Long-Term Effectiveness and Safety of Denosumab for Osteoporosis in Patients With Rheumatic Diseases.

Abstract

The long-term effectiveness of denosumab, an antireceptor activator of nuclear factor-κB ligand monoclonal antibody, for increasing bone mineral density (BMD) and reducing fracture risk in postmenopausal women with osteoporosis (OP) has been demonstrated; however, the long-term effectiveness and safety in patients with rheumatic diseases (RDs) remain unclear. Therefore, the present study investigated the long-term effectiveness and safety of denosumab for OP in patients with RDs. This retrospective study included patients who received denosumab between August 2013 and August 2022. We evaluated BMD at the lumbar spine for up to 7 years and at the femur for up to 3 years. The effects of glucocorticoid (GC) usage, age, and renal function on BMD in patients receiving denosumab were assessed. The retention rate and adverse events were also evaluated. One hundred sixty-five patients with RDs were enrolled (median age 66.5 years, 92.1% female, 68.5% receiving GC therapy). Lumbar spine BMD significantly increased over 7 years (<i>P</i> < 0.001), whereas femoral neck, trochanter, and total hip BMD significantly increased for up to 3 years (<i>P</i> < 0.001). Lumbar spine BMD significantly increased regardless of GC dose, age, or renal dysfunction. The retention rate of denosumab at 7 years was 68.1%. The most common serious adverse event was infection. Two cases of osteonecrosis of the jaw and 10 new fractures were observed during treatment with denosumab. The present study suggests that the long-term use of denosumab is an effective and generally safe option for increasing BMD in patients with RDs.