New UCB data analysis adds to demonstrated efficacy of romosozumab▼ to reduce the risk of fractures

Brussels (Belgium), 25 March 2022 – 07:00 (CEST) – UCB, a global biopharmaceutical company, today presented two post-hoc analyses highlighting the improvements in BMD and reduction in fracture risk as well as the safety in patients treated with romosozumab.

The data were presented at the International Osteoporosis Foundation (IOF) and the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO): World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Disease (WCO) 2022. 

“Patients who suffer from severe osteoporosis are always at risk of fragility fractures – at times, even a bump or fall from standing height can lead to a broken bone. That is why a treatment option that can reduce fracture risk is so important for patients” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions & Head of US, UCB.

Chapurlat et al. analysed the data of postmenopausal women with osteoporosis that were randomised to romosozumab 210 mg monthly (QM) or comparator (FRAME: PBO QM; ARCH: alendronate [ALN] 70 mg QW) for 12 months). After 12 months all patients received ALN in ARCH or denosumab (DMAB) in FRAME. The results showed that within 12 months of treatment with romosozumab, most patients achieved the STEs for any reduction in fracture risk. At both 12 and 24 months, higher proportions of patients met the STEs with romosozumab compared to alendronate for all fracture types.¹ 

Another post-hoc analysis of the efficacy and adverse event reporting data of romosozumab by Lane et al. expanded on the lower occurrence of on-study clinical fractures with romosozumab vs placebo in FRAME (romosozumab: 58/3589; PBO: 92/3591) and with romosozumab vs alendronate in ARCH (romosozumab: 79/2046; ALN 110/2047). The most common first clinical fracture was of the radius (about 30%) in both FRAME (romosozumab: 22/58; PBO: 27/92) and ARCH (romosozumab: 28/79; ALN: 33/110). These fractures occurred with no specific pattern relative to the timing of romosozumab administration. Following a fracture, the next romosozumab dose was administered after a median of 15 days (mean: 21 ) in FRAME and 14 days (mean: 21 ) in ARCH.² No patients experienced adverse events or complications related to fracture healing.

“At UCB we are committed to improving outcomes in patients living with osteoporosis , closing the treatment gap and reducing the risk of fragility fractures,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions & Head of US, UCB.

Osteoporosis causes bones to become weak and fragile, which can lead to long-term morbidity and/or future fragility fractures. Fragility fractures can result in significant burden on a person’s life, often making everyday activities such as eating, dressing, shopping or driving difficult. It is estimated that 4.3 million fragility fractures are happening every year in Europe.³ 

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About the study methodology and patient population

Chapurlat et al. 

Postmenopausal women with osteoporosis were randomised to romosozumab 210 mg monthly (QM) or comparator (FRAME: placebo [PBO] QM; ARCH: alendronate [ALN] 70 mg QW) for 12 months. After a year all patients received ALN in ARCH or denosumab (DMAB) in FRAME.

Lane et al. 

Postmenopausal women with OP were randomised to receive romosozumab 210 mg monthly (QM) or comparator (FRAME: PBO QM; ARCH: ALN 70 mg weekly) for 12 months followed by antiresorptive therapy (FRAME: denosumab; ARCH: ALN). In patients who experienced clinical fractures during the trials, relationship to timing of romosozumab dose after fracture was reported as well as treatment emergent adverse events (TEAEs) and specific skeletal AEs.

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. Romosozumab 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 European Summary of Product Characteristics for other adverse reactions and full prescribing information. Available at Evenity, INN-romosozumab (europa.eu) 

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.

Forward looking statements 
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References

1. Chapurlat, R. van den Bergh, J. Ralston, S.H. Ferrari, S. McClung, M. Lorentzon, M. Makras, P. Lewiecki, M. Matsumoto, T. Timoshanko, J. Wang, Z. Libanati. C.. 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. Abstract #513
2. Lane, J. Cosman, F. Langdahl, B. Stone, M. Oates, M. Timoshanko, J. Wand, Z. Libanati, C. Kurth. A. Use of romosozumab in those who experienced an on-study fracture : results from the randomised FRAME and ARCH phase 3 trials. Abstract #1061.
3. IOF. Scope report 2021. [Online] Available at: https://www.osteoporosis.foundation/sites/iofbonehealth/files/2022-01/SCOPE%20Summary%20Report.pdf  (Last accessed March 2022).