Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab

Abstract

Objectives: This study aimed to evaluate the safety of CT-P13 in patients with rheumatoid arthritis (RA) during long-term treatment or after switching from innovator infliximab (IFX).

Methods: Patients who completed 54 weeks of treatment in a phase I/II study (PI/II) received CT-P13 at an initial dose of 3 mg/kg at Week 62, with dose increases permitted up to 10 mg/kg. The primary endpoint was adverse event (AE) incidence.

Results: Thirty-four of 38 patients in the maintenance group and 29 of 33 in the switch group reported at least one AE. Safety profiles in both groups were similar to those in PI/II. Eleven of 28 patients who were positive for anti-drug antibodies (ADA) at Week 62 discontinued the study before Week 110. Forty-one of 43 ADA-negative patients remained negative, and 10 of 28 ADA-positive patients became negative during the study. The mean DAS28 (ESR) at Week 134 was 3.166 in the maintenance group and 3.955 in the switch group.

Conclusions: CT-P13 was well tolerated in patients who maintained the treatment after 54 weeks and in patients who switched to CT-P13 after 54 weeks of IFX treatment. The study also demonstrated a stable clinical efficacy of CT-P13 in RA patients.

Keywords:

• Biosimilar
• CT-P13
• Infliximab
• Long-term safety
• Rheumatoid arthritis

Acknowledgments

The studies described herein were funded by Celltrion, Inc. and Nippon Kayaku Co., Ltd. The authors acknowledge all investigators at the following hospitals for their contribution to the study: Sapporo City General Hospital; Hokkaido Medical Center for Rheumatic Diseases; Inoue Hospital; Saitama Medical Centre, Saitama Medical University; School of Medicine, Keio University; Tokyo Medical and Dental University; Institute of Rheumatology, Tokyo Women’s Medical University; Niigata Rheumatic Center; Shizuoka Kousei Hospital; Aichi Medical University School of Medicine; Kyoto University Graduate School of Medicine; National Hospital Organization Osaka-Minami Medical Center; Matsubara Mayflower Hospital; Higashihiroshima Memorial Hospital; University of Occupational and Environmental Health; Kyushu University Graduate School of Medical Sciences; Nagasaki University Graduate School of Biomedical Sciences; Sasebo Chuo Hospital; Shimin-No-Mori Hospital; Kagoshima Red Cross Hospital. All costs associated with development of this manuscript were funded by Nippon Kayaku Co., Ltd.

Conflict of interest

Y.T. has received grants, personal fees, and non-financial support from Nippon Kayaku Co., Ltd. during this study, personal fees from Nippon Kayaku Co., Ltd., and grants from Mitsubishi Tanabe Pharma Corp., Takeda Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Astellas Pharma Inc., Eisai Co., Ltd., Taisho Toyama Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., AbbVie GK, and Bristol-Myers K.K. outside the submitted work.

H.Y. has received grants and personal fees from Nippon Kayaku Co., Ltd. during this study, and personal fees from Nippon Kayaku Co., Ltd. outside the submitted work.

T.T. has received grants, personal fees, and non-financial support from Nippon Kayaku Co., Ltd., AbbVie GK, Bristol-Myers K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd. and Mitsubishi Tanabe Pharma Corp., grants and non-financial support from Daiichi Sankyo Co., Ltd., personal fees from Pfizer Japan Inc., grants from Takeda Pharmaceutical Co., Ltd. during this study; grants, personal fees, and non-financial support from Astellas Pharma Inc., and grants from Santen Pharmaceutical Co., Ltd., Teijin Pharma Ltd., Asahi Kasei Pharma Corp., Taisho Toyama Pharmaceutical Co., Ltd. and SymBio Pharmaceuticals Ltd. outside the submitted work.

M.I. has received grants and non-financial support from Nippon Kayaku Co., Ltd. during the conduct of the study; and personal fees from Nippon Kayaku Co., Ltd. outside the submitted work.

K.S. has received grants and non-financial support from Nippon Kayaku Co., Ltd. during this study.

Y.S. has received grants and non-financial support from Nippon Kayaku Co., Ltd. during this study.

S.J.L. is a full-time employee of Celltrion, Inc. and has received personal fees and non-financial support from Celltrion, Inc. during this study, as well as personal fees and non-financial support from Celltrion, Inc. outside the submitted work.

Y.N. is a board member with stock ownership of Nippon Kayaku Co., Ltd., and has received personal fees and non-financial support from Nippon Kayaku Co., Ltd. during this study, as well as personal fees and non-financial support from Nippon Kayaku Co., Ltd. outside the submitted work.

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