UCB (EBR:UCB) UCB Media Room: UCB Reinforces Commitment to Rheumatology with 15 Abstracts including New Late-Breaking Data at ACR Convergence 2022

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08/11/2022 18:01
https://mb.cision.com/Public/18595/3663475/a3ca183b23c7b65b_800x800ar.png ** UCB Reinforces Commitment to Rheumatology with 15 Abstracts including Ne= w Late-Breaking Data at ACR Convergence 2022 ------------------------------------------------------------ =C2=B7 Late-breaking 52-week data on investigational bimekizumab in the tre= atment of adults with active psoriatic arthritis and active axial spondyloa= rthritis to be presented =C2=B7 New data on CIMZIA^=C2=AE (certolizumab pegol) and bimekizumab under= score UCB=E2=80=99s commitment to innovative research in rheumatology Brussels (Belgium), 8th November 2022 (18:00 CET) =E2=80=93 UCB, a global b= iopharmaceutical company, today announced that it will present 15 abstracts= across its rheumatology portfolio at ACR Convergence 2022 to be held in Ph= iladelphia, November 10=E2=80=9314, 2022. The abstracts, including two with= late-breaking data, have been accepted as four oral presentations, eight e= -posters, and three =E2=80=98Ignite Talks=E2=80=99 which are five-minute in= -person presentations focused on the highest ranked posters at the meeting.= =C2=A0 =E2=80=9CThe breadth of new data we are presenting at ACR Convergence 2022,= including the first presentation of bimekizumab 52-week data in psoriatic = arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthri= tis, underscore our commitment to address unmet patient needs and to raise = standards of care,=E2=80=9D said Emmanuel Caeymaex, Executive Vice Presiden= t, Immunology Solutions and Head of U.S., UCB.=C2=A0 UCB is investigating bimekizumab in psoriatic arthritis (PsA), non-radiogra= phic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) als= o known as radiographic axSpA. The efficacy and safety of bimekizumab in Ps= A, nr-axSpA and AS have not been established, and it is not approved for us= e in these indications by any regulatory authority worldwide. Bimekizumab data highlights Data evaluating bimekizumab in the treatment of PsA and across the spectrum= of axSpA will be shared across three oral presentations, three =E2=80=98Ig= nite Talks=E2=80=99 and six e-posters. One oral presentation and one =E2=80=98Ignite Talk=E2=80=99 will detail lat= e-breaking 52-week data from the bimekizumab studies. The oral presentation= will present results from the Phase 3 BE OPTIMAL study evaluating bimekizu= mab in patients with active PsA who were biologic na=C3=AFve. The =E2=80=98= Ignite Talk=E2=80=99 will share data from the Phase 3 BE MOBILE 1 and BE MO= BILE 2 studies evaluating bimekizumab in the treatment of nr-axSpA and AS, = respectively.=C2=A0 A second oral presentation will share data from the Phase 3 BE COMPLETE stu= dy, evaluating bimekizumab in the treatment of active PsA in patients with = a previous inadequate response or intolerance to Tumor Necrosis Factor Inhi= bitors (TNFi-IR). A third oral presentation will share 24-week data from th= e Phase 3 BE MOBILE 1 study evaluating bimekizumab in nr-axSpA. =C2=A0 In addition, 24-week data from the BE MOBILE 2 study evaluating bimekizumab= in the treatment of AS and key patient reported outcomes from the Phase 3 = BE MOBILE 1 and BE MOBILE 2 studies will be presented in two =E2=80=98Ignit= e Talks=E2=80=99.=C2=A0 CIMZIA^=C2=AE (certolizumab pegol) data highlights Data evaluating certolizumab pegol in the treatment of active axSpA will al= so be shared across one oral presentation and two e-posters. The oral prese= ntation will detail an exploratory analysis which aims to evaluate the rela= tionship between objective signs of inflammation and clinical outcomes foll= owing 12 weeks of certolizumab pegol treatment in patients with active axSp= A. =C2=A0 The following is a guide to the UCB-sponsored data presentations at ACR Convergence 2022: Bimekizumab abstracts: Psoriatic Arthritis=C2=A0 =C2=B7 Bimekizumab Treatment in Biologic DMARD-Na=C3=AFve Patients with Act= ive Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3= , Randomized, Placebo-Controlled, Active Reference Study C. Ritchlin, L. C. Coates, I. McInnes, P. J. Mease, J. Merola, Y. Tanaka, A= . Asahina, L. Gossec, A. Gottlieb, D. Tha=C3=A7i, B. Ink, D. Assudani, R. B= ajracharya, V. Shende, J. Coarse, R. Landew=C3=A9 #L02 Oral presentation: Monday, November 14, 9:15am =E2=80=93 9:25am (ET) =C2=B7 Bimekizumab Treatment in Patients with Active Psoriatic Arthritis an= d Inadequate Response to Tumor Necrosis Factor Inhibitors: 16-week Efficacy= and Safety from a Phase 3, Randomized, Double-Blind, Placebo-Controlled St= udy J. Merola, R. Landew=C3=A9, I.B. McInnes, P.J. Mease, C. Ritchlin, Y. Tanak= a, A. Asahina, F. Behrens, D. Gladman, L. Gossec, R. Warren, B. Ink, D. Ass= udani, R. Bajracharya, J. Coarse, L. Coates #1599 Oral presentation: Sunday, November 13, 3:30pm =E2=80=93 3:40pm (ET) =C2=B7 Bimekizumab Treatment Improves Health-Related Quality of Life in Bio= logic DMARD-Na=C3=AFve and TNFi-IR Patients with Active PsA: Pooled 16-Week= Results From two Phase 3 Randomized, Placebo-Controlled Studies D. Gladman, L.E. Kristensen, D. Tha=C3=A7i, P. Gisondi, L. Gossec, M.E. Hus= ni, A. Gottlieb, H. Dobashi, B. Ink, D. Assudani, R. Bajracharya, J. Coarse= , J. Lambert, W. Tillett=C2=A0 #2122 e-Poster: Monday, November 14, 1:00pm =E2=80=93 3:00pm (ET) =C2=B7 Bimekizumab Improvements in Efficacy on Disease Activity Assessed vi= a Composite Endpoints in Biologic DMARD-na=C3=AFve and TNFi-IR Patients wit= h Active PsA: Pooled 16-Week Results from Phase 3 Randomized, Placebo-Contr= olled Studies P.J. Mease, L. Coates, R. Landew=C3=A9, I.B. McInnes, C. Ritchlin, T. Atsum= i, F. Behrens, D. Gladman, L. Gossec, P. Nash, B. Ink, D. Assudani, R. Bajr= acharya, J. Coarse, A.R. Prickett, A.B. Gottlieb # 2117 e-Poster: Monday, November 14, 1:00pm =E2=80=93 3:00pm (ET) =C2=B7 Bimekizumab Treatment Results in Improvements in Fatigue and Pain in= Biologic DMARD-Na=C3=AFve or TNFi-IR Patients with Active Psoriatic Arthri= tis: Pooled 16- Week Results from Two Phase 3 Randomized, Placebo-Controlle= d Studies M.E. Husni, P.J. Mease, J. Merola, F. Behrens, E.G. Favalli, D. McGonagle, = W. Tillett, S. Tsuji, B. Ink, D. Assudani, R. Bajracharya, J. Coarse, J. La= mbert, L. Gossec=C2=A0 #2119 e-Poster: Monday, November 14, 1:00pm =E2=80=93 3:00pm (ET) =C2=B7 Achieving Increasingly Stringent Clinical Disease Control Criteria i= s Associated with Greater Improvements in Patient-Centric Measures of Physi= cal Function and Pain in Patients with Active PsA: 16-Week Results from Two= Phase 3 Randomized, Placebo-Controlled Studies J. Walsh, L. Coates, P.J. Mease, J. Merola, P. Nash, A. Ogdie, W. Tillett, = P. Gisondi, B. Ink, D. Assudani, R. Bajracharya, J. Lambert, V. Taieb, D. W= illems, L.E. Kristensen=C2=A0 #2118 e-Poster: Monday, November 14, 1:00pm =E2=80=93 3:00pm (ET) Bimekizumab abstracts: Axial Spondyloarthritis =C2=B7 Bimekizumab Maintains Improvements in Efficacy Endpoints and has a C= onsistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic= Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Paral= lel Phase 3 Studies=C2=A0 X. Baraliakos, A. Deodhar, D. van der Heijde, M. Magrey, W. Maksymowych, T.= Tomita, H. Xu, M. Oortgiesen, U. Massow, C. Fleurinck, A. M. Ellis, T. Vau= x, J. Shepherd-Smith, A. Marten, L. S. Gensler #L14 Ignite Talk: Monday, November 14, 2:35pm =E2=80=93 2:40pm (ET) =C2=B7 Bimekizumab Improves Signs and Symptoms, Including Inflammation, in = Patients with Active Non-Radiographic Axial Spondyloarthritis: 24-Week Effi= cacy & Safety from a Phase 3, Multicenter, Randomized, Placebo-Controlled S= tudy A. Deodhar, D. van der Heijde, L. Gensler, H. Xu, K. Gaffney, H. Dobashi, W= .P. Maksymowych, M. Rudwaleit, M. Magrey, D. Elewaut, M. Oortgiesen, C. Fle= urinck, N. de Peyrecave, A. Ellis, T. Vaux, J. Shepherd-Smith, X. Baraliako= s=C2=A0 #0544 Oral presentation: Saturday, November 12, 5:00pm =E2=80=93 5.10pm (ET) =C2=B7 Bimekizumab Improves Signs and Symptoms, Including Inflammation, in = Patients with Active Ankylosing Spondylitis: 24-Week Efficacy & Safety From= a Phase 3, Multicenter, Randomized, Placebo Controlled Study D. van der Heijde, X. Baraliakos, M. Dougados, M. Brown, D. Poddubnyy, F. v= an den Bosch, N. Haroon, H. Xu, T. Tomita, L. Gensler, M. Oortgiesen, C. Fl= eurinck, N. de Peyrecave, T. Vaux, A Marten, A. Deodhar=C2=A0 #0411 Ignite Talk: Sunday, November 13, 9:10am =E2=80=93 9.15am (ET) =C2=B7 Bimekizumab Improves Key Patient Reported Symptoms of Axial Spondylo= arthritis Including Spinal Pain and Fatigue: Results from Two Phase 3 Studi= es P.J. Mease, A. Deodhar, M. Dougados, M. Dubreuil, M. Magrey, H. Marzo-Orteg= a, M. Rudwaleit, C. de la Loge, A. Ellis, C. Fleurinck, M. Oortgiesen, V. T= aieb, L. Gensler #0409 Ignite Talk: Sunday, November 13, 9:00am =E2=80=93 9:05am (ET) =C2=B7 Bimekizumab Improves Physical Function and Health-Related Quality of= Life in Patients with Axial Spondyloarthritis: Results From Two Phase 3 St= udies M. Dubreuil, K. Gaffney, L. Gensler, J. Kay, V. Navarro-Comp=C3=A1n, C. de = la Loge, A. Ellis, C. Fleurinck, M. Oortgiesen, V. Taieb, A. Deodhar=C2=A0 #0412 e-Poster: Saturday, November 12, 1:00pm =E2=80=93 3:00pm (ET) =C2=B7 Achieving Increasingly Stringent Clinical Response Criteria & Lower = Levels Of Disease Activity is Associated With Greater Improvements In Physi= cal Function And HRQoL in Patients With Active Axial Spondyloarthritis: 16-= Week Results From Two Phase 3 Randomized, Placebo-Controlled Studies M. Magrey, A. Deodhar, P.J. Mease, V. Navarro-Comp=C3=A1n, S. Ramiro, M. Ru= dwaleit, C. de la Loge, C. Fleurinck, V. Taieb, M.F. M=C3=B8rup, M. Oortgie= sen, J. Kay #0410 e-Poster: Saturday, November 12, 1:00pm =E2=80=93 3:00pm (ET) CIMZIA^=C2=AE (certolizumab pegol) abstracts: Axial Spondyloarthritis =C2=B7 An Exploratory Analysis of the Potential Disconnect Between Objectiv= e Inflammatory Response and Clinical Response following Certolizumab Pegol = Treatment in Patients with Active Axial Spondyloarthritis M. Rudwaleit, F. van den Bosch, H. Marzo-Ortega, V. Navarro-Comp=C3=A1n, R.= Tham, T. Kumke, L. Bauer, M. Kim, L. Gensler=C2=A0 #0543 Oral presentation: Saturday, November 12, 4:45pm =E2=80=93 4:55pm (ET) =C2=B7 Long-Term Clinical Outcomes of Certolizumab Pegol Treatment in Patie= nts with Active Non=E2=80=91Radiographic Axial Spondyloarthritis Stratified= by Baseline MRI and C-Reactive Protein Status P.C. Robinson, W.P. Maksymowych, L. Gensler, M. Rudwaleit, B. Hoepken, L. B= auer, T. Kumke, M. Kim, A. Deodhar=C2=A0 #0408 e-Poster: Saturday, November 12, 1:00pm =E2=80=93 3:00pm (ET) =C2=B7 Comparison of Established and New, Preliminarily Proposed ASAS Cut-O= ffs for Inflammatory MRI Lesions in the Sacroiliac Joints of Axial Spondylo= arthritis Patients and Implications for Recruitment in Clinical Studies X. Baraliakos, P. Machado, L. Bauer, B. Hoepken, M. Kim, T. Kumke, R. Tham,= M. Rudwaleit=C2=A0 #1010 e-Poster: Sunday, November 13, 9:00am =E2=80=93 10:30am (ET) Abstracts to be presented at ACR Convergence 2022 are available at ACR Conv= ergence 2022 Archives - ACR Meeting Abstracts (acrabstrats.org)=C2=A0 (http= s://acrabstracts.org/meetings/acr-convergence-2022/) Notes to editors: About BE OPTIMAL BE OPTIMAL was a randomized, multicenter, double-blind, placebo-controlled,= active reference (adalimumab), parallel-group, Phase 3 study designed to e= valuate the efficacy and safety of bimekizumab in the treatment of adult pa= tients with active psoriatic arthritis, who are biologic disease-modifying = anti-rheumatic drug na=C3=AFve. For additional details on the study, visit = BE OPTIMAL (https://www.clinicaltrials.gov/ct2/show/NCT03895203?term=3DBE+O= PTIMAL&draw=3D2&rank=3D1) on clinicaltrials.gov.^1 About BE COMPLETE BE COMPLETE was a randomized, multicenter, double-blind, placebo-controlled= , parallel-group, Phase 3 study designed to evaluate the efficacy and safet= y of bimekizumab in adults with active psoriatic arthritis and an inadequat= e response to tumor necrosis factor-alpha inhibitors (TNF=CE=B1i). All enro= lled study participants had a history of inadequate response (lack of effic= acy after at least three months of therapy at an approved dose) or intolera= nce to treatment with one or two TNF=CE=B1i for either psoriatic arthritis = or psoriasis. For additional details on the study, visit BE COMPLETE (https= ://www.clinicaltrials.gov/ct2/show/NCT03896581) on clinicaltrials.gov.^2 About BE MOBILE 1 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 nr-axSpA. F= or additional details on the study, visit BE MOBILE 1 (https://clinicaltria= ls.gov/ct2/show/NCT03928704) on clinicaltrials.gov.^3 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. For add= itional details on the study, visit BE MOBILE 2 (https://www.clinicaltrials= .gov/ct2/show/NCT03928743) on clinicaltrials.gov.^4 About CIMZIA^=C2=AE in the U.S.^5 CIMZIA^=C2=AE is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Facto= r). CIMZIA has a high affinity for human TNF-alpha, selectively neutralizin= g the pathophysiological effects of TNF-alpha.=C2=A0 CIMZIA is also indicated for the treatment of adults with moderately to sev= erely active rheumatoid arthritis (RA), adults with active psoriatic arthri= tis (PsA), adults with active ankylosing spondylitis (AS), and adults with = active non-radiographic axial spondyloarthritis (nr-axSpA) with objective s= igns of inflammation. CIMZIA is indicated for the treatment of moderate to severe plaque psoriasi= s (PSO) in adults who are candidates for systemic therapy or phototherapy.= =C2=A0 In addition, CIMZIA is indicated for reducing signs and symptoms of Crohn's= disease (CD) and maintaining clinical response in adult patients with mode= rately to severely active disease who have had an inadequate response to co= nventional therapy. See important safety information including risk of seri= ous bacterial, viral and fungal infections and tuberculosis below. IMPORTANT SAFETY INFORMATION about CIMZIA in the U.S. CONTRAINDICATIONS CIMZIA is contraindicated in patients with a history of hypersensitivity re= action to certolizumab pegol or to any of the excipients. Reactions have in= cluded angioedema, anaphylaxis, serum sickness, and urticaria. SERIOUS INFECTIONS Patients treated with CIMZIA are at increased risk for developing serious i= nfections that may lead to hospitalization or death. Most patients who deve= loped these infections were taking concomitant immunosuppressants such as m= ethotrexate or corticosteroids.=C2=A0 Discontinue CIMZIA if a patient develops a serious infection or sepsis. Reported infections include: =C2=B7 Active tuberculosis (TB), including reactivation of latent TB. Patie= nts with TB have frequently presented with disseminated or extrapulmonary d= isease. Test patients for latent TB before CIMZIA use and during therapy. I= nitiate treatment for latent TB prior to CIMZIA use. =C2=B7 Invasive fungal infections, including histoplasmosis, coccidioidomyc= osis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patien= ts with histoplasmosis or other invasive fungal infections may present with= disseminated, rather than localized, disease. Antigen and antibody testing= for histoplasmosis may be negative in some patients with active infection.= Consider empiric anti-fungal therapy in patients at risk for invasive fung= al infections who develop severe systemic illness. =C2=B7 Bacterial, viral, and other infections due to opportunistic pathogen= s, including Legionella and Listeria.=C2=A0 Carefully consider the risks and benefits of treatment with CIMZIA prior to= initiating therapy in the following patients: with chronic or recurrent in= fection; who have been exposed to TB; =C2=A0with a history of opportunistic= infection; who resided in or traveled in regions where mycoses are endemic= ; with underlying conditions that may predispose them to infection. Monitor= patients closely for the development of signs and symptoms of infection du= ring and after treatment with CIMZIA, including the possible development of= TB in patients who tested negative for latent TB infection prior to initia= ting therapy. =C2=B7 Do not start CIMZIA during an active infection, including localized = infections. =C2=B7 Patients older than 65 years, patients with co-morbid conditions, an= d/or patients taking concomitant immunosuppressants may be at greater risk = of infection. =C2=B7 If an infection develops, monitor carefully and initiate appropriate= therapy. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children= and adolescent patients treated with TNF blockers, of which CIMZIA is a me= mber. CIMZIA is not indicated for use in pediatric patients. =C2=B7 Consider the risks and benefits of CIMZIA treatment prior to initiat= ing or continuing therapy in a patient with known malignancy. =C2=B7 In clinical trials, more cases of malignancies were observed among C= IMZIA-treated patients compared to control patients. =C2=B7 In CIMZIA clinical trials, there was an approximately 2-fold higher = rate of lymphoma than expected in the general U.S. population. Patients wit= h rheumatoid arthritis, particularly those with highly active disease, are = at a higher risk of lymphoma than the general population. =C2=B7 Malignancies, some fatal, have been reported among children, adolesc= ents, and young adults being treated with TNF blockers. Approximately half = of the cases were lymphoma, while the rest were other types of malignancies= , including rare types associated with immunosuppression and malignancies n= ot usually seen in this patient population. =C2=B7 Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare= type of T-cell lymphoma, have been reported in patients treated with TNF b= lockers, including CIMZIA. These cases have had a very aggressive disease c= ourse and have been fatal. The majority of reported TNF blocker cases have = occurred in patients with Crohn's disease or ulcerative colitis, and the ma= jority were in adolescent and young adult males. Almost all of these patien= ts had received treatment with azathioprine or 6-mercaptopurine concomitant= ly with a TNF blocker at or prior to diagnosis. Carefully assess the risks = and benefits of treating with CIMZIA in these patient types. =C2=B7 Cases of acute and chronic leukemia were reported with TNF blocker u= se. HEART FAILURE =C2=B7 Worsening and new onset congestive heart failure (CHF) has been repo= rted with TNF blockers. Exercise caution and monitor carefully. HYPERSENSITIVITY =C2=B7 Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness,= and urticaria have been reported following CIMZIA administration. If a ser= ious allergic reaction occurs, stop CIMZIA and institute appropriate therap= y. The needle shield inside the removable cap of the CIMZIA prefilled syrin= ge contains a plastic derivative of natural rubber latex which may cause an= allergic reaction in individuals sensitive to latex. HEPATITIS B VIRUS REACTIVATION =C2=B7 Use of TNF blockers, including CIMZIA, may increase the risk of reac= tivation of hepatitis B virus (HBV) in patients who are chronic carriers. S= ome cases have been fatal. =C2=B7 Test patients for HBV infection before initiating treatment with CIM= ZIA. =C2=B7 Exercise caution in patients who are carriers of HBV and monitor the= m before and during CIMZIA treatment. =C2=B7 Discontinue CIMZIA and begin antiviral therapy in patients who devel= op HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatm= ent. NEUROLOGIC REACTIONS =C2=B7 TNF blockers, including CIMZIA, have been associated with rare cases= of new onset or exacerbation of central nervous system and peripheral demy= elinating diseases, including multiple sclerosis, seizure disorder, optic n= euritis, peripheral neuropathy, and Guillain-Barr=C3=A9 syndrome. HEMATOLOGIC REACTIONS =C2=B7 Rare reports of pancytopenia, including aplastic anemia, have been r= eported with TNF blockers. Medically significant cytopenia has been infrequ= ently reported with CIMZIA. =C2=B7 Consider stopping CIMZIA if significant hematologic abnormalities oc= cur. DRUG INTERACTIONS =C2=B7 Do not use CIMZIA in combination with other biological DMARDS. AUTOIMMUNITY =C2=B7 Treatment with CIMZIA may result in the formation of autoantibodies = and, rarely, in development of a lupus-like syndrome. Discontinue treatment= if symptoms of a lupus-like syndrome develop. IMMUNIZATIONS =C2=B7 Patients on CIMZIA should not receive live or live-attenuated vaccin= es. ADVERSE REACTIONS =C2=B7 The most common adverse reactions in CIMZIA clinical trials (=E2=89= =A58%) were: upper respiratory infections (18%), rash (9%), and urinary tra= ct infections (8%). For full prescribing information, please visit https://www.ucb.com/_up/ucb_com_products/documents/Cimzia_09_11_2019_en.pdf= =C2=A0 CIMZIA^=C2=AE is a registered trademark of the UCB Group of Companies.=C2= =A0 About certolizumab pegol in the EU/EEA^6 In the EU, CIMZIA^=C2=AE (certolizumab pegol) in combination with methotrex= ate (MTX) is indicated for the treatment of moderate to severe active RA in= adult patients when the response to disease-modifying antirheumatic drugs = (DMARDs) including MTX, has been inadequate. Certolizumab pegol can be give= n as monotherapy in case of intolerance to MTX or when continued treatment = with MTX is inappropriate. Certolizumab pegol in combination with MTX is al= so indicated for the treatment of severe, active and progressive RA in adul= ts not previously treated with MTX or other DMARDs. Certolizumab pegol has = been shown to reduce the rate of progression of joint damage as measured by= X-ray and to improve physical function, when given in combination with MTX= . Certolizumab pegol, in combination with MTX, is also indicated for the trea= tment of active psoriatic arthritis in adults when the response to previous= DMARD therapy has been inadequate. Certolizumab pegol can be given as mono= therapy in case of intolerance to MTX or when continued treatment with MTX = is inappropriate. Certolizumab pegol is also indicated in the EU for the treatment of adult p= atients with severe active axial spondyloarthritis (axSpA), comprising:=C2= =A0 =C2=B7 Ankylosing spondylitis (AS) =E2=80=93 adults with severe active AS w= ho have had an inadequate response to, or are intolerant to non-steroidal a= nti-inflammatory drugs (NSAIDs).=C2=A0 =C2=B7 Axial spondyloarthritis (axSpA) without radiographic evidence of AS = =E2=80=93 adults with severe active axSpA without radiographic evidence of = AS but with objective signs of inflammation by elevated C-reactive protein = (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate re= sponse to, or are intolerant to NSAIDs. Certolizumab pegol is also indicated for the treatment of moderate to sever= e plaque psoriasis in adults who are candidates for systemic therapy.=C2=A0 Cimzia^=C2=AE (certolizumab pegol) EU/EEA Important Safety Information^6 Cimzia^=C2=AE was studied in 4,049 patients with rheumatoid arthritis (RA) = in controlled and open label trials for up to 92 months. The commonly repor= ted adverse reactions (1-10%) in clinical trials with certolizumab pegol an= d post-marketing were viral infections (includes herpes =C2=A0zoster, papil= lomavirus, influenza), bacterial infections (including abscess), rash, head= ache =C2=A0(including migraine), asthenia, leukopenia (including lymphopeni= a, neutropenia), eosinophilic disorder, pain (any sites), pyrexia, sensory = abnormalities, hypertension, =C2=A0pruritus (any sites), hepatitis (includi= ng hepatic enzyme increase), injection site reactions, and nausea. Serious = adverse reactions include sepsis, opportunistic infections, tuberculosis (i= ncluding miliary, disseminated and extrapulmonary), herpes zoster, lymphoma= , leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (i= ncludes heart failure), ischemic coronary artery disorders, pancytopenia, h= ypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrova= scular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), an= d renal impairment/nephropathy (includes nephritis). In RA controlled clini= cal trials, 4.4% of patients discontinued taking certolizumab pegol due to = adverse events vs. 2.7% for placebo. Certolizumab pegol was initially studied in 325 patients with active axial = spondyloarthritis (including ankylosing spondylitis and non-radiographic ax= ial spondyloarthritis) in the AS001 clinical study for up to 4 years, which= includes a 24-week placebo-controlled phase followed by a 24-week dose-bli= nd period and a 156-week open-label treatment period. Certolizumab pegol wa= s subsequently studied in 317 patients with non-radiographic axial spondylo= arthritis in a placebo-controlled study for 52 weeks (AS0006). Certolizumab= pegol was also studied in patients with axial spondyloarthritis (including= ankylosing spondylitis and non-radiographic axial spondyloarthritis) in a = clinical study for up to 96 weeks, which included a 48-week open-label run-= in phase (N=3D736) followed by a 48-week placebo-controlled phase (N=3D313)= for patients in sustained remission (C-OPTIMISE). Certolizumab pegol was a= lso studied in a 96-week open-label study in 89 axSpA patients with a histo= ry of documented anterior uveitis flares. In all 4 studies, the safety prof= ile for these patients was consistent with the safety profile in rheumatoid= arthritis and previous experience with certolizumab pegol. Certolizumab pegol was studied in 409 patients with psoriatic arthritis (Ps= A) in a clinical study for up to 4 years which included a 24-week placebo-c= ontrolled phase followed by a 24-week dose-blind period and a 168-week open= -label treatment period.=C2=A0 The safety profile for axSpA and PsA patients treated with certolizumab peg= ol was consistent with the safety profile in RA and previous experience wit= h certolizumab pegol. Certolizumab pegol was studied in 1112 patients with psoriasis in controlle= d and open-label studies for up to 3 years. In the Phase III program, the i= nitial and maintenance periods were followed by a 96-week open-label treatm= ent period. The long-term safety profile of certolizumab pegol 400 mg every= 2 weeks and certolizumab pegol 200 mg every 2 weeks was generally similar = and consistent with previous experience with certolizumab pegol. Certolizumab pegol is contraindicated in patients with hypersensitivity to = the active substance or any of the excipients, active tuberculosis or other= severe infections such as sepsis or opportunistic infections, and moderate= to severe heart failure. Serious infections including sepsis, tuberculosis and opportunistic infecti= ons (e.g. histoplasmosis, nocardia, candidiasis) have been reported in pati= ents receiving certolizumab pegol. Some of these events have been fatal. Be= fore initiation of therapy with certolizumab pegol, all patients must be ev= aluated for both active and inactive (latent) tuberculosis infection. If ac= tive tuberculosis is diagnosed prior to or during treatment, certolizumab p= egol therapy must not be initiated and must be discontinued. If latent tube= rculosis is diagnosed, appropriate anti- tuberculosis therapy must be start= ed before initiating treatment with certolizumab pegol.=C2=A0 Reactivation of hepatitis B has occurred in patients receiving a TNF-antago= nist including certolizumab pegol who are chronic carriers of the virus (i.= e. surface antigen positive). Some cases have had a fatal outcome. Patients= should be tested for HBV infection before initiating treatment with certol= izumab pegol. Carriers of HBV who require treatment with certolizumab pegol= should be closely monitored and in the case of HBV reactivation Certolizum= ab pegol should be stopped and effective anti-viral therapy with appropriat= e supportive treatment should be initiated. TNF antagonists including certolizumab pegol may increase the risk of new o= nset or exacerbation of clinical symptoms and/or radiographic evidence of d= emyelinating disease including multiple sclerosis; of formation of autoanti= bodies and uncommonly of the development of a lupus-like syndrome; of sever= e hypersensitivity reactions. If a patient develops any of these adverse re= actions, certolizumab pegol should be discontinued and appropriate therapy = instituted. With the current knowledge, a possible risk for the development of lymphoma= s, leukaemia or other malignancies in patients treated with a TNF antagonis= t cannot be excluded. Rare cases of neurological disorders, including seizu= re disorder, neuritis and peripheral neuropathy, have been reported in pati= ents treated with certolizumab pegol. Adverse reactions of the haematologic system, including medically significa= nt cytopenia, have been reported with certolizumab pegol. Advise all patien= ts to seek immediate medical attention if they develop signs and symptoms s= uggestive of blood dyscrasias or infection (e.g., persistent fever, bruisin= g, bleeding, pallor) while on certolizumab pegol. Consider discontinuation = of certolizumab pegol therapy in patients with confirmed significant haemat= ological abnormalities. The use of certolizumab pegol in combination with anakinra or abatacept is = not recommended due to a potential increased risk of serious infections. As= no data are available, certolizumab pegol should not be administered concu= rrently with live vaccines. The 14-day half-life of certolizumab pegol shou= ld be taken into consideration if a surgical procedure is planned. A patien= t who requires surgery while on certolizumab pegol should be closely monito= red for infections. Please consult the full prescribing information in relation to other side e= ffects, full safety and prescribing information.=C2=A0 European SmPC date of revision June 2022. https://www.ema.europa.eu/en/docu= ments/product-information/cimzia-epar-product-information_en.pdf Last Acces= sed November 2022 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.^7,8=C2=A0 In August 202= 1, bimekizumab was approved in the European Union (EU)/European Economic Ar= ea (EEA) and in Great Britain, for the treatment of moderate to severe plaq= ue psoriasis in adults who are candidates for systemic therapy.^8,9=C2=A0Th= e label information may differ in other countries. Please check local presc= ribing information. In the U.S., the efficacy and safety of bimekizumab hav= e 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 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 May 2022. Last accessed: November 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. A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment = of Subjects with Active Psoriatic Arthritis (BE OPTIMAL). ClinicalTrials.go= v. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03895203?term= =3DBE+OPTIMAL&draw=3D2&rank=3D1 Last accessed: November 2022. 2. A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatm= ent of Subjects with Active Psoriatic Arthritis (BE COMPLETE). ClinicalTria= ls.gov. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03896581= Last accessed: November 2022. 3. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects w= ith Active Non-radiographic Axial Spondyloarthritis (BE MOBILE 1). Clinical= Trials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT03928704= Last accessed: November 2022. 4. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects w= ith Active Ankylosing Spondylitis (BE MOBILE 2). ClinicalTrials.gov. Availa= ble from: https://www.clinicaltrials.gov/ct2/show/NCT03928743 Last accessed= : November 2022. 5. CIMZIA (certolizumab pegol) US Prescribing Information. Available at: Ci= mzia_09_11_2019_en.pdf (ucb.com) (https://www.ucb.com/_up/ucb_com_products/= documents/Cimzia_09_11_2019_en.pdf) Last accessed: November 2022. 6. CIMZIA^=C2=AE (certolizumab pegol) EU Summary of Product Characteristics= . June 2022. https://www.ema.europa.eu/en/documents/product-information/cim= zia-epar-product-information_en.pdf. Last accessed November 2022. 7. 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):991-1= 001. 8. BIMZELX=C2=AE (bimekizumab) EU Summary of Product Characteristics, March= 2022. Available at:=C2=A0https://www.ema.europa.eu/en/documents/product-in= formation/bimzelx-epar-product-information_en.pdf. Last accessed: November = 2022. 9. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Avai= lable at: https://www.medicines.org.uk/emc/product/12834/smpc#gref. Last ac= cessed: November 2022. GenericFile UCB PR ACR Data Highlights Nov 08 2022 ENG (https://mb.cision.com/Public/18= 595/3663475/802f6268d130f454.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x121184x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium