Romosozumab-aqqg

(Evenity®)

Evenity®

Drug updated on 4/18/2024

Dosage FormInjection (subcutaneous; 105 mg/1.17 mL)
Drug ClassSclerostin inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

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Summary
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  • Romosozumab-aqqg (Evenity) is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture. This includes those with a history of osteoporotic fracture, multiple risk factors for fracture, or those who have failed or are intolerant to other available osteoporosis therapy.
  • Nineteen systematic reviews and meta-analyses provide information on the comparative effectiveness, safety profiles, and subgroup considerations related to Evenity.
  • Evenity has consistently shown its ability to reduce the risk of clinical, vertebral, and non-vertebral fractures in postmenopausal women compared with placebo, bisphosphonates such as alendronate, denosumab, and teriparatide.
  • Romosozumab-aqqg increases bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck within 12 months more effectively than bisphosphonates. It is comparable or superior to denosumab and teriparatide, depending on outcome measures.
  • Analysis of the safety profile relative to other treatments indicates a generally favorable profile. However, it does show increased risks of hypersensitivity reactions and injection site reactions but lower overall adverse events compared to alendronate.
  • Although some evidence suggests an increased risk of cardiovascular adverse events compared to placebo and other treatments from one study, the overall evidence suggests that these rates are within an acceptable range considering the benefits offered by this drug.
  • The effectiveness in increasing BMD and reducing fracture risks does not seem significantly affected by baseline indicators, thus indicating broad applicability across varying degrees of severity among postmenopausal populations suffering from osteoporosis.
  • Evidence also points towards notable efficacy among population groups who have previously failed or are intolerant towards existing therapies, thereby highlighting its role as an alternative treatment option.

Product Monograph / Prescribing Information

Document TitleYearSource
Evenity (romosozumab-aqqg) Prescribing Information.2020Amgen Inc., Thousand Oaks, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Fracture risk reduction and safety by osteoporosis treatment compared with placebo or active comparator in postmenopausal women: systematic review, network meta-analysis, and meta-regression analysis of randomised clinical trials.2023British Medical Journal
Meta-analysis of the effects of denosumab and romosozumab on bone mineral density and turnover markers in patients with osteoporosis.2023Frontiers in Endorcinology
Evidence for the cardiovascular effects of osteoporosis treatments in randomized trials of post-menopausal women: a systematic review and Bayesian network meta-analysis.2023Bone
Evaluation of the efficacy and safety of romosozumab (evenity) for the treatment of osteoporotic vertebral compression fracture in postmenopausal women: a systematic review and meta-analysis of randomized controlled trials (CDM-J).2023Pharmacoepidemiology & Drug Safety
Importance of time point–specific indirect treatment comparisons of osteoporosis treatments: a systematic literature review and network meta-analyses.2022Clinical Therapeutics
Efficacy and safety of anti-sclerostin antibodies in the treatment of osteoporosis: a meta-analysis and systematic review.2022Journal of Clinical Densitometry
Romosozumab versus teriparatide for the treatment of postmenopausal osteoporosis: a systematic review and meta-analysis through a grade analysis of evidence.2021Orthopaedic Surgery
Antiresorptive and anabolic medications used in the perioperative period of patients with osteoporosis undergoing spine surgery: their impact on the biology of fusion and systematic review of the literature.2021Journal of Neurosurgery
A systematic review and meta-analysis of efficacy and safety of romosozumab in postmenopausal osteoporosis.2021Osteoporosis International
Denosumab and romosozumab do not increase the risk of cardiovascular events in patients with primary osteoporosis: a reanalysis of the meta-analysis.2020Bone
Risk of falls in postmenopausal women treated with romosozumab: preliminary indices from a meta-analysis of randomized, controlled trials.2020Osteoporosis and Sarcopenia
Osteoporosis drugs for prevention of clinical fracture in white postmenopausal women: a network meta-analysis of survival data.2020Osteoporosis International
Denosumab or romosozumab therapy and risk of cardiovascular events in patients with primary osteoporosis: systematic review and meta-analysis.2020Bone
Safety of romosozumab in osteoporotic men and postmenopausal women: a meta-analysis and systematic review.2020Monoclonal Antibodies in Immunodiagnosis and Immunotherapy
Efficacy and safety of romosozumab in treatment for low bone mineral density: a systematic review and meta-analysis.2020Clinical Rheumatology
Clinical efficacy and safety of drug interventions for primary and secondary prevention of osteoporotic fractures in postmenopausal women: network meta-analysis followed by factor and cluster analysis.2020PLOS One
Comparative efficacy and safety of pharmacological interventions for osteoporosis in postmenopausal women: a network meta-analysis (Chongqing, China).2019Menopause
Efficacy of pharmacological therapies for the prevention of fractures in postmenopausal women: a network meta-analysis.2019The Journal of Clinical Endocrinology and Metabolism
Comparative efficacy of bone anabolic therapies in women with postmenopausal osteoporosis: a systematic review and network meta-analysis of randomized controlled trials.2019Maturitas
Effect of medications on prevention of secondary osteoporotic vertebral compression fracture, non-vertebral fracture, and discontinuation due to adverse events: a meta-analysis of randomized controlled trials.2019BMC Musculoskeletal Disorders

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