UCB (EBR:UCB) UCB Media Room: The Lancet Publishes Results from Two Bimekizumab Phase 3 Studies in Psoriatic Arthritis

Directive transparence : information réglementée

07/12/2022 07:00
https://mb.cision.com/Public/18595/3678198/8c5ef91b9e68177c_800x800ar.png ** The Lancet Publishes Results from Two Bimekizumab Phase 3 Studies in Pso= riatic Arthritis ------------------------------------------------------------ =C2=B7 Two articles report results from the Phase 3 BE OPTIMAL and BE COMPL= ETE studies evaluating bimekizumab, a selective inhibitor of IL-17A and IL-= 17F, in patients with psoriatic arthritis =C2=A0 Brussels (Belgium), 7th December 2022 =E2=80=93 07:00 (CET) =E2=80=93 UCB, = a global biopharmaceutical company, today announced that The Lancet =C2=A0h= as published two articles detailing 24-week results from the Phase 3 BE OPT= IMAL study and 16-week results from the Phase 3 BE COMPLETE study, evaluati= ng the efficacy and safety of bimekizumab in the treatment of adults with a= ctive psoriatic arthritis who were biologic-na=C3=AFve and tumour necrosis = factor inhibitor inadequate responders (TNFi-IR), respectively.^1,2=C2=A0 =E2=80=9CPublication of two articles in tandem in The Lancet, one of the wo= rld=E2=80=99s most prestigious peer-reviewed journals, highlights the signi= ficance of these Phase 3 bimekizumab studies to the medical community. We l= ook forward to continuing to work with regulatory agencies to make bimekizu= mab available to people living with psoriatic arthritis as soon as possible= ,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Sol= utions and Head of US, UCB. Data from BE OPTIMAL and BE COMPLETE show that both studies met their prima= ry and all ranked secondary endpoints.^1,2 A significantly higher proportio= n of patients treated with bimekizumab achieved improvements in joint sympt= oms at week 16 compared with placebo =E2=80=93 as measured by ACR50, the pr= imary endpoint =E2=80=93 with a consistent clinical response observed in bo= th biologic-na=C3=AFve and TNFi-IR populations (p<0.0001 for each). In addi= tion, at week 16, a significantly higher proportion of bimekizumab-treated = patients compared with placebo achieved high levels of skin clearance =E2= =80=93 as measured by PASI 90, a secondary endpoint =E2=80=93 with a consis= tent clinical response in both populations (p<0.0001 for each). The safety = profile of bimekizumab was consistent with safety data seen in previous stu= dies with no new observed safety signals.^1,2=C2=A0 In September 2022, UCB announced that the European Medicines Agency had acc= epted the marketing authorization application for bimekizumab for the treat= ment of active psoriatic arthritis in adults (https://www.ucb.com/stories-m= edia/Press-Releases/article/European-Medicine-Agency-Accepts-Marketing-Auth= orization-Applications-for-Bimekizumab-in-Psoriatic-Arthritis-and-Axial-Spo= ndyloarthritis) . =C2=A0 The efficacy and safety of bimekizumab in the treatment of psoriatic arthri= tis have not been established and it is not approved for the treatment of p= soriatic arthritis by any regulatory authority worldwide. Notes to editors: About BE OPTIMAL BE OPTIMAL was a randomized, multicenter, double-blind, placebo-controlled,= active reference (adalimumab), parallel-group, Phase 3 study designed to e= valuate the efficacy and safety of bimekizumab in the treatment of adult pa= tients with active psoriatic arthritis, who are biologic disease-modifying = anti-rheumatic drug na=C3=AFve. For additional details on the study, see ar= ticle in The Lancet.^1=C2=A0 About BE COMPLETE BE COMPLETE was a randomized, multicenter, double-blind, placebo-controlled= , parallel-group, Phase 3 study designed to evaluate the efficacy and safet= y of bimekizumab in adults with active psoriatic arthritis and an inadequat= e response to tumor necrosis factor-alpha inhibitors (TNF=CE=B1i).^2 All en= rolled study participants had a history of inadequate response (lack of eff= icacy after at least three months of therapy at an approved dose) or intole= rance to treatment with one or two TNF=CE=B1i for either psoriatic arthriti= s or psoriasis. For additional details on the study, see article in The Lan= cet.^2=C2=A0 About Psoriatic Arthritis Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic, syst= emic inflammatory condition affecting both the joints and skin, with a prev= alence of 0.02 percent to 0.25 percent of the population, and 6 percent to = 41 percent of patients with psoriasis.^3 Symptoms include joint pain and st= iffness, skin plaques, swollen toes and fingers (dactylitis), and inflammat= ion of the sites where tendons or ligaments insert into the bone (enthesiti= s).^4 About bimekizumab Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to sel= ectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)= , two key cytokines driving inflammatory processes.^5,6=C2=A0 In August 202= 1, bimekizumab was approved in the European Union (EU)/European Economic Ar= ea (EEA) and in Great Britain, for the treatment of moderate to severe plaq= ue psoriasis in adults who are candidates for systemic therapy.^6,7=C2=A0Th= e label information may differ in other countries. Please check local presc= ribing information. About BIMZELX^=C2=AE=C2=A0=E2=96=BC (bimekizumab) in the EU/EEA In the EU/ EEA, BIMZELX^=C2=AE is indicated for the treatment of moderate t= o severe plaque psoriasis in adults who are candidates for systemic therapy= .^6=C2=A0 BIMZELX^=C2=AE=E2=96=BC=C2=A0(bimekizumab) EU/EEA Important Safety Informat= ion in Psoriasis^6 The most frequently reported adverse reactions with bimekizumab were upper = respiratory tract infections (14.5%) (most frequently nasopharyngitis) and = oral candidiasis (7.3%). Common adverse reactions (=E2=89=A51/100 to <1/10)= were oral candidiasis, tinea infections, ear infections, herpes simplex in= fections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headach= e, dermatitis and eczema, acne, injection site reactions and fatigue. Elder= ly may be more likely to experience certain adverse reactions such as oral = candidiasis, dermatitis and eczema when using bimekizumab. Bimekizumab is contraindicated in patients with hypersensitivity to the act= ive substance or any of the excipients and in patients with clinically impo= rtant active infections (e.g. active tuberculosis).=C2=A0 Bimekizumab may increase the risk of infections. Treatment with bimekizumab= must not be administered in patients with any clinically important active = infection. Patients treated with bimekizumab should be instructed to seek m= edical advice if signs or symptoms suggestive of an infection occur. Prior = to initiating treatment with bimekizumab, patients should be evaluated for = tuberculosis (TB) infection. Bimekizumab should not be given in patients wi= th active TB and patients receiving bimekizumab should be monitored for sig= ns and symptoms of active TB.=C2=A0 Cases of new or exacerbations of inflammatory bowel disease have been repor= ted with bimekizumab. Bimekizumab is not recommended in patients with infla= mmatory bowel disease. If a patient develops signs and symptoms of inflamma= tory bowel disease or experiences an exacerbation of pre-existing inflammat= ory bowel disease, bimekizumab should be discontinued and appropriate medic= al management should be initiated. Serious hypersensitivity reactions inclu= ding anaphylactic reactions have been observed with IL-17 inhibitors. If a = serious hypersensitivity reaction occurs, administration of bimekizumab sho= uld be discontinued immediately and appropriate therapy initiated.=C2=A0 Live vaccines should not be given in patients treated with bimekizumab. Please consult the summary of product characteristics in relation to other = side effects, full safety and prescribing information. https://www.ema.euro= pa.eu/en/documents/product-information/bimzelx-epar-product-information_en.= pdf EU summary of product characteristics date of revision May 2022 Last accessed: December 2022. =E2=96=BC=C2=A0This medicinal product is subject to additional monitoring. = This will allow quick identification of new safety information. Healthcare = professionals are asked to report any suspected adverse reactions=C2=A0 For further information, contact UCB:=C2=A0 Investor Relations Antje Witte T +32.2.559.94.14=C2=A0 email antje.witte@ucb.com=C2=A0 Corporate Communications Laurent Schots=C2=A0 T +32.2.559.92.64=C2=A0 email laurent.schots@ucb.com Brand Communications Eimear O=E2=80=99Brien T +32.2.559.92.71 email eimear.obrien@ucb.com=C2=A0 About UCB=C2=A0 UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company = focused on the discovery and development of innovative medicines and soluti= ons to transform the lives of people living with severe diseases of the imm= une system or of the central nervous system. With approximately 8,600 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Foll= ow us on Twitter: @UCB_news. 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UCB expressly disclaims any duty = to update any information contained in this press release, either to confir= m the actual results or to report or reflect any change in its forward-look= ing statements with regard thereto or any change in events, conditions or c= ircumstances on which any such statement is based, unless such statement is= required pursuant to applicable laws and regulations.=C2=A0 Additionally, information contained in this document shall not constitute a= n offer to sell or the solicitation of an offer to buy any securities, nor = shall there be any offer, solicitation or sale of securities in any jurisdi= ction in which such offer, solicitation or sale would be unlawful prior to = the registration or qualification under the securities laws of such jurisdi= ction.=C2=A0 =C2=A0 References 1. McInnes I.B., Asahina A, Coates L.C. et al. Bimekizumab in patients with= psoriatic arthritis, na=C3=AFve to biologic treatment: a randomised, doubl= e-blind, placebo-controlled, phase 3 trial (BE OPTIMAL) The Lancet. 2022. P= ublished online. Available at: =C2=A0https://www.thelancet.com/journals/lan= cet/article/PIIS0140-6736(22)02302-9/fulltext=C2=A0 2. Merola J.F., Landew=C3=A9 R, McInnes I.B. et al. Bimekizumab in patients= with active psoriatic arthritis and previous inadequate response or intole= rance to tumour necrosis factor-=CE=B1 inhibitors: a randomised, double-bli= nd, placebo-controlled, phase 3 trial (BE COMPLETE) The Lancet. 2022. Publi= shed online. Available at: https://www.thelancet.com/journals/lancet/articl= e/PIIS0140-6736(22)02303-0/fulltext 3. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Cli= n North Am. 2015;41(4):545=E2=80=93568.=C2=A0 4. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: The di= agnosis and pharmacologic treatment of psoriatic arthritis in patients with= psoriasis. Drugs. 2014;74(4):423=E2=80=93441. 5. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi= mekizumab, a humanized monoclonal antibody and selective dual inhibitor of = IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991= =E2=80=931001. 6. BIMZELX=C2=AE (bimekizumab) EU Summary of Product Characteristics. =C2= =A0https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-= product-information_en.pdf. Last accessed: December 2022. 7. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Avai= lable at: https://www.medicines.org.uk/emc/product/12834; https://www.medic= ines.org.uk/emc/product/12833. Last accessed: December 2022. 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