TY - JOUR
T1 - Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study
AU - Nishimoto, Norihiro
AU - Amano, Koichi
AU - Hirabayashi, Yasuhiko
AU - Horiuchi, Takahiko
AU - Ishii, Tomonori
AU - Iwahashi, Mitsuhiro
AU - Iwamoto, Masahiro
AU - Kohsaka, Hitoshi
AU - Kondo, Masakazu
AU - Matsubara, Tsukasa
AU - Mimura, Toshihide
AU - Miyahara, Hisaaki
AU - Ohta, Shuji
AU - Saeki, Yukihiko
AU - Saito, Kazuyoshi
AU - Sano, Hajime
AU - Takasugi, Kiyoshi
AU - Takeuchi, Tsutomu
AU - Tohma, Shigeto
AU - Tsuru, Tomomi
AU - Ueki, Yukitaka
AU - Yamana, Jiro
AU - Hashimoto, Jun
AU - Matsutani, Takaji
AU - Murakami, Miho
AU - Takagi, Nobuhiro
N1 - Funding Information:
Acknowledgments The authors wish to thank all members of the MRA study group for RA for treating the patients. This study was funded by Chugai Pharmaceutical Co. Ltd.
Funding Information:
Conflict of interest N. Nishimoto has served as a consultant to and received honoraria from Chugai Pharmaceutical Co. Ltd. NN also works as a scientific advisor to F. Hoffmann-La Roche, which is developing TCZ in collaboration with Chugai Pharmaceutical Co. Ltd. NN also has received research grants from Chugai Pharmaceutical Co. Ltd., Bristol-Myers Japan, and Pfizer Japan Inc. K. Amano has received research grants from Chugai Pharmaceutical Co. Ltd., Astellas Pharm Inc., and Mitsubishi Tanabe Pharma. Y. Hirabayashi has received speakers’ bureau honoraria from Chugai Pharmaceutical Co. Ltd. M. Iwamoto has received royalties from Chugai Pharmaceutical Co. Ltd. H. Kohsaka has received research grants, consultant fees, and/or speakers’ bureau honoraria from Bristol-Myers Japan, Pfizer Japan Inc., and Takeda Pharmaceutical Co. Ltd. T. Mimura has received research grants from Abbott Japan, Chugai Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma, and Takeda Pharmaceutical Co. Ltd. T. Takeuchi has received research grants, consultant fees, and/or speakers’ bureau honoraria from Abbott Japan, Bristol-Myers Squibb, Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd., Janssen Pharmaceutical KK, Mitsubishi Tanabe Pharma, Novartis, Pfizer Japan Inc., and Takeda Pharmaceutical Co. Ltd. S. Tohma has received a research grant from Pfizer Japan Inc. and has received subsidies or donations from the Health and Labour Sciences Research Grants for Research on Allergic Disease and Immunology and from Chugai Pharmaceutical Co. Ltd. N. Takagi is a full-time employee of Chugai Pharmaceutical Co. Ltd. All other authors have declared no conflicts of interest.
PY - 2014/1
Y1 - 2014/1
N2 - Objectives To evaluate the safety and efficacy of retreatment with tocilizumab (TCZ) in patients who had participated in the DREAM study (Drug free remission/low disease activity after cessation of tocilizumab [Actemar] monotherapy study) and had experienced loss of efficacy. Methods Patients were retreated with TCZ or other disease modifying antirheumatic drugs (DMARDs). Disease activity was measured using the 28-joint disease activity score (DAS28) for 12 weeks. Results A total of 164 eligible patients, including 161 who experienced loss of efficacy within 52 weeks of the DREAM study, resumed treatment: 157 with TCZ and 7 with DMARDs and/or infliximab. Of TCZ-treated patients, 88.5 % (139 patients) achieved DAS28 <2.6 within 12 weeks, whereas among patients treated with DMARDs and/or infliximab only 14.3 % (1 patient) achieved DAS28 <2.6. Adverse events were observed in 70 TCZ-treated patients (44.0 %), but no serious infusion reactions were observed. Conclusions Retreatment with TCZ was well-tolerated and effective in patients who had responded to the preceding TCZ monotherapy but had experienced loss of efficacy after cessation of TCZ.
AB - Objectives To evaluate the safety and efficacy of retreatment with tocilizumab (TCZ) in patients who had participated in the DREAM study (Drug free remission/low disease activity after cessation of tocilizumab [Actemar] monotherapy study) and had experienced loss of efficacy. Methods Patients were retreated with TCZ or other disease modifying antirheumatic drugs (DMARDs). Disease activity was measured using the 28-joint disease activity score (DAS28) for 12 weeks. Results A total of 164 eligible patients, including 161 who experienced loss of efficacy within 52 weeks of the DREAM study, resumed treatment: 157 with TCZ and 7 with DMARDs and/or infliximab. Of TCZ-treated patients, 88.5 % (139 patients) achieved DAS28 <2.6 within 12 weeks, whereas among patients treated with DMARDs and/or infliximab only 14.3 % (1 patient) achieved DAS28 <2.6. Adverse events were observed in 70 TCZ-treated patients (44.0 %), but no serious infusion reactions were observed. Conclusions Retreatment with TCZ was well-tolerated and effective in patients who had responded to the preceding TCZ monotherapy but had experienced loss of efficacy after cessation of TCZ.
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U2 - 10.3109/14397595.2013.854080
DO - 10.3109/14397595.2013.854080
M3 - Article
C2 - 24261755
AN - SCOPUS:84904987888
VL - 24
SP - 26
EP - 32
JO - Modern Rheumatology
JF - Modern Rheumatology
SN - 1439-7595
IS - 1
ER -