WCO-IOF-ESCEO 2022 – Post-hoc analysis on the proportion of patients treated with EVENITY[® ]▼(romosozumab) reaching surrogate threshold effect that predicts fracture risk reduction

Brussels (Belgium), 24 March 2022 – 07:00 (CEST) – UCB confirmed its commitment to the treatment and management of osteoporosis and fragility fractures today, with the presentation of nine abstracts and two UCB-sponsored events – a symposium and a meet-the-expert session – at WCO-IOF-ESCEO 2022. This year’s International Osteoporosis Foundation (IOF) and European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO): World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Disease (WCO) will again take place virtually from the 24th – 26th March.

“At UCB, we are committed to innovative research that can help to reduce the risk of fractures and positively impact the lives of people living with severe osteoporosis. We look forward to presenting a new analysis at WCO-IOF-ESCEO focused on predicting osteoporotic fracture reduction,’’ said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions & Head of US, UCB. 

“Congresses such as WCO-IOF-ESCEO are important forums to discuss the latest research and options in the prevention and treatment of osteoporosis.”

Data presented at WCO-IOF-ESCEO 2022:

• The proportion of patients who reach the BMD surrogate threshold effect on romosozumab: a post hoc analysis of the randomised FRAME and ARCH phase 3 trials. R. Chapurlat, J. van den Bergh, S. H Ralston, S. Ferrari, M. McClung, M. Lorentzon, P. Makras, M. Lewiecki, T. Matsumoto, J. Timoshanko, Z. Wang, C. Libanati (abstract #513)
• Use of romosozumab in those who experienced an on-study fracture: results from the randomised FRAME and ARCH phase 3 trials. J. Lane, F. Cosman, B. Langdahl, M- Stone, M. Oates, J. Timoshanko, Z. Wand, C. Libanati, A. Kurth. (abstract #1061)

Collaboration abstracts:

• Automated detection of vertebral fractures in routine CT scans of the chest and abdomen: external validation of a deep learning algorithm. J. Nicolaes, M. Kriegbaum Skødt, C. Libanati, C. Dyer Smith, K. Rose Olsen, C. Cooper, B. Abrahamsen (abstract #347)
• Vertebral fracture as risk factor for subsequent vertebral fracture: ICD-10 based analysis of a real-world database. C.-C. Glüer, L. Engelke, M. Kistler, F. Thomasius, P. Hadji, B. Schweikert, C. Libanati, A. Moayyeri (abstract #792)
• Vertebral fractures on routine CT scans predict major osteoporotic fracture and hip fracture: observational cohort study. M. Kriegbaum Skødt, J. Nicolaes, C.S. Smith, K.R. Olsen, C. Libanati, C. Cooper, B. Abrahamsen (abstract #509)
• Mild vertebral fractures – do they matter? M. Kriegbaum Skødt, J. Nicolaes, C.D. Smith, K.R. Olsen, C. Libanati, C. Cooper, B. Abrahamsen (abstract #514)
• Opportunistically identified vertebral fractures on routine CT scans are predictive of increased mortality: observational cohort study. M. Kriegbaum Skødt, J. Nicolaes, C.D. Smith, K.R. Olsen, C. Libanati, C. Cooper, B. Abrahamsen (abstract #521)

Amgen-lead abstracts:

• Trends in osteoporotic fractures and related in-hospital complications during the COVID-19 pandemic in Alberta, Canada. J. P Brown, D. L Kendler, A. G Juby, P. Schneider, R. Wani, M. Packalen, S. Avcil, S. Li, C. Waters-Banker, E. Graves, S. McMullen, T. Oliveira 
• Trends in osteoporosis care patterns during the COVID-19 pandemic in Alberta, Canada. D. L Kendler, J. P Brown, A. G Juby, P. Schneider, R. Wani, M. Packalen, S. Avcil, S. Li, M. S Farris, E. Graves, S. McMullen, T. Oliveira 

For further information, contact UCB: 

Global Communications
Adriaan Snauwaert
T+32 497 70 23 46
Adriaan.Snauwaert@ucb.com
    
Laurent Schots
T +32 2 559 92 64
Laurent.Schots@ucb.com

Investor Relations
Antje Witte
T +32 2 559 9414
Antje.Witte@ucb.com 

About EVENITY®▼ (romosozumab)
Romosozumab is a bone-forming monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which simultaneously results in increased bone formation and to a lesser extent decreased bone resorption. The romosozumab development program includes 19 clinical studies that enrolled approximately 14,000 patients. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global phase 3 program that included two large fracture trials comparing romosozumab to either placebo or active comparator in over 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.

Important Safety Information about EVENITY^® (romosozumab) in the EU/EEA
In the EU, Romosozumab is indicated for treatment of severe osteoporosis in postmenopausal women at high risk of fracture. Contraindications: Romosozumab is contraindicated in patients who are allergic to romosozumab or any of the excipients, who have low levels of calcium in the blood (hypocalcaemia), or who have a history of myocardial infarction (heart attack) or stroke. Myocardial infarction or stroke: Heart attack and stroke have been reported in patients receiving Romosozumab in randomised controlled trials (uncommon). Treatment with Romosozumab should not be initiated in patients with a history of heart attack or stroke. When determining whether to use Romosozumab for an individual patient, the presence of risk factors for cardiovascular problems, including established cardiovascular disease, high blood pressure, high blood fat levels, diabetes, smoking or kidney problems, should be evaluated. Romosozumab should only be used if the prescriber and patient agree that the benefit outweighs the risk. If a patient experiences a myocardial infarction or stroke during therapy, treatment with Romosozumab should be discontinued. Hypocalcaemia: Transient hypocalcaemia has been observed in patients receiving Romosozumab. Hypocalcaemia should be corrected prior to initiating therapy with Romosozumab and patients should be monitored for signs and symptoms of hypocalcaemia. If any patient presents with suspected symptoms of hypocalcaemia during treatment, calcium levels should be measured. Patients should be adequately supplemented with calcium and vitamin D. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29ml/min/1.73m2) or receiving dialysis are at greater risk of developing hypocalcaemia and the safety data for these patients are limited. Calcium levels should be monitored in these patients. Hypersensitivity: Clinically significant hypersensitivity reactions, including angioedema, erythema multiforme, and urticaria occurred in the Romosozumab group in clinical trials. If an anaphylactic or other clinically significant allergic reaction occurs, appropriate therapy should be initiated and use of Romosozumab should be discontinued. Osteonecrosis of the Jaw: Osteonecrosis of the jaw (ONJ) has been reported rarely in patients receiving Romosozumab. The following risk factors should be considered when evaluating a patient’s risk of developing ONJ: (1) potency of the medicinal product that inhibits bone resorption (the risk increases with the antiresorptive potency of the compound), and cumulative dose of bone resorption therapy, (2) cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking, (3) concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck, (4) poor oral hygiene, periodontal disease, poorly fitting dentures, history of dental disease, invasive dental procedures e.g. tooth extractions. All patients should be encouraged to maintain good oral hygiene and receive routine dental check-ups. Dentures should fit correctly. Patients under dental treatment, or who will undergo dental surgery (e.g. tooth extractions) whilst being treated with Romosozumab should inform their doctor about their dental treatment and inform their dentist that they are receiving Romosozumab. Patients should immediately report any oral symptoms such as dental mobility, pain or swelling or non-healing of sores or pus discharge during treatment with Romosozumab. Patients who are suspected of having or who develop ONJ while receiving Romosozumab should receive care by a dentist or an oral surgeon with expertise in ONJ. Discontinuation of Romosozumab therapy should be considered until the condition resolves and contributing risk factors are mitigated where possible. Atypical Femoral Fractures: Atypical low-energy or low trauma fracture of the femoral shaft, which can occur spontaneously, has been reported rarely in patients receiving Romosozumab. Any patient who presents with new or unusual thigh, hip, or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patient presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of Romosozumab therapy should be considered, based on an individual benefit-risk assessment. Adverse Reactions: The most common adverse reactions were nasopharyngitis (13.6%) and arthralgia (12.4%). Common adverse reactions included hypersensitivity, sinusitis, rash, dermatitis, headache, neck pain, muscle spasms and injection site reactions (most frequent injection site reactions were pain and erythema). Uncommon adverse reactions were urticaria, hypocalcaemia, stroke, myocardial infarction and cataract. Finally, rare side effects were serious allergic reactions which caused swelling of the face, throat, hands, feet, ankles or lower legs (angioedema) and acute skin eruption (erythema multiforme).

Refer to the attached European Summary of Product Characteristics for other adverse reactions and full prescribing information for EVENITY®▼. Available at https://www.ema.europa.eu/en/documents/product-information/evenity-epar-product-information_en.pdf.

▼ This medicinal product is subject to additional monitoring.

EVENITY^® is a registered trademark of the UCB Group of Companies.

About UCB
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 8 000 people operating in more than 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

About the Amgen and UCB 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.

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References

1. IOF. Scope report 2021. [Online] Available at: https://www.osteoporosis.foundation/sites/iofbonehealth/files/2022-01/SCOPE%20Summary%20Report.pdf  (Last accessed February 2022).