UCB (EBR:UCB) UCB Media Room: ASBMR 2022

Transparency directive : regulatory news

09/09/2022 07:01

https://mb.cision.com/Public/18595/3626810/bfb7641196362f41_800x800ar.png ** ASBMR 2022: 3D modelling of hip DXA scans in postmenopausal women with o= steoporosis reveals superior improvements in bone density of romosozumab ve= rsus controls ------------------------------------------------------------ =C2=B7 Post-hoc analyses of the FRAME, ARCH and the STRUCTURE phase 3 trial= s using 3D modelling techniques showed significant cortical and trabecular = bone improvements during the first year in romosozumab-treated patients. =C2=B7 Romosozumab-treated patients achieved greater increases in cortical = volumetric BMD (CvBMD), cortical thickness (Cth), cortical surface BMD (CsB= MD) and trabecular volumetric BMD (TvBMD) than comparator groups, from as e= arly as Month 6 through to Month 12.=C2=A0 =C2=B7 Data further demonstrated that patients at high risk of fracture may= benefit the most from treatment with romosozumab first, followed by an ant= iresorptive.=C2=A0 =C2=B7 Additional data offered new insights into neurological factors contr= ibuting to fracture risk, the impact of the COVID pandemic and subsequent p= ublic health lockdowns on the existing treatment and care gaps, and the use= of artificial intelligence in osteoporosis screening.=C2=A0 Brussels (Belgium), 9 September 2022 =E2=80=93 07:00 (CEST) =E2=80=93 UCB a= nd Amgen, global biopharmaceutical companies, today presented abstracts of = three post-hoc analyses focusing on 3D modelling techniques that highlight = significant cortical and trabecular bone improvements in patients treated w= ith romosozumab. The data were presented along with additional 17 abstracts= , at the American Society for Bone and Mineral Research (ASBMR) 2022 Annual= Congress, taking place from 9th =E2=80=93 12th September in Austin, Texas,= USA.=C2=A0 DXA-based modelling enables estimation of cortical and trabecular bone para= meters comparable to QCT measurements and generates outputs to visualize an= d monitor osteoporosis (OP) treatment. =C2=A0In both analyses, Lewiecki et = al. used DXA-based modelling of the hip to assess 3D bone changes and map t= he distribution of changes in bone parameters over time in patients from FR= AME, ARCH and STRUCTURE.^1 In the first abstract, Lewiecki et al. looked at 3D modelling from hip DXA = scans in postmenopausal women with osteoporosis who received oral bisphosph= onate therapy for =E2=89=A53 years and ALN for =E2=89=A51 year prior to scr= eening, and were randomized to ROMO or a comparator (STRUCTURE: teriparatid= e [TPTD]) for 12 months. The analysis found greater increases in CvBMD, Cth= , CsBMD and TvBMD from as early as Month 6 following treatment with ROMO vs= TPTD, with additional gains observed through to Month 12. The results also= showed TPTD treatment led to a loss in CvBMD, Cth and CsBMD.^2=C2=A0 Another abstract by Lewiecki et al. reported the results of a post-hoc anal= ysis from the FRAME and ARCH studies. Postmenopausal women with osteoporosi= s were randomized to romosozumab 210 mg monthly (ROMO) or a comparator (FRA= ME: PBO; ARCH: alendronate [ALN] 70 mg) for 12 months. After 12 months, all= patients received denosumab (DMAB) in FRAME or ALN in ARCH. 3D modelling f= rom hip DXA scans found that at Month 12, treatment with ROMO vs PBO in FRA= ME and ROMO vs ALN in ARCH resulted in greater increases in cortical volume= tric bone mineral density (CvBMD), cortical thickness (Cth), cortical surfa= ce BMD (CsBMD) and trabecular volumetric BMD (TvBMD). At month 24, the cumu= lative gains in CvBMD, Cth, CsBMD and TvBMD were greater in the ROMO/DMAB v= s PBO/DMAB sequence (P<0.001) and in the ROMO/ALN vs ALN/ALN sequence (P<0.= 05).^1 This data further corroborates the Cosman et al. and McClung et al. = studies that showed greater BMD gains, reduced new vertebral fracture incid= ence and lower incidence of clinical, non-vertebral and hip fractures with = ROMO/DMAB treatment, and significant improved bone microarchitecture with R= OMO/ALN treatment, respectively.^3,4 =C2=A0 Osteoporosis is the most common chronic metabolic bone disease.^5 Character= ised by compromised bone strength, the condition causes approximately 9 mil= lion fractures each year.^5,6 Fragility fractures can result in significant= burden on a person=E2=80=99s life, often making everyday activities such a= s eating, dressing, shopping or driving difficult.^7 =E2=80=9CAs people are living longer, the burden of fragility fractures due= to osteoporosis requires effective addressing. So we are proud to communic= ate additional data supporting romosozumab as a bone forming option for pos= tmenopausal women with severe osteoporosis at high risk of fracture,=E2=80= =9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions = & Head of US, UCB. =E2=80=9CASBMR 2022 provides an integral forum for clini= cians and scientists around the world to come together and share the latest= breakthroughs and innovations and so we at UCB are proud to be participati= ng with a wealth of scientific research this year. Our goal is to ensure os= teoporosis care is a priority now and in the future, so we can continue to = improve patient outcomes.=E2=80=9D=C2=A0 During ASBMR 2022, UCB and Amgen showcased their commitment to the screenin= g, treatment, and management of osteoporosis with the presentation of a tot= al of 19 abstracts.=C2=A0 UCB & Amgen abstracts: =C2=B7 One Year of Romosozumab Followed by One Year of Denosumab Compared W= ith Two Years of Denosumab: BMD and Fracture Results From the FRAME and FRA= ME Extension Studies. F. Cosman, M. Oates, D. Betah, S. Ferrari, J. Timosha= nko, Z. Wang, M. McClung=C2=A0 =C2=B7 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. Wan= i, M. Packalen, S. Avcil, S. Li, M.S. Farris, E. Graves, S. McMullen, T. Ol= iveira=C2=A0 =C2=B7 Current trends in osteoporosis epidemiology and the widening treatme= nt gap among commercially-insured postmenopausal women in the United States= (US). M. Kim, P. Samai, M. Phelan, M. McDermott, C. Deignan, T. Lin, M.A. = Brookhart =C2=B7 Cortical and trabecular bone improvements with romosozumab followed = by denosumab or alendronate assessed using 3D modeling from DXA images. E.M= . Lewiecki, D. Betah, L. Humbert, C. Libanati, M. Oates, Y. Shi, R. Winzenr= ieth, S. Ferrari, F. Omura =C2=B7 Comparison of romosozumab and teriparatide effects on cortical and t= rabecular bone using 3D modeling from DXA images in postmenopausal women tr= ansitioning from bisphosphonate therapy. E.M. Lewiecki, D. Betah, L. Humber= t, C. Libanati, M. Oates, Y. Shi, R. Winzenrieth, S. Ferrari, F. Omura =C2=B7 Clinical Characteristics, Including History of Myocardial Infarction= and Stroke, Among US PMO Women Initiating Treatment with Romosozumab and O= ther Antiosteoporosis Therapies. T. Lin, Y. Liu, T. Arora, M. Oates, C. Dei= gnan, Z. Yu, J.R. Curtis=C2=A0 =C2=B7 Effect of Romosozumab on Bone Microarchitecture as Assessed by Tissu= e Thickness=E2=80=93Adjusted Trabecular Bone Score in Postmenopausal Women = with Osteoporosis: Results from the ARCH Study. M.R. McClung, D. Betah, B.Z= . Leder, D.L. Kendler, M. Oates, J. Timoshanko, Z. Wang =C2=B7 Romosozumab Efficacy in Postmenopausal Women Without Prior Fracture = Who Fulfill AACE Criteria for Osteoanabolic Therapy: Post-Hoc Analysis of C= linical Trial Data. M. McClung, D. Betah, C. Deignan, Y. Shi, J. Timoshanko= , F. Cosman=C2=A0 =C2=B7 Crystal Bone: Validation of a Novel AI/ML Algorithm in the Optum Rel= iant dataset to Identify Patients at Risk of Osteoporotic Fracture in the N= ext 2 Years. E. Mody, R. Yood, C. Deignan, T. Rosenflanz, P. Zhang, T. Kell= ey, N. Payne, C. Andersen=C2=A0 =C2=B7 Crystal Bone: Validation of a Novel AI/ML Algorithm in the Stanford = Health Care dataset to Identify Patients at Risk of Osteoporotic Fracture i= n the Next 2 Years. D.E. Sellmeyer, C. Deignan, T. Rosenflanz, Y. Nazarenko= , P. Zhang, C. Andersen=C2=A0 =C2=B7 One- and five-year survival after fragility fracture: Real-world ret= rospective matched-cohort study in Ontario, Canada. G. Vincent, J.D. Adachi= , E. Schemitsch, J. Tarride, M. Luen, R.J. Wani, J.P. Brown =C2=B7 The Impact of Osteoporotic Fractures on Activities of Daily Living a= nd the Indirect Economic Measures in Five Countries. E. Yeh, O. Rajkovic-Ho= oley, M. Silvey, W.S. Ambler, R. Pinedo-Villanueva, N. Harvey, A. Moayyeri= =C2=A0 Research Collaboration abstracts supported by UCB and Amgen:=C2=A0 =C2=B7 Gradients of risk of clinical risk factors for hip and vertebral fra= cture depend on age and are typically larger at younger age. K. Engelke, C.= C. Gl=C3=BCer, M. Kistler, F. Thomasius, P. Hadji, B. Schweikert, C. Libana= ti, A. Moayyeri=C2=A0 =C2=B7 Retrospective Standalone Performance Testing of a Machine Learning A= lgorithm for Opportunistically Detecting Vertebral Fractures on Chest and A= bdomen CT images in a Chinese population. J. Nicolaes, Y. Liu, P. Huang, Y.= Zhao, L. Wang, A. Yu, J. Dunkel, C. Libanati, X. Cheng=C2=A0 =C2=B7 Evaluation of Romosozumab=E2=80=99s Effects on Bone Marrow Adiposity= in Postmenopausal Osteoporotic Women: Results from The FRAME Bone Biopsy S= ub-Study. P. Chavassieux, J.P. Roux, C. Libanati, Y Shi, R. Chapurlat=C2=A0 =C2=B7 Neurological Clinical Risk Factors For Fracture =E2=80=93 an underap= preciated domain: ICD Code-Based Analysis of a German Health Insurance Data= base. F. Thomasius, K. Engelke, P. Hadji, M. Kistler, B. Schweikert, A. Moa= yyeri, C. Libanati, C.C. Gl=C3=BCer =C2=B7 Gradients of risk of clinical risk factors for hip and vertebral fra= cture are generally larger in men than in women: results from a large healt= h insurance database. C.C. Gl=C3=BCer, K. Engelke, M. Kistler, F. Thomasius= , P. Hadji, B. Schweikert, A. Moayyeri, C. Libanati=C2=A0 =C2=B7 Inhibition/deletion of Wise (Sostdc1) potentiates cortical bone buil= ding effects of Sost deficiency. R.B. Choi, G.G. Loots, A.G. Robling (abstr= act #XX) =C2=B7 Nmp4 Underlies the Treatment Plateaus of Osteoanabolics. C. Korff, E= .G. Atkinson, D.J. Horan, M. Adaway, A.G. Robling, J.P. Bidwell=C2=A0 For further information, contact UCB:=C2=A0 Global Communications Adriaan Snauwaert T+32 497 70 23 46 Adriaan.snauwaert@ucb.com Investor Relations Antje Witte T +32 2 559 9414 Antje.witte@ucb.com=C2=A0 About the study methodology and patient population FRAME and ARCH (Lewiecki et al.) Postmenopausal women with osteoporosis were randomized to romosozumab (ROMO= ) 210 mg monthly or comparator (FRAME: PBO; ARCH: alendronate [ALN] 70mg) f= or 12 months. After 12 months all patients received denosumab (DMAB) in FRA= ME or ALN in ARCH. For each study, data from a subset of 200 randomly selec= ted women per treatment group who had total hip DXA scans at baseline (BL),= month (M) 12, and M24 and had provided consent for future research were in= cluded in the analysis. Percentage change from BL to M12 and M24 in cortica= l volumetric BMD (CvBMD), cortical thickness (Cth), cortical surface BMD (C= sBMD), and trabecular vBMD (TvBMD) were evaluated. Percentage changes were = assessed by repeated measures model adjusting for baseline covariates. STRUCTURE (Lewiecki et al.) Postmenopausal women with osteoporosis who had received oral bisphosphonate= (BP) therapy for =E2=89=A53 years and ALN for =E2=89=A51 year prior to scr= eening were then randomized 1:1 to receive open-label ROMO or teriparatide = (TPTD) for 12M. Data from women who had total hip DXA scans at baseline (BL= ), M6, and M12 and had provided consent for future research were included i= n this analysis. Data from 308 women from STRUCTURE (ROMO, 160; TPTD, 148) = who had evaluable 3D assessments at BL, M6, and M12 were analyzed. Percenta= ge change from BL to M6 and M12 in cortical vBMD (CvBMD), cortical thicknes= s (Cth), cortical surface BMD (CsBMD), and TvBMD were evaluated. Percentage= changes were assessed by repeated measures model adjusting for BL covariat= es. About EVENITY=C2=AE=E2=96=BC (romosozumab)^8 Romosozumab is a bone-forming monoclonal antibody. It is designed to work b= y inhibiting the activity of sclerostin, which simultaneously results in in= creased bone formation and to a lesser extent decreased bone resorption. Th= e romosozumab development program includes 19 clinical studies that enrolle= d approximately 14,000 patients. EVENITY has been studied for its potential= to reduce the risk of fractures in an extensive global phase 3 program tha= t included two large fracture trials comparing romosozumab to either placeb= o or active comparator in over 11,000 postmenopausal women with osteoporosi= s. Amgen and UCB are co-developing romosozumab.=E2=96=BCThis product is sub= ject to additional monitoring. This will allow quick identification of new = safety information. Healthcare professionals are asked to report any suspec= ted adverse reactions. Important Safety Information about EVENITY^=C2=AE (romosozumab) in the EU/E= EA In the EU, Romosozumab is indicated for treatment of severe osteoporosis in= postmenopausal women at high risk of fracture. Contraindications: Romosozu= mab is contraindicated in patients who are allergic to romosozumab or any o= f the excipients, who have low levels of calcium in the blood (hypocalcaemi= a), or who have a history of myocardial infarction (heart attack) or stroke= . Myocardial infarction or stroke: Heart attack and stroke have been report= ed in patients receiving Romosozumab in randomised controlled trials (uncom= mon). Treatment with Romosozumab should not be initiated in patients with a= history of heart attack or stroke. When determining whether to use Romosoz= umab for an individual patient, the presence of risk factors for cardiovasc= ular problems, including established cardiovascular disease, high blood pre= ssure, 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 myoc= ardial infarction or stroke during therapy, treatment with Romosozumab shou= ld be discontinued. Hypocalcaemia: Transient hypocalcaemia has been observe= d in patients receiving Romosozumab. Hypocalcaemia should be corrected prio= r to initiating therapy with Romosozumab and patients should be monitored f= or signs and symptoms of hypocalcaemia. If any patient presents with suspec= ted symptoms of hypocalcaemia during treatment, calcium levels should be me= asured. 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 ris= k of developing hypocalcaemia and the safety data for these patients are li= mited. Calcium levels should be monitored in these patients. Hypersensitivi= ty: Clinically significant hypersensitivity reactions, including angioedema= , erythema multiforme, and urticaria occurred in the Romosozumab group in c= linical trials. If an anaphylactic or other clinically significant allergic= reaction occurs, appropriate therapy should be initiated and use of Romoso= zumab should be discontinued. Osteonecrosis of the Jaw: Osteonecrosis of th= e jaw (ONJ) has been reported rarely in patients receiving Romosozumab. The= following risk factors should be considered when evaluating a patient=E2= =80=99s risk of developing ONJ: (1) potency of the medicinal product that i= nhibits bone resorption (the risk increases with the antiresorptive potency= of the compound), and cumulative dose of bone resorption therapy, (2) canc= er, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking= , (3) concomitant therapies: corticosteroids, chemotherapy, angiogenesis in= hibitors, radiotherapy to head and neck, (4) poor oral hygiene, periodontal= disease, poorly fitting dentures, history of dental disease, invasive dent= al procedures e.g. tooth extractions. All patients should be encouraged to = maintain good oral hygiene and receive routine dental check-ups. Dentures s= hould fit correctly. Patients under dental treatment, or who will undergo d= ental surgery (e.g. tooth extractions) whilst being treated with Romosozuma= b should inform their doctor about their dental treatment and inform their = dentist that they are receiving Romosozumab. Patients should immediately re= port any oral symptoms such as dental mobility, pain or swelling or non-hea= ling 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 condi= tion resolves and contributing risk factors are mitigated where possible. A= typical Femoral Fractures: Atypical low-energy or low trauma fracture of th= e femoral shaft, which can occur spontaneously, has been reported rarely in= patients receiving Romosozumab. Any patient who presents with new or unusu= al thigh, hip, or groin pain should be suspected of having an atypical frac= ture and should be evaluated to rule out an incomplete femur fracture. Pati= ent presenting with an atypical femur fracture should also be assessed for = symptoms and signs of fracture in the contralateral limb. Interruption of R= omosozumab therapy should be considered, based on an individual benefit-ris= k assessment. Adverse Reactions: The most common adverse reactions were nas= opharyngitis (13.6%) and arthralgia (12.4%). Common adverse reactions inclu= ded hypersensitivity, sinusitis, rash, dermatitis, headache, neck pain, mus= cle spasms and injection site reactions (most frequent injection site react= ions were pain and erythema). Uncommon adverse reactions were urticaria, hy= pocalcaemia, 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 erup= tion (erythema multiforme). EVENITY^=C2=AE is a registered trademark of the UCB Group of Companies.=C2= =A0 About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With more than 8 000 people op= erating in more than 40 countries, the company generated revenue of =E2=82= =AC5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). F= ollow 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 tar= geting the protein sclerostin. As part of this agreement, the two companies= continue to collaborate on the development of romosozumab for the treatmen= t of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB= are joining forces to translate a genetic discovery into a new medicine, t= urning conceptual science into a reality. Forward looking statements=C2=A0 This press release contains forward-looking statements based on current pla= ns, estimates and beliefs of management. All statements, other than stateme= nts of historical fact, are statements that could be deemed forward-looking= statements, including estimates of revenues, operating margins, capital ex= penditures, cash, other financial information, expected legal, political, r= egulatory or clinical results and other such estimates and results. By thei= r nature, such forward-looking statements are not guarantees of future perf= ormance and are subject to risks, uncertainties and assumptions which could= cause actual results to differ materially from those that may be implied b= y such forward-looking statements contained in this press release. Importan= t factors that could result in such differences include: changes in general= economic, business and competitive conditions, the inability to obtain nec= essary regulatory approvals or to obtain them on acceptable terms, costs as= sociated with research and development, changes in the prospects for produc= ts in the pipeline or under development by UCB, effects of future judicial = decisions or governmental investigations, product liability claims, challen= ges to patent protection for products or product candidates, changes in law= s or regulations, exchange rate fluctuations, changes or uncertainties in t= ax laws or the administration of such laws and hiring and retention of its = employees.=C2=A0 UCB is providing this information as of the date of this press release and = expressly disclaims any duty to update any information contained in this pr= ess release, either to confirm the actual results or to report a change in = its expectations. There is no guarantee that new product candidates in the = pipeline will progress to product approval or that new indications for exis= ting products will be developed and approved. Products or potential product= s which are the subject of partnerships, joint ventures or licensing collab= orations may be subject to differences between the partners. Also, UCB or o= thers could discover safety, side effects or manufacturing problems with it= s products after they are marketed. Moreover, sales may be impacted by inte= rnational and domestic trends toward managed care and health care cost cont= ainment and the reimbursement policies imposed by third-party payers as wel= l as legislation affecting biopharmaceutical pricing and reimbursement. References 1. Lewiecki E.M., Betah D., Humbert L., Libanati C., Oates M., Shi Y., Winz= enrieth R., Ferrari S., Omura F. Cortical and trabecular bone improvements = with romosozumab followed by denosumab or alendronate assessed using 3D mod= eling from DXA images. Abstract=C2=A0 2. Lewiecki E.M., Betah D., Humbert L., Libanati C., Oates M., Shi Y., Winz= enrieth R., Ferrari S., Omura F. Comparison of romosozumab and teriparatide= effects on cortical and trabecular bone using 3D modeling from DXA images = in postmenopausal women transitioning from bisphosphonate therapy.=C2=A0 3. Cosman F., Oates M., Betah D., Ferrari S., Timoshanko J., Wang Z., McClu= ng M. One Year of Romosozumab Followed by One Year of Denosumab Compared Wi= th Two Years of Denosumab: BMD and Fracture Results From the FRAME and FRAM= E Extension Studies.=C2=A0 4. McClung M.R., Betah D., Leder B.Z., Kendler D.L., Oates M., Timoshanko J= ., Wang Z. Effect of Romosozumab on Bone Microarchitecture as Assessed by T= issue Thickness=E2=80=93Adjusted Trabecular Bone Score in Postmenopausal Wo= men with Osteoporosis: Results from the ARCH Study.=C2=A0 5. S=C3=B6zen T., =C3=96z=C4=B1=C5=9F=C4=B1k L., Ba=C5=9Faran N.=C3=87. An = overview and management of osteoporosis. Eur J Rheumatol. 2017;4(1):46-56 6. Johnell O., Kanis, J.A. An estimate of the worldwide prevalence and disa= bility associated with osteoporotic fractures. Osteoporosis Int, 2006. 17(1= 2):1726-33 7. IOF SCOPE report 2021 [Online]. Available at: https://www.osteoporosis.f= oundation/sites/iofbonehealth/files/2021-06/Kanis2021_Article_SCOPE2021ANew= ScorecardForOsteo.pdf (Last accessed August 2022) 8. Evenity^=C2=AE SmPC, current version. GenericFile 220908 ASBMR 2022 data and curtain raiser press release FINAL ENG (https://= mb.cision.com/Public/18595/3626810/9f3b7a172fdc55a1.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x115450x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium

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