| Title: | Post-hoc analysis showing better clinical response with the loading dose of certolizumab pegol in Japanese patients with active rheumatoid arthritis |
| Authors: | Takeuchi, Tsutomu Browse this author →KAKEN DB |
| Yamamoto, Kazuhiko Browse this author →KAKEN DB |
| Yamanaka, Hisashi Browse this author →KAKEN DB |
| Ishiguro, Naoki Browse this author →KAKEN DB |
| Tanaka, Yoshiya 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 |
| Kobayashi, Mariko Browse this author |
| Shoji, Toshiharu Browse this author |
| Togo, Osamu Browse this author |
| Miyasaka, Nobuyuki Browse this author →KAKEN DB |
| Koike, Takao Browse this author →KAKEN DB |
| Keywords: | Certolizumab pegol |
| Loading dose |
| Randomized controlled trial |
| Rheumatoid arthritis |
| Tumor necrosis factor-alpha inhibitor |
| Issue Date: | 2016 |
| Publisher: | Taylor & Francis |
| Journal Title: | Modern Rheumatology |
| Volume: | 26 |
| Issue: | 4 |
| Start Page: | 473 |
| End Page: | 480 |
| Publisher DOI: | 10.3109/14397595.2015.1109182 |
| Abstract: | Objectives: To compare the efficacy and safety of certolizumab pegol (CZP) with and without loading dose (LD) in a post-hoc analysis of two Japanese clinical studies. Methods: Data from the double-blind trials (DBT) J-RAPID and HIKARI, and their open-label extension (OLE) studies, were used. Patients randomized to CZP 200 mg every 2 weeks (Q2W) groups starting with LD (400 mg Weeks 0/2/4; LD group; J-RAPID: n = 82, HIKARI: n = 116) and patients randomized to placebo groups who subsequently started CZP Q2W without LD in the OLEs (No-LD group; J-RAPID: n = 61, HIKARI: n = 99) were analyzed. Efficacy and pharmacokinetics were assessed during 24 weeks. Adverse events were reported from all studies. Results: In both trials, the LD groups showed more rapid initial ACR20/50/70 kinetics, and maintained higher ACR50/70 responses until 24 weeks, compared with the No-LD groups. Anti-CZP antibody development was less frequent in the LD groups (J-RAPID: 1.2% versus 4.9%; HIKARI: 17.2% versus 27.3%). Similar safety profiles were reported between LD and No-LD groups (any AEs: 281.8 versus 315.7 [J-RAPID], 282.6 versus 321.3 [HIKARI] [incidence rate/100 patient-years]). Conclusions: Despite limitations, including comparing DBT and OLE studies, these results suggest that a CZP LD improves clinical response in active rheumatoid arthritis without altering the safety profile. |
| Rights: | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Type: | article |
| URI: | http://hdl.handle.net/2115/62845 |
| 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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