Denosumab biosimilar displays noninferiority in postmenopausal patients with osteoporosis
Click Here to Manage Email Alerts
A denosumab biosimilar candidate demonstrated noninferior efficacy to its reference product, with similar safety profile, in postmenopausal patients with osteoporosis, according to data published in Arthritis Research & Therapy.
“Considering the global aging population and the expected increase in osteoporosis incidence, developing drugs and preventive approaches are of great importance in managing osteoporosis and its consequences,” Ahmadreza Jamshidi, MD, of the Rheumatology Research Center at Shariati Hospital, at the Tehran University of Medical Sciences, in Iran, and co-authors, wrote.
To compare the efficacy and safety of the biosimilar candidate Arylia (AryoGen Pharmed) to that of reference denosumab (Prolia, Amgen) in postmenopausal patients with osteoporosis, Jamshidi and colleagues designed a randomized, double-blind, active-controlled, noninferiority study, conducted between April 2017 and August 2020. The study’s primary endpoint was the noninferiority of the biosimilar compared with the reference drug, specifically regarding change in bone mineral density (BMD) at the lumbar spine, total hip and femoral neck over 18 months.
Patients were eligible for inclusion if they were postmenopausal women aged 45 to 75 years and had a T score from –2.5 to –4 at the lumbar spine, total hip or femoral neck. Patients who had a high risk for fracture were also included. Exclusion criteria included conditions that might impact the safety or efficacy of the analyzed drugs, including osteoporosis of the jaw risk factors, malignancy, untreated hypocalcemia, recent bisphosphonate treatment, corticosteroid therapy, being confined to bed and an inability to measure bone mineral density.
A total of 190 patients were randomized 1:1 to receive either 60 mg of the biosimilar or reference therapy subcutaneously every 6 months. Patients in both cohorts also received supplemental calcium and vitamin D during the study. Participants were evaluated at baseline and months 1, 3, 6, 9, 12, 15 and 18. Adverse events were monitored at each visit, and any clinically significant change in physical examination, vital signs, and laboratory data was considered an adverse event.
Adverse events of special interest included infections and infestations, eczema, atypical femoral fracture, bone fracture, osteoporosis of the jaw, cardiovascular disorder, neoplasm benign, malignant and unspecified and acute pancreatitis.
According to the researchers, the biosimilar and reference product were found to be comparable in terms of safety and adverse events. In addition, biosimilar met the threshold for noninferiority. The mean difference between BMD increases was 0.39 (95% CI, –1.34 to 2.11) at the lumbar spine site, 0.04 (95% CI, –1.61 to 1.69) at the total hip site and 0.41 (95% CI, –1.58 to 2.4) at the femoral neck.
“This study demonstrated the noninferiority of the biosimilar denosumab (Arylia) to the reference product in osteoporotic postmenopausal women,” Jamshidi and colleagues wrote. “In general, there was no difference in the lumbar spine, total hip, or femoral neck BMD percentage change, the trend of bone metabolism biomarkers, or the occurrence of new vertebral fractures between the biosimilar denosumab and the reference product.”
Collapse
Read more about
Click Here to Manage Email Alerts