Categories
Change Password!
Reset Password!
This study put-forward supportive information concerning the safety
and tolerability of both short‐term and longer‐term treatment using denosumab
with no indication of increased low‐frequency AEs and common AEs in patients
receiving this drug in years’ 4–6 than years’ 1–3.
Denosumab is newly developed human monoclonal antibody that acts against receptor activator of NF-κB ligand (RANKL) which in turn decreases osteoclast formation, their function and survival rate. It is approved for the treatment of post-menopausal women with osteoporosis who has increased risk for fracture, among other indications.
A pivotal 3-year fracture trial FREEDOM was done in which denosumab (60 mg) was administered subcutaneously after every 6 months. The results indicated that there was significant reduction in new vertebral (68%) fractures, hip (40%) fractures, non-vertebral (20%) fractures and bone turnover marker and an increase in bone mineral density (BMD) when comparison was done with placebo in post-menopausal women with osteoporosis.
Questions have arisen regarding
imbalances of certain low-frequency adverse events (AEs) observed in FREEDOM,
as well as the top 5 most frequent adverse reactions listed in the United
States prescribing information (USPI; back pain, pain in extremity,
musculoskeletal pain, hypercholesterolemia, and cystitis). The incidences of
these AEs was examined in women who originally received placebo during FREEDOM
and then received denosumab for up to 3 years during the FREEDOM Extension
(Crossover Group). It provided a unique opportunity for comparison with the
original 3-year denosumab FREEDOM results. The incidences of these AEs were
also examined over 6 years of denosumab treatment (Long-term Group; i.e.,
comparing a second 3 years of treatment with findings in the first 3 years).
Increasing trends did not indicate any imbalances of either low-frequency AEs
or common AEs which were observed in FREEDOM.
Seminars in Arthritis and Rheumatism
Safety Observations With Three Years of Denosumab Exposure: Comparison Between Subjects Who Received Denosumab During the Randomized FREEDOM Trial and Subjects Who Crossed Over to Denosumab During the FREEDOM Extension
Nelson B Watts et al.
Comments (0)