Sustainable Efficacy of Switching from Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis

Atsushi Ogata, Tatsuya Atsumi, Takaaki Fukuda, Yasuhiko Hirabayashi, Masaaki Inaba, Naoki Ishiguro, Motokazu Kai, Daisuke Kawabata, Daihei Kida, Hitoshi Kohsaka, Ryutaro Matsumura, Seiji Minota, Masaya Mukai, Takayuki Sumida, Kiyoshi Takasugi, Shigenori Tamaki, Tsutomu Takeuchi, Atsuhisa Ueda, Kazuhiko Yamamoto, Hisashi Yamanaka & 2 others Hajime Yoshifuji, Akira Nomura

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objective To evaluate the efficacy and safety of switching from intravenous (IV) tocilizumab (TCZ) to subcutaneous (SC) TCZ monotherapy in rheumatoid arthritis patients. Methods Patients who had completed 24 weeks of TCZ-SC (162 mg/2 weeks) or TCZ-IV (8 mg/kg/4 weeks) monotherapy in the double-blind period of the MUSASHI study were enrolled in an 84-week open-label extension period. All received TCZ-SC (162 mg/2 weeks) monotherapy. Effects of the IV to SC switch were evaluated at week 36 (12 weeks after switching). Results Overall, 319 patients received ≥1 dose of TCZ-SC during the open-label extension period; 160 switched from TCZ-IV to TCZ-SC (TCZ IV/SC) and 159 continued TCZ-SC (TCZ SC/SC). Disease Activity Score in 28 joints using the erythrocyte sedimentation rate clinical remission rates were 62.5% (100 of 160) for TCZ IV/SC and 50.0% (79 of 158) for TCZ SC/SC at week 24, and were maintained at 62.5% (100 of 160) and 57.0% (90 of 158), respectively, at week 36. In the TCZ IV/SC group, 9% of patients (9 of 100) who had achieved remission at week 24 could not maintain remission at week 36. In TCZ IV/SC patients weighing ≥70 kg, the percentage with a sufficient serum TCZ concentration (≥1 μg/ml) decreased from 90.9% (10 of 11) at week 24 to 45.5% (5 of 11) at week 36. Overall safety profiles were similar in TCZ IV/SC and TCZ SC/SC except for mild injection site reactions in TCZ IV/SC. Conclusion Efficacy is adequately maintained in most patients switching from TCZ-IV (8 mg/kg/4 weeks) to TCZ-SC (162 mg/2 weeks) monotherapy. Patients receiving TCZ-IV can switch to TCZ-SC without serious safety concerns. Clinical efficacy may be reduced after switching in some patients with high body weight.

Original languageEnglish
Pages (from-to)1354-1362
Number of pages9
JournalArthritis Care and Research
Volume67
Issue number10
DOIs
Publication statusPublished - 2015 Oct 1

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Rheumatoid Arthritis
tocilizumab
Safety
Blood Sedimentation

ASJC Scopus subject areas

  • Rheumatology

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Sustainable Efficacy of Switching from Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis. / Ogata, Atsushi; Atsumi, Tatsuya; Fukuda, Takaaki; Hirabayashi, Yasuhiko; Inaba, Masaaki; Ishiguro, Naoki; Kai, Motokazu; Kawabata, Daisuke; Kida, Daihei; Kohsaka, Hitoshi; Matsumura, Ryutaro; Minota, Seiji; Mukai, Masaya; Sumida, Takayuki; Takasugi, Kiyoshi; Tamaki, Shigenori; Takeuchi, Tsutomu; Ueda, Atsuhisa; Yamamoto, Kazuhiko; Yamanaka, Hisashi; Yoshifuji, Hajime; Nomura, Akira.

In: Arthritis Care and Research, Vol. 67, No. 10, 01.10.2015, p. 1354-1362.

Research output: Contribution to journalArticle

Ogata, A, Atsumi, T, Fukuda, T, Hirabayashi, Y, Inaba, M, Ishiguro, N, Kai, M, Kawabata, D, Kida, D, Kohsaka, H, Matsumura, R, Minota, S, Mukai, M, Sumida, T, Takasugi, K, Tamaki, S, Takeuchi, T, Ueda, A, Yamamoto, K, Yamanaka, H, Yoshifuji, H & Nomura, A 2015, 'Sustainable Efficacy of Switching from Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis', Arthritis Care and Research, vol. 67, no. 10, pp. 1354-1362. https://doi.org/10.1002/acr.22598
Ogata, Atsushi ; Atsumi, Tatsuya ; Fukuda, Takaaki ; Hirabayashi, Yasuhiko ; Inaba, Masaaki ; Ishiguro, Naoki ; Kai, Motokazu ; Kawabata, Daisuke ; Kida, Daihei ; Kohsaka, Hitoshi ; Matsumura, Ryutaro ; Minota, Seiji ; Mukai, Masaya ; Sumida, Takayuki ; Takasugi, Kiyoshi ; Tamaki, Shigenori ; Takeuchi, Tsutomu ; Ueda, Atsuhisa ; Yamamoto, Kazuhiko ; Yamanaka, Hisashi ; Yoshifuji, Hajime ; Nomura, Akira. / Sustainable Efficacy of Switching from Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis. In: Arthritis Care and Research. 2015 ; Vol. 67, No. 10. pp. 1354-1362.
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abstract = "Objective To evaluate the efficacy and safety of switching from intravenous (IV) tocilizumab (TCZ) to subcutaneous (SC) TCZ monotherapy in rheumatoid arthritis patients. Methods Patients who had completed 24 weeks of TCZ-SC (162 mg/2 weeks) or TCZ-IV (8 mg/kg/4 weeks) monotherapy in the double-blind period of the MUSASHI study were enrolled in an 84-week open-label extension period. All received TCZ-SC (162 mg/2 weeks) monotherapy. Effects of the IV to SC switch were evaluated at week 36 (12 weeks after switching). Results Overall, 319 patients received ≥1 dose of TCZ-SC during the open-label extension period; 160 switched from TCZ-IV to TCZ-SC (TCZ IV/SC) and 159 continued TCZ-SC (TCZ SC/SC). Disease Activity Score in 28 joints using the erythrocyte sedimentation rate clinical remission rates were 62.5{\%} (100 of 160) for TCZ IV/SC and 50.0{\%} (79 of 158) for TCZ SC/SC at week 24, and were maintained at 62.5{\%} (100 of 160) and 57.0{\%} (90 of 158), respectively, at week 36. In the TCZ IV/SC group, 9{\%} of patients (9 of 100) who had achieved remission at week 24 could not maintain remission at week 36. In TCZ IV/SC patients weighing ≥70 kg, the percentage with a sufficient serum TCZ concentration (≥1 μg/ml) decreased from 90.9{\%} (10 of 11) at week 24 to 45.5{\%} (5 of 11) at week 36. Overall safety profiles were similar in TCZ IV/SC and TCZ SC/SC except for mild injection site reactions in TCZ IV/SC. Conclusion Efficacy is adequately maintained in most patients switching from TCZ-IV (8 mg/kg/4 weeks) to TCZ-SC (162 mg/2 weeks) monotherapy. Patients receiving TCZ-IV can switch to TCZ-SC without serious safety concerns. Clinical efficacy may be reduced after switching in some patients with high body weight.",
author = "Atsushi Ogata and Tatsuya Atsumi and Takaaki Fukuda and Yasuhiko Hirabayashi and Masaaki Inaba and Naoki Ishiguro and Motokazu Kai and Daisuke Kawabata and Daihei Kida and Hitoshi Kohsaka and Ryutaro Matsumura and Seiji Minota and Masaya Mukai and Takayuki Sumida and Kiyoshi Takasugi and Shigenori Tamaki and Tsutomu Takeuchi and Atsuhisa Ueda and Kazuhiko Yamamoto and Hisashi Yamanaka and Hajime Yoshifuji and Akira Nomura",
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TY - JOUR

T1 - Sustainable Efficacy of Switching from Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis

AU - Ogata, Atsushi

AU - Atsumi, Tatsuya

AU - Fukuda, Takaaki

AU - Hirabayashi, Yasuhiko

AU - Inaba, Masaaki

AU - Ishiguro, Naoki

AU - Kai, Motokazu

AU - Kawabata, Daisuke

AU - Kida, Daihei

AU - Kohsaka, Hitoshi

AU - Matsumura, Ryutaro

AU - Minota, Seiji

AU - Mukai, Masaya

AU - Sumida, Takayuki

AU - Takasugi, Kiyoshi

AU - Tamaki, Shigenori

AU - Takeuchi, Tsutomu

AU - Ueda, Atsuhisa

AU - Yamamoto, Kazuhiko

AU - Yamanaka, Hisashi

AU - Yoshifuji, Hajime

AU - Nomura, Akira

PY - 2015/10/1

Y1 - 2015/10/1

N2 - Objective To evaluate the efficacy and safety of switching from intravenous (IV) tocilizumab (TCZ) to subcutaneous (SC) TCZ monotherapy in rheumatoid arthritis patients. Methods Patients who had completed 24 weeks of TCZ-SC (162 mg/2 weeks) or TCZ-IV (8 mg/kg/4 weeks) monotherapy in the double-blind period of the MUSASHI study were enrolled in an 84-week open-label extension period. All received TCZ-SC (162 mg/2 weeks) monotherapy. Effects of the IV to SC switch were evaluated at week 36 (12 weeks after switching). Results Overall, 319 patients received ≥1 dose of TCZ-SC during the open-label extension period; 160 switched from TCZ-IV to TCZ-SC (TCZ IV/SC) and 159 continued TCZ-SC (TCZ SC/SC). Disease Activity Score in 28 joints using the erythrocyte sedimentation rate clinical remission rates were 62.5% (100 of 160) for TCZ IV/SC and 50.0% (79 of 158) for TCZ SC/SC at week 24, and were maintained at 62.5% (100 of 160) and 57.0% (90 of 158), respectively, at week 36. In the TCZ IV/SC group, 9% of patients (9 of 100) who had achieved remission at week 24 could not maintain remission at week 36. In TCZ IV/SC patients weighing ≥70 kg, the percentage with a sufficient serum TCZ concentration (≥1 μg/ml) decreased from 90.9% (10 of 11) at week 24 to 45.5% (5 of 11) at week 36. Overall safety profiles were similar in TCZ IV/SC and TCZ SC/SC except for mild injection site reactions in TCZ IV/SC. Conclusion Efficacy is adequately maintained in most patients switching from TCZ-IV (8 mg/kg/4 weeks) to TCZ-SC (162 mg/2 weeks) monotherapy. Patients receiving TCZ-IV can switch to TCZ-SC without serious safety concerns. Clinical efficacy may be reduced after switching in some patients with high body weight.

AB - Objective To evaluate the efficacy and safety of switching from intravenous (IV) tocilizumab (TCZ) to subcutaneous (SC) TCZ monotherapy in rheumatoid arthritis patients. Methods Patients who had completed 24 weeks of TCZ-SC (162 mg/2 weeks) or TCZ-IV (8 mg/kg/4 weeks) monotherapy in the double-blind period of the MUSASHI study were enrolled in an 84-week open-label extension period. All received TCZ-SC (162 mg/2 weeks) monotherapy. Effects of the IV to SC switch were evaluated at week 36 (12 weeks after switching). Results Overall, 319 patients received ≥1 dose of TCZ-SC during the open-label extension period; 160 switched from TCZ-IV to TCZ-SC (TCZ IV/SC) and 159 continued TCZ-SC (TCZ SC/SC). Disease Activity Score in 28 joints using the erythrocyte sedimentation rate clinical remission rates were 62.5% (100 of 160) for TCZ IV/SC and 50.0% (79 of 158) for TCZ SC/SC at week 24, and were maintained at 62.5% (100 of 160) and 57.0% (90 of 158), respectively, at week 36. In the TCZ IV/SC group, 9% of patients (9 of 100) who had achieved remission at week 24 could not maintain remission at week 36. In TCZ IV/SC patients weighing ≥70 kg, the percentage with a sufficient serum TCZ concentration (≥1 μg/ml) decreased from 90.9% (10 of 11) at week 24 to 45.5% (5 of 11) at week 36. Overall safety profiles were similar in TCZ IV/SC and TCZ SC/SC except for mild injection site reactions in TCZ IV/SC. Conclusion Efficacy is adequately maintained in most patients switching from TCZ-IV (8 mg/kg/4 weeks) to TCZ-SC (162 mg/2 weeks) monotherapy. Patients receiving TCZ-IV can switch to TCZ-SC without serious safety concerns. Clinical efficacy may be reduced after switching in some patients with high body weight.

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