UCB (EBR:UCB) UCB Media Room - Key Rheumatology Data

Transparency directive : regulatory news

06/11/2020 14:07

https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513= 9PTmAm2ORJ-2Fb7C-2B6entZ3Q56PHZbJ0db6f0cQDe6eSZitYE4uZ4m3CTukWRf2PFBuJHW8YS= ot2aEIJUJaQBzZIqv3KsTIDr71wAzWcf79ee_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7Ki= DwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZ= xSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa= 2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgTOjhtna4LxBpNyqEzjDLdsAffeI67uZAYfW8= sOde-2Fz4prPh33K5ho2siUG5TVLQWZu1S9-2FGnYyBTAxXH3n279yCu7LmRC0dwu3GYT80eiAK= QtDno3dnJbUMJrfWEgPlmLSrXHr5YoQCVfG7uZ6YQQY-3D ** UCB Showcases Key Rheumatology Data at American College of Rheumatology = Convergence 2020 ------------------------------------------------------------ =C2=B7 C-VIEW study results show CIMZIA^=C2=AE (certolizumab pegol) provide= d reductions in acute anterior uveitis (AAU) flares in patients with axial = spondyloarthritis (axSpA) =C2=B7 C-axSpAnd study shows clinically relevant responses in nr-axSpA pati= ents with either MRI and/or CRP positivity at study baseline =C2=B7 Long-term findings from Phase 2b studies on UCB=E2=80=99s investigat= ional IL-17A and IL-17F inhibitor, bimekizumab, demonstrateconsistent durab= ility of clinical responses in patients with ankylosing spondylitis (AS) an= d psoriatic arthritis (PsA) Brussels, Belgium =E2=80=93 November 5, 2020 =E2=80=93 UCB, a global biopha= rmaceutical company, today announced new data on its TNF inhibitor, CIMZIA^= =C2=AE (certolizumab pegol), and investigational IL-17A and IL-17F inhibito= r, bimekizumab. Data are being presented at the American College of Rheumat= ology (ACR) Convergence 2020 virtual congress on November 5-9, 2020. =E2=80=9CThe important data we are sharing at ACR Convergence 2020 further = highlight UCB=E2=80=99s impressive rheumatology research and our unwavering= commitment to addressing the unmet needs of patients living with rheumatic= diseases. The data demonstrate the real-world difference that CIMZIA can m= ake for axSpA and PsA patients by providing major improvements in disease a= ctivity. Our bimekizumab data further support the selective inhibition of I= L-17F in addition to IL-17A in AS and PsA, showing that bimekizumab has the= potential to provide durable clinical responses impacting overall quality = of life,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President Immunolo= gy Solutions and Head of US, UCB. UCB is sharing two-year data from the Phase 4 C-VIEW study addressing a sig= nificant unmet need for axSpA patients with a history of acute anterior uve= itis (AAU). AAU is the most common extra-articular manifestation in axSpA, = affecting up to 40 percent of patients and causing significant pain and ris= k of irreversible visual impairment.^[i] (https://u7061146.ct.sendgrid.net/= ls/click?upn=3DvgPU0L08DtdYS96St647-2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHl= OgqDj8Vbc5rd23Nd5xqiCbohR6wrmhAt8M2KhMa7A5hYossEA-3DYyC0_xDPID0vOuylFAU8fv4= e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCO= G9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M= -2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgSxg9ZYjLpWzyn8Hm= wn7uYzhFBgaglVJQGVNMQuWNnaFQd4O4tngmzPDkxSoWLgMaYRQLIJHoZ7DLBRYMCaqef-2Bd12= 3zqA9UgwgU4mB-2FvdKft9UcJigdyd-2FsBP2JJyc7dFEhYcvI94XwKSLvV7Sa4iE-3D The C-VIEW open-label study investigated the impact of CIMZIA treatment on = AAU flares in patients with axSpA and a recent history of AAU over a two-ye= ar period.[i] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DoAq-2FBqldth= 4pR0LkVwhBuKmBeHsG4Y8GTgp2Ia1I8QM-3DKGH4_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVW= u7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9= g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-= 2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgckMO2TGcJgQaXdw5cbOLgPrZkO-2F1Cf= bMqH17ol88pPwcgysmrP-2BvashjR9AetqEKRTmoUQ-2BEHLRlyZlEN5MrLqsS9egw-2FI30FvM= HMh-2BBl88369XcrgEbt1vKd9lIeJBubtTkH4WhglCwsc3MQowZjY-3D The primary effica= cy variable was the incidence of AAU flares rate during 96 weeks of CIMZIA = treatment versus pre-baseline period.^[i] (https://u7061146.ct.sendgrid.net= /ls/click?upn=3DvgPU0L08DtdYS96St647-2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJH= lOgqDj8Vbc5rd23Nd5xqiCbohR6wrmhAt8M2KhMa7A5hYossEA-3DgfCM_xDPID0vOuylFAU8fv= 4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoC= OG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7= M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgVDUwgK4b-2F1YiD= H9mp8wSWkUhT8U2NyvxB-2Fk0YD3l1joCtXssisVSgfoYQbaoU994jhYOhQGwuSo3of277cZlU9= t7KPzWGwS6hMKFGrkwoMOEwTC4VICWt-2BDnTUK86ndtDgqmaJJ3Kwb6ubE9LcKrno-3D =C2= =A0Findings revealed an 82 percent reduction in the incidence of AAU flares= during CIMZIA treatment compared to pre-baseline (rate ratio [95 percent C= I]: 0.18 [0.12, 0.28], p< 0.001).^[i] (https://u7061146.ct.sendgrid.net/ls/= click?upn=3DvgPU0L08DtdYS96St647-2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgq= Dj8Vbc5rd23Nd5xqiCbohR6wrmhAt8M2KhMa7A5hYossEA-3DmDhS_xDPID0vOuylFAU8fv4e60= wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9e= kocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B= -2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1Lgf-2FKeFq31f47o5unkC= eRvf60A-2FZLfh5NJHAVM9BXGX8AAqtvEkTpNXNHQ9X2CHOAFXCmlL0Fbael1-2FTqOykU3Ne97= 40EnIxV8SWDozCeHxAaCyY2QTUbAQaHePZ32xXpS0fvWwrzALwcCf8014Y5wz8-3D Improveme= nts in axSpA signs and symptoms were observed by week 96 with 75.6 percent = of patients achieving Assessment of SpondyloArthritis international Society= 20 (ASAS20) and 58.5 percent achieving ASAS40 responses.^[i] (https://u706= 1146.ct.sendgrid.net/ls/click?upn=3DvgPU0L08DtdYS96St647-2FWTri9gpFTm0xN6MV= 3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd5xqiCbohR6wrmhAt8M2KhMa7A5hYossEA-3Dgd= D3_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW= -2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2Bd= QkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2= uc1LgR8R6eJV6WGx0qWoRb51HwW4LSVR17Oud7mUs3t7XlNGbTX-2FEk6e9UvW2-2FvOk7zTjxf= 2ltD-2B8VNWYSK4EYtlr49uHU4wSy-2F-2BTyk6DhnTCWE5OJRMsVuvw7nv6EoV5tW2rliqZLgH= -2FHf7IW5pdLEmlqg-3D =C2=A0No new safety signals were identified, compared = to previous reports.^[i] (https://u7061146.ct.sendgrid.net/ls/click?upn=3Dv= gPU0L08DtdYS96St647-2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd= 5xqiCbohR6wrmhAt8M2KhMa7A5hYossEA-3DJaa1_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVW= u7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9= g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-= 2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1Lgdr4ApDcMn2sqAuUU-2B5BFMcL-2FU-2F= 8VXc5UgWqc-2Fqw5GrcQl2IvPoQL3dphzTb3gNZFet7FOCnrxh-2BZ1MOg43DN5sQjFuhgBiLh0= jbkfR9L4sWyCTzSnRe2UeCEuEh6LD4u8wX4itHPwCii4wVYFI8UNg-3D Additionally, UCB is presenting findings from a post hoc analysis of Phase = 3 C-axSpAnd study evaluating CIMZIA treatment in patients with non-radiogra= phic axial spondyloarthritis (nr-axSpA).^[ii] (https://u7061146.ct.sendgrid= .net/ls/click?upn=3DoAq-2FBqldth4pR0LkVwhBuBLQehfFfo8o6Dk01cZaI50-3DCqjm_xD= PID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZ= lGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyi= mWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1Lg= XOxppa9jwREmsMcyfhc2tsrhDc2zT-2BfAo6iq1jWz5I7bFO5nByFyK6uAt4YUBdcgoDDKmLl4Q= CsvM4eCkw-2Fq9U-2FS7yyc0Ar8kGTeX112uU-2FF-2FtrMDsXSmy0dGLDRIZLXhmJzToT9UEIj= QmZEHcHLwo-3D The study identified that patients with nr-axSpA and either e= vidence at baseline of sacroiliitis on MRI [MRI+] and/or C-reactive protein= at least 10mg/ml [CRP+] have clinically relevant responses when treated wi= th CIMZIA over a 52-week period. Relevant responses were measured by percen= tage of patients achieving major improvement in ASDAS (ASDAS-MI) and ASAS40= .^[ii] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DoAq-2FBqldth4pR0LkV= whBuBLQehfFfo8o6Dk01cZaI50-3DPScH_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwj= I3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSs= FWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9= SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgYBD3ZBZUuiOgEJSC0e2Kb0GzUf5W-2BlF5VUMmR= ompnlfNQIVrAEfcn9mxevITIJJiMHh0tpOpzflNqCqKUbAx3q9ePkwg7rG-2BfLW56xnxZdDen9= 841HmwNpwiUPsA5crbguvDbSJ-2BK8Hc2Jk95XeN6k-3D Across all three subgroups (M= RI+/CRP+, MRI-/CRP+, and MRI+/CRP-), response rates were higher compared to= placebo for both ASDAS-MI and ASAS40 at Week 12 and Week 52.^[ii] (https:/= /u7061146.ct.sendgrid.net/ls/click?upn=3DoAq-2FBqldth4pR0LkVwhBuBLQehfFfo8o= 6Dk01cZaI50-3DZRFF_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bS= l0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rtt= kKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4= U80FXANGvQDfUDq2uc1LgY1-2Bj7qclYXmBxj3xQu9-2B9-2BSozc8754HnuBAY2mfhCxqBmpTa= 0oVh8h6lFUtUShjG2Xv-2BS9JtYYJTqS30UlArwncZV0X9HGmP8DPx2yHpoFy0jNrLcUMhHD5P6= lX93GOG8Lu4hFguPQaHAetw43iV8k-3D Data presentations from two Phase 2b studies on UCB=E2=80=99s investigation= al IL-17A and IL-17F inhibitor, bimekizumab, highlight rapid clinical impro= vements in joint and skin outcomes; as well as quality of life measures (Qo= L) in PsA; and long-term tolerability and consistently durable clinical res= ponses in AS and PsA patients treated with bimekizumab. =C2=B7 The BE AGILE open-label extension (OLE) study investigated long-term= efficacy and safety of bimekizumab treatment in patients with AS over a to= tal treatment duration of 2-years exposure. All patients who entered the OL= E trial either continued on 160mg bimekizumab every four weeks (Q4W) or dos= ed down from 320mg Q4W to 160mg Q4W.^[iii] (https://u7061146.ct.sendgrid.ne= t/ls/click?upn=3DoAq-2FBqldth4pR0LkVwhBuFBcNiBA2efNfLIHxSZVXCM-3DTVSS_xDPID= 0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB= 52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWU= Fqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgWV5= fMv2dAyAtfpX8zWOG9NsHO8H57WLJZnLlk0mV55-2FMVOVNiDxLwbpRcNS9ZdwPeACbMm-2BJXL= 94gnUMmrcqQ8KgCUKVErSdgBdKts4HvysWiR0RkXNylQUPrGeB59uIZKPK7ONBlwnJivjhjtGl6= U-3D Rapid and sustained improvements in all efficacy outcomes observed in = patients treated with bimekizumab in the BE AGILE study during weeks 0-48, = were maintained during the OLE from week 48=E2=80=9396 using non-responder = imputation methodology.^[iii] (https://u7061146.ct.sendgrid.net/ls/click?up= n=3DoAq-2FBqldth4pR0LkVwhBuFBcNiBA2efNfLIHxSZVXCM-3DZLlg_xDPID0vOuylFAU8fv4= e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCO= G9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M= -2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgWzK8hVwXZDvH3aii= EeWyoe4ZgAQG7uknMWmSLL-2FVWBExlIUmim7lDnLyz5-2B5qbqU3kbkevDNTqDamzSIEWxvJ-2= BtzSRQyLCtRrk4uHcgV-2BFyRVaTwoJA84iyQ8uCOdvRO-2FzAHzP3cHsLAdZnBNOr1AI-3D Fu= rthermore, dose reduction at week 48 from 320 mg Q4W to 160 mg Q4W was not = followed by loss of response to week 96 and there were no unexpected safety= findings versus previous studies.^[iii] (https://u7061146.ct.sendgrid.net/= ls/click?upn=3DoAq-2FBqldth4pR0LkVwhBuFBcNiBA2efNfLIHxSZVXCM-3DdWyE_xDPID0v= OuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52= Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFq= jiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1Lge4A8J= q7kfaQylXnDgAvSDL-2BWsHPrIOKt27kLKtF-2BdfArufm-2FkrLUFxwIoiCp-2BS-2FiQpkwd5= z2mxDKOFcFPE4rIGK9S2HkCKrc9L9PKByEUl1dznYp2pUS6rGokZI2qZVXSzB3XTccNmW-2FvMe= qyOp2pU-3D =C2=A0 =C2=B7 The Phase 2b BE ACTIVE study showed that bimekizumab-treated patient= s with active PsA achieved rapid clinical improvements in joint and skin ou= tcomes as well as improvements in patient-reported quality of life (QoL) me= asures.^[iv] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DoAq-2FBqldth4= pR0LkVwhBuMl2pAI8RYqjEa-2BDKWHYIYM-3DlQZd_xDPID0vOuylFAU8fv4e60wei4JxqEGBdV= Wu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c= 9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf= -2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgbCiCSO8QPsmmo-2B5dyc71qTFQQF8Br= SJul8YCt707pDUsR9EiDq-2F-2FAZnvCLXHaU4cDzxoj1lV-2BKs8k4QqQJYq4IkklDuao7lKVk= Wrg4kwZ6JMe6j8cZLMkv0uAmVDW84MmFQYhKN9JOAb6TODSdIWpY-3D Of the patients in = the bimekizumab dosing groups (160 mg, 160 mg with a 320 mg loading dose, o= r 320 mg Q4W), 47.5 to 58.5 percent achieved Health Assessment Questionnair= e Disability Index (HAQ-DI) achieving Minimal Clinically Important Differen= ce (MCID), and more than 75 percent achieved Psoriatic Arthritis Impact of = Disease-9 (PsAID-9) Patient Acceptable Symptom State (PASS) across weeks 12= , 24 and 48, for both measures.^[iv] (https://u7061146.ct.sendgrid.net/ls/c= lick?upn=3DoAq-2FBqldth4pR0LkVwhBuMl2pAI8RYqjEa-2BDKWHYIYM-3DF5JH_xDPID0vOu= ylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zl= f-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqji= ie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgQl5egJb= M0m60FfKIE4LE23ICaStq6-2BnGQxdN4BQ7KZH1MFlQua8cuLxYQoUvyuEcI4MqobppNgKpF-2F= LzYDynsUyEDkZvqVZPR2bZJMGY-2Fddhp5SZ6l-2F66UFJEmUUrzjzDUMYEaU-2F-2FTbPtAMMT= i4310-3D These results reinforce bimekizumab=E2=80=99s strong potential to = positively impact QoL for patients with PsA.^[iv] (https://u7061146.ct.send= grid.net/ls/click?upn=3DoAq-2FBqldth4pR0LkVwhBuMl2pAI8RYqjEa-2BDKWHYIYM-3Do= dYL_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqdd= W-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2B= dQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq= 2uc1LgTlg3V-2FWp2olu8OavlIGi8ivw13RSfIvz-2BAxJU9kyQ6GWMGLrjKYzAI9kJqnGKGd-2= FITEUKNsk23SU1CW0W8iXdKFBK2QeEkmkmXDXeS3NeWDTqRkdn7DRMWAiikIlcWqEvIEWrROdoa= -2BleeMJgnRjRk-3D =C2=B7 The BE ACTIVE OLE study investigated long-term efficacy and safety o= f bimekizumab treatment in patients with active PsA over a total treatment = duration of 2-years exposure.^[v] (https://u7061146.ct.sendgrid.net/ls/clic= k?upn=3DoAq-2FBqldth4pR0LkVwhBuC5O4f98-2BWjSlNxDjVYDxjI-3D4XeK_xDPID0vOuylF= AU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2= FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2= L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgYszP3wt2mM= NkO4iguc2eDzAyxNHZLYXdWLESoe6I7dpNYIhzMM25MQ-2F6elquXttLZNRmOUdG5f1qLNhpIg2= P7kDPBhfMF6YVuPhdZxWQIJZgiLZXBM5hT6x1RAlA8neUlGtro9bdimhNGjqQJoYrOI-3D All = patients who entered the OLE trial received 160 mg Q4W.^[v] (https://u70611= 46.ct.sendgrid.net/ls/click?upn=3DoAq-2FBqldth4pR0LkVwhBuC5O4f98-2BWjSlNxDj= VYDxjI-3D6Lek_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0Kxv= Ps6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebV= hW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FX= ANGvQDfUDq2uc1LgeY73cQChRWPX-2F-2FYJFGoICxQc1UWnlJn-2BuLOVQPggs4ekaoiJNeWIj= 1NCUdgAdSw-2BiTd1Zpc6O-2Ft92sBX6FWEaqxn9wDxuEcKfoveLYAq-2BcXBLipbkiNzMX-2B0= k-2FBVM-2FTypfOf6m7thC0iefpxN8QMC4-3D A high proportion of patients initial= ly randomized to the three highest bimekizumab doses (160 mg, 160 mg with a= 320 mg loading dose, or 320 mg Q4W) in the BE ACTIVE study and achieved hi= gh levels of disease control at Week 12 demonstrated maintenance of respons= es for at least 2 years of therapy across both joint and skin outcomes.^[v]= (https://u7061146.ct.sendgrid.net/ls/click?upn=3DoAq-2FBqldth4pR0LkVwhBuC5= O4f98-2BWjSlNxDjVYDxjI-3D7q3k_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8= sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV= 73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93= v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgVe2T1kfvsxmBeHiahKa8LTw4t3mxDp72-2BO25mBNZT= -2BNCpmNB4fYrBZ3VKtrRZfc9NVg1RUceElV9OHvUMsRzPWfWoEoIsV5-2BEi4j7dcgr4Ia1dtC= Xom7u5AHNiLiAw25GqcYHeLqNlx63g7mpLan2g-3D Rates of treatment-emergent adver= se events (TEAEs) occurred in 87.7 percent of patients and serious TEAEs in= 9.3 percent of patients. The findings suggest bimekizumab maintains a robu= st treatment response and high level of disease control up to two years.^[v= ] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DoAq-2FBqldth4pR0LkVwhBuC= 5O4f98-2BWjSlNxDjVYDxjI-3DcOQd_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b= 8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWz= V73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD9= 3v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgbmJmDj0pXW8IZ9lKUSvescudNKNw-2BQmLPk7DMIFr= h762bSlZ6y-2BE5NdXqVSzrBgbsFaQboLHm-2BIyRKQwbYZvqnyB9h1AiEa0gGTZH-2BBQXCFa-= 2FiCFBDD9GEU69KeM184dW6kguFKiTNA-2FfCzMInmasQ-3D The safety and efficacy of bimekizumab have not been established and it is = not approved by any regulatory authority worldwide. Following is a guide to the UCB-sponsored data presentations: Bimekizumab e-Posters: Bimekizumab Long-Term Efficacy and Safety Over 96 Weeks in Patients with An= kylosing Spondylitis: Interim Results from a Phase 2B Open-Label Extension = Study X Baraliakos, A Deodhar, M Dougados, M Oortgiesen, N de Peyrecave, M Bauer,= T Vaux, C Fleurinck, D van der Heijde Bimekizumab Treatment is Associated with Improvements in Back Pain and Fati= gue in Patients with Active Psoriatic Arthritis: 48-Week Results from a Pha= se 2B Study A Deodhar, L Gossec, PJ Mease, J Coarse, H Edens, N de Peyrecave, D Assudan= i, B Ink, CT Ritchlin Bimekizumab Improves Patient-Reported Outcomes in Psoriatic Arthritis: 48-W= eek Results from a Phase 2B Study and Association Between Patient-Reported = Outcomes and Disease Activity L Gossec, PJ Mease, AB Gottlieb, D Assudani, J Coarse, B Ink, LC Coates Bimekizumab Maintenance of Response in Patients with Psoriatic Arthritis: 2= -Year Results from a Phase 2B Dose-Ranging Study and its Open-Label Extensi= on JF Merola, F Behrens, AJ Kivitz, PJ Mease, IB McInnes, B Ink, D Assudani, P= Joshi, J Coarse, CT Ritchlin CIMZIA e-Posters: Certolizumab Pegol Efficacy in Patients with Non-Radiographic Axial Spondyl= oarthritis Stratified by Baseline MRI and C-Reactive Protein Status A Deodhar, LS Gensler, S Hall, PC Robinson, B Hoepken, L Bauer, T Kumke, WP= Maksymowych Predictors of Response in Patients with Non-Radiographic Axial Spondyloarth= ritis Receiving Certolizumab Pegol in the C-axSpAnd Study WP Maksymowych, T Kumke, SE Auteri, B Hoepken, L Bauer, M Rudwaleit Reduction of Anterior Uveitis Flares in Patients with Axial Spondyloarthrit= is During Certolizumab Pegol Treatment: 96-Week Results from the C-VIEW Stu= dy I van der Horst-Bruinsma, RE van Bentum, FD Verbraak, T Rath, JT Rosenbaum,= B Hoepken, O Irvin-Sellers, T Kumke, L Bauer, M Rudwaleit Network Meta-Analysis of Long-Term Efficacy (ASAS40) of Biologic Disease-Mo= difying Anti-Rheumatic Drugs (bDMARDs) in bDMARD-Na=C3=AFve Patients with N= on-Radiographic Axial Spondyloarthritis S Kiri, M Kim, M Betts, M Chitnis, K Fahrbach, J Tarpey, M Turner Achievement of Remission is Associated with Improvement in Functionality in= Certolizumab Pegol-Treated Patients with Psoriatic Arthritis, Irrespective= of Pre-Existing Radiographic Structural Damage LC Coates, D van der Heijde, LE Kristensen, WR Tillett, J Eells, T Nurminen= , A Deodhar About Bimekizumab Bimekizumab is an investigational humanized monoclonal IgG1 antibody that s= electively inhibits both IL-17A and IL-17F, two key cytokines driving infla= mmatory processes.^[vi] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DoA= q-2FBqldth4pR0LkVwhBuAnv0NgTaTQOiGJnaHvEglI-3DiCWI_xDPID0vOuylFAU8fv4e60wei= 4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekoc= Vj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2B= qFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgagvCu57AfkqK8VxvDUvN8R= NQvnE185XfMcDBgdkiTrD-2B5mqWPeqbULKCU8nGQa5aw8mCAXIewHafoLz7s9Y-2FZstHKKMuu= 7lf21MH2lijlsS4niGJCw7rHw-2FK7xy9-2FbKhqf3ru0zlOljAaoumGjr5wc-3D IL-17F has= overlapping biology with IL-17A and drives inflammation independently to I= L-17A.^[vii] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DoAq-2FBqldth4= pR0LkVwhBuFTgNr2ESIHhcZyRQtfLCeQ-3D4v4E_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu= 7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g= 1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2= Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgTkPDXDelM07vjP1WUfOmIq0UZ-2F0mdT8= 9CO-2B90f-2F1sub5W2eLqEVEFvkUFAt2qf91I5HBoksz7XRot9Ql95vAl7TbtXZ3ilqgSJS7pI= tpVhONBmQORlIExudkBnX6XkBWsdO3kWP3HQ00T6gk6dzrkA-3D ,[viii] (https://u70611= 46.ct.sendgrid.net/ls/click?upn=3DoAq-2FBqldth4pR0LkVwhBuLcPIYk5ZPXgBoACvGk= xgMo-3DJ325_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs= 6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW= 9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXAN= GvQDfUDq2uc1LgQs6TRU7Y0OMVcim35R-2BS22JpGSkmisuqHkCE6e-2FKBxG1cvU1-2FpdqPIh= kC-2FeubmpLSmynAQBV-2Fl4Pj6BLJ2ZxvImpTVYukgSeOKW7YjAvKfTTLjwXSXs1mc1EWml3YF= DJcG7B7y8-2B83-2Fl5uuF3vm4cc-3D ,[ix] (https://u7061146.ct.sendgrid.net/ls/= click?upn=3DoAq-2FBqldth4pR0LkVwhBuAW-2FECEiktYFAhNm39VAZCo-3DbMPD_xDPID0vO= uylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Z= lf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqj= iie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgW193QF= FTZh7dtQBp7Bz-2FiF4CZSfAeEeWiwC9-2F1LC3dYssCudsEvgOqQEg1YvPUdSjj3TAFs5VaR86= VpeRRwWmlY6kOk89y02TMa0OekLgLQZ72DBKEMpmxVoI8Gik31Fng6ID-2F6gUowgUgohBRQn78= -3D ,[x] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DoAq-2FBqldth4pR0L= kVwhBuAD-2F9Led7NOXiJRBklEPFxc-3DUDGo_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7K= iDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1w= ZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Bo= a2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgUC6LEpp6rCJto0IwGjmWorU0DYRz149955m= QSbVV-2B030T2IGVTcbGA0rS39PAL5-2BfcgzL4ed6z-2FlfND3WCIZa4V0XpjxIsFBGeuLnSA6= iADOaL8CNxXpGvNrA0nAD7UeNIeMAvE70fDD13gngtg5q4-3D ,[xi] (https://u7061146.c= t.sendgrid.net/ls/click?upn=3DoAq-2FBqldth4pR0LkVwhBuC3QqARYenFWib-2FO1bVUF= ko-3D7xqc_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6E= FaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9Z= UHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGv= QDfUDq2uc1LgZi8h-2Bm55EsxHDXqPtFbToVBCCgeoYHyelS8RbyUOFuOpIrcCfxCzQ3YFNyPVM= HDeZJOshe650QiBRGtLi4Eb-2BBeROywZ1B-2BZ5ye7Kp012-2ByFM4TZI-2FHCYHQZruWm4C7R= LjGAVrOcffMeJ8SegTlrg8-3D Selective inhibition of IL-17F in addition to IL-= 17A suppresses inflammation to a greater extent than IL-17A inhibition alon= e.10^,11 The safety and efficacy of bimekizumab are being evaluated across = multiple disease states as part of a robust clinical program. About CIMZIA^=C2=AE=C2=A0in the US 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 reducing signs and symptoms of Crohn's disease (CD)= and maintaining clinical response in adult patients with moderately to sev= erely active disease who have had an inadequate response to conventional th= erapy. 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. In addition, CIMZIA is indicated for the treatment of moderate to severe pl= aque psoriasis (PSO) in adults who are candidates for systemic therapy or p= hototherapy. See important safety information including risk of serious bac= terial, 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. 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=A0 who have been exposed to TB;=C2=A0 with 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 maligna= ncies, including rare types associated with immunosuppression and malignanc= ies 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=A0 Almost 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. 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://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdKdn= kD23fns-2FvC-2FH2O-2FRu906jSnkSmAsA6kkfIJiZLZFYPecTEBc0DLeE4Es5opQAqUaLqtEK= -2BdxgvhbitwZiSbXHp-2BKk1OjR8zGw0xJqLE9D4-_xDPID0vOuylFAU8fv4e60wei4JxqEGBd= VWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9= c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqD= f-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1Lga4DmC-2BNfVzH3d1-2FCnEyhbTZnxa= WFbtQqPXKyxmq2QVKpX6-2BePbbIAp6dVjn-2BnLK9Tjx2fiJQAOCh1EcSDc9V-2B0U-2FhlGEM= GZnH8AWXfpaV8p-2Fb7Xz9ISkM2u-2FIGtrJz-2F-2BnV90hhwflidEWem6JRMAuU-3D About CIMZIA^=C2=AE=C2=A0in the EU/EEA In the EU, CIMZIA^=C2=AE=C2=A0in combination with methotrexate (MTX) is ind= icated for the treatment of moderate to severe active RA in adult patients = inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) = including 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 Cimzia^=C2=AE (certolizumab pegol) EU/EEA* Important Safety Information 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 percent) in clinical trials with Cimzia^=C2=AE = and post-marketing were viral infections (includes herpes zoster, papilloma= virus, influenza), bacterial infections (including abscess), rash, headache= (including migraine), asthenia, leukopenia (including lymphopenia, neutrop= enia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalit= ies, hypertension, pruritus (any sites), hepatitis (including hepatic enzym= e increase), injection site reactions, and nausea. Serious adverse reaction= s include sepsis, opportunistic infections, tuberculosis (including miliary= , disseminated and extrapulmonary), herpes zoster, lymphoma, leukaemia, sol= id organ tumours, angioneurotic oedema, cardiomyopathies (includes heart fa= ilure), ischemic coronary artery disorders, pancytopenia, hypercoagulation = (including thrombophlebitis, pulmonary embolism), cerebrovascular accident,= vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairme= nt/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4 = percent of patients discontinued taking Cimzia^=C2=AE due to adverse events= vs. 2.7 percent for placebo. Cimzia^=C2=AE was initially studied in 325 patients with active axial spond= yloarthritis (including ankylosing spondylitis and non-radiographic axial s= pondyloarthritis) in the AS001 clinical study for up to 4 years, which incl= udes a 24-week placebo-controlled phase followed by a 24-week dose-blind pe= riod and a 156-week open-label treatment period. Cimzia^=C2=AE was subseque= ntly studied in 317 patients with non-radiographic axial spondyloarthritis = in a placebo-controlled study for 52 weeks (AS0006). Cimzia^=C2=AE was also= studied in patients with axial spondyloarthritis (including ankylosing spo= ndylitis 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=3D7= 36) followed by a 48-week placebo-controlled phase (N=3D313) for patients i= n sustained remission (C-OPTIMISE). In all 3 studies, the safety profile fo= r these patients was consistent with the safety profile in rheumatoid arthr= itis and previous experience with Cimzia^=C2=AE.=C2=A0 Cimzia^=C2=AE was studied in 409 patients with psoriatic arthritis (PsA) in= a clinical study for up to 4 years which included a 24-week placebo-contro= lled phase followed by a 24-week dose-blind period and a 168-week open-labe= l treatment period. The safety profile for axSpA and PsA patients treated with Cimzia^=C2=AE wa= s consistent with the safety profile in RA and previous experience with Cim= zia^=C2=AE. Cimzia^=C2=AE was studied in 1112 patients with psoriasis in controlled and= open-label studies for up to 3 years. In the Phase III program, the initia= l and maintenance periods were followed by a 96-week open-label treatment p= eriod. The long-term safety profile of Cimzia^=C2=AE 400 mg every 2 weeks a= nd Cimzia^=C2=AE 200 mg every 2 weeks was generally similar and consistent = with previous experience with Cimzia. Cimzia^=C2=AE is contraindicated in patients with hypersensitivity to the a= ctive substance or any of the excipients, active tuberculosis or other seve= re infections such as sepsis or opportunistic infections, and moderate to s= evere heart failure. Serious infections including sepsis, tuberculosis and opportunistic infecti= ons (e.g. histoplasmosis, nocardia, candidiasis) have been reported in pati= ents receiving Cimzia^=C2=AE. Some of these events have been fatal. Before = initiation of therapy with Cimzia^=C2=AE, all patients must be evaluated fo= r both active and inactive (latent) tuberculosis infection. If active tuber= culosis is diagnosed prior to or during treatment, Cimzia^=C2=AE therapy mu= st not be initiated and must be discontinued. If latent tuberculosis is dia= gnosed, appropriate anti-tuberculosis therapy must be started before initia= ting treatment with Cimzia^=C2=AE. Reactivation of hepatitis B has occurred in patients receiving a TNF-antago= nist including Cimzia^=C2=AE who are chronic carriers of the virus (i.e. su= rface antigen positive). Some cases have had a fatal outcome. Patients shou= ld be tested for HBV infection before initiating treatment with Cimzia^=C2= =AE. Carriers of HBV who require treatment with Cimzia^=C2=AE should be clo= sely monitored and in the case of HBV reactivation Cimzia^=C2=AE should be = stopped and effective anti-viral therapy with appropriate supportive treatm= ent should be initiated. TNF antagonists including Cimzia^=C2=AE may increase the risk of new onset = or exacerbation of clinical symptoms and/or radiographic evidence of demyel= inating disease including multiple sclerosis; of formation of autoantibodie= s and uncommonly of the development of a lupus-like syndrome; of severe hyp= ersensitivity reactions. If a patient develops any of these adverse reactio= ns, Cimzia^=C2=AE 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 Cimzia^=C2=AE. Adverse reactions of the haematologic system, including medically significa= nt cytopenia, have been reported with Cimzia^=C2=AE. Advise all patients to= seek immediate medical attention if they develop signs and symptoms sugges= tive of blood dyscrasias or infection (e.g., persistent fever, bruising, bl= eeding, pallor) while on Cimzia^=C2=AE. Consider discontinuation of Cimzia^= =C2=AE therapy in patients with confirmed significant haematological abnorm= alities. The use of Cimzia^=C2=AE in combination with anakinra or abatacept is not r= ecommended due to a potential increased risk of serious infections. As no d= ata are available, Cimzia^=C2=AE should not be administered concurrently wi= th live vaccines. The 14-day half-life of Cimzia^=C2=AEshould be taken into= consideration if a surgical procedure is planned. A patient who requires s= urgery while on Cimzia^=C2=AE should be closely monitored for infections. Please consult the full prescribing information in relation to other side e= ffects, full safety and prescribing information. European SmPC date of revision July 2020. https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3E= U-2FWvZebf3RrOmE3Tk7MlrShjDNSVHpnfL6TfOxZowbuWXJCI8bbCZVOamVwH9nu7OTyWvLsHd= N1-2FyZYmHi9NLhb7vDDKsRPZltwUi15U5BPBnLh0FBflBDzTkqACQ-3D-3DgNFx_xDPID0vOuy= lFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf= -2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjii= e2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgbqTkkxw0= gVLB1whBeLL5NWH2keGp-2B2Df5a2Cm5DRFgIhOhw6yRFm8-2FccOsz6QN34qVMrJs15T-2FYc1= CSHxBHqXYxCDrk1Fq4EKNhJedBu6dUpC2aKbfYqgcmnnbRJw-2BknmmbUOVvkYYHYnSmM3cwAZI= -3D CIMZIA^=C2=AE=C2=A0is a registered trademark of the UCB Group of Companies. [i] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DvgPU0L08DtdYS96St647-2= FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd5xqiCbohR6wrmhAt8M2Kh= Ma7A5hYossEA-3DkHLo_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86b= Sl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1rt= tkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z= 4U80FXANGvQDfUDq2uc1LgWHvIvEq0yWcCzWLF1AYlCxgLfe82Ac47jqLkT6O26T-2By6efzafL= iTmYbb9tTXoawDE9Wqz5Oa-2B3BugJslJ28l4wjzC-2FK-2FJ9qTu8V72F-2BbmGVkXmsVdNAUL= dvZf8BXE1OJJDFPcHcb3JtAXF5PEghHc-3D van der Horst-Bruinsma I, van Bentum RE= , Verbraak FD, et al. Reduction of anterior uveitis flares in patients with= axial spondyloarthritis during certolizumab pegol treatment: 96-week resul= ts from the c-view study. Abstract to be presented at ACR 2020, 5-9 Novembe= r. [ii] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DvgPU0L08DtdYS96St647-= 2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd5xqiCbohR6wizlFR7zUi= XQgPJJrEATglQ-3D0tkR_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86= bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1r= ttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8= z4U80FXANGvQDfUDq2uc1LgUdzoRGMv3N-2F90zAhLXzzpsrPIa-2B8aXr-2FbOM9HAT0TQEkh3= aLp8IxsCtVbBrHJlPDrghZNWK4MS7We6-2FFPoc8YegiUfITP-2FZJX9OJ5dMKPIgoZq-2FZjcU= 5R-2FJVAPH7b-2BAYowBjnQgSB3gaJ9J9SHVYRI-3D Deodhar A, LS Gensler, Hall S, e= t al. Certolizumab pegol efficacy in patients with nonradiographic axial sp= ondyloarthritis stratified by baseline mri and creactive protein status. Ab= stract to be presented at ACR 2020, 5-9 November. [iii] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DvgPU0L08DtdYS96St647= -2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd5xqiCbohR6wll6rtIsL= EnLdDjAKMa6COI-3DvGeS_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL8= 6bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1= rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq= 8z4U80FXANGvQDfUDq2uc1LgZu0s8osO8qkj3itQ-2BIl8PYll5fiBRqCjxT3IZ5uydnBV3WDsh= IWU-2ByveUQJ3OUe-2BbDISsv-2FWeFr-2BYAhrOMXOrijZIfA24sfEgaDfhomU2lanuTXEuJ0P= bKlqj6p3tJ2XdrbJ-2BwkffyvJujkVj2XjWk-3D Baraliakos X, Deodhar A, Dougados M= , et al. Bimekizumab long-term efficacy and safety over 96 weeks in patient= s with ankylosing spondylitis: interim results from a phase 2b open-label e= xtension study. Abstract to be presented at ACR 2020, 5-9 November. [iv] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DvgPU0L08DtdYS96St647-= 2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd5xqiCbohR6wnPevxnjHx= BkRNrrZx0S5KE-3DZXgE_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86= bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1r= ttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8= z4U80FXANGvQDfUDq2uc1Lgeg3D5y70Ck3PrT0hoyq4BuZZ8O9gll-2FG-2BQV6qIlaTfIyFnTb= dDwRsMsk89DJvOym7fTbguUGzR4X-2BZ9vNgdOPhLW-2F11K7g1n5Z1dqpuwIbAWLbu53UxXsbX= xgd47193v2TkY5CEq88M-2F6x-2B1WH6FhE-3D Gossec L, Mease PJ, Gottlieb AB, et = al. Bimekizumab improves patient-reported outcomes in psoriatic 2 arthritis= : 48-week results from a phase 2b study and association 3 between patient-r= eported outcomes and disease activity. Abstract to be presented at ACR 2020= , 5-9 November. [v] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DvgPU0L08DtdYS96St647-2= FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd5xqiCbohR6wqGtalAyvKl= KS8OS6CoQ-2B-2FE-3DFxyr_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46D= L86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqty= y1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZe= Xq8z4U80FXANGvQDfUDq2uc1Lgd4LfSGiuPjOK5zE-2B8IkPru37di48KDIXPZpwSEOt3s6-2FT= dvHNxhGMy9x5ioiJzdrVgCTgAvcdFwI-2BswYgqlbcwk1pJ5DJwK5xTYTrUrMgRTw638oBrxI23= H4p7nP1lfxbEieVTY-2FWieIplkc1DMRH8-3D Merola JF, Behrens F, Kivitz AJ, et a= l. Bimekizumab maintenance of response in patients with psoriatic arthritis= : 2 year results from a phase 2b dose ranging study and its open label exte= nsion. Abstract to be presented at ACR 2020, 5-9 November. ^^[vi] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DvgPU0L08DtdYS96St64= 7-2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd5xqiCbohR6wlG0KBW4= cuH7AizLmKKol4Q-3DZTpn_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL= 86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy= 1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeX= q8z4U80FXANGvQDfUDq2uc1LgQ8fhfEKWEtD3ruz-2FccWoeCbCZvyo8cqdL8QNYUwOWzQ0glQu= D2DRfoefgIVDkho0UVN1CBoQlA28NXPKBRvnvUp8DjjlHWKv-2BcoI-2Bm8jbyDHFjpZtOcN3wP= YKa7qtkOMQ5bhKPeTNtUAfYCi-2FCRtVs-3D Glatt S, Helmer E, Haier B, et al. Fir= st-in-human randomized study of bimekizumab, a humanized monoclonal antibod= y and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br = J Clin Pharmacol. 2017;83(5):991-1001. ^^[vii] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DvgPU0L08DtdYS96St6= 47-2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd5xqiCbohR6wqy-2FD= PGVtWXt2q98vyDjiTw-3D1EQd_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN4= 6DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pq= tyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZW= ZeXq8z4U80FXANGvQDfUDq2uc1LgeJf6uvd4Hi2jC-2BlAcmAWVE2a5gb-2FWuJL5Ai9kN9UMFm= fl25u7Gf7eH-2F6kiQ1Npqp8Sm-2B0NtbvSPpZVpyi8DhGx5FwUBs4CHl2MCog-2FqhAhBk0yJP= IavJ8zaZA1NT7rdaqLpG7ug1iaw5lovoCw-2FzPs-3D ^ Yang XO, Chang SH, Park H, et= al. Regulation of inflammatory responses by IL-17F. J Exp Med. 2008;205(5)= :1063=E2=80=931075. ^^[viii] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DvgPU0L08DtdYS96St= 647-2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd5xqiCbohR6wpjLwP= PoOF6BDtyzyhlM0uo-3D9UuO_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46= DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqt= yy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZ= eXq8z4U80FXANGvQDfUDq2uc1LgRQTTn8lQ2heSRLMdOYMOJm67uGhz2eVnxXSvJbGlkveWqyXd= csDGSXnV7EV-2FtG9AVAh-2BDpPyK-2FeqEwQN9Pj-2FsQ6UFJLpV0ii3SrbZlL4cGBUtDn0zsm= QkhC-2FufrDCXeVw7qqfAv92Pz-2Fl2b5M7uaCo-3D Hymowitz SG, Filvaroff EH, Yin J= P, et al. IL-17s adopt a cystine knot fold: structure and activity of a nov= el cytokine, IL-17F, and implications for receptor binding. Embo J. 2001;20= (19):5332=E2=80=935341. ^^[ix] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DvgPU0L08DtdYS96St64= 7-2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd5xqiCbohR6wjEb3txI= DqwgBsM9b2NOFw0-3D-zH4_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL= 86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy= 1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeX= q8z4U80FXANGvQDfUDq2uc1LgRCFqgxwnkrx-2BkCq8mGM6C4lwcIajB9wsWbbG3BQQ65HRyLHQ= bMFGLtw-2BhmLdddE2NvmuMgPCpCtZkdQ-2F1BwsWNRHctryH0PsJO2qiMQdUWL3er3BBq-2FSk= EcqrggOULyiIlC2G4fHKxnbD1OooZGV5A-3D van Baarsen LG, Lebre MC, van der Coel= en D, et al. Heterogeneous expression pattern of interleukin 17A (IL-17A), = IL-17F and their receptors in synovium of rheumatoid arthritis, psoriatic a= rthritis and osteoarthritis: possible explanation for nonresponse to anti-I= L-17 therapy? Arthritis Res Ther. 2014;16(4):426. ^^[x] (https://u7061146.ct.sendgrid.net/ls/click?upn=3DvgPU0L08DtdYS96St647= -2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8Vbc5rd23Nd5xqiCbohR6wqMcnjc89= -2BpUh0tDE0wAXpk-3Dkhmu_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46D= L86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqty= y1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZe= Xq8z4U80FXANGvQDfUDq2uc1LgWR81NHjJjyH52NYtSA8GPLd5snWidYjzusQslO1Flbt2efpEt= PA3LnFB80c7-2BUVPiVLsyzI6fOu2XqwXNGqwT4v1kR9S3-2FNyrrse1sY2-2B7gvQZ-2BnwKXl= B4PCyzWH9J-2FdPFx7jyVaONnsvP2P-2FTZKGY-3D ^ Maroof A, Okoye R, Smallie T, e= t al. Bimekizumab dual inhibition of IL-17A and IL-17F provides evidence of= IL-17F contribution to chronic inflammation in disease-relevant cells. Ann= Rheum Dis. 2017;76(2):213.^^[xi] (https://u7061146.ct.sendgrid.net/ls/clic= k?upn=3DvgPU0L08DtdYS96St647-2FWTri9gpFTm0xN6MV3nJXOmyXtVYPGXbkMyJHlOgqDj8V= bc5rd23Nd5xqiCbohR6wonKcbUhJWAB-2Badjit7S4hE-3D6spE_xDPID0vOuylFAU8fv4e60we= i4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9eko= cVj-2F2X9c9g1wZxSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2= BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgezLBDgCC4e-2BS7gsWoR3= rAGlT1V-2BfC22NifBjBHaii9WAfHxPDeEik8yO7uy64JUZ4Ii1ijHOSaZyJ5YI-2BBqrXLkdF3= vUueiRJaUk-2Fym-2BLDGjEISzCUTCA3EnWwTUbg8zlaENKK-2BucRMguWB-2BryamR0-3D ^ G= latt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation by = bimekizumab in psoriatic arthritis: evidence from preclinical experiments a= nd a randomised placebo-controlled clinical trial that IL-17F contributes t= o human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532. For further information, UCB: Corporate Communications Laurent Schots, Media Relations, UCB T+32.2.559.92.64 laurent.schots@ucb.com Investor Relations Antje Witte,=C2=A0=C2=A0 =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=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, Investor Relations, UCB T+32.2.559.9588 isabelle.ghellynck@ucb.com Brand Communications Andrea Christopher, Immunology Communications, UCB=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0 T +1.404.483.7329 andrea.christopher@ucb.com About UCB 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 more than 7 600 people in= approximately 40 countries, the company generated revenue of =E2=82=AC 4.9= billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow = us on Twitter: @UCB_news. Forward looking statements UCB 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 partnersh= ips, joint ventures or licensing collaborations may be subject to differenc= es 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 pa= rtnership. UCB=E2=80=99 efforts to acquire other products or companies and = to integrate the operations of such acquired companies may not be as succes= sful as UCB may have believed at the moment of acquisition. Also, UCB or ot= hers could discover safety, side effects or manufacturing problems with its= products and/or devices after they are marketed. The discovery of signific= ant problems with a product similar to one of UCB=E2=80=99s products that i= mplicate an entire class of products may have a material adverse effect on = sales of the entire class of affected products. Moreover, sales may be impa= cted by international and domestic trends toward managed care and health ca= re cost containment, including pricing pressure, political and public scrut= iny, customer and prescriber patterns or practices, and the reimbursement p= olicies imposed by third-party payers as well as legislation affecting biop= harmaceutical pricing and reimbursement activities and outcomes. Finally, a= breakdown, cyberattack or information security breach could compromise the= confidentiality, integrity and availability of UCB=E2=80=99s data and syst= ems. 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. Additionally, inform= ation contained in this document shall not constitute an offer to sell or t= he solicitation of an offer to buy any securities, nor shall there be any o= ffer, solicitation or sale of securities in any jurisdiction in which such = offer, solicitation or sale would be unlawful prior to the registration or = qualification under the securities laws of such jurisdiction. GenericFile ACR 2020 Data Highlights Press Release (https://u7061146.ct.sendgrid.net/ls= /click?upn=3D4tNED-2FM8iDZJQyQ53jATUf69zsppm9KssuIC9gumXJeajgJl8MtkU1CFgesz= I5Bzti0ppnDV9jMnyvXm4vH42g-3D-3DdIsP_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7Ki= DwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZ= xSsFWzV73pqtyy1rttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa= 2s9SD93v6ZWZeXq8z4U80FXANGvQDfUDq2uc1LgXgggMFMbSgW4TneueW4qkw6f2ZKva0rONNSW= fP1WlQNRprMs8jCB1EjxJ5Ayhqwdfci-2FeOO6Gmm38-2FyiTBfur5VcP-2FWcSX2SEa6rnZ2y4= AA2P8sfvX-2F5OYSp4d-2B6jsraXRwYo2U8iOeKWpQAQlTbw0-3D=0D =0D ______________________=0D If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jAT= UeYfdhr1xEBQnaPhR2RKx1tfe2VKDZTewv5u80JomRcXBhm6lGWHhVShJ-2FxtfBR3KWIv0jCv8= kMDRJANBNcwGQI6o1ipGMNGzP4nq6hXUR9-2FNZuB3Kge-2FwbPCP5cSX-2B5aQ-2BR8pYiTglx= 4OS6-2B9CRHjw-3D9Z-m_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86= bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wZxSsFWzV73pqtyy1r= ttkKebVhW9ZUHl-2BdQkIyimWUFqjiie2L16V7M-2B-2BqFY9cqqDf-2Boa2s9SD93v6ZWZeXq8= z4U80FXANGvQDfUDq2uc1LgYMC7KUD-2FoLOBGVrwgkHxdAS3WE3HCmHHV0yH5sukaiLijcnt0f= D-2F-2FOK4DKWGFu9w-2F5KZDYNxghph2N2e5GtBBhM5mwf7fUKDpaCeduFusxdDoGV4PR9gmDW= AsJwydl1Ue4Khm-2FdthO1G6N1dcB1Ias-3D=0D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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