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UCB (EBR:UCB) UCB Media Room: ACR 2029 Data Highlights

Directive transparence : information réglementée

08/11/2019 07:01
https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQBx1W2= 7HkUdGSImvHQ6Hnxedv-2BdJULzFC0tPCFWgOl4UfKcJ6c3cfNCkSTLuxmL7z-2FEG8Z5F8bl2v= OgQSo8vsoXj9Amg5NxAKkelKg1uiWFja_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFR= w6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsABbRlm1-= 2Fe3ZjI-2ByINDSO8P-2BChnfWe-2F1pTXnr6dP43qtuN8dhYguGZL31iI72GbUX4RRUSdEFxvh= N9v-2BejEbFC3AdzynzXwEURTj-2BI1NKOS5Af5xBe94MhfwsqUdsUydGOS4LX8AO3lL0v4cip5= pJ-2FvmzA1XKBih-2F1RDDid0fchFQreJifKkYkHfMeUNdfI3Wp-2B-2FH0PAW7jiqWE5JTMhb7= VxIKuPcL2U7g0AlFpRek7X0HeujY99HOY67h9RSRaGyko-3D ** UCB Presents New Data From Rheumatology Portfolio Addressing Unmet Needs= in Axial Spondyloarthritis, Psoriatic Arthritis and Lupus at 2019 ACR/ARP ------------------------------------------------------------ =C2=B7 Oral presentations include data on improvements in clinical and pati= ent-reported outcomes with early CIMZIA (certolizumab pegol) treatment in n= on-radiographic axial spondyloarthritis, and a reduction in anterior uveiti= s flares in axial spondyloarthritis patients following one year of treatmen= t with CIMZIA =C2=B7 Oral presentations of new 48-week data from Phase 2b trials of inves= tigational molecule bimekizumab support the potential value of dual neutral= ization of IL-17A and IL-17F in psoriatic arthritis and ankylosing spondyli= tis =C2=B7 Oral presentation of data from the Phase 2b trial of investigational= molecule dapirolizumab pegol in patients with moderately to severely activ= e systemic lupus erythematosus Brussels, Belgium =E2=80=93 08=C2=A0November 2019 =E2=80=93 UCB, a global b= iopharmaceutical company, today announced important new rheumatology data b= eing presented on CIMZIA^=C2=AE (certolizumab pegol) and investigational mo= lecules bimekizumab and dapirolizumab pegol at the 2019 American College of= Rheumatology and the Association of Rheumatology Professionals (ACR/ARP) A= nnual Meeting in Atlanta, on November 8-13.=C2=A0 =E2=80=9CUCB research presented at the 2019 ACR/ARP congress reflects our l= eadership in addressing unmet patient needs and providing treatment options= that could make a meaningful difference for people living with axSpA, PsA = and lupus. The breadth and depth of UCB=E2=80=99s 13 data presentations are= intended to improve our understanding of how best to address these serious= diseases, which profoundly impact patients=E2=80=99 lives. UCB continues t= o deliver on its Patient Value Strategy to connect the unmet needs of patie= nts with innovative science,=E2=80=9D said Emmanuel Caeymaex, Head of Immun= ology and Executive Vice President, Immunology Solutions, UCB.=C2=A0 A post-hoc analysis of the 52-week data from the Phase 3 C-AXSPAND study of= CIMZIA will be shared in an oral presentation. The analysis showed that no= n-radiographic axial spondyloarthrtis (nr-axSpA) patients with less than fi= ve years of symptoms prior to initiation of CIMZIA treatment had greater im= provements across signs and symptoms of disease and quality of life, compar= ed to patients with at least five years of symptoms prior to CIMZIA treatme= nt.^1=C2=A0These data suggest the value of diagnosing nr-axSpA patients and= initiating anti-TNF treatment at an early stage of disease to help improve= clinical outcomes. Nr-axSpA is a chronic inflammatory arthritis predominan= tly affecting the spine and sacroiliac joints, and is a distinct condition = within the spondyloarthritis family of chronic inflammatory diseases. In nr= -axSpA, there is no definitive radiographic sacroiliitis, though more sensi= tive magnetic resonance imaging (MRI) testing may detect evidence of active= sacroiliitis, visible as inflammation in the sacroiliac joints.^2 Earlier this year, CIMZIA became the first and only treatment to gain FDA a= pproval in the U.S. for the treatment of active nr-axSpA with objective sig= ns of inflammation. The approval was based on the C-AXSPAND study, which de= monstrated a statistically significant number of patients treated with CIMZ= IA, in addition to non-biologic background medications (NBBM), reached a Ma= jor Improvement in ASDAS (Ankylosing Spondylitis Disease Activity Score) ov= er the 52-week trial, versus placebo plus NBBM.^3 Interim 48-week results from a Phase 4 multicenter open-label C-VIEW study = will be shared in an oral presentation, showing a significant impact of CIM= ZIA on reductions in the acute anterior uveitis flare rate in axial spondyl= oarthritis (axSpA) patients. C-VIEW is the first study to include a broad p= opulation of axSpA patients with active disease, HLA-B27 positivity and a d= ocumented history of acute anterior uveitis, the most common extra-articula= r manifestation in axSpA, affecting up to 40 percent of patients and causin= g a significant burden.^4 Additional presentations focus on patient-reported outcomes for axSpA patie= nts treated with CIMZIA. Positive C-AXSPAND study results show substantial = improvements in sleep quality and other clinical outcomes that are importan= t to patients, such as stiffness and fatigue.^5=C2=A0New research on the im= pact of treatment with CIMZIA on improvements in work and household product= ivity as well as social participation for patients with nr-axSpA will be pr= esented.^6 Additional data from the RAPID-axSpA study showing that CIMZIA t= reatment in axSpA patients was associated with rapid and sustained reductio= n in active inflammation, no increase in sclerosis and erosions, and a negl= igible increase in fatty lesions in the vertebral edges of the spine also w= ill be presented.^7 The RAPID-PsA study on CIMZIA in psoriatic arthritis (PsA) evaluated the re= lationship between PsA disease activity and structural progression over 216= weeks of treatment with CIMZIA. The study showed that it is important for = patients to achieve remission or low disease activity to prevent long-term = structural damage, particularly in patients at risk of radiographic progres= sion.^8=C2=A0 An oral presentation will share efficacy and safety data from the Phase 2b = clinical trial of the investigational molecule, dapirolizumab pegol, in pat= ients with moderately to severely active systemic lupus erythematosus (SLE)= .^9 The primary objective of the study was to establish a dose-response rel= ationship for dapirolizumab pegol using pre-specified models. The study dem= onstrated consistent and potentially meaningful improvements for the majori= ty of clinical endpoints in patients treated with dapirolizumab pegol compa= red with placebo. Upon study drug withdrawal, immunologic parameters return= ed to baseline levels, while pre-specified clinical outcomes stabilized. No= ne of the pre-specified dose-response models could be selected; thus, the p= rimary endpoint was not met. Dapirolizumab pegol was well tolerated and dem= onstrated an acceptable safety profile. UCB and Biogen are collaborating on= the development and commercialization of dapirolizumab pegol and have init= iated preparations for a Phase 3 program in patients with active SLE despit= e standard-of-care treatment. In addition, the company will share 48-week results from the Phase 2b dose = finding studies of its investigational pipeline molecule, bimekizumab, in P= sA and ankylosing spondylitis (AS) in separate oral presentations. The stud= ies showed that treatment with bimekizumab resulted in achievement of low a= nd/or minimal disease activity in patients with PsA, which were maintained = to week 48 as well as sustained improvement in patients with active AS.^10,= 11 The AS study showed that significantly more bimekizumab-treated patients= achieved ASAS40 (Assessment of SpondyloArthritis International Society 40 = percent response) at week 12, compared to placebo, and that these results w= ere sustained to week 48 in the majority of patients. The safety profile wa= s consistent with previous Phase 2 studies, with no new safety findings obs= erved.^11 The safety and efficacy of bimekizumab and dapirolizumab pegol have not bee= n established, and they are not approved by any regulatory authority worldw= ide. UCB also will be sponsoring a symposium featuring a panel of experts discus= sing the challenges in recognizing, diagnosing and managing nr-axSpA. A ful= l list of UCB-sponsored data can be found below. Following is a guide to the UCB-sponsored data presentations: UCB Sponsored Non-CME Symposia:=C2=A0 A New Horizon in Recognition and Management of Patients With nr-axSpA, A. D= eodhar, W. Maksymowych, L. Gensler, M. Rudwaleit =E2=80=A2=C2=A0 Date/time: November 11, 2019: 6:30PM-8:30PM ET =E2=80=A2=C2=A0 Location: Marriott Hotel, Rooms A601 and A602 CIMZIA Oral Presentations: Earlier Treatment of Non-Radiographic Axial Spondyloarthritis with Certoliz= umab Pegol Results in Improved=C2=A0Clinical and Patient-Reported Outcomes,= J. Kay, L. Gensler, A. Deodhar, W. Maksymowych, N. Haroon, S. Auteri, N. d= e Peyrecave, T. Kumke, B. Hoepken, L. Bauer, M. Rudwaleit =E2=80=A2=C2=A0=C2=A0Date/time: November 10, 2019: 4:30PM-6:00PM ET =E2=80=A2=C2=A0=C2=A0Location: GWCC Building B, B405-B407 Reduction of Anterior Uveitis Flares in Patients with Axial Spondyloarthrit= is Following 1 Year of Treatment with Certolizumab Pegol: 48-Week Interim R= esults from a 96-Week Open-Label Study, I. van der Horst-Bruinsma, R. van B= entum, F. D. Verbraak, T. Rath, J. Rosenbaum, M. Misterska-Sk=C3=B3ra, B. H= oepken, O. Irvin-Sellers, B. VanLunen, L. Bauer, M. Rudwaleit =E2=80=A2=C2=A0 Date/time: November 10, 2019: 4:30PM-6:00PM ET =E2=80=A2=C2=A0 Location: GWCC Building B, B405-B407 CIMZIA Posters: Certolizumab Pegol-Treated Patients with Non-Radiographic Axial Spondyloart= hritis Demonstrate Improvements in Sleep Quality and Other Patient Reported Outcomes, L. Gensl= er, J. Kay, W. Maksymowych, N. Haroon, L. Bauer, B. Hoepken, N. de Peyrecav= e, T. Kumke, A. Deodhar=C2=A0 =E2=80=A2=C2=A0=C2=A0Date/time: November 11, 2019: 9:00AM-11:00AM ET =E2=80=A2=C2=A0=C2=A0Location: Hall B5 Certolizumab Pegol Improves Work and Household Productivity and Social Part= icipation Over 1 Year of=C2=A0Treatment in Patients With Non-Radiographic A= xial Spondyloarthritis, A. Deodhar, L. Gensler, J. Kay, W. Maksymowych, N. = Haroon, R. Landew=C3=A9, M. Rudwaleit, S. Hall, L. Bauer, B. Hoepken, N. de= Peyrecave, T. Kumke, D. van der Heijde=C2=A0 =E2=80=A2=C2=A0=C2=A0Date/time: November 11, 2019: 9:00AM-11:00AM ET =E2=80=A2=C2=A0=C2=A0Location: Hall B5 Long=E2=80=91Term Certolizumab Pegol Treatment of Axial Spondyloarthritis i= s Associated with Rapid and Sustained Reduction of Active Inflammation and Minimal Structural Changes i= n the Spine: 4=E2=80=91Year MRI Results, X. Baraliakos, S. Kruse, A. Auteri= , N. de Peyrecave, T. Nurminen, T. Kumke, B. Hoepken, J. Braun, =C2=A0 =E2=80=A2=C2=A0=C2=A0Date/time: November 11, 2019: 9:00AM-11:00AM ET =E2=80=A2=C2=A0=C2=A0Location: Hall B5 Achievement of Very Low Disease Activity and Remission Treatment Targets is= Associated with Reduced Radiographic Progression in Patients with Psoriati= c Arthritis Treated with Certolizumab Pegol, L. Coates, J. F. Merola, A. Ka= vanaugh, P. Mease, O. Davies, O. Irvin-Sellers, T. Nurminen, D. van der Hei= jde =E2=80=A2=C2=A0=C2=A0Date/time: November 11, 2019: 9:00AM-11:00AM ET =E2=80=A2=C2=A0=C2=A0Location: Hall B5 Body Mass Index and Systemic Corticosteroid Use as Indicators of Disease Bu= rden and Their Influence on the Safety Profile of Certolizumab Pegol Across= Indications, A. Blauvelt, J. Curtis, C. Gaujoux-Viala, T. Kvien, W. Sandbo= rn, K. Winthrop, C. Popova, X. Mariette =E2=80=A2=C2=A0=C2=A0Date/time: November 12, 2019: 9:00AM-11:00AM ET =E2=80=A2=C2=A0=C2=A0Location: Hall B5 Bimekizumab Oral Presentations: Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with = Active Ankylosing Spondylitis: 48-Week Efficacy and Safety Results From a P= hase 2b, Randomized, Blinded, Placebo-Controlled, Dose-Ranging Study, D. va= n der Heijde, L. Gensler, A. Deodhar, X. Baraliakos, D. Poddubnyy, A. Kivit= z, M. Oortgiesen, D. Baeten, N. Goldammer, J. Coarse, M. Farmer, M. Dougados =E2=80=A2=C2=A0=C2=A0Date/time: November 10, 2019: 4:30PM-6:00PM ET =E2=80=A2=C2=A0=C2=A0Location: GWCC Building B, B405-B407 Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with = Active Psoriatic Arthritis: Disease Activity and Remission in a 48-week Pha= se 2b, Randomized, Double Blind, Placebo-Controlled, Dose-Ranging Study, P.= Mease, L. Gossec, L. Coates, A. Gottlieb, D. Assudani, J. Coarse, O. Irvin= -Sellers, D. Gladman =E2=80=A2=C2=A0=C2=A0Date/time: November 13, 2019: 9:00AM =E2=80=93 10:30AM= ET =E2=80=A2=C2=A0=C2=A0Location: GWCC Building B, B309 =C2=A0 Dapirolizumab Pegol Oral Presentations: Efficacy and Safety of Dapirolizumab Pegol in Patients with Moderately to S= everely Active Systemic Lupus Erythematosus: A Randomized, Placebo-Controll= ed Study, R. Furie, I. Bruce, T. D=C3=B6rner, M. Leon, P. Leszczy=C5=84ski,= M. Urowitz, B. Haier, C. Brittain, J. Liu, C. Barbey, C. Stach=C2=A0 =E2=80=A2=C2=A0=C2=A0Date/time: November 10, 2019: 4:30PM-6:00PM ET =E2=80=A2=C2=A0=C2=A0Location: GWCC Building A, A411-A412 UCB Sponsored Real-World Data on Chronic Rheumatic Diseases: Gender Differences in Comorbidities and Treatment Utilization among Ankylos= ing Spondylitis Patients Initiating a Biologic in a Real-World Setting, A. = Sheahan, M. Balamane, E. Lee, R. Suruki =E2=80=A2=C2=A0=C2=A0Date/time: November 10, 2019: 9:00AM-11:00AM ET =E2=80=A2=C2=A0=C2=A0Location: Hall B5 Inadequate Response within a Year of Biologic and Oral Synthetic DMARD Trea= tment Initiation among Psoriatic Arthritis Patients in the USA Real-World S= etting, S. Grabich, A. Sheahan, O. Davies, R. Suruki=C2=A0 =E2=80=A2=C2=A0=C2=A0Date/time: November 11, 2019: 9:00AM-11:00AM ET =E2=80=A2=C2=A0=C2=A0Location: Hall B5 Opioid Use Surrounding Diagnosis of Inflammatory Arthritis, A. Sheahan, V. = Sloan, J. Stark, R. Suruki =E2=80=A2=C2=A0=C2=A0Date/time: November 12, 2019: 9:00AM-11:00AM ET =E2=80=A2=C2=A0=C2=A0Location: Hall B5 About Bimekizumab Bimekizumab is an investigational humanized monoclonal IgG1 antibody that p= otently and selectively neutralizes IL-17A and IL-17F, two key cytokines dr= iving inflammatory processes.^12=C2=A0IL-17A and IL-17F have similar pro-in= flammatory functions and independently synergize with other inflammatory me= diators to drive chronic inflammation and damage across multiple tissues.^1= 3,14=C2=A0 About Dapirolizumab Pegol Dapirolizumab pegol is an investigational anti-CD40L pegylated Fab being de= veloped in systemic lupus erythematosus (SLE) jointly by UCB and Biogen. Th= rough interactions with its receptor, CD40, CD40L plays an important role i= n regulating interactions between T cells and other immune cells, notably B= cells and antigen presenting cells, and thus affects several important fun= ctional events thought to be involved in autoimmune disease. About CIMZIA^=C2=AE in the US=C2=A0 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. CIMZIA is indicated for the treatment of adults with moderately to severely= active rheumatoid arthritis (RA), adults with active psoriatic arthritis (= PsA), and adults with active ankylosing spondylitis (AS). CIMZIA is indicat= ed for the treatment of adults with active non-radiographic axial spondyloa= rthritis (nr-axSpA) with objective signs of inflammation. CIMZIA is also indicated for the treatment of moderate to severe plaque pso= riasis in adults who are candidates for systemic therapy or phototherapy.= =C2=A0 In addition, it is indicated for reducing signs and symptoms of Crohn's dis= ease (CD) and maintaining clinical response in adult patients with moderate= ly to severely active disease who have had an inadequate response to conven= tional therapy. See important safety information including risk of serious = bacterial, viral and fungal infections and tuberculosis below. Important Safety Information about CIMZIA^=C2=AE in the US=C2=A0 CONTRAINDICATIONS CIMZIA^=C2=AE is contraindicated in patients with a history of hypersensiti= vity reaction to certolizumab pegol or to any of the excipients. Reactions = have included 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. 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. Carefully consider the risks and benefits of treatment with CIMZIA prior to= initiating therapy in the following patients: with chronic or recurrent in= fection; =C2=A0who have been exposed to TB; =C2=A0with a history of opportu= nistic infection; who resided in or traveled in regions where mycoses are e= ndemic; with underlying conditions that may predispose them to infection. M= onitor patients closely for the development of signs and symptoms of infect= ion during and after treatment with CIMZIA, including the possible developm= ent of TB in patients who tested negative for latent TB infection prior to = initiating 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. =C2=A0Approximately= half of the cases were lymphoma, while the rest were other types of malign= ancies, including rare types associated with immunosuppression and malignan= cies not 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=E2=80=99s disease or ulcerative colitis, an= d the majority were in adolescent and young adult males. =C2=A0Almost all o= f these patients had received treatment with azathioprine or 6-mercaptopuri= ne concomitantly with a TNF blocker at or prior to diagnosis. Carefully ass= ess 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.=C2=A0 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. =C2=A0The needle shield inside the removable cap of the CIMZIA prefilled= syringe contains a derivative of natural rubber latex which may cause an a= llergic 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.=C2=A0 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 trac= t infections (8%).=C2=A0 For full prescribing information, please visit=C2=A0 https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQBy2UW= H9fSPssYmY6IL1fnfgZA-2B8DN9W8Jlh327lf5Bgcllgl-2F5pQ7KKkRtaWHQB2pT39pSl0sOI8= nfctUlhymT8-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjz= wcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsABbRlm1-2Fe3ZjI-2ByINDSO8P= -2BChnfWe-2F1pTXnr6dP43qtuN8dhYguGZL31iI72GbUX4RRUSdEFxvhN9v-2BejEbFC3Adzyn= zXwEURTj-2BI1NKOS5ARXO2ofZtj4HFquznHYwJneKJj-2BGkC8NAhxpQIoiEoZFjV0HTb-2FsD= KyR0E0nnuqzoblsJ-2FUw-2F-2Fhi0PmW-2FsHTs7yRyrZfuFzwLPmNFy0pHDyXvIRfw3OU-2B5= 7thS9RmzvQ6pzlH76wagcGMNOuuMTcyA4-3D About CIMZIA^=C2=AE in the EU/EEA In the EU, CIMZIA^=C2=AE in combination with methotrexate (MTX) is indicate= d for the treatment of moderate to severe active RA in adult patients inade= quately responsive to disease-modifying anti-rheumatic drugs (DMARDs) inclu= ding MTX.=C2=A0 CIMZIA can be given as monotherapy in case of intolerance to MTX or when co= ntinued treatment with MTX is inappropriate. CIMZIA in combination with MTX= is also indicated for the treatment of severe, active and progressive RA i= n adults not previously treated with MTX or other DMARDs. CIMZIA 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 combinati= on with MTX. CIMZIA, in combination with MTX, is also indicated for the treatment of act= ive psoriatic arthritis in adults when the response to previous DMARD thera= py has been inadequate. CIMZIA can be given as monotherapy in case of intol= erance to MTX or when continued treatment with MTX is inappropriate. CIMZIA is also indicated in the EU for the treatment of adult patients 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. CIMZIA is also indicated for the treatment of moderate to severe plaque pso= riasis in adults who are candidates for systemic therapy.=C2=A0 About CIMZIA^=C2=AE in Fertility, Pregnancy and Lactation in the EU/EEA =C2=A0 Women of childbearing potential The use of adequate contraception should be considered for women of childbe= aring potential. For women planning pregnancy, continued contraception may = be considered for 5 months after the last CIMZIA^=C2=AE dose due to its eli= mination rate, but the need for treatment of the woman should also be taken= into account (see below). =C2=A0 Pregnancy Data from more than 500 prospectively collected pregnancies exposed to CIMZ= IA with known pregnancy outcomes, including more than 400 pregnancies expos= ed during the first trimester, does not indicate a malformative effect of C= IMZIA. However, the available clinical experience is too limited to, with a= reasonable certainty, conclude that there is no increased risk associated = with CIMZIA administration during pregnancy. =C2=A0 Animal studies using a rodent anti-rat TNF=CE=B1 did not reveal evidence of= impaired fertility or harm to the foetus. However, these are insufficient = with respect to human reproductive toxicity. Due to its inhibition of TNF= =CE=B1, CIMZIA administered during pregnancy could affect normal immune res= ponse in the newborn. =C2=A0 CIMZIA should only be used during pregnancy if clinically needed. Non-clini= cal studies suggest low or negligible level of placental transfer of a homo= logue Fab-fragment of certolizumab pegol (no Fc region). =C2=A0 In a clinical study 16 women were treated with certolizumab pegol (200 mg e= very 2 weeks or 400 mg every 4 weeks) during pregnancy. Certolizumab pegol = plasma concentrations measured in 14 infants at birth were Below the Limit = of Quantification (BLQ) in 13 samples; one was 0.042 =C2=B5g/ml with an inf= ant/mother plasma ratio at birth of 0.09%. At Week 4 and Week 8, all infant= concentrations were BLQ. The clinical significance of low levels certolizu= mab pegol for infants is unknown. It is recommended to wait a minimum of 5 = months following the mother's last CIMZIA administration during pregnancy b= efore administration of live or live-attenuated vaccines (e.g. BCG vaccine)= , unless the benefit of the vaccination clearly outweighs the theoretical r= isk of administration of live or live-attenuated vaccines to the infants. =C2=A0 Breastfeeding In a clinical study in 17 lactating women treated with CIMZIA, minimal tran= sfer of certolizumab pegol from plasma to breast milk was observed. The per= centage of the maternal certolizumab pegol dose reaching an infant during a= 24 hour period was estimated to 0.04% to 0.30%. In addition, since certoli= zumab pegol is a protein that is degraded in the gastrointestinal tract aft= er oral administration, the absolute bioavailability is expected to be very= low in a breastfed infant. Consequently, CIMZIA can be used during breastf= eeding. Important Safety Information about CIMZIA^=C2=AE in the EU/EEA=C2=A0 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 CIMZIA and post-marke= ting were viral infections (includes herpeszoster, papillomavirus, influenz= a), bacterial infections (including abscess), rash, headache (including mig= raine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosi= nophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypert= ension, pruritus (any sites), hepatitis (including hepatic enzyme increase)= , injection site reactions, and nausea. Serious adverse reactions include s= epsis, opportunistic infections, tuberculosis (including miliary, dissemina= ted and extrapulmonary), herpes zoster, lymphoma, leukaemia, solid organ tu= mours, angioneurotic oedema, cardiomyopathies (includes heart failure), isc= hemic coronary artery disorders, pancytopaenia, hypercoagulation (including= thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculiti= s, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephrop= athy (includes nephritis). In RA controlled clinical trials, 4.4% of patien= ts discontinued taking CIMZIA due to adverse events vs. 2.7% for placebo. CIMZIA is contraindicated in patients with hypersensitivity to the active s= ubstance or any of the excipients, active tuberculosis or other severe infe= ctions such as sepsis or opportunistic infections and moderate to severe he= art failure. Serious infections including sepsis, tuberculosis and opportunistic infecti= ons (e.g., histoplasmosis, nocardia, candidiasis) have been reported in pat= ients receiving CIMZIA. Some of these events have been fatal. Monitor patie= nts closely for signs and symptoms of infections including tuberculosis bef= ore, during and after treatment with CIMZIA. Treatment with CIMZIA must not= be initiated in patients with a clinically important active infection. If = an infection develops, monitor carefully and stop CIMZIA until the infectio= n is controlled. Before initiation of therapy with CIMZIA, all patients mus= t be evaluated for both active and inactive (latent) tuberculosis infection= . If active tuberculosis is diagnosed prior to or during treatment, CIMZIA = therapy must not be initiated and must be discontinued. If latent tuberculo= sis is diagnosed, appropriate anti-tuberculosis therapy must be started bef= ore initiating treatment with CIMZIA. Patients should be instructed to seek= medical advice if signs/symptoms (e.g., persistent cough, wasting/weight l= oss, low grade fever, listlessness) suggestive of tuberculosis occur during= or after therapy with CIMZIA.=C2=A0 Reactivation of hepatitis B has occurred in patients receiving a TNF-antago= nist including CIMZIA 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 CIMZIA. Carriers = of HBV who require treatment with CIMZIA should be closely monitored and in= the case of HBV reactivation CIMZIA should be stopped and effective anti-v= iral therapy with appropriate supportive treatment should be initiated.=C2= =A0 TNF antagonists including CIMZIA may increase the risk of new onset or exac= erbation of clinical symptoms and/or radiographic evidence of demyelinating= disease, including multiple sclerosis; of formation of autoantibodies and = uncommonly of the development of a lupus-like syndrome; of severe hypersens= itivity reactions. If a patient develops any of these adverse reactions, CI= MZIA should be discontinued and appropriate therapy instituted.=C2=A0 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 CIMZIA.=C2=A0 Adverse reactions of the haematologic system, including medically significa= nt cytopaenia, have been reported with CIMZIA. Advise all patients to seek = immediate medical attention if they develop signs and symptoms suggestive o= f blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding= , pallor) while on CIMZIA. Consider discontinuation of CIMZIA therapy in pa= tients with confirmed significant haematological abnormalities.=C2=A0 The use of CIMZIA in combination with anakinra or abatacept is not recommen= ded due to a potential increased risk of serious infections. As no data are= available, CIMZIA should not be administered concurrently with live vaccin= es. The 14-day half-life of CIMZIA should be taken into consideration if a = surgical procedure is planned. A patient who requires surgery while on CIMZ= IA should be closely monitored for infections.=C2=A0 CIMZIA was studied in 325 patients with active axial spondyloarthritis (axS= pA) and in 409 patients with psoriatic arthritis (PsA) for up to four years= . The safety profile for axSpA and PsA patients treated with CIMZIA was con= sistent with the safety profile in RA and previous experience with CIMZIA.= =C2=A0 CIMZIA was studied in 1112 patients with psoriasis in controlled and open-l= abel studies for up to 18 months. The safety profile of CIMZIA 400 mg every= two weeks and CIMZIA 200 mg every two weeks were generally similar.=C2=A0 Please consult the full prescribing information in relation to other side e= ffects, full safety and prescribing information. European SmPC date of revi= sion June 2019. https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-= 2F12d8lSllQB1bgRcJUw8Y6HnHitlehmUp9p23N1ICSEkr9hUTj0vim7zTMmQo26bK8O-2BjuX8= 8sB9OJdL3Ci054qpQT9GBqra6-2FDw0ibG27mjCbSf4S7UMrupa-2BEnqWl-2F2366286Qbwkg-= 3D-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0= hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsABbRlm1-2Fe3ZjI-2ByINDSO8P-2BChnfWe= -2F1pTXnr6dP43qtuN8dhYguGZL31iI72GbUX4RRUSdEFxvhN9v-2BejEbFC3AdzynzXwEURTj-= 2BI1NKOS5AeIMZXgaMN-2BokI8iKVknNsdEgDTuv3j2qgyEC4z5mzJhyY8N-2FyB3ZIP33W1Zf7= RgP9KJFPiTh3HV0t8IKNoEY9uzyCIqQAUnRDGVYNwYFBhRdLIsPgMxibo3YAN41inx1x0RhLVB2= UreVUXbs8mQwQc-3D CIMZIA^=C2=AE is a registered trademark of the UCB Group of Companies. For further information, UCB:=C2=A0 Corporate Communications Laurent Schots=C2=A0 Media Relations, UCB =C2=A0 T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0 Investor Relations Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 Investor Relations, UCB T +32.2.559.94.14 antje.witte@ucb.com Isabelle Ghellynck, =C2=A0Investor Relations, UCB T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0 Brand Communications Andrea Levin Christopher, Immunology Communications, UCB T +1.404.483.7329, andrea.christopher@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 in immunol= ogy and neurology. With 7,500 people in approximately 40 countries, the com= pany generated revenue of =E2=82=AC 4.6 billion in 2018. UCB is listed on E= uronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news Forward looking statements =E2=80=93 UCB This press release contains forward-looking statements based on current pla= ns, estimates and beliefs of management. All statements, other than stateme= nts of historical fact, are statements that could be deemed forward-looking= statements, including estimates of revenues, operating margins, capital ex= penditures, cash, other financial information, expected legal, political, r= egulatory or clinical results and other such estimates and results. By thei= r nature, such forward-looking statements are not guarantees of future perf= ormance and are subject to risks, uncertainties and assumptions which could= cause actual results to differ materially from those that may be implied b= y such forward-looking statements contained in this press release. Importan= t factors that could result in such differences include: changes in general= economic, business and competitive conditions, the inability to obtain nec= essary regulatory approvals or to obtain them on acceptable terms, costs as= sociated with research and development, changes in the prospects for produc= ts in the pipeline or under development by UCB, effects of future judicial = decisions or governmental investigations, product liability claims, challen= ges to patent protection for products or product candidates, changes in law= s or regulations, exchange rate fluctuations, changes or uncertainties in t= ax laws or the administration of such laws and hiring and retention of its = employees. UCB is providing this information as of the date of this press r= elease and expressly disclaims any duty to update any information contained= in this press release, either to confirm the actual results or to report a= change in its expectations. There is no guarantee that new product candidates in the pipeline will prog= ress to product approval or that new indications for existing products will= be developed and approved. Products or potential products which are the su= bject of partnerships, joint ventures or licensing collaborations may be su= bject to differences between the partners. Also, UCB or others could discov= er safety, side effects or manufacturing problems with its products after t= hey are marketed. Moreover, sales may be impacted by international and dome= stic trends toward managed care and health care cost containment and the re= imbursement policies imposed by third-party payers as well as legislation a= ffecting biopharmaceutical pricing and reimbursement. References: 1. Kay J, et al. Earlier Treatment of Non-Radiographic Axial Spondyloarthri= tis with Certolizumab Pegol Results in Improved=C2=A0Clinical and Patient-R= eported Outcomes. Abstract to be presented at ACR/ARHP 2019, November 8-13 = Atlanta, Georgia.=C2=A0 2. Khmelinskii N, et al. The Role of Imaging in Diagnosing Axial Spondyloar= thritis. Front Med. 2018;5:106.=C2=A0 3. Deodhar A, et al. A Fifty-Two-Week, Randomized, Placebo-Controlled Trial= of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis. Arthriti= s Rheumatol. 2019;71(7):1101=E2=80=931111.=C2=A0 4. Van der Horst-Bruinsma I, et al. Reduction of Anterior Uveitis Flares in= Patients with Axial Spondyloarthritis Following 1 Year of Treatment with C= ertolizumab Pegol: 48-Week Interim Results from a 96-Week Open-Label Study.= Abstract to be presented at ACR/ARHP 2019, November 8-13 Atlanta, Georgia.= =C2=A0 5. Gensler L, et al. Certolizumab Pegol-Treated Patients with Non-Radiograp= hic Axial Spondyloarthritis Demonstrate=C2=A0Improvements in Sleep Quality = and Other Patient Reported Outcomes. Abstract to be presented at ACR/ARHP 2= 019, November 8-13 Atlanta, Georgia.=C2=A0 6. Deodhar A, et al. Certolizumab Pegol Improves Work and Household Product= ivity and Social Participation Over 1 Year of=C2=A0Treatment in Patients Wi= th Non-Radiographic Axial Spondyloarthritis. Abstract to be presented at AC= R/ARHP 2019, November 8-13 Atlanta, Georgia. 7. Baraliakos X, et al. Long-Term Certolizumab Pegol Treatment of Axial Spo= ndyloarthritis is Associated with Rapid and Sustained Reduction of Active I= nflammation and Minimal Structural Changes in the Spine: 4=E2=80=91Year MRI= Results. Abstract to be presented at 2019 ACR/ARP, 8-13 November, Atlanta,= GA. 8. Merola J, et al. Achievement of Very Low Disease Activity and Remission = Treatment Targets Is Associated with Reduced Radiographic Progression in Pa= tients with Psoriatic Arthritis Treated with Certolizumab Pegol. Abstract t= o be presented at ACR/ARHP 2019, November 8-13 Atlanta, Georgia. 9. Furie R, et al. Efficacy and Safety of Dapirolizumab Pegol in Patients w= ith Moderately to Severely Active Systemic Lupus Erythematosus: A Randomize= d, Placebo-Controlled Study. Abstract to be presented at 2019 ACR/ARP, 8-13= November, Atlanta, GA. 10. Mease P, et al. Dual Neutralization of IL-17A and IL-17F with Bimekizum= ab in Patients with Active Psoriatic Arthritis: Disease Activity and Remiss= ion in a 48-week Phase 2b, Randomized, Double Blind, Placebo-Controlled, Do= se-Ranging Study. Abstract to be presented at ACR/ARHP 2019, November 8-13 = Atlanta, Georgia. 11. Van der Heijde D, et al. Dual Neutralization of IL-17A and IL-17F with = Bimekizumab in Patients with Active Ankylosing Spondylitis: 48-Week Efficac= y and Safety Results From a Phase 2b, Randomized, Blinded, Placebo-Controll= ed, Dose-Ranging Study. Abstract to be presented at ACR/ARHP 2019, November= 8-13 Atlanta, Georgia. 12. 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. 13. Toy D, Kugler D, Wolfson M, et al. Cutting edge: interleukin 17 signals= through a heteromeric receptor complex. J Immunol Baltim Md 1950. 2006;177= (1):36-39. doi:10.4049/jimmunol.177.1.36 14. Wright JF, Bennett F, Li B, et al. The human IL-17F/IL-17A heterodimeri= c cytokine signals through the IL-17RA/IL-17RC receptor complex. J Immunol = Baltim Md 1950. 2008;181(4):2799-2805. doi:10.4049/jimmunol.181.4.2799 GenericFile UCB ACR 2019 Data Highlights Release (https://u7061146.ct.sendgrid.net/wf/c= lick?upn=3DG62jSYfZdO-2F12d8lSllQBx1W27HkUdGSImvHQ6Hnxedv-2BdJULzFC0tPCFWgO= l4UfXW-2FI0Imh3rZCLGE6-2FOV3VR-2BIO9LAL9x6cihBJ0y3sl8-3D_-2B-2Ft0TnE1oEbVIW= S8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZTjzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElH= Q9EZfLoWbvi8z1TsABbRlm1-2Fe3ZjI-2ByINDSO8P-2BChnfWe-2F1pTXnr6dP43qtuN8dhYgu= GZL31iI72GbUX4RRUSdEFxvhN9v-2BejEbFC3AdzynzXwEURTj-2BI1NKOS5Ab4JJgIepMg5-2B= Ws-2BGsS4x571pYY-2Fbk4US-2FBHo1c8HUY-2B1lN2Z32UdLA7oKBetqIDbgCnKhKEH3dc-2BI= PLSMxArpIWrtFVy2mtpMNGUqV3zW4SiXwFMEdGSpLEuoQ1-2BmjlO78Azozerne7dafQItRNcf4= -3D=0D =0D ______________________=0D If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/wf/click?upn=3DG62jSYfZdO-2F12d8lSllQ= Bz2p53T0v-2BoEIvbo6vDi8C-2BOyFzyb6obo-2BzKSgNKq4mroBxvdt1f1hqBOtp29xUBz4vUH= 507F4SMnwr-2BbVvrMnSYRDciW7fwSChFaFHmLBr-2FlMCaiVH8z-2BN0v6YoVZQMc6PgoZpiyk= HiJYjxRMtf9go-3D_-2B-2Ft0TnE1oEbVIWS8vHM8JK8eu8RpJ4re5BwmFRw6Tr0XlsWOeqQqZT= jzwcPKItQR0hTxd9ZQ7rBLYSOuAKeTefElHQ9EZfLoWbvi8z1TsABbRlm1-2Fe3ZjI-2ByINDSO= 8P-2BChnfWe-2F1pTXnr6dP43qtuN8dhYguGZL31iI72GbUX4RRUSdEFxvhN9v-2BejEbFC3Adz= ynzXwEURTj-2BI1NKOS5AbJHucHpisKsGXh1s-2B-2FyJFI49z7mI6GbqmwsD7cw2TmY51AocCA= 1NEWvEL4I5qwrsB-2FUamIWeASbSYArht7qZf0IVabgc4k5WdOWkPCiYO9ERKtYGhXav0oaKfMp= tLMIz3op-2Bf6Z-2B-2B0OJapsLUTE7zY-3D=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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