TY - JOUR
T1 - Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis
T2 - Retrospective analyses of data collectedduring the first year of adalimumab treatment in routine clinical practice (HARMONY study)
AU - Takeuchi, Tsutomu
AU - Tanaka, Yoshiya
AU - Kaneko, Yuko
AU - Tanaka, Eiichi
AU - Hirata, Shintaro
AU - Kurasawa, Takahiko
AU - Kubo, Satoshi
AU - Saito, Kazuyoshi
AU - Shidara, Kumi
AU - Kimura, Noriko
AU - Nagasawa, Hayato
AU - Kameda, Hideto
AU - Amano, Koichi
AU - Yamanaka, Hisashi
N1 - Funding Information:
Acknowledgments The authors thank all medical staff in all institutions for providing the data. This work was supported in part by a Research Grant-In-Aid for Scientific Research from the Ministry of Health, Labor and Welfare of Japan, and the Ministry of Education, Culture, Sports, Science and Technology of Japan.
Funding Information:
Conflict of interest Dr. Takeuchi has received consulting fees, speaking fees, honoraria and/or research grant support from Mitsu-bishi-Tanabe Pharma Corporation, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Pfizer Japan Inc., Abbott Japan Co., Ltd., Daiichi-Sankyo Co., Ltd., Janssen Pharmaceutical K. K., Astra-Zeneca K. K., Takeda Industrial Pharmaceutical Co., Ltd., Astellas Pharma Inc., and Bristol-Myers Squibb. Dr. Tanaka has received consulting fees, speaking fees, and/or honoraria from Mitsubishi-Tanabe Pharma Corporation, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Pfizer Japan Inc., Abbott Japan Co., Ltd., Daiichi-Sankyo Co., Ltd., Janssen Pharmaceutical K. K., Astra-Zeneca K. K., Takeda Industrial Pharmaceutical Co., Ltd., Astellas Pharma Inc., Asahikasei Pharma Corporation, and GlaxoSmithKline K. K., and has received research grant support from Mitsubishi-Tanabe Pharma Corporation, Bristol-Myers Squibb, Takeda Industrial Pharmaceutical Co., Ltd., MSD K. K., Astellas Pharma Inc., Eisai Co., Ltd., Chugai Pharmaceutical Co., Ltd., Pfizer Japan Inc., and Daiichi-Sankyo Co., Ltd. Dr. Yamanaka has received research grants from Abbott Japan Co., Ltd., Bristol-Myers Squibb, Chugai Pharmaceutical Co., Ltd, Eisai Co., Ltd., Janssen Pharmaceutical K.K, Mitsubishi Tanabe Pharma Corporation, Otsuka Pharmaceutical Co., Ltd, Pfizer Japan Inc., Takeda Industrial Pharmaceutical Co., Ltd., and UCB Japan Co., Ltd, and speakers honoraria/consulting fees from Abbott Japan Co., Ltd, Bristol-Myers Squibb, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Corporation, Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., Takeda Industrial Pharmaceutical Co., Ltd., and UCB Japan Co., Ltd. Dr. Amano has received research grants from Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, and Astellas Pharmaceutical Co., Ltd. Dr. Kameda has received consulting fees, speaking fees, and honoraria from Mitsubishi-Tanabe Pharma Corporation, Eisai Co., Ltd., Pfizer Japan Inc., and Abbott Japan Co., Ltd.
PY - 2012/6
Y1 - 2012/6
N2 - We retrospectively investigated the ability of adalimumab (ADA) to reduce disease activity, improve physical function, and retard the progression of structural damage in 167 patients with rheumatoid arthritis. Clinicaland functional outcomes were compared between patients with or without prior biologic treatment and those with or without concomitant methotrexate (MTX) treatment. At week 52, 38.3% achieved clinical remission: 42.4 and 28.6% of patients achieved remission in those without and with previous biologics, respectively, while 42.7 and 12.5% of patients achieved remission in those with and without concomitant MTX, respectively. ADA treatment significantly reduced the rate of radiographic progression from 27.1 ± 46.0 (median 13.6; 25th-75th percentiles 8.3 to 28.9) at baseline to 0.8 ± 5.0 (median 0.0; 25th-75th percentiles -0.9 to 2.0) at week 52 (P\0.0001). Radiographic progression was absent in 59.8% of patients. Sixty adverse events (34.21/100 patient-years) were reported, 16 of which were serious (9.12/100 patient-years). ADA therapy is highly effective for reducing disease activity, improving physical function, and limiting radiographic progression. It is generally safe and well tolerated by Japanese RA patients in routine clinical practice.
AB - We retrospectively investigated the ability of adalimumab (ADA) to reduce disease activity, improve physical function, and retard the progression of structural damage in 167 patients with rheumatoid arthritis. Clinicaland functional outcomes were compared between patients with or without prior biologic treatment and those with or without concomitant methotrexate (MTX) treatment. At week 52, 38.3% achieved clinical remission: 42.4 and 28.6% of patients achieved remission in those without and with previous biologics, respectively, while 42.7 and 12.5% of patients achieved remission in those with and without concomitant MTX, respectively. ADA treatment significantly reduced the rate of radiographic progression from 27.1 ± 46.0 (median 13.6; 25th-75th percentiles 8.3 to 28.9) at baseline to 0.8 ± 5.0 (median 0.0; 25th-75th percentiles -0.9 to 2.0) at week 52 (P\0.0001). Radiographic progression was absent in 59.8% of patients. Sixty adverse events (34.21/100 patient-years) were reported, 16 of which were serious (9.12/100 patient-years). ADA therapy is highly effective for reducing disease activity, improving physical function, and limiting radiographic progression. It is generally safe and well tolerated by Japanese RA patients in routine clinical practice.
KW - Adalimumab
KW - Japanese
KW - Radiographic outcome
KW - Retrospective study
KW - Rheumatoid arthritis
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U2 - 10.1007/s10165-011-0516-6
DO - 10.1007/s10165-011-0516-6
M3 - Article
C2 - 21898074
AN - SCOPUS:84865372548
VL - 22
SP - 327
EP - 338
JO - Modern Rheumatology
JF - Modern Rheumatology
SN - 1439-7595
IS - 3
ER -