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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 Patients withdrawn at 16 weeks due to lack of efficacy and DB completers without a 24-week American College of Rheumatology (ACR)20 response received CZP 200 mg every 2 weeks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)
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Submitter: 小池 隆夫
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