UCB (EBR:UCB) UCB Media Room: Annals of the Rheumatic Diseases Publishes Results from Two Bimekizumab Phase 3 Studies in Axial Spondyloarthritis

Directive transparence : information réglementée

18/01/2023 07:01
https://mb.cision.com/Public/18595/3698956/a1fc4b3ef46b9029_800x800ar.png ** Annals of the Rheumatic Diseases Publishes Results from Two Bimekizumab = Phase 3 Studies in Axial Spondyloarthritis ------------------------------------------------------------ =C2=B7 Publication of 24-week results from the BE MOBILE 1 and BE MOBILE 2 = studies, evaluating bimekizumab, an IL-17A and IL-17F inhibitor, across the= full spectrum of axial spondyloarthritis=C2=A0 =C2=A0 Brussels (Belgium), 18 January 2023 =E2=80=93 07:00 (CET) =E2=80=93 UCB, a = global biopharmaceutical company, today announced that Annals of the Rheuma= tic Diseases has published 24-week results from the Phase 3 BE MOBILE 1 and= BE MOBILE 2 studies, evaluating the efficacy and safety of bimekizumab in = the treatment of adults with active axial spondyloarthritis (axSpA), includ= ing active non-radiographic axial spondyloarthritis (nr-axSpA; BE MOBILE 1)= and active ankylosing spondylitis (AS; BE MOBILE 2), also known as radiogr= aphic axSpA.^1 =E2=80=9CBE MOBILE 1 and BE MOBILE 2 represent the first phase 3 studies to= evaluate the inhibition of IL-17F in addition to IL-17A with bimekizumab a= cross the spectrum of axSpA. In both studies, treatment with bimekizumab re= sulted in rapid and clinically relevant improvements in outcomes, compared = with placebo. The observed depth of response as well as the consistency of = results in nr-axSpA and AS reinforce our confidence in bimekizumab as a pot= ential new treatment option across the full spectrum of the disease,=E2=80= =9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions = and Head of U.S., UCB.=C2=A0 The two phase 3 studies, BE MOBILE 1 and BE MOBILE 2, met all primary and r= anked secondary endpoints at Week 16.^1 In both studies, a significantly hi= gher proportion of patients treated with bimekizumab achieved statistically= significant and clinically meaningful improvements in nr-axSpA and AS, as = defined by the primary endpoint of Assessment of SpondyloArthritis internat= ional Society =E2=89=A540 percent improvement (ASAS40) response at Week 16 = compared with placebo (p<0.001).^1 In patients who received bimekizumab fro= m baseline, the proportion of patients achieving ASAS40 response continued = to increase to Week 24, and in patients who switched from placebo to bimeki= zumab at Week 16, the ASAS40 responses at Week 24 reached similar levels to= those seen in bimekizumab-randomized patients.^1 The safety profile of bim= ekizumab was consistent with safety data seen in previous studies, with no = new observed safety signals.^1 The publication of results from two Phase 3 axSpA studies in Annals of the = Rheumatic Diseases closely follows UCB news (https://www.ucb.com/stories-me= dia/Press-Releases/article/The-Lancet-Publishes-Results-from-Two-Bimekizuma= b-Phase-3-Studies-in-Psoriatic-Arthritis) in December 2022 that The Lancet = published two articles detailing results from two Phase 3 studies evaluatin= g bimekizumab in adult patients with active psoriatic arthritis (PsA).=C2= =A0 In September 2022, UCB announced (https://www.ucb.com/stories-media/Press-R= eleases/article/European-Medicine-Agency-Accepts-Marketing-Authorization-Ap= plications-for-Bimekizumab-in-Psoriatic-Arthritis-and-Axial-Spondyloarthrit= is) that the European Medicines Agency had accepted for regulatory review t= he marketing authorization application for bimekizumab for the treatment of= adult patients with active axSpA and active PsA. The efficacy and safety o= f bimekizumab in the treatment of axSpA and PsA have not been established a= nd it is not approved for the treatment of active axSpA or active PsA by an= y regulatory authority worldwide. Notes to editors: About BE MOBILE 1 =C2=A0 =C2=A0 BE MOBILE 1 was a randomized, multicenter, double-blind, placebo-controlled= , parallel-group, Phase 3 study designed to evaluate the efficacy and safet= y of bimekizumab in the treatment of adult patients with active=C2=A0nr-axS= pA. For additional details on the study, see article published in Annals of= the Rheumatic Diseases.^1=C2=A0 About BE MOBILE 2 BE MOBILE 2 was a randomized, multicenter, double-blind, placebo-controlled= , parallel-group, Phase 3 study designed to evaluate the efficacy and safet= y of bimekizumab in the treatment of adult patients with active AS. =C2=A0F= or additional details on the study, see article published in Annals of the = Rheumatic Diseases.^1=C2=A0 About Axial Spondyloarthritis Axial Spondyloarthritis (axSpA), which includes both non-radiographic axSpA= (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axS= pA (r-axSpA), is a chronic, immune-mediated, inflammatory disease.^2=C2=A0 = nr-axSpA is defined clinically by the absence of definitive x-ray evidence = of structural damage to the sacroiliac joints.^2 axSpA is a painful conditi= on that primarily affects the spine and the joints linking the pelvis and l= ower spine (sacroiliac joints).^2 The leading symptom of axSpA in a majorit= y of patients is inflammatory back pain that improves with exercise, but no= t with rest.^2 Other common clinical features frequently include anterior u= veitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel dis= ease and dactylitis.^2 The overall prevalence of axSpA is 0.3 percent to 1.= 3 percent of adults.^3,4=C2=A0 Approximately half of all patients with axSp= A are patients with nr-axSpA.^2 axSpA onset usually occurs before the age o= f 45.^2 Approximately 10 to 40 percent of patients with nr-axSpA progress t= o AS over 2 to 10 years.^2=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.^5,6 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.^6,7=C2=A0The labe= l information may differ in other countries. Please check local prescribing= information. About BIMZELX^=C2=AE=E2=96=BC (bimekizumab) in the EU/EEA In the EU/EEA, BIMZELX^=C2=AE is indicated for the treatment of moderate to= severe plaque psoriasis in adults who are candidates for systemic therapy.= ^6 BIMZELX^=C2=AE=E2=96=BC(bimekizumab) EU/EEA Important Safety Information in= Psoriasis6 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 December 2022. Last accessed: January 2023. =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. 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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. van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of= bimekizumab in axial spondyloarthritis: results of two parallel phase 3 ra= ndomized controlled trials Ann Rheum Dis Epub ahead of print: 2023; doi:10.= 1136/ard-2022-223595 2. Deodhar A. Understanding axial spondyloarthritis: A primer for managed c= are. Am J Manag Care. 2019;25:S319=E2=80=93S330. 3. 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=E2=80=93910. 4. 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. 5. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi= mekizumab, 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= =E2=80=931001. 6. 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: January 2023. 7. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Avai= lable at: http://www.medicines.org.uk/emc/product/12834/smpc#gref Last Acce= ssed: January 2023. GenericFile UCB PR BKZ Annals of Rheumatic Diseases Jan 18 2023 ENG (https://mb.cision.= com/Public/18595/3698956/82ffbb0008ebf4ef.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x126417x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium