UCB (EBR:UCB) UCB Media Room: bimekizumab data at ACR 2022

Transparency directive : regulatory news

10/11/2022 07:00

https://mb.cision.com/Public/18595/3664497/8a15d6f32cb1113b_800x800ar.png ** Bimekizumab Demonstrated Sustained Clinical Responses to Week 52 in Phas= e 3 Studies in Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthriti= s and Ankylosing Spondylitis ------------------------------------------------------------ =C2=B7 New late-breaking 52-week data from Phase 3 bimekizumab investigatio= nal studies in psoriatic arthritis and across the spectrum of axial spondyl= oarthritis, including non-radiographic axial spondyloarthritis and ankylosi= ng spondylitis, presented at ACR Convergence 2022 =C2=B7 In BE OPTIMAL, clinical joint and skin clearance responses in psoria= tic arthritis were sustained to week 52 with bimekizumab treatment=C2=A0 =C2=B7 In BE MOBILE 1 and BE MOBILE 2, treatment with bimekizumab resulted = in sustained clinical responses to week 52, including suppression of inflam= mation and improvements in function and quality of life across the full spe= ctrum of axial spondyloarthritis=C2=A0 =C2=B7 The adverse event profile of bimekizumab to week 52 in psoriatic art= hritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis= is consistent with previous observations with no new safety signals Brussels (Belgium), 10th November 2022 =E2=80=93 07:00 (CET) =C2=A0=E2=80= =93 UCB, a global biopharmaceutical company, today announced the first pres= entation of long-term, 52-week data from three Phase 3 studies evaluating t= he efficacy and safety of bimekizumab in adults with active psoriatic arthr= itis (PsA) who were biologic-na=C3=AFve (BE OPTIMAL), in adults with active= non-radiographic axial spondyloarthritis (nr-axSpA; BE MOBILE 1), and in a= dults with active ankylosing spondylitis, also known as radiographic axSpA = (AS; BE MOBILE 2).^1,2 These late-breaking data are being presented at ACR = Convergence 2022 in Philadelphia, November 10=E2=80=9314, 2022.^1,2 The saf= ety and efficacy of bimekizumab in PsA, nr-axSpA and AS have not been estab= lished, and it is not approved for use in PsA, nr-axSpA or AS by any regula= tory authority worldwide. Data from BE OPTIMAL showed that clinical joint and skin clearance response= s in patients with active psoriatic arthritis were sustained to week 52 wit= h bimekizumab treatment.^1 In addition, data from BE MOBILE 1 and BE MOBILE= 2, showed that across the full spectrum of axSpA, encompassing nr-axSpA an= d AS, treatment with bimekizumab resulted in sustained improvement in the s= igns and symptoms of disease, including suppression of inflammation and imp= rovements in physical function and quality of life, to week 52.^2 These out= comes were consistent across both TNF-inhibitor (TNFi) na=C3=AFve and TNFi-= inadequate responder populations.^2 In all three studies, the adverse event= profile of bimekizumab was consistent with data seen in previous studies w= ith no new observed signals.^1,2=C2=A0 =E2=80=9CThe 52-week data shared today demonstrate the high thresholds of d= isease control that were achieved by the majority of patients across these = three studies. The results build on the previously announced 24-week data a= nd show that bimekizumab sustained a clinically meaningful impact for patie= nts through one year,=E2=80=9D said Emmanuel Caeymaex, Executive Vice Presi= dent, Immunology Solutions and Head of U.S., UCB. BE OPTIMAL (PsA): Phase 3 Study Results (52 weeks)^1=C2=A0 In BE OPTIMAL, patients were randomized (3:2:1) to bimekizumab (160 mg ever= y four weeks [Q4W]; N=3D431), placebo (N=3D281) or the active reference arm= (adalimumab 40 mg every two weeks [Q2W]; N=3D140). Patients initially rand= omized to placebo were switched to bimekizumab at week 16. A total of 89.3 = percent of randomized patients completed week 52. Key 52-week results from = the BE OPTIMAL study are presented below and build upon previously announce= d 16- and 24-week results (https://www.ucb.com/stories-media/Press-Releases= /article/UCB-Announces-First-Detailed-Data-from-Two-Phase-3-Bimekizumab-Stu= dies-in-Psoriatic-Arthritis-to-be-Presented-at-EULAR-2022) . =C2=B7 ACR50: At week 52, 54.5 percent of patients continuously treated wit= h bimekizumab, 53.0 percent of patients who switched from placebo to bimeki= zumab at week 16, and 50.0 percent of patients in the reference arm (adalim= umab) achieved ACR50.=C2=A0 =C2=B7 Complete Skin Clearance (PASI 100): At week 52, in patients with bas= eline psoriasis =E2=89=A53 percent body surface area^=C2=A5, 60.8 percent o= f patients continuously treated with bimekizumab, 65.0 percent of patients = who switched from placebo to bimekizumab at week 16, and 48.5 percent of pa= tients in the reference arm (adalimumab) achieved PASI 100.=C2=A0 =C2=B7 Minimal Disease Activity (MDA): At week 52, 55.0 percent of patients= continuously treated with bimekizumab, 53.7 percent of patients who switch= ed from placebo to bimekizumab at week 16, and 52.9 percent of patients in = the reference arm (adalimumab) achieved MDA. =E2=80=9CThe long-term bimekizumab data presented at ACR Convergence 2022 i= n patients with psoriatic arthritis show clinically meaningful improvements= in joint and skin outcomes through to one year. In BE OPTIMAL, at week 52,= over six out of 10 patients treated with bimekizumab achieved complete ski= n clearance and one in two patients achieved minimal disease activity. Long= -term data such as these are important since they may help to inform clinic= al decision making of the future,=E2=80=9D said Christopher Ritchlin MD, MP= H, Professor of Medicine and faculty member in the Allergy, Immunology & Rh= eumatology Division, University of Rochester Medical School, Rochester, New= York, U.S. Over 52 weeks, 79.1 percent of patients treated with bimekizumab had =E2=89= =A5 one treatment emergent adverse event (TEAE) and 80.7 percent on adalimu= mab.^1 The three most frequent TEAEs with bimekizumab treatment were nasoph= aryngitis (12.0 percent), upper respiratory tract infection (7.1 percent) a= nd urinary tract infection (6.1 percent).^1 =C2=A0 BE MOBILE 1 and BE MOBILE 2 (axSpA): Phase 3 Study Results (52 weeks)^2 In BE MOBILE 1 and BE MOBILE 2, patients were randomized to bimekizumab (16= 0 mg Q4W; N=3D128 for BE MOBILE 1 and N=3D221 for BE MOBILE 2) or to placeb= o (N=3D126 for BE MOBILE 1 and N=3D111 for BE MOBILE 2). Patients initially= randomized to placebo were switched to bimekizumab at week 16. A total of = 86.6 percent randomized patients with nr-axSpA and 89.8 percent with AS com= pleted week 52. Key 52-week results from the BE MOBILE 1 and BE MOBILE 2 st= udies are presented below and build upon previously announced 16- and 24-we= ek results (https://www.ucb.com/stories-media/Press-Releases/article/First-= Presentations-of-Phase-3-Data-for-Bimekizumab-Across-the-Full-Spectrum-of-A= xial-Spondyloarthritis-to-be-Shared-at-EULAR-2022) : =C2=B7 ASAS40: At week 52, 60.9 percent of nr-axSpA patients and 58.4 perce= nt of AS patients continuously treated with bimekizumab achieved ASAS40, wi= th consistent outcomes across both TNFi-na=C3=AFve and TNFi-inadequate resp= onder populations.=C2=A0 =C2=B7 Low Disease Activity and Remission: At week 52, 61.6 percent of nr-a= xSpA patients and 57.1 percent of AS patients continuously treated with bim= ekizumab achieved low disease activity (ASDAS<2.1); at week 52, inactive di= sease or clinical remission (ASDAS<1.3) was achieved by 25.2 percent of nr-= axSpA patients and 23.4 percent of AS patients continuously treated with bi= mekizumab. =C2=B7 Objective Inflammation: The reductions from baseline in objective si= gns of inflammation (Magnetic Resonance Imaging [MRI], hs-C-Reactive Protei= n [hs-CRP]) for patients with nr-axSpA and AS were sustained through week 5= 2. In addition, improvements in function as measured by the Bath Ankylosing Sp= ondylitis Functional Index (BASFI) and quality of life, as measured by Anky= losing Spondylitis Quality of Life (ASQoL), were sustained through week 52. =E2=80=9CResults presented today from BE MOBILE 1 and BE MOBILE 2 demonstra= te that treatment with bimekizumab provided consistent and sustained improv= ements to one year in key signs and symptoms across the full spectrum of ax= ial spondyloarthritis, with similar outcomes regardless of previous treatme= nt with TNF inhibitors. These positive results are the first Phase 3 data e= valuating a dual IL-17A and IL-17F inhibitor, bimekizumab, in the long-term= treatment of patients living with non-radiographic axial spondyloarthritis= and ankylosing spondylitis,=E2=80=9D said Professor Xenofon Baraliakos, Rh= eumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Germany. Over 52 weeks, 75.0 percent of nr-axSpA patients treated with bimekizumab a= nd 75.5 percent of AS patients had =E2=89=A51 TEAE.^2 The most frequent TEA= Es were nasopharyngitis (nr-axSpA 12.3 percent; AS 9.1 percent), upper resp= iratory tract infection (nr-axSpA 9.4 percent; AS 6.4 percent) and oral can= didiasis (nr-axSpA 7.4 percent; AS 6.1 percent); few COVID-19 infections we= re reported (nr-axSpA: 7.0 percent; AS; 2.1 percent).^2 The incidence of se= rious TEAEs was low (nr-axSpA 4.4 percent; AS 7.1 percent).^2 =C2=A0 Notes to editors: The primary endpoint in the BE OPTIMAL study was ACR50 at week 16 with rank= ed secondary endpoints including PASI90 and MDA at week 16; the primary end= point in the BE MOBILE 1 and BE MOBILE 2 studies was ASAS40 at week 16. ^=C2=A5In patients with psoriasis affecting =E2=89=A53% body surface area a= t baseline; n=3D217 for patients continuing treatment with bimekizumab; n= =3D140 for patients switching from placebo to bimekizumab at week 16 and n= =3D68 for patients continuing treatment with adalimumab=C2=A0 About Psoriatic Arthritis Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic syste= mic inflammatory condition affecting both the joints and skin, with a preva= lence of 0.02 percent to 0.25 percent of the population, and 6 percent to 4= 1 percent of patients with psoriasis.^3 Symptoms include joint pain and sti= ffness, skin plaques, swollen toes and fingers (dactylitis), and inflammati= on of the sites where tendons or ligaments insert into the bone (enthesitis= ).^4 About Axial Spondyloarthritis Axial Spondyloarthritis (axSpA), which includes both non-radiographic axSpA= and ankylosing spondylitis (AS), also known as radiographic axSpA (r-axSpA= ), is a chronic, immune-mediated, inflammatory disease.^5 nr-axSpA is defin= ed clinically by the absence of definitive x-ray evidence of structural dam= age to the sacroiliac joints.^5 AxSpA is a painful condition that primarily= affects the spine and the joints linking the pelvis and lower spine (sacro= iliac joints).^5 The leading symptom of axSpA in a majority of patients is = inflammatory back pain that improves with exercise, but not with rest.^5 Ot= her common clinical features frequently include anterior uveitis, enthesiti= s, peripheral arthritis, psoriasis, inflammatory bowel disease and dactylit= is.^5 The overall prevalence of axSpA is 0.3 percent to 1.2 percent of adul= ts.^6,7 Approximately half of all patients with axSpA are patients with nr-= axSpA.^5 AxSpA onset usually occurs before the age of 45.^5 Approximately 1= 0 to 40 percent of patients with nr-axSpA progress to ankylosing spondyliti= s over 2 to 10 years.^5 About bimekizumab Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to sel= ectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)= , two key cytokines driving inflammatory processes.^8,9 In August 2021, bim= ekizumab was approved in the European Union (EU)/European Economic Area (EE= A) and in Great Britain, for the treatment of moderate to severe plaque pso= riasis in adults who are candidates for systemic therapy.^9,10 The label in= formation may differ in other countries. Please check local prescribing inf= ormation. In the U.S., the efficacy and safety of bimekizumab have not been= established for any indication and it is not approved by the U.S. Food and= Drug Administration (FDA). BIMZELX^=C2=AE =E2=96=BC(bimekizumab) EU/EEA Important Safety Information i= n Psoriasis^9 The most frequently reported adverse reactions with bimekizumab were upper = respiratory tract infections (14.5%) (most frequently nasopharyngitis) and = oral candidiasis (7.3%). Common adverse reactions (=E2=89=A51/100 to <1/10)= were oral candidiasis, tinea infections, ear infections, herpes simplex in= fections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headach= e, dermatitis and eczema, acne, injection site reactions and fatigue. Elder= ly may be more likely to experience certain adverse reactions such as oral = candidiasis, dermatitis and eczema when using bimekizumab. Bimekizumab is contraindicated in patients with hypersensitivity to the act= ive substance or any of the excipients and in patients with clinically impo= rtant active infections (e.g. active tuberculosis).=C2=A0 Bimekizumab may increase the risk of infections. Treatment with bimekizumab= must not be administered in patients with any clinically important active = infection. Patients treated with bimekizumab should be instructed to seek m= edical advice if signs or symptoms suggestive of an infection occur. Prior = to initiating treatment with bimekizumab, patients should be evaluated for = tuberculosis (TB) infection. Bimekizumab should not be given in patients wi= th active TB and patients receiving bimekizumab should be monitored for sig= ns and symptoms of active TB.=C2=A0 Cases of new or exacerbations of inflammatory bowel disease have been repor= ted with bimekizumab. Bimekizumab is not recommended in patients with infla= mmatory bowel disease. If a patient develops signs and symptoms of inflamma= tory bowel disease or experiences an exacerbation of pre-existing inflammat= ory bowel disease, bimekizumab should be discontinued and appropriate medic= al management should be initiated. Serious hypersensitivity reactions inclu= ding anaphylactic reactions have been observed with IL-17 inhibitors. If a = serious hypersensitivity reaction occurs, administration of bimekizumab sho= uld be discontinued immediately and appropriate therapy initiated.=C2=A0 Live vaccines should not be given in patients treated with bimekizumab. Please consult the summary of product characteristics in relation to other = side effects, full safety and prescribing information. https://www.ema.euro= pa.eu/en/documents/product-information/bimzelx-epar-product-information_en.= pdf EU summary of product characteristics date of revision: May 2022. Last accessed: November 2022.=C2=A0=C2=A0 =C2=A0 =E2=96=BC=C2=A0This medicinal product is subject to additional monitoring. = This will allow quick identification of new safety information. Healthcare = professionals are asked to report any suspected adverse reactions=C2=A0 For further information, contact UCB:=C2=A0 Investor Relations Antje Witte T +32.2.559.94.14=C2=A0 email antje.witte@ucb.com=C2=A0 Corporate Communications Laurent Schots=C2=A0 T +32.2.559.92.64=C2=A0 email laurent.schots@ucb.com Brand Communications Eimear O=E2=80=99Brien T +32.2.559.92.71 email eimear.obrien@ucb.com=C2=A0 About UCB=C2=A0 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 approximately 8,600 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Foll= ow us on Twitter: @UCB_news. Forward looking statements=C2=A0 This press release may contain forward-looking statements including, withou= t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, = =E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends= =E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim= ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont= inue=E2=80=9D and similar expressions. These forward-looking statements are= based on current plans, estimates and beliefs of management. All statement= s, other than statements of historical facts, are statements that could be = deemed forward-looking statements, including estimates of revenues, operati= ng margins, capital expenditures, cash, other financial information, expect= ed legal, arbitration, political, regulatory or clinical results or practic= es and other such estimates and results. By their nature, such forward-look= ing statements are not guarantees of future performance and are subject to = known and unknown risks, uncertainties and assumptions which might cause th= e actual results, financial condition, performance or achievements of UCB, = or industry results, to differ materially from those that may be expressed = or implied by such forward-looking statements contained in this press relea= se. Important factors that could result in such differences include: the gl= obal spread and impact of COVID-19, changes in general economic, business a= nd competitive conditions, the inability to obtain necessary regulatory app= rovals or to obtain them on acceptable terms or within expected timing, cos= ts associated with research and development, changes in the prospects for p= roducts in the pipeline or under development by UCB, effects of future judi= cial decisions or governmental investigations, safety, quality, data integr= ity or manufacturing issues; potential or actual data security and data pri= vacy breaches, or disruptions of our information technology systems, produc= t liability claims, challenges to patent protection for products or product= candidates, competition from other products including biosimilars, changes= in laws or regulations, exchange rate fluctuations, changes or uncertainti= es in tax laws or the administration of such laws, and hiring and retention= of its employees. There is no guarantee that new product candidates will b= e discovered or identified in the pipeline, will progress to product approv= al or that new indications for existing products will be developed and appr= oved. Movement from concept to commercial product is uncertain; preclinical= results do not guarantee safety and efficacy of product candidates in huma= ns. So far, the complexity of the human body cannot be reproduced in comput= er models, cell culture systems or animal models. The length of the timing = to complete clinical trials and to get regulatory approval for product mark= eting has varied in the past and UCB expects similar unpredictability going= forward. Products or potential products, which are the subject of partners= hips, joint ventures or licensing collaborations may be subject to differen= ces disputes between the partners or may prove to be not as safe, effective= or commercially successful as UCB may have believed at the start of such p= artnership. UCB=E2=80=99s efforts to acquire other products or companies an= d to integrate the operations of such acquired companies may not be as succ= essful as UCB may have believed at the moment of acquisition. Also, UCB or = others could discover safety, side effects or manufacturing problems with i= ts products and/or devices after they are marketed. The discovery of signif= icant problems with a product similar to one of UCB=E2=80=99s products that= implicate an entire class of products may have a material adverse effect o= n sales of the entire class of affected products. Moreover, sales may be im= pacted by international and domestic trends toward managed care and health = care cost containment, including pricing pressure, political and public scr= utiny, customer and prescriber patterns or practices, and the reimbursement= policies imposed by third-party payers as well as legislation affecting bi= opharmaceutical pricing and reimbursement activities and outcomes. Finally,= a breakdown, cyberattack or information security breach could compromise t= he confidentiality, integrity and availability of UCB=E2=80=99s data and sy= stems.=C2=A0 Given these uncertainties, you should not place undue reliance on any of su= ch forward-looking statements. There can be no guarantee that the investiga= tional or approved products described in this press release will be submitt= ed or approved for sale or for any additional indications or labelling in a= ny market, or at any particular time, nor can there be any guarantee that s= uch products will be or will continue to be commercially successful in the = future. UCB is providing this information, including forward-looking statements, on= ly as of the date of this press release and it does not reflect any potenti= al impact from the evolving COVID-19 pandemic, unless indicated otherwise. = UCB is following the worldwide developments diligently to assess the financ= ial significance of this pandemic to UCB. UCB expressly disclaims any duty = to update any information contained in this press release, either to confir= m the actual results or to report or reflect any change in its forward-look= ing statements with regard thereto or any change in events, conditions or c= ircumstances on which any such statement is based, unless such statement is= required pursuant to applicable laws and regulations.=C2=A0 Additionally, information contained in this document shall not constitute a= n offer to sell or the solicitation of an offer to buy any securities, nor = shall there be any offer, solicitation or sale of securities in any jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction.=C2=A0 References=C2=A0 1. Ritchlin C, Coates L, McInnes I, et al. Bimekizumab treatment in biologi= c DMARD-na=C3=AFve patients with active psoriatic arthritis: 52-week effica= cy and safety results from a Phase 3, randomized, placebo-controlled, activ= e reference study. #L02 Presented at ACR Convergence 2022. https://acrabstr= acts.org/abstract/bimekizumab-treatment-in-biologic-dmard-naive-patients-wi= th-active-psoriatic-arthritis-52-week-efficacy-and-safety-results-from-a-ph= ase-3-randomized-placebo-controlled-active-reference-study/=C2=A0 =C2=A0 2. Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab maintains = improvements in efficacy endpoints and has a consistent safety profile thro= ugh 52 weeks in patients with non-radiographic axial spondyloarthritis and = ankylosing spondylitis: results from two parallel Phase 3 studies. #L14 Pre= sented at ACR Convergence 2022. https://acrabstracts.org/abstract/bimekizum= ab-maintains-improvements-in-efficacy-endpoints-and-has-a-consistent-safety= -profile-through-52-weeks-in-patients-with-non-radiographic-axial-spondyloa= rthritis-and-ankylosing-spondylitis-resu/=C2=A0 3. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Cli= n North Am. 2015; 41(4): 545=E2=80=93568. 4. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the di= agnosis and pharmacologic treatment of psoriatic arthritis in patients with= psoriasis. Drugs. 2014; 74:423-441. 5. Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed C= are. Am J Manag Care. 2019;25:S319-S330. 6. Reveille J, Witter J, Weisman M. Prevalence of axial spondylarthritis in= the United States: estimates from a cross-sectional survey. Arthritis Care= Res. 2012;64(6):905-910. 7. Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondylo= arthritis in the UK: a cross-sectional cohort study. BMC Musculoskelet Diso= rd. 2015;21;16:392. 8. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi= mekizumab, a humanized monoclonal =C2=A0 =C2=A0antibody and selective dual = inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 201= 7;83(5):991-1001. 9. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics.=C2= =A0https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-= product-information_en.pdf. Last accessed: November 2022. 10. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. htt= ps://www.medicines.org.uk/emc/product/12834; https://www.medicines.org.uk/e= mc/product/12833. Last accessed: November 2022. GenericFile UCB PR ACR 2022 ENG (https://mb.cision.com/Public/18595/3664497/b625afe91f4= 02dbd.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x121320x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium

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