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Long-term efficacy and safety of certolizumab pegol in Japanese rheumatoid arthritis patients who could not receive methotrexate : 52-week results from an open-label extension of the HIKARI study

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Title: Long-term efficacy and safety of certolizumab pegol in Japanese rheumatoid arthritis patients who could not receive methotrexate : 52-week results from an open-label extension of the HIKARI study
Authors: Tanaka, Yoshiya Browse this author →KAKEN DB
Yamamoto, Kazuhiko Browse this author →KAKEN DB
Takeuchi, Tsutomu Browse this author →KAKEN DB
Yamanaka, Hisashi Browse this author →KAKEN DB
Ishiguro, Naoki Browse this author →KAKEN DB
Eguchi, Katsumi Browse this author →KAKEN DB
Watanabe, Akira Browse this author →KAKEN DB
Origasa, Hideki Browse this author →KAKEN DB
Shoji, Toshiharu Browse this author
Miyasaka, Nobuyuki Browse this author →KAKEN DB
Koike, Takao Browse this author →KAKEN DB
Keywords: Certolizumab pegol
Monotherapy
Rheumatoid arthritis
TNF α
TNF inhibitor
Issue Date: 2014
Publisher: Informa Healthcare
Journal Title: Modern Rheumatology
Volume: 24
Issue: 5
Start Page: 725
End Page: 733
Publisher DOI: 10.3109/14397595.2013.865822
Abstract: Objectives. To evaluate the long-term efficacy and safety of certolizumab pegol (CZP) treatment and to assess the efficacy of two CZP maintenance dosing schedules in Japanese rheumatoid arthritis (RA) patients who could not receive methotrexate (MTX). Methods. HIKARI double-blind (DB) patients were entered into an open-label extension (OLE) study. Patients withdrawn at 16 weeks due to lack of efficacy and DB completers without a 24-week American College of Rheumatology (ACR)20 response received CZP 200 mg every 2 weeks (Q2W). DB completers with 24-week ACR20 responses were randomized to CZP 200 mg Q2W or CZP 400 mg every 4 weeks. Results. The ACR20/ACR50/ACR70 response rates of DB completers (n = 98) were 82.7%/56.1%/34.7% at OLE entry, and 83.7%/65.3%/48.0% at 52 weeks, respectively. Other clinical, functional, and radiographic outcomes were sustained during long-term administration of CZP, even without MTX. No new unexpected adverse events were observed during long-term CZP treatment. The efficacy and safety of CZP treatment were similar between the two dosing schedules. Conclusions. Long-term CZP administration is efficacious and safe for RA patients. No obvious differences in clinical efficacy and safety were observed between the two dosing schedules. The choice between two maintenace regimens adds flexibility in administration schedules for RA patients and physicians.
Rights: http://creativecommons.org/licenses/by/3.0
Type: article
URI: http://hdl.handle.net/2115/62842
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 小池 隆夫

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