Sustainable Efficacy of Switching From Intravenous to Subcutaneous Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis
| Autor: | Yasuhiko Hirabayashi, Ryutaro Matsumura, Takaaki Fukuda, Kiyoshi Takasugi, Masaaki Inaba, Seiji Minota, Naoki Ishiguro, Tatsuya Atsumi, Atsuhisa Ueda, Tsutomu Takeuchi, Daisuke Kawabata, Shigenori Tamaki, Kazuhiko Yamamoto, Atsushi Ogata, Hisashi Yamanaka, Akira Nomura, Motokazu Kai, Hitoshi Kohsaka, Masaya Mukai, Daihei Kida, Takayuki Sumida, Hajime Yoshifuji |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Injections Subcutaneous Arthritis Rheumatoid Arthritis Antibodies Monoclonal Humanized Severity of Illness Index Gastroenterology Drug Administration Schedule law.invention Arthritis Rheumatoid chemistry.chemical_compound Tocilizumab Double-Blind Method Japan Rheumatology Randomized controlled trial law Internal medicine Severity of illness medicine Humans In patient Range of Motion Articular Pain Measurement Dose-Response Relationship Drug medicine.diagnostic_test business.industry Middle Aged medicine.disease Surgery Dose–response relationship Treatment Outcome chemistry Patient Satisfaction Erythrocyte sedimentation rate Rheumatoid arthritis Injections Intravenous Female business Follow-Up Studies |
| Zdroj: | Arthritis Care & Research |
| ISSN: | 2151-4658 2151-464X |
| DOI: | 10.1002/acr.22598 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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