UCB (EBR:UCB) UCB Media Room: Latest analyses of bimekizumab phase 3 studies in moderate to severe hidradenitis suppurativa to be presented at EHSF 2024

Directive transparence : information réglementée

09/02/2024 07:00
https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513= 9PTmAm2ORJ-2Fb7C-2B6ekbnNioRzG-2F1tQvuizBSv8nUwAPU0rnDOeNVeak663X40L-2FY2DT= vbbjWJOPwfCyqaM-3D3xzt_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr= -2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011X= KEBm5Xlxg2PNYS8j2dt-2FPjf7GBT92Q71s6SFKCcQZOz7LPMBkxM4KX-2BbePSzOWDXo1MzdvJ= F-2BdIi58IfnwronFPqSjZLcNYH3RJOxP4AMm9SRYpRbtCxhlq-2FfM53GI7EdTG9qStX5kEo5J= iVOTZ2uVWLdgB6BXE4qSKhTp-2Fc5uR-2FgqOakhfKfwQyMB0uUnKkMSq1Ss2-2BGav3Nx28OoQ= WWTGuvudRYRxos-2FUzrHfCIJb8o98iJsh4-3D ** Latest analyses of bimekizumab phase 3 studies in moderate to severe hid= radenitis suppurativa to be presented at EHSF 2024 ------------------------------------------------------------ =C2=B7 At Week 48, ~7 of 10 patients treated with bimekizumab achieved IHS4= -55, an IHS4 dichotomous outcome, that measures treatment effect and signif= ies reduction in abscesses, nodules and draining tunnels =C2=B7 Bimekizumab treatment demonstrated improvements in overall lesion co= unt and lesion clearance, across abscesses, inflammatory nodules and draini= ng tunnels over 48 weeks =C2=B7 Patient-reported data showed that high levels of clinical responses = observed with bimekizumab treatment translated into benefits in health-rela= ted quality of life=C2=A0 Brussels (Belgium), 9th February 2024 =E2=80=93 07:00 CET =E2=80=93 UCB, a = global biopharmaceutical company, today announced results from the latest p= ost hoc analyses of the Phase 3 studies, BE HEARD I and BE HEARD II, evalua= ting the efficacy and safety of bimekizumab in the treatment of adults with= moderate to severe hidradenitis suppurativa (HS).^1,2,3,4=C2=A0 These data= are being presented at the 13th Conference of the European Hidradenitis Su= ppurativa Foundation (EHSF) in Lyon, France (7-9 February).=C2=A0 =E2=80=9CThe analyses presented at EHSF 2024 build on the Phase 3 data comm= unicated to date and reinforce our belief in the potential of bimekizumab t= o make a meaningful difference to patients,=E2=80=9D said Emmanuel Caeymaex= , Executive Vice President, Immunology Solutions, and Head of U.S., UCB. = =E2=80=9CResults presented re-affirm the high levels of sustained clinical = response achieved with bimekizumab treatment, the positive impact on health= -related quality of life as reported by patients, and the importance of tim= ely treatment following diagnosis.=E2=80=9D=C2=A0 =E2=80=9CThe achievement of IHS4-55 shows reduction in inflammatory nodules= , abscesses and draining tunnels. This is a novel dichotomous version of th= e International Hidradenitis Suppurativa Severity Score System that allows = for the inclusion and quantification of draining tunnels in a validated man= ner and reflects at least 55% improvement in the total score from baseline.= With bimekizumab, the analyses showed that over 48 weeks, the majority of = patients, ~7 out of 10, achieved IHS4-55,=E2=80=9D said Professor Tzellos, = Department of Dermatology, Nordland Hospital Trust, Bod=C3=B8, Norway.=C2= =A0 The efficacy and safety of bimekizumab in HS have not been established and = it is not approved for use in HS by any regulatory authority worldwide.=C2= =A0 The BE HEARD I and II studies included an initial (Weeks 0=E2=80=9316) and = maintenance treatment period (Weeks 16=E2=80=9348). At baseline, adult pati= ents (n=3D1,014) were randomized 2:2:2:1 (initial/maintenance) to receive, = either bimekizumab 320 mg every two weeks (Q2W)/Q2W (n=3D288), bimekizumab = Q2W/Q4W (n=3D292), bimekizumab Q4W/Q4W (n=3D288) or placebo/bimekizumab Q2W= (n=3D146). Primary data from these studies have been previously reported.^= 1,2,3 Highlights of the bimekizumab BE HEARD I and BE HEARD II Data Presented at = EHSF 2024=C2=A0 =C2=B7 Dichotomous IHS4: At Week 16, a greater proportion of patients achie= ved IHS4-55 with bimekizumab treatment vs placebo (51.1-62.9% vs. 25.7=E2= =80=9330.8%).1=E2=80=A0 By Week 48, these responses were sustained or incre= ased (pooled, 71.0=E2=80=9377.4%).^1=E2=80=A0 Patients that switched from p= lacebo to bimekizumab achieved comparable responses to those receiving cont= inuous bimekizumab treatment (pooled, 76.2%).^1=E2=80=A0 The higher thresho= lds of IHS4-75 and IHS4-90 were also achieved by greater proportions of pat= ients treated with bimekizumab vs placebo at Week 16 (IHS4-75: 30.6=E2=80= =9344.7% vs 15.7=E2=80=9323.1%; IHS4-90: 16.5=E2=80=9323.0% vs 7.1=E2=80=93= 10.8%).^1=E2=80=A0 By Week 48, these responses were sustained or increased = (IHS4-75 pooled, 56.0-61.9%; IHS4-90 pooled, 36.2-44.1%).^1=E2=80=A0 =C2=B7 Lesion Count and Clearance Across Lesion Type and Anatomical Area: A= t Week 16, bimekizumab treatment demonstrated improvements in overall lesio= n count. Following bimekizumab treatment lesion clearance also increased at= Week 16.^2 Results were sustained or improved across 48 weeks of treatment= .^2 Improvements were observed across different anatomical regions and acro= ss all three lesion types presented (abscesses, inflammatory nodules and dr= aining tunnels).^2 =C2=B7 Depth of Response and Impact on Quality of Life: The vast majority o= f patients (69.5=E2=80=9374.8%) who achieved Hidradenitis Suppurativa Clini= cal Response 50 (HiSCR50) at Week 16 reported a Hidradenitis Suppurativa Qu= ality of Life (HiSQoL) rating of =E2=80=98None/Mild=E2=80=99 at Week 16.^3 = A higher proportion of patients reported a HiSQoL rating of =E2=80=98None/M= ild=E2=80=99 at Week 16 if they achieved HiSCR75 (77.2=E2=80=9384.3%) or Hi= SCR90 (80.0=E2=80=9389.3%) at Week 16.^3 A similar trend was also observed = at Week 48.^3 =C2=B7 Clinical Response Across Duration Quartiles: At Week 16, patients tr= eated with bimekizumab in the lowest (<2.40 years) disease duration quartil= es achieved HiSCR50/HiSCR75 of 67.5% (n=3D133/197)/48.2% (95/197) vs 43.8% = (n=3D14/32)/21.9%(n=3D7/32) for placebo.^4 Patients treated with bimekizuma= b in the highest (=E2=89=A510.87 years) disease duration quartiles achieved= HiSCR50/HiSCR75 of 53.8% (n=3D99/184)/34.2% (n=3D63/184) vs. 28.9% (n=3D13= /45)/20.0% (n=3D9/45) =C2=A0for placebo. Results with bimekizumab were sust= ained across 48 weeks of treatment.^4 =E2=80=A0Observed Case Analysis=C2=A0 Notes to editors: About BE HEARD I and BE HEARD II BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled= , parallel-group, multicenter, Phase 3 studies designed to evaluate the eff= icacy and safety of bimekizumab in adults with moderate to severe hidradeni= tis suppurativa (HS).^1,2,3,4 The primary endpoint in both studies was HiSC= R50 at Week 16.^5=C2=A0 A key secondary endpoint was HiSCR75 at Week 16. Hi= SCR50 and HiSCR75 are defined as at least either a 50 or 75% reduction from= baseline in the total abscess and inflammatory nodule count with no increa= se from baseline in abscess or draining tunnel count.^5 About IHS4-55, IHS4-75 and IHS4-90 Hidradenitis suppurativa (HS) severity can be assessed using the Internatio= nal Hidradenitis Suppurativa Severity Score System (IHS4) that includes the= number of inflammatory nodules, abscesses and draining tunnels and classif= ies disease severity as mild (=E2=89=A43 points), moderate (4=E2=80=9310 po= ints) or severe (=E2=89=A511 points).^1 In order to discriminate between ac= tive treatment and placebo, a novel outcome measure built on the IHS4 was d= eveloped using dichotomous thresholds.1 IHS4-55 is a dichotomous version of= IHS4 that is based on an improvement of at least 55% in the total score fr= om baseline.^1 IHS4-55 response is achieved if a patient=E2=80=99s IHS4 sco= re improves by at least 55% from baseline.^1 Similarly, IHS4-75 and IHS4-90= responses are achieved if a patient=E2=80=99s IHS4 score improves by 75% o= r 90%, respectively, from baseline.^1 About hidradenitis suppurativa (HS) Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilit= ating inflammatory skin disease that is associated with systemic manifestat= ions.^6,7=C2=A0 The main symptoms are nodules, abscesses, and pus-dischargi= ng fistulas (channels leading out of the skin) which typically occur in the= armpits, groin, and buttocks.^6,7 People with HS experience flare-ups of t= he disease as well as severe pain, which can have a major impact on quality= of life. HS most commonly develops in early adulthood and affects approxim= ately one percent of the population in most studied countries.^6,7 Approxim= ately one-third of people with HS have a family history of HS, and lifestyl= e factors such as smoking and obesity can also play a crucial role in the c= linical course of HS. =C2=A0The symptoms of pain, discharge and scarring ar= e not only a physical burden.^6,7 People with HS also experience stigma: wo= rrying about, or directly experiencing, negative attitudes and reactions fr= om society in response to their symptoms.^6,7,9 These feelings can lead to = embarrassment, social isolation, low self-esteem and sexual life impairment= , and impact all areas of life, including interpersonal relationships, educ= ation, and work.^9=C2=A0 About BIMZELX^=C2=AE=E2=96=BC ^10 BIMZELX^=C2=AE (bimekizumab) is a humanized monoclonal IgG1 antibody that i= s designed to selectively inhibit both interleukin 17A (IL-17A) and interle= ukin 17F (IL-17F), two key cytokines driving inflammatory processes.^11 The= therapeutic indications in the European Union are: =C2=B7 Plaque psoriasis: Bimekizumab is indicated for the treatment of mode= rate to severe plaque psoriasis in adults who are candidates for systemic t= herapy.^10 =C2=B7 Psoriatic arthritis: Bimekizumab, alone or in combination with metho= trexate, is indicated for the treatment of active psoriatic arthritis in ad= ults who have had an inadequate response or who have been intolerant to one= or more disease-modifying antirheumatic drugs (DMARDs).^10 =C2=B7 Axial Spondyloarthritis: Bimekizumab is indicated for the treatment = of adults with active non radiographic axial spondyloarthritis with objecti= ve signs of inflammation as indicated by elevated C reactive protein (CRP),= and/or magnetic resonance imaging (MRI) who have responded inadequately or= are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for = the treatment of adults with active ankylosing spondylitis who have respond= ed inadequately or are intolerant to conventional therapy.^10 BIMZELX^=C2=AE (bimekizumab) EU/EEA* Important Safety Information^10 The most frequently reported adverse reactions with bimekizumab were upper = respiratory tract infections (14.5%, 14.6%, 16.3% in plaque psoriasis (PSO)= , psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), respective= ly) and oral candidiasis (7.3%, 2.3%, 3.7% in PSO, PsA and axSpA, respectiv= ely). Common adverse reactions (=E2=89=A51/100 to <1/10) were oral candidia= sis, tinea infections, ear infections, herpes simplex infections, oropharyn= geal candidiasis, gastroenteritis, folliculitis, headache, rash, dermatitis= and eczema, acne, injection site reactions and fatigue. Elderly individual= s may be more likely to experience certain adverse reactions such as oral c= andidiasis, dermatitis and eczema when using bimekizumab. Bimekizumab is contraindicated in patients with hypersensitivity to the act= ive substance or any of the excipients and in patients with clinically impo= rtant active infections (e.g. active tuberculosis). Bimekizumab may increase the risk of infections. Treatment with bimekizumab= must not be initiated in patients with any clinically important active inf= ection. Patients treated with bimekizumab should be instructed to seek medi= cal advice if signs or symptoms suggestive of an infection occur. If a pati= ent develops an infection the patient should be carefully monitored. If the= infection becomes serious or is not responding to standard therapy, treatm= ent should be discontinued until the infection resolves. Prior to initiatin= g treatment with bimekizumab, patients should be evaluated for tuberculosis= (TB) infection. Bimekizumab should not be given in patients with active TB= . Patients receiving bimekizumab should be monitored for signs and symptoms= of active TB. Cases of new or exacerbations of inflammatory bowel disease have been repor= ted with bimekizumab. Bimekizumab is not recommended in patients with infla= mmatory bowel disease. If a patient develops signs and symptoms of inflamma= tory bowel disease or experiences an exacerbation of pre-existing inflammat= ory bowel disease, bimekizumab should be discontinued and appropriate medic= al management should be initiated.Serious hypersensitivity reactions includ= ing anaphylactic reactions have been observed with IL-17 inhibitors. If a s= erious hypersensitivity reaction occurs, administration of bimekizumab shou= ld be discontinued immediately and appropriate therapy initiated. Live vaccines should not be given in patients treated with bimekizumab. Please consult the Summary of Product Characteristics in relation to other = side effects, full safety and prescribing information:=C2=A0 https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3E= U-2FWvZebf3RrOmE3Tk7MlrShjDNSVHpnfL6TfOxZowbuWXJCI8bbCZVOamVwH6uJI6dDXHRika= HhL8HIZVsPc5Q6uIhYECs-2Fl2G-2Bmd0FmcyR4Sx9QdcHWQECFWENWQ-3D-3DUy0H_xDPID0vO= uylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPs= k4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg2PNYS8j2dt-2FPjf7GBT92= Q71s6SFKCcQZOz7LPMBkxM4KX-2BbePSzOWDXo1MzdvJF-2BdIi58IfnwronFPqSjZLcNXYy0zP= l3HLM91xpnuyQjjvWCMLFomAJq3yLV7mptlEH7VjSeuW-2BTpvEeDWK3c0xVK0j98jcGt9bGuHK= hwfV7p5HXk3w5UCFeYCgfScSGyIRouN9vLbRDnXufkQs0ue2Dqcyu4ArinbFWuQ1Xsv-2F7Fg-3= D European SmPC date of revision: November 2023.=C2=A0 Last accessed: February 2024. ^*EU/EEA means European Union/European Economic Area =E2=96=BCThis medicinal product is subject to additional monitoring. This w= ill allow quick identification of new safety information. Healthcare profes= sionals are asked to report any suspected adverse reactions. For further information, contact UCB:=C2=A0 Investor Relations Antje Witte T: +32.2.559.94.14=C2=A0 Email: antje.witte@ucb.com=C2=A0 Corporate Communications Laurent Schots=C2=A0 T: +32.2.559.92.64=C2=A0 Email: laurent.schots@ucb.com Brand Communications Eimear O=E2=80=99Brien T: +32.2.559.92.71 Email: eimear.obrien@ucb.com=C2=A0 About UCB=C2=A0 UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With approximately 8,700 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.5 billion in 2022 UCB is listed on Euronext Brussels (symbol: UCB). Follo= w us on Twitter: @UCB_news. 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UCB expressly disclaims any duty t= o update any information contained in this press release, either to confirm= the actual results or to report or reflect any change in its forward-looki= ng statements with regard thereto or any change in events, conditions or ci= rcumstances on which any such statement is based, unless such statement is = required pursuant to applicable laws and regulations.=C2=A0 Additionally, information contained in this document shall not constitute a= n offer to sell or the solicitation of an offer to buy any securities, nor = shall there be any offer, solicitation or sale of securities in any jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction.=C2=A0 References 1. Tzellos T, Alavi A, Kyrgidis A, et al. Bimekizumab Impact on Dichotomous= IHS4 Response Levels in Patients with Moderate to Severe Hidradenitis Supp= urativa: Results up to Week 48 from BE HEARD I & II. Abstract presented at = EHSF 2024. =C2=A0 2. van der Zee HH, Kirby B, Bechara FG, et al. Bimekizumab Impact on Lesion= Count by Anatomical Region in Moderate to Severe Hidradenitis Suppurativa:= Results to Week 48 from BE HEARD I & II. Abstract presented at EHSF 2024. 3. Kirby JS, Daveluy D, Pinter A, et al. Bimekizumab in Patients with Moder= ate to Severe Hidradenitis Suppurativa: A Focus on Patient Quality of Life = and Depth of Responses from BE HEARD I & II to Week 48. Abstract presented = at EHSF 2024.=C2=A0 4. Kimball A, Shi VY, Porter M, et al. Bimekizumab Efficacy by Disease Dura= tion in Patients with Moderate to Severe Hidradenitis Suppurativa: Week 48 = Results from BE HEARD I & II. Abstract presented at EHSF 2024. 5. Kimball AB, Zouboulis CC, Sayed C, et al. 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Available at: https://u7061146.ct.= sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3EU-2FWvZebf3RrOmE3Tk7= MlrShjDNSVHpnfL6TfOxZowbuWXJCI8bbCZVOamVwH6uJI6dDXHRikaHhL8HIZVsPc5Q6uIhYEC= s-2Fl2G-2Bmd0FmcyR4Sx9QdcHWQECFWENWQ-3D-3DSUpX_xDPID0vOuylFAU8fv4e60wei4Jxq= EGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7v= QEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg2PNYS8j2dt-2FPjf7GBT92Q71s6SFKCcQZOz7LPMBk= xM4KX-2BbePSzOWDXo1MzdvJF-2BdIi58IfnwronFPqSjZLcNUfTcOpcBUuROzn6-2FfF-2FNzZ= jEXQBa-2F86uP125lSIfc-2FqCAYQqOgKWWey1j2PHwdVFGXDtDLdZ0wXmvAN2m7uVT-2BNm5wK= Sef56lz4gEIAH8rBs9niSYOGNa5t9WbY9O57fkPz1L2vGrjhg2rNa3LZEPY-3D Last accesse= d: February 2024. =C2=A0 11. 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= =E2=80=931001. 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