Early response to certolizumab pegol predicts long-term outcomes in patients with active rheumatoid arthritis: results from the Japanese studies

Abstract

Objectives. A post-hoc analysis was performed to determine the relationship between the timing and magnitude of DAS28(ESR) response and long term outcomes in Japanese patients after 1 year of CZP treatment.

Methods. Our analysis included 82 J-RAPID trial patients treated with CZP 200 mg and methotrexate, and 116 HIKARI trial patients treated with CZP 200 mg alone or with disease-modifying agents other than methotrexate. Remission rates and changes in mTSS at year 1 were compared to the DAS28(ESR) response at week 12 of CZP treatment.

Results. After 1 year of treatment, remission was achieved in 41.3% of the J-RAPID and 34.9% of the HIKARI patients with a week 12 DAS28(ESR) response of ≥ 1.2. In comparison, patients with a DAS28(ESR) response of < 1.2 at week 12 only had a < 7% probability of achieving remission and displayed higher change in mTSS after 1-year treatment.

Conclusions. The likelihood of remission and extent of radiographic progression after 1 year was associated with the week 12 DAS28(ESR) response. The DAS28(ESR) response at 12 weeks could be beneficial for identifying patients that are unlikely to respond to prolonged CZP treatment.

Keywords:

• Certolizumab pegol
• Long-term outcomes
• Radiographic progression
• Remission
• Rheumatoid arthritis

Acknowledgements

We thank the investigators who were part of J-RAPID and HIKARI studies. This study was funded by UCB. Ikuko Kambayashi provided editorial services for this manuscript. All costs associated with development of this manuscript were funded by UCB.

Conflict of interest

T. Takeuchi has received grants from Abbott Japan Co., Ltd., Astellas Pharma, Bristol–Myers K.K., Chugai Pharmaceutical Co, Ltd., Daiichi Sankyo Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Sanofi–Aventis K.K., Santen Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Teijin Pharma Ltd., AbbiVie GK, Asahikasei Pharma Corp., and Taisho Toyama Pharmaceutical Co., Ltd., speaking fees from Abbott Japan Co., Ltd., Bristol–Myers K.K., Chugai Pharmaceutical Co,. Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., Astellas Pharma, and Diaichi Sankyo Co., Ltd., and consultant fees from Astra Zeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Co., Asahi Kasei Medical K.K., AbbiVie GK, and Daiichi Sankyo Co., Ltd.

K. Yamamoto has served as a consultant for UCB, Pfizer, Abbott, BMS, Roche, Chugai, Mitsubishi-Tanabe and Eisai and has received research funding from UCB, Pfizer, Abbott, Santen, Mitsubishi-Tanabe and Eisai.

H. Yamanaka have received honorarium for the lecture from AbbVie, Chugai, Daiichi Sankyo, Eisai, Mitsubishi Tanabe, Pfizer, Takeda, Teijin Pharma. H Yamanaka have received research grant from AbbVie, Asahikasei Pharma, Astellas, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, GlaxoSmithKline, Janssen, Mitsubishi Tanabe, MSD, Nippon Kayaku, Pfizer, Santen, Taishotoyama, Takeda, Teijin Pharma.

N. Ishiguro has received research funding from Takeda, Mitsubishi-Tanabe, Astellas, Chugai, Abbott, Bristol-Myers Squibb, Eisai, Daiichi Sankyo Company Ltd,Janssen, Kaken and Pfizer and has served on speaker bureaus for Daiichi Sankyo Company Ltd, Takeda Pharmaceutical Co Ltd, Hisamitsu Pharmaceutical Co Inc, Otsuka Pharmaceutical Co Ltd, Taisho Toyama Pharmaceutical Co Ltd, Kaken Pharmaceutical Co Ltd, Eisai Co Ltd, Janssen Pharmaceutical K.K, Bristol-Myers Squibb, Abbott Japan, Chugai Pharmaceutical Co Ltd, Mitsubishi Tanabe Pharmaceutical, UCB Japan, Astellas Pharma Inc, and Pfizer Japan Inc.

Y. Tanaka, has received consulting fees, speaking fees, and/or honoraria from Mitsubishi-Tanabe, Eisai, Chugai, Abbott Japan, Astellas, Daiichi-Sankyo, AbbVie, Janssen, Pfizer, Takeda, Astra-Zeneca, Eli Lilly Japan, GlaxoSmithKline, Quintiles, MSD, Asahi-Kasei and has received research grants from Bristol-Myers, Mitsubishi-Tanabe, AbbVie, MSD, Chugai, Astellas, Daiichi-Sankyo.

K. Eguchi has served as a consultant for UCB.

A. Watanabe has received research support from Daiichi-Sankyo, Kyorin, Shionogi, Taisho, Dainippon-Sumitomo, Taiho, Toyama Chemical and Meiji Seika and has served on speaker bureaus for MSD, GSK, Shionogi, Daiichi-Sankyo, Taisho-Toyama, Dainippon-Sumitomo, Mitsubishi-Tanabe and Pfizer.

H. Origasa has served as a consultant for UCB and Astellas.

T. Shoji is an employee of UCB.

N. Miyasaka has received research support from Pfizer, Takeda, Mitsubishi-Tanabe, Chugai, Abbott, Eisai and Astellas.

T. Koike has served on speaker bureaus for UCB, Pfizer, Chugai, Abbott, Mitsubishi-Tanabe, Takeda, Eisai, Santen, Astellas, Taisho-Toyama, BMS, Teijin and Daiichi-Sankyo.

Supplementary material available online

Supplementary Tables 1–3.