TY - JOUR
T1 - Efficacy and safety of peficitinib (ASP015K) in patients with rheumatoid arthritis and an inadequate response to conventional DMARDs
T2 - A randomised, double-blind, placebo-controlled phase III trial (RAJ3)
AU - Tanaka, Yoshiya
AU - Takeuchi, Tsutomu
AU - Tanaka, Sakae
AU - Kawakami, Atsushi
AU - Iwasaki, Manabu
AU - Song, Yeong Wook
AU - Chen, Yi Hsing
AU - Wei, James Cheng Chung
AU - Lee, Sang Heon
AU - Rokuda, Mitsuhiro
AU - Izutsu, Hiroyuki
AU - Ushijima, Satoshi
AU - Kaneko, Yuichiro
AU - Akazawa, Rio
AU - Shiomi, Teruaki
AU - Yamada, Emi
N1 - Funding Information:
This study was supported by astellas Pharma, inc.
Publisher Copyright:
© © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2019/10/1
Y1 - 2019/10/1
N2 - 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 150 mg once daily. The primary endpoint was American College of Rheumatology (ACR)20 response at week 12/early termination (ET). Secondary endpoints (assessed throughout) included ACR20, ACR50 and ACR70 response, changes from baseline in disease activity scores (DAS)28 and ACR core parameters, adverse events (AEs) and changes in clinical or laboratory measurements. Results In total, 507 patients received treatment. 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). ACR50/70 response rates were also higher for both peficitinib doses versus placebo. Improvements in ACR response were maintained until week 52. Changes from baseline in DAS28-C-reactive protein/erythrocyte sedimentation rate and the ACR core set were significantly greater for both peficitinib doses versus placebo at week 12/ET (p<0.001). AE incidence was similar across treatment arms. Incidence of serious infection and herpes zoster-related disease was higher with peficitinib versus placebo, but with no clear dose-dependent increase. Conclusions In patients with RA and inadequate response to DMARDs, peficitinib 100 mg once daily or 150 mg once daily was efficacious in reducing RA symptoms and was well tolerated compared with placebo. Trial registration number NCT02308163.
AB - 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 150 mg once daily. The primary endpoint was American College of Rheumatology (ACR)20 response at week 12/early termination (ET). Secondary endpoints (assessed throughout) included ACR20, ACR50 and ACR70 response, changes from baseline in disease activity scores (DAS)28 and ACR core parameters, adverse events (AEs) and changes in clinical or laboratory measurements. Results In total, 507 patients received treatment. 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). ACR50/70 response rates were also higher for both peficitinib doses versus placebo. Improvements in ACR response were maintained until week 52. Changes from baseline in DAS28-C-reactive protein/erythrocyte sedimentation rate and the ACR core set were significantly greater for both peficitinib doses versus placebo at week 12/ET (p<0.001). AE incidence was similar across treatment arms. Incidence of serious infection and herpes zoster-related disease was higher with peficitinib versus placebo, but with no clear dose-dependent increase. Conclusions In patients with RA and inadequate response to DMARDs, peficitinib 100 mg once daily or 150 mg once daily was efficacious in reducing RA symptoms and was well tolerated compared with placebo. Trial registration number NCT02308163.
KW - DAS28
KW - disease activity
KW - dmards (synthetic)
KW - rheumatoid arthritis
KW - treatment
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U2 - 10.1136/annrheumdis-2019-215163
DO - 10.1136/annrheumdis-2019-215163
M3 - Article
C2 - 31350270
AN - SCOPUS:85070080188
SN - 0003-4967
VL - 78
SP - 1320
EP - 1332
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 10
ER -