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UCB (EBR:UCB) UCB Media Room: First Presentations of Phase 3 Data for Bimekizumab Across the Full Spectrum of Axial Spondyloarthritis to be Shared at EULAR 2022

Transparency directive : regulatory news

23/05/2022 08:31
https://mb.cision.com/Public/18595/3569596/9ab3ec56ee1724e0_800x800ar.png ** First Presentations of Phase 3 Data for Bimekizumab Across the Full Spec= trum of Axial Spondyloarthritis to be Shared at EULAR 2022 ------------------------------------------------------------ =C2=B7 New data from BE MOBILE 1 and BE MOBILE 2 show that bimekizumab achi= eved consistent improvements versus placebo in signs and symptoms across th= e full spectrum of axial spondyloarthritis (axSpA), including non-radiograp= hic axSpA (nr-axSpA) and ankylosing spondylitis (AS) =C2=B7 Treatment with bimekizumab delivered clinically meaningful efficacy = outcomes in nr-axSpA and AS, as measured by the proportion of patients achi= eving the primary endpoint (ASAS40) and all ranked secondary endpoints vers= us placebo Brussels (Belgium), 23 May 2022 =E2=80=93 8:30 am (CEST) =E2=80=93 UCB, a g= lobal pharmaceutical company, today announced new 24-week data from two Pha= se 3 studies, BE MOBILE 1 and BE MOBILE 2, evaluating bimekizumab in the tr= eatment of active non-radiographic axial spondyloarthritis (nr-axSpA) and a= ctive ankylosing spondylitis (AS).^1,2=C2=A0Both studies met their primary = and all ranked secondary endpoints at week 16, with statistical significanc= e, demonstrating improvements versus placebo in the signs and symptoms of d= isease across the full spectrum of axSpA with consistent outcomes for patie= nts with nr-axSpA and patients with AS.^1,2 The safety profile of bimekizum= ab in both studies was consistent with safety data seen in previous studies= with no new observed safety signals.^1,2 =C2=A0=C2=A0 UCB also announced today new post-hoc analyses from the open-label extensio= n of the Phase 2b BE AGILE study, in which bimekizumab showed maintenance o= f clinical responses over three years in patients with active AS.^3 Data fr= om all three studies will be presented at the European Congress of Rheumato= logy, EULAR 2022, in Copenhagen, Denmark, June 1=E2=80=934. Bimekizumab is = not approved for use in nr-axSpA or AS by any regulatory authority worldwid= e. The safety and efficacy of bimekizumab in nr-axSpA and AS have not been = established. =E2=80=9CWe are pleased to share the first detailed data from our Phase 3 c= linical program of bimekizumab in non-radiographic axSpA and ankylosing spo= ndylitis, which showcase the clinical potential of bimekizumab to improve p= atient outcomes across the full spectrum of this debilitating disease,=E2= =80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solutio= ns and Head of U.S., UCB. =E2=80=9CPeople with axSpA often live with the co= ndition for many years before diagnosis, with limited options available tod= ay to treat non-radiographic axSpA. We are driven to bring differentiated s= olutions that address unmet needs, and these results are an important step = in our mission, setting the foundation for future regulatory discussions.= =E2=80=9D=C2=A0 BE MOBILE 1 and BE MOBILE 2: Phase 3 Study Results (24 weeks)^1,2 In BE MOBILE 1 and BE MOBILE 2, patients treated with bimekizumab (160 mg e= very 4 weeks [Q4W]) achieved statistically significant and clinically meani= ngful improvements in the signs and symptoms of axSpA, as defined by the pr= imary endpoint measure of Assessment of SpondyloArthritis International Soc= iety 40 (ASAS40) at week 16 compared to placebo.^1,2 =C2=A0Response rates i= ncreased to week 24 and a rapid achievement of ASAS40 response was seen for= patients switching from placebo to bimekizumab at week 16.^1,2=C2=A0 =C2=B7 BE MOBILE 1 (nr-axSpA): At week 16, 47.7 percent (n=3D61/128) of bim= ekizumab-treated patients achieved ASAS40 versus 21.4 percent (n=3D27/126) = with placebo (p<0.001).^1=C2=A0 =C2=B7 BE MOBILE 2 (AS): At week 16, 44.8 percent (n=3D99/221) of bimekizum= ab-treated patients achieved ASAS40 versus 22.5 percent (n=3D25/111) with p= lacebo (p<0.001).^2=C2=A0 =E2=80=9CToday=E2=80=99s findings from the BE MOBILE 1 and BE MOBILE 2 stud= ies provide clear evidence supporting the potential of bimekizumab in both = nr-axSpA and AS, and highlight the meaningful clinical outcomes that can be= achieved by targeting IL-17F in addition to IL-17A. Patients with nr-axSpA= and AS have a similar burden of disease and a treatment that could potenti= ally show consistent outcomes across the full spectrum of disease is encour= aging,=E2=80=9D said Professor Atul Deodhar, MD, MRCP, Professor of Medicin= e, Division of Arthritis and Rheumatic Diseases, Oregon Health & Science Un= iversity, Portland, OR, U.S. In both studies, at week 16, patients treated with bimekizumab achieved sta= tistically significant improvements in all ranked secondary endpoints compa= red with placebo, including ASAS partial remission (ASAS-PR), disease activ= ity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (= BASDAI), physical function as measured by the Bath Ankylosing Spondylitis F= unctional Index (BASFI), and quality of life as measured by Ankylosing Spon= dylitis Quality of Life (ASQoL) questionnaire.^1,2=C2=A0 BE MOBILE 1 (nr-axSpA):=C2=A0 =C2=B7 At week 16, 25.8 percent (n=3D33/128) of bimekizumab-treated patient= s achieved ASAS-PR versus 7.1 percent (n=3D9/126) of patients with placebo = (p<0.001).^1=C2=A0 =C2=B7 At week 16, mean change from baseline in BASDAI (-3.1 bimekizumab ve= rsus -1.5 placebo, p<0.001).^1 =C2=B7 At week 16, mean change from baseline in BASFI (-2.5 bimekizumab ver= sus -1.0 placebo, p<0.001).^1=C2=A0 =C2=B7 At week 16, mean change from baseline in ASQoL (-5.2 bimekizumab ver= sus -2.5 placebo, p<0.001).^1 BE MOBILE 2 (AS):=C2=A0 =C2=B7 At week 16, 24.0 percent (n=3D53/221) of bimekizumab-treated patient= s achieved ASAS-PR versus 7.2 percent (n=3D8/111) of patients with placebo = (p<0.001).^2 =C2=B7 At week 16, mean change from baseline in BASDAI (-2.9 bimekizumab ve= rsus -1.9 placebo, p<0.001).^2=C2=A0 =C2=B7 At week 16, mean change from baseline in BASFI (-2.2 bimekizumab ver= sus -1.1 placebo, p<0.001).^2=C2=A0 =C2=B7 At week 16, mean change from baseline in ASQoL (-4.9 bimekizumab ver= sus -3.2 placebo, p<0.001).^2 Other efficacy outcomes in BE MOBILE 1 and BE MOBILE 2 included changes in = Ankylosing Spondylitis Disease Activity Score (ASDAS) states, and changes i= n inflammation in the sacroiliac joints and spine as measured by Magnetic R= esonance Imaging (MRI).^1,2 At the start of both studies, almost all patien= ts (>97 percent) had high or very high disease activity.^1,2 At week 24, in= both studies, approximately half of the patients treated with bimekizumab = from the start of each study achieved ASDAS low disease activity defined as= ASDAS<2.1.^1,2 Treatment with bimekizumab also resulted in substantial red= uctions in inflammation in the sacroiliac joints and spine for both AS and = nr-axSpA patients at week 16.^1,2=C2=A0 Professor D=C3=A9sir=C3=A9e van der Heijde, Professor of Rheumatology, Leid= en University Medical Center, Leiden, the Netherlands, said, =E2=80=9CPatie= nts with axSpA live with a range of debilitating symptoms including chronic= back pain and difficulties performing everyday tasks. These interim result= s from the BE MOBILE 1 and BE MOBILE 2 studies are encouraging, showing tha= t treatment with bimekizumab versus placebo improved signs and symptoms, re= duced disease activity and inflammation, and improved physical function. We= look forward to the 52-week results from these studies expected later this= year.=E2=80=9D In BE MOBILE 1, the most common treatment emergent adverse events (TEAEs) o= ver 16 weeks with bimekizumab were nasopharyngitis (9.4 percent), upper res= piratory tract infection (7.0 percent) and oral candidiasis (3.1 percent).^= 1 =C2=A0In BE MOBILE 2, the most common TEAEs over 16 weeks were nasopharyn= gitis (7.7 percent), headache (4.1 percent) and oral candidiasis (4.1 perce= nt).^2 Up to 16 weeks, the incidence of serious adverse events was low with= bimekizumab in both studies (0 percent in BE MOBILE 1 and 1.8 percent in B= E MOBILE 2).^1,2 In BE MOBILE 1, no cases of inflammatory bowel disease (IB= D) were reported with patients taking bimekizumab.1 In BE MOBILE 2, two IBD= cases (0.9 percent) occurred in patients treated with bimekizumab.^2 BE AGILE Phase 2b Open-Label Extension: 3 Year Study Results^3=C2=A0 Post-hoc analyses of the Phase 2b BE AGILE study and its open-label extensi= on showed that treatment with bimekizumab (160 mg Q4W) provided maintenance= of clinical responses over three years (156 weeks) in patients with active= AS who initially responded at week 12, and irrespective of the initial dos= ing regimen (160 mg Q4W, [N=3D60] or 320 mg Q4W, [N=3D61].^3 At week 12, 40= .3 per-cent of patients had achieved low disease activity (ASDAS<2.1), and = 89.2 percent of these patients maintained this low level of disease activit= y at week 156.^3 =C2=A0Efficacy measured by ASAS40 response was also sustai= ned over three years, with 47.1 percent of patients having achieved ASAS40 = at week 12, 64.9 percent at week 48 and 71.9 percent at week 156.^3 =C2=A0 Notes to editors : About BE MOBILE 1 =C2=A0 =C2=A0 BE MOBILE 1 is a randomized, multicenter, double-blind, placebo-controlled,= parallel-group, Phase 3 study designed to evaluate the efficacy and safety= of bimekizumab in the treatment of adult patients with active nr-axSpA.^1 = The study is ongoing with 24-week results presented above. For additional d= etails on the study, visit BE MOBILE 1 on clinicaltrials.gov (https://clini= caltrials.gov/ct2/show/NCT03928704) .^4 About BE MOBILE 2 BE MOBILE 2 is a randomized, multicenter, double-blind, placebo-controlled,= parallel-group, Phase 3 study designed to evaluate the efficacy and safety= of bimekizumab in the treatment of adult patients with active AS.^2 The st= udy is ongoing with 24-week results presented above. For additional details= on the study, visit BE MOBILE 2 on clinicaltrials.gov (https://www.clinica= ltrials.gov/ct2/show/NCT03928743) .^5 About BE AGILE and the open-label extension study (BE AGILE 2) BE AGILE was a multicenter, Phase 2b, randomized, double-blind, placebo-con= trolled, parallel-group, dose-ranging study to evaluate the efficacy and sa= fety of bimekizumab in patients with active ankylosing spondylitis (AS).^6 = BE AGILE 2 is a multicenter, open-label extension study to evaluate the lon= g term safety and efficacy of bimekizumab in patients with active AS. =C2= =A0For additional details, visit BE AGILE 2 on clinicaltrials.gov (https://= www.clinicaltrials.gov/ct2/show/NCT03355573) .^7 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.^8=C2=A0 nr-axSpA is= defined clinically by the absence of definitive x-ray evidence of structur= al damage to the sacroiliac joints.^8 AxSpA is a painful condition that pri= marily affects the spine and the joints linking the pelvis and lower spine = (sacroiliac joints).^8 The leading symptom of axSpA in a majority of patien= ts is inflammatory back pain that improves with exercise, but not with rest= .^8 Other common clinical features frequently include anterior uveitis, ent= hesitis, peripheral arthritis, psoriasis, inflammatory bowel disease and da= ctylitis.^8 The overall prevalence of axSpA is 0.3 percent to 1.3 percent o= f adults.^9,10=C2=A0Approximately half of all patients with axSpA are patie= nts with nr-axSpA.^8 AxSpA onset usually occurs before the age of 45.^8 App= roximately 10 to 40 percent of patients with nr-axSpA progress to ankylosin= g spondylitis over 2 to 10 years.^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.^11,14 Bimekizumab is in= Phase 3 clinical development for the treatment of active axSpA with 24-wee= k interim analysis results from the BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 = (AS) studies to be presented at EULAR 2022.^1,2 In addition, bimekizumab is= in Phase 3 clinical development for the treatment of active psoriatic arth= ritis with 24-week interim analysis from the BE OPTIMAL study and 16-week a= nalysis from the BE COMPLETE study to be presented at EULAR 2022.^12,13=C2= =A0=C2=A0 About BIMZELX^=C2=AE=E2=96=BC(bimekizumab) in the European Union /European = Economic Area=C2=A0 In the European Union (EU)/European Economic Area (EEA) BIMZELX^=C2=AE is i= ndicated for the treatment of moderate to severe plaque psoriasis in adults= who are candidates for systemic therapy.^14=C2=A0=C2=A0 BIMZELX^=C2=AE=E2=96=BC(bimekizumab) EU/EEA Important Safety Information 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: May 2022. =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 1. Deodhar A, van der Heijde D, Gensler LS et al. Bimekizumab in patients w= ith active non-radiographic axial spondyloarthritis: 24-week efficacy and s= afety from BE MOBILE 1, a phase 3, multicentre, randomised, placebo-control= led study. To be presented at EULAR 2022 =C2=A0in Copenhagen, Denmark, June= 1-4. =C2=A0 2. van der Heijde D, Baraliakos X, Dougados M et al. Bimekizumab in patient= s with active ankylosing spondylitis: 24-week efficacy and safety from BE M= OBILE 2, a phase 3, multicentre, randomised, placebo-controlled study. To b= e presented at EULAR 2022 =C2=A0in Copenhagen, Denmark, June 1-4. 3. Navarro-Comp=C3=A1n V, Rudwaleit M, de Peyrecave N et al. Maintenance of= response to bimekizumab over 3 years of treatment in patients with active = ankylosing spondylitis: post-hoc analyses from the BE AGILE study and its o= pen-label extension. To be presented at EULAR 2022 in Copenhagen, Denmark, = June 1-4. 4. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek= izumab in Subjects With Active Nonradiographic Axial Spondyloarthritis (BE = MOBILE 1). Available at: https://clinicaltrials.gov/ct2/show/NCT03928704. = =C2=A0Last accessed: May 2022. 5. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek= izumab in Subjects With Active Ankylosing Spondylitis (BE MOBILE 2). Availa= ble at: https://www.clinicaltrials.gov/ct2/show/NCT03928743. Last accessed:= May 2022 6. van der Heijde D, Gensler L, Deodhar A, et al. Dual Neutralisation of in= terleukin-17A and interleukin-17F With Bimekizumab in Patients With Active = Ankylosing Spondylitis: Results From a 48-week Phase IIb, Randomised, Doubl= e-Blind, Placebo-Controlled, Dose-Ranging Study. Ann Rheum Dis. 2020;79(5):= 595-604. 7. ClinicalTrials.gov. A Study to Evaluate the Long Term Safety and Efficac= y of Bimekizumab in Subjects With Ankylosing Spondylitis (BE AGILE 2). Avai= lable at: https://www.clinicaltrials.gov/ct2/show/NCT03355573. Last accesse= d: May 2022. 8. Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed C= are. Am J Manag Care. 2019;25:S319-S330. 9. 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. 10. Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondyl= oarthritis in the UK: a cross-sectional cohort study. BMC Musculoskelet Dis= ord. 2015;21(16):392. 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. ClinicalTrials.gov. A Study to Test the Efficacy and Safety of Bimekizu= mab in the Treatment of Subjects with Active Psoriatic Arthritis (BE OPTIMA= L). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03895203?term= =3DBE+OPTIMAL&draw=3D2&rank=3D1 Last accessed: May 2022. 13. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bime= kizumab in the Treatment of Subjects with Active Psoriatic Arthritis (BE CO= MPLETE). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03896581 = Last accessed: May 2022. 14. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics. htt= ps://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-produc= t-information_en.pdf. Last accessed: May 2022. GenericFile GL-N-BK-axSpA-2200010 FINAL (https://mb.cision.com/Public/18595/3569596/8e3= 55f76b40de2fb.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x106123x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium


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