TY - JOUR
T1 - Discontinuation of adalimumab treatment in rheumatoid arthritis patients after achieving low disease activity
AU - Harigai, Masayoshi
AU - Takeuchi, Tsutomu
AU - Tanaka, Yoshiya
AU - Matsubara, Tsukasa
AU - Yamanaka, Hisashi
AU - Miyasaka, Nobuyuki
N1 - Funding Information:
Conflict of interest MH has received consulting fees from Mitsu-bishi Tanabe Pharma Corp., Chugai Pharmaceutical Company, Jans-sen Pharmaceutical KK, and Abbott Japan Co. Ltd., and has received research grants from Mitsubishi Tanabe Pharma Corp., Takeda Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd., Abbott Japan Co. Ltd., Pfizer Japan Inc., Bristol-Myers Japan, Sanofi-Aventis KK, and Santen Pharmaceutical Co. Ltd. TT declares associations with the following companies: Abbott, AstraZeneca, K.K., Bristol-Myers Squibb, Chugai Pharmaceutical, Eisai Pharmaceuticals, Eli Lilly, K.K., Janssen Pharmaceutica, Mitsubishi Tanabe Pharma, Novartis, Ohtsuka Pharmaceuticals, Takeda Pharmaceuticals, and Pfizer Japan. HY 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 Pharmaceutical Company Limited, UCB Japan Co. Ltd, and speaker’s honoraria/consulting fees from Abbott Japan Co., Ltd, Bristol-Myers Squibb, Chugai Pharmaceutical, Eisai Co., Ltd., Jans-sen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Corporation, Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., Takeda Pharmaceutical Company Limited, and UCB Japan Co. Ltd. NM has received research grants from Abbott, Astellas Pharmaceutical Banyu Pharmaceutical, Chugai Pharmaceutical, Daiichi Sankyo Pharmaceutical, Eisai Pharmaceutical, Janssen Pharmaceutical, Mitsubishi Tanabe Pharmaceutical, Takeda Pharmaceutical, and Teijin Pharmaceutical.
Funding Information:
Acknowledgments This work was supported by a grant-in-aid from the Ministry of Health, Labor and Welfare, Japan (H23-meneki-sitei-016 to M. Harigai and N. Miyasaka), and was supported by the grant from the Japanese Ministry of Education. Global Center of Excellence (GCOE) Program, ‘‘International Research Center for Molecular Science in Tooth and Bone Diseases’’ (to N. Miyasaka).
PY - 2012/11
Y1 - 2012/11
N2 - Objective We implemented a retrospective study to explore discontinuation of therapy with adalimumab (ADA) without exacerbation in rheumatoid arthritis (RA) patients who had achieved low disease activity (LDA) with the biological agent. Methods We enrolled 46 RA patients who had completed open extension of a double-blind, placebo-controlled trial of ADA monotherapy in Japan and who had LDA (DAS28- CRP <2.7) at the last administration of ADA in the extension trials; this date was defined as week 0 in the present study. Treatment of RA was at the discretion of the attending physician after week 0. The primary endpoint of this study was the percentage of patients who maintained discontinuation of biological agents and LDA for 52 weeks. Results Twenty-four of the enrolled patients continued ADA while the rest discontinued ADA after the administration of the drug at week 0. Fourteen of the 22 patients did not restart biological agents, and 4 (18.2%) of these maintained LDA through week 52. All 4 of these patients had received ADA monotherapy before week 0. Conclusion Some RA patients who have achieved LDA with ADA monotherapy can discontinue the biologic without incurring increased disease activity. A prospective randomized study is required to confirm the results of our study.
AB - Objective We implemented a retrospective study to explore discontinuation of therapy with adalimumab (ADA) without exacerbation in rheumatoid arthritis (RA) patients who had achieved low disease activity (LDA) with the biological agent. Methods We enrolled 46 RA patients who had completed open extension of a double-blind, placebo-controlled trial of ADA monotherapy in Japan and who had LDA (DAS28- CRP <2.7) at the last administration of ADA in the extension trials; this date was defined as week 0 in the present study. Treatment of RA was at the discretion of the attending physician after week 0. The primary endpoint of this study was the percentage of patients who maintained discontinuation of biological agents and LDA for 52 weeks. Results Twenty-four of the enrolled patients continued ADA while the rest discontinued ADA after the administration of the drug at week 0. Fourteen of the 22 patients did not restart biological agents, and 4 (18.2%) of these maintained LDA through week 52. All 4 of these patients had received ADA monotherapy before week 0. Conclusion Some RA patients who have achieved LDA with ADA monotherapy can discontinue the biologic without incurring increased disease activity. A prospective randomized study is required to confirm the results of our study.
KW - Adalimumab
KW - Biological disease-modifying antirheumatic drug
KW - Low disease activity
KW - Rheumatoid arthritis
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U2 - 10.1007/s10165-011-0586-5
DO - 10.1007/s10165-011-0586-5
M3 - Article
C2 - 22270346
AN - SCOPUS:84870322518
VL - 22
SP - 814
EP - 822
JO - Japanese Journal of Rheumatology
JF - Japanese Journal of Rheumatology
SN - 1439-7595
IS - 6
ER -