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:10.3109/14397595.2013.854080

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

Internal Medicine

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14 Citations (Scopus)

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)	26-32
Number of pages	7
Journal	Modern Rheumatology
Volume	24
Issue number	1
DOIs	https://doi.org/10.3109/14397595.2013.854080
Publication status	Published - Jan 2014

All Science Journal Classification (ASJC) codes

Rheumatology

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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. (2014). Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study. Modern Rheumatology, 24(1), 26-32. https://doi.org/10.3109/14397595.2013.854080

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, Vol. 24, No. 1, 01.2014, p. 26-32.

Research output: Contribution to journal › Article

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 2014, 'Retreatment efficacy and safety of tocilizumab in patients with rheumatoid arthritis in recurrence (RESTORE) study', Modern Rheumatology, vol. 24, no. 1, pp. 26-32. https://doi.org/10.3109/14397595.2013.854080

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. 2014 ; Vol. 24, No. 1. pp. 26-32.

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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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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

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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.

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