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Research ArticleAccepted Article
Open Access

Effects of denosumab in Japanese rheumatoid arthritis patients treated with conventional anti-rheumatic drugs: 36-month extension of a phase 3 study

Yoshiya Tanaka, Tsutomu Takeuchi, Satoshi Soen, Hisashi Yamanaka, Toshiyuki Yoneda, Sakae Tanaka, Takaya Nitta, Naoki Okubo, Harry K. Genant and Désirée van der Heijde
The Journal of Rheumatology April 2021, jrheum.201376; DOI: https://doi.org/10.3899/jrheum.201376
Yoshiya Tanaka
First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp
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Tsutomu Takeuchi
First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp
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Satoshi Soen
First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp
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Hisashi Yamanaka
First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp
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Toshiyuki Yoneda
First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp
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Sakae Tanaka
First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp
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Takaya Nitta
First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp
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Naoki Okubo
First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp
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Harry K. Genant
First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp
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Désirée van der Heijde
First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan; Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan; Department of Orthopedics and Rheumatology, Kindai University Nara Hospital, Ikoma, Japan; Director of Rheumatology, Sanno Medical Center, Tokyo, Japan; Department of Biochemistry, Osaka University Graduate School of Dentistry, Osaka, Japan; Orthopedic Surgery and Spinal Surgery, The University of Tokyo, Tokyo, Japan; Daiichi Sankyo Co., Ltd, Japan; Departments of Radiology, Medicine and Orthopedic Surgery, University of California, California, USA; Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. This study was funded by Daiichi Sankyo Co., Ltd. Address correspondence to Yoshiya Tanaka First Department of Internal Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan. E-mail: tanaka@med.uoeh-u.ac.jp
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Abstract

Objective To evaluate safety and efficacy of long-term denosumab 60 mg every 6 (Q6M) or 3 months (Q3M) in rheumatoid arthritis (RA) patients.

Methods This 12-month, randomised, double-blind, placebo-controlled, multicentre phase 3 trial with an open-label extension period from 12 to 36 months (DESIRABLE) enrolled Japanese RA patients treated with placebo for 12 months then denosumab Q6M (P/Q6M) or denosumab Q3M (P/Q3M); denosumab Q6M for 36 months (Q6M/Q6M); or denosumab Q3M for 36 months (Q3M/Q3M). Efficacy was assessed by van der Heijde modified total Sharp (mTSS), bone erosion (ES), and joint space narrowing (JSN) scores.

Results Long-term treatment better maintained mTSS and ES suppression in the P/Q3M and Q3M/Q3M versus P/Q6M and Q6M/Q6M groups; changes from baseline in total mTSS at 36 months were 2.8 (standard error 0.4), 1.7 (0.3), 3.0 (0.4), and 2.4 (0.3), respectively; corresponding changes in ES were 1.3 (0.2), 0.4 (0.2), 1.4 (0.2), and 1.1 (0.2). No JSN effect was observed. Bone mineral density consistently increased in all groups after denosumab initiation, regardless of concomitant glucocorticoid administration. Serum C-telopeptide of type I collagen decreased rapidly at 1-month post-denosumab administration (both in the initial 12- month [Q3M, Q6M groups] and long-term treatment [P/Q3M, P/Q6M groups] phases). Adverse event incidence leading to study drug discontinuation was similar across treatment groups.

Conclusion Denosumab treatment maintained inhibition of progression of joint destruction up to 36 months. Based on effects on ES progression, higher dosing frequency at an earlier treatment stage may be needed to optimise treatment. Denosumab was generally well tolerated.

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1 Feb 2023
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Accepted manuscript
Effects of denosumab in Japanese rheumatoid arthritis patients treated with conventional anti-rheumatic drugs: 36-month extension of a phase 3 study
Yoshiya Tanaka, Tsutomu Takeuchi, Satoshi Soen, Hisashi Yamanaka, Toshiyuki Yoneda, Sakae Tanaka, Takaya Nitta, Naoki Okubo, Harry K. Genant, Désirée van der Heijde
The Journal of Rheumatology Apr 2021, jrheum.201376; DOI: 10.3899/jrheum.201376

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Accepted manuscript
Effects of denosumab in Japanese rheumatoid arthritis patients treated with conventional anti-rheumatic drugs: 36-month extension of a phase 3 study
Yoshiya Tanaka, Tsutomu Takeuchi, Satoshi Soen, Hisashi Yamanaka, Toshiyuki Yoneda, Sakae Tanaka, Takaya Nitta, Naoki Okubo, Harry K. Genant, Désirée van der Heijde
The Journal of Rheumatology Apr 2021, jrheum.201376; DOI: 10.3899/jrheum.201376
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