Denosumab: Anti-RANKL antibody |
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Authors: | Paul D Miller |
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Institution: | (1) Department of Medicine, University of Colorado Health Sciences Center, Colorado Center for Bone Research, 3190 South Wadsworth Boulevard, Lakewood, CO 80227, USA |
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Abstract: | Denosumab (anti-receptor activator of nuclear factorκB ligand RANKL] antibody) is a novel agent, a fully human monoclonal
antibody that inhibits osteoclastic-medicated bone resorption by binding to osteoblast-produced RANKL. By reducing RANKL binding
to the osteoclast receptor RANK, bone resorption and turnover decrease. In phase 2 dose-ranging studies, denosumab had a rapid
onset and offset effect. Also, in patients who had received 2 years of denosumab and were discontinued for the third year,
rechallenge with denosumab during the fourth year demonstrated a return of responsiveness to denosumab that mimicked the initial
treatment. Phase 3 pivotal fracture data were recently presented with positive outcome data; denosumab (60 mg subcutaneously
every 6 months) significantly reduced vertebral, nonvertebral, and hip fracture risk compared with placebo, and had an excellent
safety profile through 3 years of use. Denosumab will offer a novel approach to managing postmenopausal osteoporosis, one
that should be associated with a high adherence rate and global fracture risk reduction. |
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