— Sustained improvements across stringent measures of disease in patients with psoriatic arthritis (PsA): One-year improvements were sustained to three years across measures of peripheral arthritis, dactylitis, enthesitis, skin psoriasis, and nail psoriasis – indicating sustained inflammation control
— Sustained clinical response to stringent endpoints in half of patients with axial spondyloarthritis (nr-axSpA and AS): From Week 16 to three years, 50% of patients never lost ASDAS low disease activity (LDA) (<2.1) status at any assessed visit – indicating sustained inflammation control
— First real-world findings demonstrate rapid quality of life (HRQoL) improvements in patients with PsA, nr-axSpA, and AS: Improvements in outcomes in routine clinical practice were reported at 24 weeks, with benefits as early as Week 2 in some patients
UCB, a global biopharmaceutical company,todayannouncednewthree-yeardatafromPhase3trials, andtheiropen-labelextensions, investigating BIMZELX®(bimekizumab-bkzx) in adults with active psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and ankylosing spondylitis (AS). BIMZELX, the first and only medicine approved to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F),1continued to demonstrate sustained control of inflammation and deep efficacy in patients living with PsA, nr-axSpA, and AS.2-6
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Sustainedimprovementsacrossstringentmeasures ofdiseaseinpatientswithPsA2
“The diverse, multi-faceted nature of PsA can make it challenging to treat, as therapy should ideally address multiple disease domains,” said Professor Laura Coates, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Diseases, University of Oxford, United Kingdom. “These compelling data show sustained improvements over three years across key PsA disease domains. This demonstrates that bimekizumab has potential to benefit a broad range of patients, and may improve long-term inflammation control and prevent structural damage.”
In patients with PsA, one-year improvements were sustained to three years across the following GRAPPA domains:* peripheral arthritis, dactylitis, enthesitis, skin psoriasis and nail psoriasis.2 Individual domain responses were consistent between bDMARD‑naïveandTNFi-IRpatients.2Further, exposure-adjusted incidence rates per 100 patient years for uveitis and definite or probable adjudicated inflammatory bowel disease (IBD) to Week 156 were 0.2 (95% confidence interval 0.1, 0.6) and 0.3 (0.1, 0.7) inBE OPTIMAL and 0 and 0.1 (0.0, 0.6) in BE COMPLETE, respectively.2 (See Appendix for further details).
Sustainedclinical responsetostringent endpointsinhalfofpatients withnr-axSpA and AS
“Inclinicalpractice, ASDASLDAisanimportanttreatmenttargetfordiseasecontrol forpeopleliving with axSpA, as it is a highly stringent measure of low disease activity,” said Professor Fabian Proft, Universitätsmedizin Berlin, Germany. “It is therefore meaningful that in this study of bimekizumab, halfofthepatientsnever losttheirASDASLDAresponse atanyassessedvisit overthree years,whileoverthreequarters ofpatients maintainedthisresponseoverthreeyears. This suggests long-term disease control, which is paramount in treating both nr-axSpA and AS.”
A high proportion of BIMZELX-randomized patients who achieved clinical responses at Week16maintainedthesetoWeek164across thefulldisease spectrumofaxSpA, including nr-axSpA and AS.4FromWeek16 through to Week 164, 50% of patients never lost their ASDAS LDA (<2.1) status at any assessed visit (MI), with a further 22.4% only losing their ASDAS LDA status at one visit, and 6.1% at two visits, respectively (MI).4Of the 152 patients (43.6%; NRI) who achieved ASDAS LDA at Week 16, 78.8% still achieved ASDAS LDA at Week 164 (MI).*4
*Proportion of patients who achieved ASDAS LDA at Week 16 and Week 164 in patients randomized to BIMZELX 160 mg every four weeks (Q4W) at baseline.4
Real-worldfindings demonstraterapidHRQoLimprovementsinpatientswithPsA, nr-axSpA, and AS5,6
Interim, post-hoc data analysis(observedcase,OC)ofpatient-reportedoutcomes fromtheSPEAKstudyinroutine clinical practice showed that:5,6
For BIMZELX-treated patients with PsA, improvements in PsAID-12 total score wereobserved to24weeks, with mean(SD) change from baseline (CfB)at Week 24of –1.9 (2.0).5 SF-36 PCS scores improved to Week 24 (mean [SD] CfB: +4.6 [7.9]), as did PGADA scores(mean[SD]CfB:–17.5[23.8]).5AtWeek2,mean(SD)CfBin PsAID-12 total score and PGADA score were -0.8 (1.6) and -7.1 (19.3), respectively.5
ForBIMZELX-treatedpatients with nr-axSpA and AS,improvementsinASASHIscorewere observed to 24 weeks, with mean (SD) CfB at Week 24 of -1.6 (3.0).6SF-36 PCS scores improved to Week 24 (mean [SD] CfB: +5.7 [7.3]), as did PGADA scores (mean [SD] CfB:-1.0 [2.5].6 At Week 2, mean (SD) change from baseline (CfB)inASASHIscoreandPGADA score were -0.7 (2.3) and -0.8 (2.1), respectively.6
“This data presented at ACR shows that bimekizumab continues to demonstrate long-term improvement in inflammation control and deep efficacy in patients living with PsA and axSpA, and emphasizesthatthiseffectisconsistentacross a spectrumofpatients withthesediseases,” said Donatello Crocetta, Chief Medical Officer, UCB.
UCBwillpresent 16abstracts on BIMZELXat ACR2025in Chicago, October 24-29, acrossnr-axSpA, AS, PsA,andpsoriasis.ThesewillcomplementsevenotherpresentationsfromUCBacross their rheumatology portfolio. This data underscores UCB's ambition to be a leader in rheumatology, commitment to advancing clinical research and innovation, and focus on developing meaningful solutions across the spectrum of rheumatic diseases.
*CoredomainsofPsAaccording toGRAPPA(Group forResearchandAssessmentofPsoriasisand Psoriatic Arthritis) recommendations.7
Studymethodology
PsA abstract:2Included patients who were randomized to subcutaneous BIMZELX160 mg or placebo every 4 weeks (Q4W) in BE OPTIMAL (biologic DMARD [bDMARD]‑naïve patients with PsA), BE COMPLETE (patients with PsA with inadequate response or intolerance to TNF inhibitors [TNFi‑IR]),BEMOBILE 1(nr-axSpA)and BE MOBILE 2(AS, i.e., radiographic axSpA).2 From Week 16, all placebo-randomized patients received BIMZELX160 mg Q4W.2Week 52/16BEOPTIMAL/BECOMPLETEcompleterswereeligibleforBEVITALopen-labelextension;BE MOBILE 1 and 2 Week 52 completers could enter BE MOVING OLE.2
AxSpA abstract:4 BE MOBILE 1 (nr-axSpA) and 2 (AS) from Week 16, all patients received subcutaneous BIMZELX 160 mg Q4W. At Week 52, eligible patients could enroll in the OLE (BE MOVING).4
Real-world study:5,6SPEAK is an ongoing 52-week, multi-country, observational study in Belgium, Czechia,France,Germany,Greece, SpainandtheUnitedKingdom.5,6Thisplanned interimanalysis reports data to April 2, 2025 (approx. 50% enrollment).5,6Adult patients with active PsA, nr-axSpA, or AS who initiatedBIMZELXinroutineclinical practicecould beincluded ifreceiving treatment per label (BIMZELX 160 mg Q4W).5,6
Notesto Editors
— ASAS40 responder rate: Assessment in SpondyloArthritis international Society ≥40% improvement4
— ASAS HI: Assessment of SpondyloArthritis international Society Health Index6
— ASDAS LDA: axSpA Disease Activity Score (ASDAS) low disease activity (LDA; <2.1)4,8
— Dactylitis: Inflammation of a finger or toe9
— Enthesitis: Inflammation where the tendons and ligaments insert into bones10
— GRAPPA domains: Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-based treatment recommendations focus on six core domains and the PsA-related conditions, uveitis and IBD. The six core domains are: peripheral arthritis, axial disease, enthesitis, dactylitis, skin psoriasis and nail psoriasis2,7
— IBD: Inflammatory Bowel Disease
— LDI: Leeds Dactylitis Index
— LEI: Leeds Enthesitis Index
— MI: Multiple imputation2
— mNAPSI: Modified nail psoriasis severity index2
— mNRI: Modified NRI2
— NRI: Non-responder imputation2
— PASI 100: 100% improvement from baseline in Psoriasis Area and Severity Index2
— PGADA: Patient Global Assessment of Disease Activity5,6
— PsAID-12: 12-item PsA Impact of Disease questionnaire5
— SF-36 PCS: Short Form 36-item Health Survey Physical Component Summary5,6
— SJC: Swollen joint count2
— TNFi-IR: Inadequate response or intolerance to tumor necrosis factor inhibitors2
— Uveitis: Inflammation of the middle layer of the eyeball called the uvea11
Appendix
Furtherdetailfrom3-yearPsAdataacross GRAPPAdomains2
Forthemajority ofGRAPPA domains, 1-year improvements were sustained to 3 years across all studies.2These include stringent measures of disease within the disease domains, for example, complete resolution of the following:2
Tableadapted fromdataextractedfromabstracttable fornailpsoriasis,peripheralarthritis,enthesitis, dactylitis, skin psoriasis, axial disease.
AboutPsoriatic Arthritis
Psoriatic arthritis is a serious, highly heterogeneous, chronic, systemic inflammatory condition affecting both the joints and skin with a prevalence of 0.02 percent to 0.25 percent of the population.12Psoriatic arthritis affects approximately 30 percent of people living with psoriasis.13It manifests as joint pain and stiffness, skin plaques, swollen toes and fingers (dactylitis) and inflammationofthesiteswheretendonsorligamentsinsert intothebone(enthesitis).14Theburden on those living with PsA extends beyond physical discomfort to reduced quality of life, withcomorbiditiesincludinghypertension,cardiovasculardisease,anxiety, anddepression.15InPsA, uncontrolled active disease can lead to long-term, irreversible structural damage.16
AboutBEOPTIMAL andBECOMPLETE
BE OPTIMAL and BE COMPLETE were two Phase 3 studies evaluating the efficacy and safety of BIMZELX in the treatment of psoriatic arthritis.17,18 The primary endpoint in both studies was the proportion of patients reaching 50% or greater improvement in American College of Rheumatology criteria (ACR50) at Week 16.17,18 BE OPTIMAL (bDMARD-naïve) and BE COMPLETE (TNFi-IR) assessed subcutaneous BIMZELX 160 mg every four weeks (Q4W) in patients withPsA;bothstudieswereplacebo-controlledtoWeek16,afterwhichplacebopatients switchedto BIMZELX.17,18
BEOPTIMALWeek52andBECOMPLETE Week16completerswereeligibleforBEVITALopen-label extension.17,18
AboutAxial Spondyloarthritis
Axial spondyloarthritis (axSpA), which includes both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), is a chronic, immune-mediated, inflammatory disease.19 nr-axSpA is defined clinically by the absence of definitive x-ray evidence of structural damage to the sacroiliac joints.19axSpAisapainful conditionthatprimarilyaffectsthespine andthejointslinkingthepelvis and lower spine (sacroiliac joints).19The leading symptom of axSpA in a majority of patients is inflammatory back pain that improves with exercise, but not with rest.19Other common clinical features frequently include anterior uveitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease, and dactylitis.19The overall prevalence of axSpA is 0.3 percent to 1.4 percent of adults.20,21 Approximately half of all patients with axSpA are patients with nr-axSpA.19axSpA onset usually occurs before the age of 45.19Approximately 10 to 40 percent of patients with nr-axSpA progress to ankylosing spondylitis over 2 to 10 years.19
AboutBEMOBILE1andBEMOBILE2
BE MOBILE 1 and BE MOBILE 2 were two Phase 3 studies evaluating the efficacy and safety of BIMZELX inthetreatment ofnr-axSpA and AS,respectively.22Theprimaryendpointin both studies was the Assessment of SpondyloArthritis international Society 40 percent (ASAS40) response at Week 16.22 BE MOBILE 1 and BE MOBILE 2 comprised a 16-week double-blind treatment period followed by a 36-week maintenance period.22 In BE MOBILE 1 and BE MOBILE 2, patients were randomized to BIMZELX (160 mg Q4W; N=128 for BE MOBILE 1 and N=221 for BE MOBILE 2) or to placebo (N=126 for BE MOBILE 1 and N=111 for BE MOBILE 2). Patients initially randomized to placebo were switched toBIMZELX (160 mg Q4W) at Week 16.22BE MOBILE 1 and BE MOBILE 2 Week 52 completers were eligible for BE MOVING open-label extension.22
AboutBIMZELX® (bimekizumab-bkzx)BIMZELX is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.1 IL-17A and IL-17F are key contributors of chronic inflammation and damage across multiple tissues, with IL-17F increasing over time.1,23-25 IL-17F is over-expressed in skin and highly elevated in the serum of patients with psoriasis (PSO), psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), ankylosing spondylitis (AS), and hidradenitis suppurativa (HS).1,23-26
TheapprovedindicationsforBIMZELXintheU.S.are:1
— Plaque psoriasis: BIMZELX is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
— Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis
— Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation
— Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis
— Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adults with moderate- to-severe hidradenitis suppurativa
BIMZELXU.S.IMPORTANTSAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
Suicidal Ideation and BehaviorBIMZELX(bimekizumab-bkzx)mayincreasetheriskofsuicidalideation andbehavior(SI/B). Acausal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression,suicidalideation, orothermoodchanges.Ifsuchchanges occur,instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re- evaluate the risks and benefits of continuing treatment.
InfectionsBIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or isadequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs orsymptomssuggestiveofclinicallyimportant infectionoccur.Ifapatient developssuchaninfection or is notresponding to standard therapy,monitorthe patient closelyanddo not administer BIMZELX until the infection resolves.
TuberculosisEvaluatepatients fortuberculosis(TB)infectionpriortoinitiatingtreatmentwithBIMZELX. Avoidthe use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closelymonitor patientsforsignsandsymptoms ofactiveTBduringandaftertreatment.
Liver Biochemical AbnormalitiesElevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX, and according to routinepatient management. Iftreatment-related increases in liver enzymes occur and drug-induced liver injuryissuspected, interruptBIMZELXuntil adiagnosisofliverinjury isexcluded. PermanentlydiscontinueuseofBIMZELX inpatientswithcausallyassociatedcombinedelevationsof transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis.
Inflammatory Bowel DiseaseCases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBDanddiscontinuetreatmentifnewonset or worsening of signs and symptoms occurs.
ImmunizationsPrior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.
Most Common Adverse ReactionsMost common (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis,headache,injectionsitereactions,tineainfections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue.
Mostcommon (≥2%)adverse reactionsinpsoriatic arthritisincludeupper respiratorytract infections, oral candidiasis, headache, diarrhea, and urinary tract infections.
Mostcommon (≥2%)adverse reactionsinnon-radiographicaxialspondyloarthritisinclude upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain,myalgia,tonsillitis,transaminaseincrease,andurinary tractinfections.
Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections,oralcandidiasis,headache,diarrhea,injection sitepain,rash,andvulvovaginalmycotic infection.
PleaseseeImportantSafetyInformationbelow andfullU.S.PrescribingInformationat www.UCB-USA.com/Innovation/Products/BIMZELX.
For further information, contactUCB:
Investor RelationsAntje WitteT +32.2.559.94.14email antje.witte@ucb.com
Brand CommunicationsNicole HergaT +1.773.960.5349email: nicole.herga@ucb.com
AboutUCBUCB,Brussels,Belgium(www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €6.1 billion in 2024. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter:@UCBUSA.
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Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward- lookingstatementsaremadeonly asofthedateofthisdocument, anddonotreflectanypotentialimpacts fromtheevolving eventorrisk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB.
UCB expressly disclaims any obligation to update any forward-looking statements inthis document, either to confirm the actual results or toreportorreflectanychangeinitsforward-lookingstatementswithregard theretooranychangeinevents,conditionsorcircumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.
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— Coates L, Landewé R, McInnes I, et al. Bimekizumab treatment in patients with active psoriatic arthritis and prior inadequate response to tumour necrosis factor inhibitors: 52-week safety and efficacy from the phase III BE COMPLETE study and its open-label extension BE VITAL. RMD Open. 2024;10(1):e003855.
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— Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
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