Long-term safety and efficacy of E6011, an anti-fractalkine monoclonal antibody, in patients with rheumatoid arthritis inadequately responding to methotrexate

Author:

Tanaka Yoshiya1,Takeuchi Tsutomu23,Yamanaka Hisashi4,Nanki Toshihiro5,Umehara Hisanori6,Yasuda Nobuyuki78,Tago Fumitoshi8,Kitahara Yasumi89,Kawakubo Makoto8,Torii Kentaro8,Hojo Seiichiro8,Kawano Tetsu710,Imai Toshio711

Affiliation:

1. University of Occupational and Environmental Health , Japan, Kitakyushu, Japan

2. Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine , Tokyo, Japan

3. Saitama Medical University , Saitama, Japan

4. Rheumatology, Sanno Medical Center , Tokyo, Japan

5. Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine , Tokyo, Japan

6. Division of Rheumatology and Immunology, Nagahama City Hospital , Shiga, Japan

7. KAN Research Institute, Inc. , Kobe, Japan

8. Eisai Co. Ltd , Tokyo, Japan

9. Eisai Inc. , Nutley, NJ, USA

10. Gastroenterology, Nichinan-City Chubu Hospital , Miyazaki, Japan

11. Advanced Therapeutic Target Discovery, Department of Gastroenterology, Kobe University Graduate School of Medicine , Hyogo, Japan

Abstract

ABSTRACT Objectives To evaluate the long-term safety and efficacy of E6011, a humanized anti-fractalkine monoclonal antibody, in patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX). Methods Active RA patients with an inadequate response to MTX were randomly assigned to the E6011 or placebo group and received the study drug subcutaneously every 2 weeks during a 24-week double-blind study period. Subjects who completed evaluations at Week 24 were rolled over into the extension phase and received open-label E6011 (200 or 400 mg) every 2 weeks until Week 102. The safety analysis was conducted up to Week 104, and the efficacy analysis was conducted up to Week 84. Results A total of 169 subjects completed the double-blind treatment phase and were rolled over into the extension phase. In total, 167 (98.8%) subjects experienced any adverse events, and the incidence of treatment-related adverse events was 56.2%. The American College of Rheumatology 20 response rates were observed between 40 and 70% during the extension phase. Conclusions E6011 was safe and well tolerated with no notable safety concerns up to 102 weeks in RA patients with an inadequate response to MTX.

Publisher

Oxford University Press (OUP)

Subject

Rheumatology

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