TY - JOUR
T1 - Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis
AU - Takeuchi, Tsutomu
AU - Yamanaka, Hisashi
AU - Tanaka, Yoshiya
AU - Sakurai, Takeo
AU - Saito, Kazuyoshi
AU - Ohtsubo, Hideo
AU - Lee, Sang Joon
AU - Nambu, Yoshihiro
N1 - Funding Information:
H. Yamanaka has received honorarium for a lecture or consultancy from Teijin Pharma Ltd., Chugai Pharmaceutical Co. Ltd., Astellas Pharma Inc., Bristol-Myers K.K., AbbVie GK, Daiichi Sankyo Co. Ltd., Nippon Kayaku Co. Ltd., Mitsubishi-Tanabe Pharma Corp., Pfizer Japan Inc., Takeda Pharmaceutical Co. Ltd., and UCB Japan Co. Ltd., and has received research grant from AbbVie GK, Asahi Kasei Pharma Corp., Astellas Pharma Inc., Bristol-Myers Squibb, Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Eisai Co. Ltd., GlaxoSmithKline K.K., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Corp., MSD K.K., Nippon Kayaku Co. Ltd., Pfizer Japan Inc., Santen Pharmaceutical Co. Ltd., Taisho Toyama Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., and Teijin Pharma Ltd. T. Sakurai has declared no conflicts of interest.
Funding Information:
Y. Tanaka has received consulting fees, speaking fees, and/or honoraria from AbbVie GK, Chugai Pharmaceutical Co. Ltd., Astellas Pharma Inc., Takeda Pharmaceutical Co. Ltd., Santen Pharmaceutical Co. Ltd., Mit-subishi Tanabe Pharma Corp., Pfizer Japan Inc., Janssen Pharmaceutical K.K., Eisai Co. Ltd., Daiichi Sankyo Co. Ltd., UCB Japan Co. Ltd., Glaxo-SmithKline K.K., Bristol-Myers K.K., Celltrion, and Nippon Kayaku Co. Ltd. and has received research grants from Mitsubishi-Tanabe Pharma Corp., Chugai Pharmaceutical Co. Ltd., MSD K.K., Astellas Pharma Inc., Novartis Pharma K.K., and Nippon Kayaku Co. Ltd.
Funding Information:
T. Takeuchi has received grants from Astellas Pharma Inc., Bristol – Myers K.K., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Eisai Co. Ltd., Mitsubishi Tanabe Pharma Corp., Pfizer Japan Inc., Santen Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., Teijin Pharma Ltd., AbbVie GK, Asahi Kasei Pharma Corp., Taisho Toyama Pharmaceutical Co. Ltd., and SymBio Pharmaceuticals Ltd., speaking fees from AbbVie GK, Bristol – Myers K.K., Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Corp., Pfizer Japan Inc., Takeda Pharmaceutical Co. Ltd., Astellas Pharma Inc., Daiichi Sankyo Co. Ltd., Celltrion, and Nippon Kayaku Co. Ltd., and consultant fees from AstraZeneca K.K., Eli Lilly Japan K.K., Novartis Pharma K.K., Mitsubishi Tanabe Pharma Corp., Asahi Kasei Medical Co. Ltd., AbbVie GK, Daiichi Sankyo Co. Ltd., Bristol – Myers K.K., and Nippon Kayaku Co. Ltd.
Funding Information:
H. Ohtsubo has received consulting fees, speaking fees, and/or honoraria from Eli Lilly Japan K.K., Bristol-Myers K.K., Asahi Kasei Pharma Corp., AbbVie GK., Janssen Pharmaceutical K.K., Astellas Pharma Inc., Daiichi Sankyo Co. Ltd., Chugai Pharmaceutical Co. Ltd., and Nippon Kayaku Co. Ltd. and has received research grants from Bristol-Myers K.K. and Nippon Kayaku Co. Ltd. S.J. Lee is an employee of Celltrion, Inc. Y. Nambu is an employee of Nippon Kayaku Co. Ltd.
Publisher Copyright:
© 2015 The Author(s). Published by Japan College of Rheumatology.
PY - 2015/9/8
Y1 - 2015/9/8
N2 - Objectives. To demonstrate the pharmacokinetic equivalence of CT-P13 and its innovator infliximab (IFX) in Japanese patients with rheumatoid arthritis (RA), and to compare the efficacy and safety of these drugs, administered for 54 weeks. Methods. In a randomized, double-blind, parallel-group, multicenter study, 3 mg/kg of CT-P13 or IFX, in combination with methotrexate (MTX) (6-16 mg/week), was administered for 54 weeks to Japanese active RA patients with an inadequate response to MTX, to demonstrate the pharmacokinetic equivalence, based on the area under the curve (AUCτ) (weeks 6-14) and Cmax (week 6) of these drugs, and to compare their efficacy and safety. Results. The CT-P13-to-IFX ratios (90% confidence intervals) of the geometric mean AUCτ and Cmax values in patients negative for antibodies to infliximab at week 14 were 111.62% (100.24-124.29%) and 104.09% (92.12-117.61%), respectively, demonstrating the pharmacokinetic equivalence of these drugs. In the full analysis set, CT-P13 and IFX showed comparable therapeutic effectiveness, as measured by the American College of Rheumatology, Disease Activity Score in 28 joints, the European League Against Rheumatism, and other efficacy criteria, at weeks 14 and 30. The incidence of adverse events was similar for these drugs. Conclusion. CT-P13 and IFX, administered at a dose of 3 mg/kg in combination with MTX to active RA patients, were pharmacokinetically equivalent and comparable in efficacy and safety.
AB - Objectives. To demonstrate the pharmacokinetic equivalence of CT-P13 and its innovator infliximab (IFX) in Japanese patients with rheumatoid arthritis (RA), and to compare the efficacy and safety of these drugs, administered for 54 weeks. Methods. In a randomized, double-blind, parallel-group, multicenter study, 3 mg/kg of CT-P13 or IFX, in combination with methotrexate (MTX) (6-16 mg/week), was administered for 54 weeks to Japanese active RA patients with an inadequate response to MTX, to demonstrate the pharmacokinetic equivalence, based on the area under the curve (AUCτ) (weeks 6-14) and Cmax (week 6) of these drugs, and to compare their efficacy and safety. Results. The CT-P13-to-IFX ratios (90% confidence intervals) of the geometric mean AUCτ and Cmax values in patients negative for antibodies to infliximab at week 14 were 111.62% (100.24-124.29%) and 104.09% (92.12-117.61%), respectively, demonstrating the pharmacokinetic equivalence of these drugs. In the full analysis set, CT-P13 and IFX showed comparable therapeutic effectiveness, as measured by the American College of Rheumatology, Disease Activity Score in 28 joints, the European League Against Rheumatism, and other efficacy criteria, at weeks 14 and 30. The incidence of adverse events was similar for these drugs. Conclusion. CT-P13 and IFX, administered at a dose of 3 mg/kg in combination with MTX to active RA patients, were pharmacokinetically equivalent and comparable in efficacy and safety.
KW - Biosimilar
KW - CT-P13
KW - Infliximab
KW - PK equivalence
KW - Rheumatoid arthritis
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U2 - 10.3109/14397595.2015.1022297
DO - 10.3109/14397595.2015.1022297
M3 - Article
C2 - 25736355
AN - SCOPUS:84947032856
VL - 25
SP - 817
EP - 824
JO - Japanese Journal of Rheumatology
JF - Japanese Journal of Rheumatology
SN - 1439-7595
IS - 6
ER -