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Featured Clinical Topic: Managing Glucocorticoid-Induced Osteoporosis with Evenity® (Romosozumab-aqqg)

19 Jan 2022 5:16 AM | Anonymous

Author: Hyoeun Ashley Kang, PharmD Candidate 2022, UMKC School of Pharmacy
Mentor: Annie Ungerman, PharmD, BCPS; Clinical Lead Pharmacist, Rheumatology Truman Medical Centers

Introduction

Romosozumab subcutaneous injection was approved by the U.S. Food and Drug Administration (FDA) in April 2019 for osteoporosis in postmenopausal women who are at high risk of fracture.Osteoporosis is a common disease state in women and affects more than 10 million individuals in the United States.1 Among multiple risk factors for developing osteoporosis, glucocorticoid (GC)-induced osteoporosis is the most common cause of secondary osteoporosis. Long-term use of GC therapy reduces bone formation and can trigger significant bone loss. In rheumatology clinics, GC medications are frequently prescribed for the treatment of rheumatoid arthritis (RA).2 Lee et al. showed that the incidence of osteoporosis is 1.9 times higher in patients with RA than without.3 Romosozumab is not mentioned in the American College of Rheumatology (ACR) Glucocorticoid-induced Osteoporosis guideline as it was last updated in 2017.

Risk of Glucocorticoid-induced Osteoporosis

Both the dose and duration of GC therapy are associated with the risk of fractures. Risk of fracture is significantly increased with relatively low daily doses of prednisolone (as low as 2.5 mg) for three to six months of therapy. According to the 2017 ACR Guideline for the Prevention and Treatment of GC-induced osteoporosis, fracture risk generated with FRAX score increased by 15% for major osteoporotic fracture and 20% for hip fracture risk in individuals who received daily doses >7.5 mg daily.5 Without appropriate treatment, bones become brittle and are more likely to fracture in the future. After a bone fracture, patients are more than 5 times as likely to fracture again within a year.6 Therefore, it is crucial to prevent and slow down bone loss to reduce the risk of fracture. 

Mechanism of Action

Romosozumab is an agent that has a different mechanism of action to stimulate bone formation than other osteoporosis treatments. Romosozumab is a monoclonal antibody that inhibits the action of sclerostin protein, which is a regulatory factor to block bone formation.Romosozumab is the first agent with a dual effect that increases bone formation (osteoblastic activity) and decreases bone resorption (osteoclastic activity).1,7

Dosage and Administration

The recommended dose of romosozumab is 210 mg by subcutaneous injection every four weeks for a total of 12 months. A healthcare professional should administer it as two separate injections of a 105 mg/1.7 mL syringe on the same day. The recommended injection sites of administration are abdomen, thigh, or upper arm. Additionally, patients should be on daily calcium and vitamin D supplements while taking romosozumab. If a dose is missed it is recommended to administer as soon as possible and reschedule subsequent doses from the date of the last dose.Use after 12 months is not advised as the effect of bone formation wanes after 12 doses.1,7

Efficacy

There are two completed head-to-head trials available that evaluate the efficacy and safety of romosozumab in the treatment of postmenopausal women with osteoporosis. Romosozumab was compared to the most commonly used antiresorptive agent Fosamax®(Alendronate) and formulation-stimulating agent Forteo®(Teriparatide). 

Safety

The most common side effects of romosozumab are arthralgia (8% to 13%), hypersensitivity reaction (7%), and headache (5% to 7%).10 Romosozumab has a black boxed warning that it can increase the risk of stroke, myocardial infarction (MI), and cardiovascular death. Thus, romosozumab should not be used in patients who previously have had an MI or stroke within the past year.7,10 The data for the Major Adverse Cardiac Events (MACE) from the ARCH trial (2017) are analyzed in Table 3.  

Conclusion

Romosozumabis the first monoclonal antibody agent designed to target sclerostin protein. The ARCH trial and STRUCTURE trial demonstrated the efficacy and safety of romosozumab versus active comparator agents. This novel pathway of romosozumab provides an important treatment option for osteoporosis in postmenopausal women who are at high risk of fracture.

 

References

 

  1. FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-osteoporosis-postmenopausal-women-high-risk-fracture. Accessed October 10, 2021.
  2. What People With Rheumatoid Arthritis Need To Know About Osteoporosis. National Institutes of Health Osteoporosis and Related Bone Diseases National Resource Center. https://www.bones.nih.gov/sites/bones/files/pdfs/rheum_arthritis_and_osteo_11-18_0.pdf. Published November 2018. Accessed October 10, 2021.
  3. Lee SG, Park YE, Park SH, et al. Increased frequency of osteoporosis and BMD below the expected range for age among South Korean women with rheumatoid arthritis. Int J Rheum Dis 2012;15:289–96.
  4. Raterman HG, Bultink IEM, Lems WF. Current treatments and new developments in the management of glucocorticoid-induced osteoporosis. Drugs 2019; 79(10):1065–1087. 
  5. Buckley L, Guyatt G, Fink HA, et al. 2017 American College of Rheumatology Guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis. Arthritis Rheumatol. 2017;69(8):1521-1537.
  6. Van Geel TA, Van Helden S, Geusens PP, Winkens B, Dinant GJ. Clinical subsequent fractures cluster in time after first fractures. Ann Rheum Dis. 2009;68(1):99-102.
  7. Evenity [prescribing information]. Thousand Oaks, California: Amgen Inc; Revised April 2020. Accessed October 11, 2021.
  8. Saag KG, Petersen J, Brandi ML, et al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017;377(15):1417-1427.
  9. Langdahl BL, Libanati C, Crittenden DB, et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial. Lancet. 2017;390(10102):1585-1594.
  10. Romosozumab. Lexicomp. https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/6798426?cesid=0QxZflMLLDc&searchUrl=%2Flco%2Faction%2Fsearch%3Fq%3Devenity%26t%3Dname%26va%3Devenity#. Updated September 30, 2021. Accessed October 15, 2021.


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