A Study to Evaluate Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to DMARDs

Summary

The objective of this study was to verify the superiority of ASP015K alone or in combination with disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response to DMARDs

Timeline

Start

2014-08-08

Primary completion

2017-01-23

Completion

2017-11-22

Outcome

Met primary endpoint

paper ACR20 response rates at week 12/ET were significantly higher in the peficitinib 100 mg (57.7%) and 150 mg (74.5%) groups versus placebo (30.7%) (p<0.001). PMID 31350270 ↗

registry Placebo vs Peficitinib 100 mg; p <0.001; Odds Ratio (OR) 3.13 (95% CI 1.76 to 5.58) NCT02308163 ↗

registry Placebo vs Peficitinib 150 mg; p <0.001; Odds Ratio (OR) 6.59 (95% CI 3.56 to 12.20) NCT02308163 ↗

Publications

• Tanaka Y, Takeuchi T, Izutsu H, Kaneko Y, Kato D, Fukuda M, Rokuda M, Schultz NM. Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis. Arthritis Res Ther. 2021 Aug 24;23(1):221. doi: 10.1186/s13075-021-02590-z.
• Toyoshima J, Kaibara A, Shibata M, Kaneko Y, Izutsu H, Nishimura T. Exposure-response modeling of peficitinib efficacy in patients with rheumatoid arthritis. Pharmacol Res Perspect. 2021 May;9(3):e00744. doi: 10.1002/prp2.744.
• Toyoshima J, Shibata M, Kaibara A, Kaneko Y, Izutsu H, Nishimura T. Population pharmacokinetic analysis of peficitinib in patients with rheumatoid arthritis. Br J Clin Pharmacol. 2021 Apr;87(4):2014-2022. doi: 10.1111/bcp.14605. Epub 2020 Dec 1.
• Tanaka Y, Takeuchi T, Tanaka S, Kawakami A, Iwasaki M, Song YW, Chen YH, Wei JC, Lee SH, Rokuda M, Izutsu H, Ushijima S, Kaneko Y, Akazawa R, Shiomi T, Yamada E. Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs: a randomised, double-blind, placebo-controlled phase III trial (RAJ3). Ann Rheum Dis. 2019 Oct;78(10):1320-1332. doi: 10.1136/annrheumdis-2019-215163. Epub 2019 Jul 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Etanercept	Protein / enzyme biologic	50 mg	Subcutaneous
Subject	peficitinib	Small molecule	100 mg	Oral
Subject	peficitinib	Small molecule	150 mg	Oral

Indications