Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study

Norihiro Nishimoto; Koichi Amano; Yasuhiko Hirabayashi; Takahiko Horiuchi; Tomonori Ishii; Mitsuhiro Iwahashi; Masahiro Iwamoto; Hitoshi Kohsaka; Masakazu Kondo; Tsukasa Matsubara; Toshihide Mimura; Hisaaki Miyahara; Shuji Ohta; Yukihiko Saeki; Kazuyoshi Saito; Hajime Sano; Kiyoshi Takasugi; Tsutomu Takeuchi; Shigeto Tohma; Tomomi Tsuru; Yukitaka Ueki; Jiro Yamana; Jun Hashimoto; Takaji Matsutani; Miho Murakami; Nobuhiro Takagi

doi:10.1007/s10165-013-0895-y

Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study

Norihiro Nishimoto, Koichi Amano, Yasuhiko Hirabayashi, Takahiko Horiuchi, Tomonori Ishii, Mitsuhiro Iwahashi, Masahiro Iwamoto, Hitoshi Kohsaka, Masakazu Kondo, Tsukasa Matsubara, Toshihide Mimura, Hisaaki Miyahara, Shuji Ohta, Yukihiko Saeki, Kazuyoshi Saito, Hajime Sano, Kiyoshi Takasugi, Tsutomu Takeuchi, Shigeto Tohma, Tomomi TsuruYukitaka Ueki, Jiro Yamana, Jun Hashimoto, Takaji Matsutani, Miho Murakami, Nobuhiro Takagi

MED - Medical Sciences

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Pages (from-to)	1-7
Number of pages	7
Journal	Modern Rheumatology
DOIs	https://doi.org/10.1007/s10165-013-0895-y
Publication status	Accepted/In press - 2013

Keywords

Drug free
Interleukin 6
Retreatment
Rheumatoid arthritis
Tocilizumab

ASJC Scopus subject areas

Rheumatology

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10.1007/s10165-013-0895-y

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Nishimoto, N., Amano, K., Hirabayashi, Y., Horiuchi, T., Ishii, T., Iwahashi, M., Iwamoto, M., Kohsaka, H., Kondo, M., Matsubara, T., Mimura, T., Miyahara, H., Ohta, S., Saeki, Y., Saito, K., Sano, H., Takasugi, K., Takeuchi, T., Tohma, S., ... Takagi, N. (Accepted/In press). Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study. Modern Rheumatology, 1-7. https://doi.org/10.1007/s10165-013-0895-y

Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study. / Nishimoto, Norihiro; Amano, Koichi; Hirabayashi, Yasuhiko; Horiuchi, Takahiko; Ishii, Tomonori; Iwahashi, Mitsuhiro; Iwamoto, Masahiro; Kohsaka, Hitoshi; Kondo, Masakazu; Matsubara, Tsukasa; Mimura, Toshihide; Miyahara, Hisaaki; Ohta, Shuji; Saeki, Yukihiko; Saito, Kazuyoshi; Sano, Hajime; Takasugi, Kiyoshi; Takeuchi, Tsutomu; Tohma, Shigeto; Tsuru, Tomomi; Ueki, Yukitaka; Yamana, Jiro; Hashimoto, Jun; Matsutani, Takaji; Murakami, Miho; Takagi, Nobuhiro.

In: Modern Rheumatology, 2013, p. 1-7.

Research output: Contribution to journal › Article › peer-review

Nishimoto, N, Amano, K, Hirabayashi, Y, Horiuchi, T, Ishii, T, Iwahashi, M, Iwamoto, M, Kohsaka, H, Kondo, M, Matsubara, T, Mimura, T, Miyahara, H, Ohta, S, Saeki, Y, Saito, K, Sano, H, Takasugi, K, Takeuchi, T, Tohma, S, Tsuru, T, Ueki, Y, Yamana, J, Hashimoto, J, Matsutani, T, Murakami, M & Takagi, N 2013, 'Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study', Modern Rheumatology, pp. 1-7. https://doi.org/10.1007/s10165-013-0895-y

Nishimoto, Norihiro ; Amano, Koichi ; Hirabayashi, Yasuhiko ; Horiuchi, Takahiko ; Ishii, Tomonori ; Iwahashi, Mitsuhiro ; Iwamoto, Masahiro ; Kohsaka, Hitoshi ; Kondo, Masakazu ; Matsubara, Tsukasa ; Mimura, Toshihide ; Miyahara, Hisaaki ; Ohta, Shuji ; Saeki, Yukihiko ; Saito, Kazuyoshi ; Sano, Hajime ; Takasugi, Kiyoshi ; Takeuchi, Tsutomu ; Tohma, Shigeto ; Tsuru, Tomomi ; Ueki, Yukitaka ; Yamana, Jiro ; Hashimoto, Jun ; Matsutani, Takaji ; Murakami, Miho ; Takagi, Nobuhiro. / Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study. In: Modern Rheumatology. 2013 ; pp. 1-7.

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title = "Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study",

abstract = "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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author = "Norihiro Nishimoto and Koichi Amano and Yasuhiko Hirabayashi and Takahiko Horiuchi and Tomonori Ishii and Mitsuhiro Iwahashi and Masahiro Iwamoto and Hitoshi Kohsaka and Masakazu Kondo and Tsukasa Matsubara and Toshihide Mimura and Hisaaki Miyahara and Shuji Ohta and Yukihiko Saeki and Kazuyoshi Saito and Hajime Sano and Kiyoshi Takasugi and Tsutomu Takeuchi and Shigeto Tohma and Tomomi Tsuru and Yukitaka Ueki and Jiro Yamana and Jun Hashimoto and Takaji Matsutani and Miho Murakami and Nobuhiro Takagi",

year = "2013",

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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

PY - 2013

Y1 - 2013

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.

KW - Drug free

KW - Interleukin 6

KW - Retreatment

KW - Rheumatoid arthritis

KW - Tocilizumab

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JF - Japanese Journal of Rheumatology

SN - 1439-7595

ER -

Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study

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