Long-term evaluation of E6011, an anti-fractalkine monoclonal antibody, in patients with rheumatoid arthritis inadequately responding to biological disease-modifying antirheumatic drugs
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- Yoshiya Tanaka
- University of Occupational and Environmental Health , Japan, Kitakyushu, Japan
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- Tsutomu Takeuchi
- Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine , Tokyo, Japan
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- Hisashi Yamanaka
- Rheumatology, Sanno Medical Center , Tokyo, Japan
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- Toshihiro Nanki
- Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine , Tokyo, Japan
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- Hisanori Umehara
- Division of Rheumatology and Immunology, Nagahama City Hospital , Shiga, Japan
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- Nobuyuki Yasuda
- KAN Research Institute Inc. , Kobe, Japan
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- Fumitoshi Tago
- Eisai Co. Ltd. , Tokyo, Japan
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- Yasumi Kitahara
- Eisai Co. Ltd. , Tokyo, Japan
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- Makoto Kawakubo
- Eisai Co. Ltd. , Tokyo, Japan
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- Kentaro Torii
- Eisai Co. Ltd. , Tokyo, Japan
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- Seiichiro Hojo
- Eisai Co. Ltd. , Tokyo, Japan
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- Tetsu Kawano
- KAN Research Institute Inc. , Kobe, Japan
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- Toshio Imai
- KAN Research Institute Inc. , Kobe, Japan
抄録
<jats:title>ABSTRACT</jats:title> <jats:sec> <jats:title>Objectives</jats:title> <jats:p>The objective of the study is to evaluate the long-term safety and efficacy of E6011, a humanized anti-fractalkine monoclonal antibody, in patients with rheumatoid arthritis with an inadequate response to biological disease-modifying antirheumatic drugs.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>In the double-blind treatment phase (24 weeks), placebo or E6011 400 mg was administered until Week 10. Thereafter, E6011 200 mg or 400 mg was administered to Week 22. Subjects who completed the evaluation at Week 24 of the treatment phase were rolled over into the extension phase. The extension phase lasted until Week 104, and all subjects received E6011 400 mg or 200 mg every 2 weeks in an open-label manner until Week 102.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>A total of 47 subjects completed the double-blind treatment phase and were rolled over into the extension phase. In total, 46 (97.9%) subjects experienced any adverse events, and the incidence of treatment-related adverse events was 57.4%. No clear efficacy trend in the American College of Rheumatology 20% response rates was observed.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>E6011 was well tolerated in active rheumatoid arthritis patients who had shown an inadequate response to biologic disease-modifying antirheumatic drugs, but no clear benefit in the American College of Rheumatology 20% response rates was observed. Further studies are needed to clarify the clinical benefit of E6011.</jats:p> </jats:sec>
収録刊行物
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- Modern Rheumatology
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Modern Rheumatology 34 (1), 45-49, 2023-01-21
Oxford University Press (OUP)
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詳細情報 詳細情報について
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- CRID
- 1360861711969155840
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- ISSN
- 14397609
- 14397595
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- データソース種別
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- Crossref