UCB (EBR:UCB) New Three-Year BIMZELX®▼ (bimekizumab) Data Reinforce Long-Term Maintenance of Complete Skin Clearance in Moderate to Severe Plaque Psoriasis

Transparency directive : regulatory news

07/09/2022 07:01

https://mb.cision.com/Public/18595/3626545/96782afa209d40cc_800x800ar.png ** New Three-Year BIMZELX^=C2=AE=E2=96=BC (bimekizumab) Data Reinforce Long= -Term Maintenance of Complete Skin Clearance in Moderate to Severe Plaque P= soriasis ------------------------------------------------------------ =C2=B7 Three-year data from the BE BRIGHT open-label extension study are be= ing presented at the 31st EADV Congress =C2=A0 =C2=B7 Over eight out of 10 patients who achieved complete skin clearance (= PASI 100) at week 16 maintained PASI 100 responses and health-related quali= ty of life outcomes through to three years=C2=A0 =C2=B7 Analysis of pooled safety data from up to three years of treatment i= n Phase 2 and 3 clinical trials showed bimekizumab was generally well toler= ated with no new safety signals identified over three years Brussels (Belgium), 7th September 2022 =E2=80=93 07:00 (CEST) =E2=80=93 UCB= , a global biopharmaceutical company, today announced new three-year result= s from the BE BRIGHT open-label extension (OLE) study evaluating the long-t= erm safety, tolerability and efficacy of BIMZELX^=C2=AE (bimekizumab) in ad= ults with moderate to severe plaque psoriasis who completed one of three pi= votal Phase 3 studies.^1 These data, together with a three-year safety anal= ysis of pooled data from Phase 2 and Phase 3 studies^2 are being presented = at the 31st European Academy of Dermatology and Venereology (EADV) Congress= in Milan, Italy, September 7=E2=80=9310. A total of eleven abstracts highl= ighting data related to bimekizumab in psoriasis are being presented at the= congress. Bimekizumab is the first selective IL-17A and IL-17F inhibitor to be approv= ed in the European Union for the treatment of moderate to severe plaque pso= riasis in adults who are candidates for systemic therapy.^3 Data presented from the BE BRIGHT OLE study showed that over eight out of 1= 0 patients who achieved complete skin clearance (PASI 100) following 16 wee= ks of bimekizumab treatment maintained PASI 100 response and health-related= quality of life outcomes through to three years with continuous maintenanc= e dosing.* In addition, approximately nine out of 10 patients who achieved = absolute PASI (PASI =E2=89=A42) at week 16 maintained this response through= to three years.^1 Pooled data from up to three years of treatment in Phase= 2 and 3 clinical trials showed that bimekizumab was generally well-tolerat= ed over this period with no safety signals identified.^2 =E2=80=9CThese positive results highlight the deep and long-lasting skin cl= earance achieved with bimekizumab, along with a consistent safety and toler= ability profile, and reinforce the positive relationship clearing skin has = on patients=E2=80=99 quality of life. These new data add to the growing bod= y of evidence supporting longer-term use of bimekizumab in moderate to seve= re plaque psoriasis,=E2=80=9D said Emmanuel Caeymaex, Executive Vice Presid= ent, Immunology Solutions and Head of U.S., UCB.=C2=A0 =E2=80=9CThe findings presented today show that bimekizumab provided mainte= nance of completely clear skin and health-related quality of life outcomes = in the majority of patients with moderate to severe plaque psoriasis over a= three-year period,=E2=80=9D said Dr Bruce Strober, Clinical Professor of D= ermatology at Yale University, Connecticut, U.S. =E2=80=9CThe goal of psori= asis treatment often is complete clearance of skin symptoms and the availab= ility of long-term data across treatment options is important since it supp= orts healthcare providers and patients to be more informed when making trea= tment decisions.=E2=80=9D Three-year data from the BE BRIGHT OLE study All patients who had completed one of the pivotal Phase 3 studies (BE SURE,= BE VIVID and BE READY) were eligible to enter the BE BRIGHT OLE study.^1 O= n OLE entry, patients were assigned to bimekizumab 320 mg every four weeks = (Q4W) or every eight weeks (Q8W) based on PASI 90 response at the end of th= e respective Phase 3 study.=C2=A0 =C2=A0In all bimekizumab-randomized patients:^1=C2=A5 =C2=B7 Among week 16 PASI 100 responders (N=3D503), 89.3 percent achieved P= ASI 100 at year one (week 52) and 82.0 percent at year three (OLE week 96) =C2=B7 Among week 16 PASI =E2=89=A42 responders (N=3D694), 96.5 percent ach= ieved PASI =E2=89=A42 at year one (week 52) and 94.2 percent at year three = (OLE week 96) =C2=B7 Among week 16 PASI 100 responders in BE SURE and BE READY only (N=3D= 330), 92.0 percent achieved the Dermatology Life Quality Index (DLQI) 0/1 a= t year one (week 56), and 88.0 percent at year three (OLE week 96) In bimekizumab-randomized patients (320 mg Q4W for 16 weeks, and then every= eight weeks [Q8W] through three years, BE SURE and BE READY only):^1=C2=A5 =C2=B7 Among week 16 PASI 100 responders (N=3D147), 93.6 percent achieved P= ASI 100 at year one (week 52) and 84.4 percent at year three (OLE week 96) =C2=B7 Among week 16 PASI =E2=89=A42 responders (N=3D189), 98.9 percent ach= ieved PASI =E2=89=A42 at year one (week 52) and 96.8 percent at year three = (OLE week 96) =C2=B7 Among week 16 PASI 100 responders (N=3D147), 95.8 percent achieved D= LQI 0/1 at year one (week 56) and 92.5 percent at year three (OLE week 96) Pooled safety data from up to three years of treatment in Phase 2 and 3 cli= nical trials Total bimekizumab exposure was 4245.3 patient-years (PY; N=3D1789) across t= he Phase 2 and 3 trials, and 3876.4 PY (N=3D1495; Q4W: 1965.6 PY; Q8W: 1914= .5 PY) in the Phase 3 trials.^2 Treatment emergent adverse events (TEAEs) o= ccurred at an exposure-adjusted incidence rate (EAIR) of 186.1 per 100 PY, = serious TEAEs were seen at an EAIR of 5.6 new cases per 100 PY and TEAEs le= ading to discontinuation at 3.5 new cases per 100 PY.^2=C2=A0 The most common TEAEs in the Phase 2 and 3 trials with bimekizumab were nas= opharyngitis, oral candidiasis and upper respiratory tract infection at EAI= Rs of 15.3, 10.2 and 7.1 new cases per 100 PY, respectively.^2 The EAIR for= oral candidiasis showed a decrease compared with two years of bimekizumab = treatment (10.2 versus 12.6 new cases per 100 PY) and was lower with bimeki= zumab dosed Q8W compared with Q4W (7.1 and 15.9 per 100 PY, respectively).^= 2 =C2=A0The vast majority of oral candidiasis events were mild to moderate = (99.4 percent) and none were serious.^2 Serious infections occurred at a ra= te of 1.2/100 PY. The most frequently reported were serious coronavirus inf= ections (0.2 per 100 PY).^2=C2=A0 *The recommended bimekizumab dose for adult patients with plaque psoriasis = is 320 mg (given as two subcutaneous injections of 160 mg) at week 0, 4, 8,= 12, 16 and every eight weeks thereafter.3 For some patients with a body we= ight=E2=89=A5120 kg who did not achieve complete skin clearance at week 16,= 320 mg every 4 weeks after week 16 may further improve treatment response.= 3 In the studies reported at EADV 2022, patients received maintenance dosin= g of bimekizumab 320 mg Q4W or Q8W. =C2=A5 Modified non-responder imputation analyses Notes to editors : About BE BRIGHT BE BRIGHT (NCT03598790) is an ongoing, multicentre, open-label extension st= udy assessing the long-term safety, tolerability and efficacy of bimekizuma= b in adult patients with moderate to severe chronic plaque psoriasis. =C2= =A0Patients who completed one of three bimekizumab Phase 3 studies, BE READ= Y, BE VIVID and BE SURE, were eligible to enrol in the BE BRIGHT study.^4 M= ore details on BE BRIGHT can be found at ClinicalTrials.gov (https://clinic= altrials.gov/ct2/show/NCT03598790) .^4 BE VIVID, BE READY and BE SURE evaluated the efficacy and safety of bimekiz= umab in the treatment of adults with moderate to severe plaque psoriasis ve= rsus placebo and ustekinumab, versus placebo, and versus adalimumab, respec= tively.^5,6,7=C2=A0=C2=A0 About psoriasis Psoriasis is a chronic inflammatory disease with primary involvement of the= skin.^8 Psoriasis signs and symptoms can vary but may include red patches = of skin covered with silvery scales; dry, cracked skin that may bleed; and = thickened, pitted or ridged nails.^9 Psoriasis also has a considerable psyc= hological and quality-of-life impact, potentially affecting work, recreatio= n, relationships, sexual functioning, family and social life.^10 This skin = condition affects men and women of all ages and ethnicities.^8=C2=A0 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.^3,11=C2=A0 In August 2021, bimekizumab was approved in the European Union (EU)/Europea= n Economic Area (EEA) and in Great Britain, for the treatment of moderate t= o severe plaque psoriasis in adults who are candidates for systemic therapy= ^3,12=C2=A0 The label information may differ in other countries. Please che= ck local prescribing information. BIMZELX^=C2=AE=E2=96=BC=C2=A0(bimekizumab) EU/EEA Important Safety Informat= ion in Psoriasis 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, fatigue. Elderly = may be more likely to experience certain adverse reactions such as oral can= didiasis, 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 March 2022. Last accessed: August 2022. =E2=96=BCThis medicinal product is subject to additional monitoring. This w= ill allow quick identification of new safety information. Healthcare profes= sionals 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. 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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 1. Strober B, Tada Y, Mrowietz U et al. Bimekizumab maintenance of response= through three years in patients with moderate to severe plaque psoriasis w= ho responded at Week 16: Results from the BE BRIGHT open-label extension tr= ial. Abstract presented at the 31st EADV Congress. 2. Gordon KB, Langley RG, Warren RB et al. Bimekizumab safety in patients w= ith moderate to severe plaque psoriasis: Analysis of pooled data from up to= three years of treatment in phase 2 and 3 clinical trials. Abstract presen= ted at the 31st EADV Congress. 3. BIMZELX (bimekizumab) EU Summary of Product Characteristics, March 2022.= Available at: https://www.ema.europa.eu/en/documents/product-information/b= imzelx-epar-product-information_en.pdf Last accessed: August 2022.=C2=A0 4. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek= izumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (= BE BRIGHT). Available at: https://clinicaltrials.gov/ct2/show/NCT03598790 L= ast accessed: August 2022. =C2=A0 5. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for = the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy a= nd safety from a 52-week, multicentre, double-blind, active comparator and = placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498. 6. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety i= n moderate to severe plaque psoriasis (BE READY): a multicentre, double-bli= nd, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;3= 97(10273):475-486. 7. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in = Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141. 8. National Psoriasis Foundation. About Psoriasis. Available at: https://ww= w.psoriasis.org/about-psoriasis/ Last accessed: August 2022. 9. NHS. Psoriasis Symptoms. Available at: https://www.nhs.uk/conditions/pso= riasis/symptoms/ (https://www.psoriasis.org/about-psoriasis/) . Last access= ed: August 2022. 10. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermat= ol Ther (Heidelb). 2013;3(2):117-130. 11. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of b= imekizumab, a humanized monoclonal antibody and selective dual inhibitor of= IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-= 1001. 12. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Ava= ilable at: https://www.medicines.org.uk/emc/product/12834;=C2=A0https://www= .medicines.org.uk/emc/product/12833 Last accessed: August 2022. GenericFile UCB PR EADV Sept 7 2022 ENG (https://mb.cision.com/Public/18595/3626545/abb= 4a5b07f176202.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x115094x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium

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UCB (EBR:UCB) New Three-Year BIMZELX®▼ (bimekizumab) Data Reinforce Long-Term Maintenance of Complete Skin Clearance in Moderate to Severe Plaque Psoriasis

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