and DMARD switchers. Methods Adults with RA on a DMARD between 2007 and 2017 were studied in a US claims database. Conventional synthetic DMARD (csDMARD) users, first biologic/targeted synthetic DMARD (b/tsDMARD) users and b/tsDMARD switchers (from a b/tsDMARD to another b/tsDMARD) were followed for inpatient VTE (pulmonary embolism (PE)/deep vein thrombosis (DVT)). Crude and adjusted...
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#1Mark C. Genovese (Stanford University)H-Index: 86
#2Maria GreenwaldH-Index: 33
Last. Alan KivitzH-Index: 58
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Introduction Peficitinib is a novel orally bioavailable, once-daily Janus kinase (JAK) inhibitor approved in Japan for the treatment of rheumatoid arthritis (RA). This 2-year extension study of two global phase IIb trials investigated the long-term safety and effectiveness of peficitinib.
5 CitationsSource
#1Peter C. Taylor (University of Oxford)H-Index: 69
#2Michael E. Weinblatt (Brigham and Women's Hospital)H-Index: 98
Last. Tsutomu Takeuchi (Keio: Keio University)H-Index: 84
view all 13 authors...
OBJECTIVE: To assess the frequency of cardiovascular and venous thromboembolic events in clinical studies of baricitinib, an oral, selective JAK1 and JAK2 inhibitor approved in more than 50 countries for the treatment of moderately-to-severely active rheumatoid arthritis (RA). METHODS: Data were pooled from 9 RA studies. Placebo comparison up to 24 weeks included data from 6 studies. Randomized dose comparison between baricitinib doses of 2 mg and 4 mg used data from 4 studies and from the assoc...
56 CitationsSource
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