EVENITYTM (romosozumab) ARCH Study Results Published in the New England Journal of Medicine
- EVENITY Followed by Alendronate Reduced the Incidence of New Vertebral, Clinical, Non-Vertebral and Hip Fractures Compared to Alendronate Alone
- Additional Details on Observed Cardiovascular Safety Signal Provided
BRUSSELS, Belgium and THOUSAND OAKS, Calif. (11th Sept, 2017) – UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) today announced detailed results from the Phase 3 ARCH study showing that 12 months of EVENITY™* (romosozumab) followed by alendronate was superior in reducing new vertebral, clinical, non-vertebral and hip fracture risk in postmenopausal women with osteoporosis at high risk for fracture, compared to alendronate alone. Overall adverse events and serious adverse events were generally similar between the treatment groups with the exception of the previously reported imbalance in positively adjudicated cardiovascular serious adverse events. The results were simultaneously published in the New England Journal of Medicine (NEJM) and presented today as a late-breaking abstract at an oral scientific session at the Annual Meeting of the American Society for Bone Mineral Research (ASBMR) in Denver.1
The study found that through 24 months, postmenopausal women with osteoporosis in the romosozumab treatment group experienced a statistically significant 48.0 percent relative reduction in the risk of a new vertebral (spine) fracture compared with those receiving alendronate alone (6.2 percent versus 11.9 percent, respectively [p<0.001]). At primary analysis, women in the romosozumab treatment group also experienced a statistically significant 27.0 percent relative reduction in the risk of clinical fracture, which includes non-vertebral fracture and clinical vertebral fracture (9.7 percent versus 13.0 percent, respectively [(p<0.001]).
“The ARCH study shows that romosozumab can provide superior fracture risk reduction over alendronate, a commonly used, first-line osteoporosis treatment,” said study lead author Kenneth F. Saag, M.D., M.Sc., professor of medicine at the University of Alabama at Birmingham School of Medicine. “By sharing the detailed results of efficacy and safety, we aim to help clinicians understand the potential future benefit:risk profile of romosozumab and its potential as a treatment option for postmenopausal women living with osteoporosis.”
At primary analysis, postmenopausal women in the romosozumab treatment group experienced a statistically significant 19.0 percent relative reduction in the risk of non-vertebral fractures (8.7 percent versus 10.6 percent, respectively [p=0.04]). A 38.0 percent relative reduction in the risk of hip fractures was also observed (2.0 percent versus 3.2 percent, respectively [nominal p=0.015]), when compared to those receiving alendronate alone.
Postmenopausal women who received romosozumab achieved greater gains in bone mineral density (BMD) from baseline at all measured sites and at all time points of the study versus those receiving alendronate alone. At month 12, the percentage change from baseline was greater with romosozumab versus alendronate at the lumbar spine (13.7 percent versus 5.0 percent, respectively [p<0.001]) and total hip (6.2 percent versus 2.8 percent, respectively [p<0.001]). In a subset of patients assessed every six months, significant gains were observed beginning at month six (p<0.001) for all sites.
Overall, adverse events and serious adverse events were generally similar between the treatment groups. An imbalance in adjudicated cardiovascular serious adverse events was observed during the 12-month period in 50 patients (2.5 percent) treated with romosozumab versus 38 patients (1.9 percent) treated with alendronate, with cardiac ischemic events and cerebrovascular events accounting for the imbalance.
The percentage of patients with adverse events and serious adverse events throughout the study as well as in the initial 12-month romosozumab treatment period were balanced between the groups, including incidences of osteoarthritis, hypersensitivity, cancer and hypocalcemia. Injection site reactions, mostly mild in severity, were reported in 4.4 percent of patients in the romosozumab treatment group and 2.6 percent in the alendronate group during the initial 12-month period.
During the open-label alendronate period, there were two positively adjudicated events of osteonecrosis of the jaw, one in a patient treated with romosozumab followed by alendronate and one treated with alendronate alone. There were six patients with positively adjudicated events of atypical femoral fracture during the open-label alendronate period, two patients treated with romosozumab followed by alendronate and four treated with alendronate alone.
- Saag K, Petersen J, Brandi ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med 2017; DOI: 10.1056/NEJMoa1708322
About the ARCH Study
ARCH (Active-contRolled FraCture Study in Postmenopausal Women with Osteoporosis at High Risk of Fracture) is a Phase 3 multicenter, international, randomized, double-blind, alendronate-controlled study of romosozumab in 4,093 postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history.
Patients were randomized 1:1 to receive either 210 mg romosozumab subcutaneously every month or 70 mg alendronate orally every week for the duration of the 12-month double-blind alendronate-controlled study period. After the double-blind active-comparator study period, patients received alendronate while remaining blinded to their initial treatment assignment. The incidence of new vertebral fracture was assessed at 24 months. The incidence of clinical fracture was assessed at the primary analysis, when 330 fractures occurred or the last patient was on the study for 24 months, whichever was later. In addition, other key fracture endpoints including non-vertebral fracture and hip fracture were assessed at primary analysis.
Romosozumab is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the activity of sclerostin, which enables romosozumab to rapidly increase bone formation and reduce bone resorption simultaneously. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.
About the UCB and Amgen Collaboration
Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on the development of romosozumab for the treatment of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB are joining forces to translate a genetic discovery into a new medicine, turning conceptual science into a reality.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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