J Rheumatol 2021 Apr 15. Epub 2021 Apr 15.
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:
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. Read More