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 YamanakaHajime Yoshifuji, Akira Nomura

研究成果: Article査読

16 被引用数 (Scopus)

抄録

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.

本文言語English
ページ(範囲)1354-1362
ページ数9
ジャーナルArthritis Care and Research
67
10
DOI
出版ステータスPublished - 2015 10 1

ASJC Scopus subject areas

  • リウマチ学

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