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UCB (EBR:UCB) UCB Media Room: Post hoc analysis showed meaningful efficacy of certolizumab pegol for RA patients with high Rheumatoid Factor (RF) levels

Directive transparence : information réglementée

11/11/2023 07:01
https://mb.cision.com/Public/18595/3873928/a3d5ba21aa488d95_800x800ar.png ** Post hoc analysis showed meaningful efficacy of certolizumab pegol for R= A patients with high Rheumatoid Factor (RF) levels ------------------------------------------------------------ =C2=B7 A post hoc analysis from the EXXELERATE trial shows that 65.7 percen= t of certolizumab pegol-treated patients, and 48.3 percent of adalimumab-tr= eated patients, with rheumatoid arthritis (RA) and high rheumatoid factor (= RF) levels achieved low disease activity at Week 104^1=C2=A0 =C2=B7 Certolizumab pegol maintained drug concentrations and achieved Low D= isease Activity regardless of RF levels in patients with established RA unt= il the end of the study period (w104)^1 =C2=B7 The results are in line with previous analyses from independent stud= ies that demonstrate the consistent efficacy of certolizumab pegol across t= he entire RA population, while TNFis with an Fc fragment showed a decline i= n efficacy in high RF patients.=C2=A0 =C2=B7 In patients with RA and high RF levels, who are at increased risk of= disease progression, certolizumab pegol has the potential to deliver meani= ngful outcomes^1 =C2=A0 Brussels (Belgium), 11 November 2023 =E2=80=93 07:00 (CEST) =E2=80=93 UCB, = a global biopharmaceutical company, will present a post hoc analysis of the= EXXELERATE trial examining the efficacy of certolizumab pegol and adalimum= ab in patients with rheumatoid arthritis (RA) with high rheumatoid factor (= RF) levels. The data are being presented at the American College of Rheumat= ology (ACR) Convergence 2023 in San Diego, U.S., November 10=E2=80=9315.^1 In the initial EXXELERATE trial comparing the efficacy of certolizumab pego= l and adalimumab, the primary endpoints of superiority were not met. The po= st hoc analysis assessed the efficacy of certolizumab pegol, a PEGylated fr= agment crystalized (Fc)-free tumor necrosis factor inhibitor (TNFi) and ada= limumab, an Fc-containing TNFi in patients with RA across RF subgroups.^1 P= atients were randomized 1:1 to certolizumab pegol 200 mg every 2 weeks plus= methotrexate (MTX) or adalimumab 40 mg every 2 weeks plus MTX. At Week 12,= patients were classified as responders or non-responders, non-responders w= ere switched to the other TNFi with possible follow-up to Week 104. The res= ults of this post hoc analysis showed that for patients in the higher RF qu= artile (=E2=89=A4Q3: =E2=89=A4203 IU/mL; >Q3: >203 IU/mL; measured by Roche= Tina-quant^=C2=AE), 65.7 percent of 453 patients treated with certolizumab= pegol achieved low disease activity at Week 104 and 48.3 percent of 454 pa= tients treated with adalimumab achieved low disease activity.^1 =E2=80=9CIt is well known that high rheumatoid factor (RF) levels are assoc= iated with a poor prognosis^2. In addition, high pre-treatment RF levels ma= y lead to decreased drug concentrations of monoclonal antibodies and potent= ially lower response to TNFis in patients with rheumatoid arthritis (RA)^1,= 3. The results of this analysis=C2=A0highlight how certolizumab pegol maint= ained constant blood concentrations and therapeutic responses regardless of= RF levels,=E2=80=9D said Professor Josef Smolen, Emeritus Professor of Int= ernal Medicine, Medical University of Vienna, Division of Rheumatology, Vie= nna, Austria. =E2=80=9CThese data may be of clinical relevance in the conte= xt of using a personalized medicine approach for patients with RA and high = RF levels^1.=E2=80=9D RA is a chronic disease that causes inflammation throughout the body and co= mmonly presents as joint pain, swelling and deformity, which results in a d= ecline in physical function and quality of life.^4,5=C2=A0It is estimated t= hat, as of 2019, more than 18 million people worldwide live with this disea= se.^6 High RF is associated with a more aggressive and destructive disease = course, which is often more difficult to treat.^7 One reason for this is th= e high levels of RF autoantibodies binding with the Fc parts of TNFis to fo= rm large immune complexes that are then degraded by macrophages, resulting = in lower bioavailability of the biologic drugs.^8,9 To treat RA when high RF levels are present, American College of Rheumatolo= gy 2021 guidelines recommend biologic disease-modifying anti-rheumatic drug= s (bDMARDS), if there is no observed improvement with MTX treatment.^10=C2= =A0 However, many bDMARDs such as TNFis contain an Fc region that RF antibo= dies bind to, which can result in a lower clinical efficacy and the need fo= r additional interventions.^11,12,13 The distinctive, FC-free structure of = certolizumab pegol could mean RF may not bind to the drug, which may allow = its concentration to remain stable over time.^14 =E2=80=9CAt UCB, we aspire to achieve long-lasting remission for as many pa= tients living with rheumatoid arthritis (RA) as possible,=E2=80=9D said Emm= anuel Caeymaex, Executive Vice President, Immunology Solutions & Head of U.= S., UCB. =E2=80=9CThe data presented at this year=E2=80=99s ACR Convergence= demonstrate the benefits of certolizumab pegol, as it continues to deliver= value for those with high unmet need late into its lifecycle and beyond. W= e are excited to continue exploring its scientific potential as a personali= zed solution for RA patients with high levels of rheumatoid factor (RF)^1.= =E2=80=9D =C2=A0 Abbreviations: ACR: American College of Rheumatology, Fc: fragment crystali= zed, MTX: methotrexate, RA: rheumatoid arthritis, RF: rheumatoid factor, TN= Fis: tumor necrosis factor-=CE=B1 inhibitors.=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=C2=A0 Global Communications Adriaan Snauwaert T: +32.497.70.23.46 Email: adriaan.snauwaert@ucb.com=C2=A0 Abbreviations: bDMARDS: biologic disease-modifying anti-rheumatic drugs, Fc= : fragment crystalized, MTX: methotrexate, RA: rheumatoid arthritis, RF: rh= eumatoid factor, TNFis: tumor necrosis factor-=CE=B1 inhibitors. =C2=A0 About the EXXELERATE trial methodology and patient population In patients with RA, high RF levels are considered a poor prognostic factor= and are associated with higher disease activity, risk of radiographic prog= ression, and decreased response to TNF inhibitors (TNFis).^7 Recent data su= ggest that patients with RA and high RF levels may achieve and maintain gre= ater clinical improvement with TNFis without a crystallizable fragment (Fc)= compared to TNFis with an Fc.^12 In this post hoc analysis of the EXXELERA= TE trial, we assessed efficacy outcomes of certolizumab pegol, a PEGylated = Fc-free TNFi, versus adalimumab (Fc-containing TNFi) in patients with RA an= d high RF levels.^1 About CIMZIA^=C2=AE (certolizumab pegol) in the EU/EEA^15 In the EU, CIMZIA=C2=AE (certolizumab pegol) in combination with methotrexa= te (MTX) is indicated for the treatment of moderate to severe active RA in = adult patients when the response to disease-modifying antirheumatic drugs (= DMARDs), including MTX, has been inadequate. Certolizumab pegol can be give= n as monotherapy in case of intolerance to MTX or when continued treatment = with MTX is inappropriate. Certolizumab pegol in combination with MTX is al= so indicated for the treatment of severe, active and progressive RA in adul= ts not previously treated with MTX or other DMARDs. Certolizumab pegol has = been shown to reduce the rate of progression of joint damage as measured by= X-ray and to improve physical function when given in combination with MTX. Certolizumab pegol, in combination with MTX, is also indicated for the trea= tment of active psoriatic arthritis in adults when the response to previous= DMARD therapy has been inadequate. Certolizumab pegol can be given as mono= therapy in case of intolerance to MTX or when continued treatment with MTX = is inappropriate. Certolizumab pegol is also indicated in the EU for the treatment of adult p= atients with severe active axial spondyloarthritis (axSpA), comprising:=C2= =A0 =C2=B7 Ankylosing spondylitis (AS) =E2=80=93 adults with severe active AS w= ho have had an inadequate response to, or are intolerant to, non-steroidal = anti-inflammatory drugs (NSAIDs).=C2=A0 =C2=B7 Axial spondyloarthritis (axSpA) without radiographic evidence of AS = =E2=80=93 adults with severe active axSpA without radiographic evidence of = AS but with objective signs of inflammation by elevated C-reactive protein = (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate re= sponse to, or are intolerant to, NSAIDs. Certolizumab pegol is also indicated for the treatment of moderate to sever= e plaque psoriasis in adults who are candidates for systemic therapy.=C2=A0 CIMZIA^=C2=AE (certolizumab pegol) EU/EEA Important Safety Information^15 Cimzia^=C2=AE was studied in 4,049 patients with rheumatoid arthritis (RA) = in controlled and open label trials for up to 92 months. In the placebo-con= trolled studies, patients receiving Cimzia had an approximately 4 times gre= ater duration of exposure compared with the placebo group. This difference = in exposure is primarily due to patients on placebo being more likely to wi= thdraw early. In addition, Studies RA-I and RA-II had a mandatory withdrawa= l for non-responders at Week 16, the majority of whom were on placebo.=C2= =A0 The commonly reported adverse reactions (=E2=89=A51/100 to <1/10) in clinic= al trials with certolizumab pegol and post-marketing were viral infections = (includes herpes =C2=A0zoster, papillomavirus, influenza), bacterial infect= ions (including abscess), rash, headache =C2=A0(including migraine), asthen= ia, leukopenia (including lymphopenia, neutropenia), eosinophilic disorder,= pain (any sites), pyrexia, sensory abnormalities, hypertension, =C2=A0prur= itus (any sites), hepatitis (including hepatic enzyme increase), injection = site reactions, and nausea.=C2=A0 Certolizumab pegol was initially studied in 325 patients with active axial = spondyloarthritis (including ankylosing spondylitis and non-radiographic ax= ial spondyloarthritis) in the AS001 clinical study for up to 4 years, which= includes a 24-week placebo-controlled phase followed by a 24-week dose-bli= nd period and a 156-week open-label treatment period. Certolizumab pegol wa= s subsequently studied in 317 patients with non-radiographic axial spondylo= arthritis in a placebo-controlled study for 52 weeks (AS0006).=C2=A0 Certolizumab pegol was also studied in patients with axial spondyloarthriti= s (including ankylosing spondylitis and non-radiographic axial spondyloarth= ritis) in a clinical study for up to 96 weeks, which included a 48-week ope= n-label run-in phase (N=3D736) followed by a 48-week placebo-controlled pha= se (N=3D313) for patients in sustained remission (C-OPTIMISE). Certolizumab= pegol was also studied in a 96-week open-label study in 89 axSpA patients = with a history of documented anterior uveitis flares. In all 4 studies, the= safety profile for these patients was consistent with the safety profile i= n rheumatoid arthritis and previous experience with certolizumab pegol. Certolizumab pegol was studied in 409 patients with psoriatic arthritis (Ps= A) in the PsA001 clinical study for up to 4 years which included a 24-week = placebo-controlled phase followed by a 24-week dose-blind period and a 168-= week open-label treatment period. The safety profile for PsA patients treat= ed with certolizumab pegol was consistent with the safety profile in RA and= previous experience with certolizumab pegol.=C2=A0 Abbreviations: AS: Ankylosing spondylitis, axSpA: Axial spondyloarthritis, = CRP: C-reactive protein, DMARDs: disease-modifying antirheumatic drugs, EEA= : European Economic Area, EU: European Union, MRI: Magnetic Resonance Imagi= ng, MTX: methotrexate, NSAIDs: non-steroidal anti-inflammatory drugs, RA: r= heumatoid arthritis, RF: Rheumatoid factor. TNFis: tumor necrosis factor-= =CE=B1 inhibitors. Certolizumab pegol was studied in 1112 patients with psoriasis in controlle= d and open-label studies for up to 3 years. In the Phase III program, the i= nitial and maintenance periods were followed by a 96-week open-label treatm= ent period. The long-term safety profile of certolizumab pegol 400 mg every= 2 weeks and certolizumab pegol 200 mg every 2 weeks was generally similar = and consistent with previous experience with certolizumab pegol. Serious adverse reactions, defined as an adverse reaction that results in d= eath, is life-threatening, requires hospitalization or prolongation of exis= ting hospitalization, results in persistent or significant disability or in= capacity, or is a birth defect, include sepsis, opportunistic infections, t= uberculosis (including miliary, disseminated and extrapulmonary), herpes zo= ster, lymphoma, leukemia, solid organ tumors, angioneurotic oedema, cardiom= yopathies (includes heart failure), ischemic coronary artery disorders, pan= cytopenia, hypercoagulation (including thrombophlebitis, pulmonary embolism= ), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes ci= rrhosis), and renal impairment/nephropathy (includes nephritis). In RA cont= rolled clinical trials, 4.4% of patients discontinued taking certolizumab p= egol due to adverse events vs. 2.7% for placebo. Certolizumab pegol is contraindicated in patients with hypersensitivity to = the active substance or any of the excipients, active tuberculosis or other= severe infections such as sepsis or opportunistic infections, and moderate= to severe heart failure. Serious infections including sepsis, tuberculosis and opportunistic infecti= ons (e.g., histoplasmosis, nocardia, candidiasis) have been reported in pat= ients receiving certolizumab pegol. Some of these events have been fatal. B= efore initiation of therapy with certolizumab pegol, all patients must be e= valuated for both active and inactive (latent) tuberculosis infection. If a= ctive tuberculosis is diagnosed prior to or during treatment, certolizumab = pegol therapy must not be initiated and must be discontinued. If latent tub= erculosis is diagnosed, appropriate anti-tuberculosis therapy must be start= ed before initiating treatment with certolizumab pegol.=C2=A0 Reactivation of hepatitis B has occurred in patients receiving a TNF-antago= nist including certolizumab pegol who are chronic carriers of the virus (i.= e., surface antigen positive). Some cases have had a fatal outcome. Patient= s should be tested for HBV infection before initiating treatment with certo= lizumab pegol. Carriers of HBV who require treatment with certolizumab pego= l should be closely monitored and in the case of HBV reactivation Certolizu= mab pegol should be stopped and effective anti-viral therapy with appropria= te supportive treatment should be initiated. TNF antagonists including certolizumab pegol may increase the risk of new o= nset or exacerbation of clinical symptoms and/or radiographic evidence of d= emyelinating disease including multiple sclerosis; of formation of antinucl= ear antibodies and uncommonly of the development of a lupus-like syndrome; = of severe hypersensitivity reactions. If a patient develops any of these ad= verse reactions, certolizumab pegol should be discontinued and appropriate = therapy instituted. With the current knowledge, a possible risk for the development of lymphoma= s, leukemia or other malignancies in patients treated with a TNF antagonist= cannot be excluded. Rare cases of neurological disorders, including seizur= e disorder, neuritis and peripheral neuropathy, have been reported in patie= nts treated with certolizumab pegol. Adverse reactions of the hematologic system, including medically significan= t cytopenia, have been reported with certolizumab pegol. Advise all patient= s to seek immediate medical attention if they develop signs and symptoms su= ggestive of blood dyscrasias or infection (e.g., persistent fever, bruising= , bleeding, pallor) while on certolizumab pegol. Consider discontinuation o= f certolizumab pegol therapy in patients with confirmed significant hematol= ogical abnormalities. Severe infections and neutropaenia were reported in clinical trials with co= ncurrent use of anakinra (an interleukin-1 antagonist) or abatacept (a CD28= modulator) and another TNF-antagonist, etanercept, with no added benefit c= ompared to TNF-antagonist therapy alone. Because of the nature of the adver= se events seen with the combination of another TNF-antagonist with either a= batacept or anakinra therapy, similar toxicities may also result from the c= ombination of anakinra or abatacept and other TNF-antagonists. Therefore th= e use of certolizumab pegol in combination with anakinra or abatacept is no= t recommended. There is limited safety experience with surgical procedures in patients tre= ated with Cimzia. The 14-day half-life of certolizumab pegol should be take= n into consideration if a surgical procedure is planned. A patient who requ= ires surgery while on Cimzia should be closely monitored for infections, an= d appropriate actions should be taken. Please consult the full prescribing = information in relation to other side effects, full safety and prescribing = information.=C2=A0 European SmPC date of revision April 2023. https://www.ema.europa.eu/en/doc= uments/product-information/cimzia-epar-product-information_en.pdf. Last acc= essed: October 2023. Abbreviations: HBV: hepatitis B, RA: rheumatoid arthritis, RF: rheumatoid f= actor, TNF: tumor necrosis factor. 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. Forward looking statements=C2=A0 This press release may contain forward-looking statements including, withou= t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, = =E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends= =E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim= ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont= inue=E2=80=9D and similar expressions. 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Important factors that could result in such differences include: change= s in general economic, business and competitive conditions, the inability t= o obtain necessary regulatory approvals or to obtain them on acceptable ter= ms or within expected timing, costs associated with research and developmen= t, changes in the prospects for products in the pipeline or under developme= nt by UCB, effects of future judicial decisions or governmental investigati= ons, safety, quality, data integrity or manufacturing issues; potential or = actual data security and data privacy breaches, or disruptions of our infor= mation technology systems, product liability claims, challenges to patent p= rotection for products or product candidates, competition from other produc= ts including biosimilars, changes in laws or regulations, exchange rate flu= ctuations, changes or uncertainties in tax laws or the administration of su= ch laws, and hiring and retention of its employees. 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UCB=E2=80=99s efforts to acqui= re other products or companies and to integrate the operations of such acqu= ired companies may not be as successful as UCB may have believed at the mom= ent of acquisition. Also, UCB or others could discover safety, side effects= or manufacturing problems with its products and/or devices after they are = marketed. The discovery of significant problems with a product similar to o= ne of UCB=E2=80=99s products that implicate an entire class of products may= have a material adverse effect on sales of the entire class of affected pr= oducts. Moreover, sales may be impacted by international and domestic trend= s toward managed care and health care cost containment, including pricing p= ressure, political and public scrutiny, customer and prescriber patterns or= practices, and the reimbursement policies imposed by third-party payers as= well as legislation affecting biopharmaceutical pricing and reimbursement = activities and outcomes. Finally, a breakdown, cyberattack or information s= ecurity breach could compromise the confidentiality, integrity and availabi= lity of UCB=E2=80=99s data and systems.=C2=A0 Given these uncertainties, you should not place undue reliance on any of su= ch forward-looking statements. There can be no guarantee that the investiga= tional or approved products described in this press release will be submitt= ed or approved for sale or for any additional indications or labelling in a= ny market, or at any particular time, nor can there be any guarantee that s= uch products will be or will continue to be commercially successful in the = future. UCB is providing this information, including forward-looking statements, on= ly as of the date of this press release. 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. Smolen J, Taylor P, Tanaka Y, et al. Do High RF Titers Impact Response t= o TNF Inhibitors? Comparison of Certolizumab Pegol and Adalimumab in Patien= ts with RA and High Titers of RF: A Post Hoc Analysis of a Phase 4 Trial. A= rthritis Rheumatol. 2023;75 (suppl 9). ACR Convergence 2023. 2148. 2. Albrecht K, Zink A. Poor prognostic factors guiding treatment decisions = in rheumatoid arthritis patients: a review of data from randomized clinical= trials and cohort studies. Arthritis Res Ther. 2017;19(1):1-8. 3. Tiwari V, Jandu JS, Bergman MJ. Rheumatoid Factor. In: StatPearls [Inter= net]. Treasure Island. 2023. 4. Sparks JA. Rheumatoid Arthritis. =C2=A0Ann Intern Med. 2019;170(1):ITC1-= ITC16. 5. Smolen JS, Aletaha D, McInnes IB. Rheumatoid arthritis. Lancet. 2016;388= (10055):2023=E2=80=9338.=C2=A0 6. World Health Organization (2023, June 20). Rheumatoid Arthritis. Availab= le at: https://www.who.int/news-room/fact-sheets/detail/Rheumatoid-arthriti= s. Last accessed: November 2023.=C2=A0 7. van Zeben D, Hazes J, Zwinderman A, et al. Clinical significance of rheu= matoid factors in early rheumatoid arthritis: results of a follow up study.= Ann Rheum Dis. 1992;51(9):1029-35. 8. Laurent L, Anquetil F, Clavel C, et al. IgM rheumatoid factor amplifies = the inflammatory response of macrophages induced by the rheumatoid arthriti= s-specific immune complexes containing anticitrullinated protein antibodies= . Ann Rheum Dis. 2015;74(7):1425-31.=C2=A0 9. Aletaha D, Alasti F, Smolen JS. Rheumatoid factor determines structural = progression of rheumatoid arthritis dependent and independent of disease ac= tivity. Ann Rheum Dis. 2012;72(6):875-80. 10. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheu= matology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Car= e Res (Hoboken). 2021;73(7):924-39.=C2=A0 11. Takeuchi T, Miyasaka N, Inui T, et al. High titers of both rheumatoid f= actor and anti-CCP antibodies at baseline in patients with rheumatoid arthr= itis are associated with increased circulating baseline TNF level, low drug= levels, and reduced clinical responses: a post hoc analysis of the RISING = study. Arthritis Res Ther. 2017;19(1):194. 12. Nakayama Y, Watanabe R, Murakami K, et al. Differential efficacy of TNF= inhibitors with or without the immunoglobulin fragment crystallizable (Fc)= portion in rheumatoid arthritis: the ANSWER cohort study. Rheumatol Int. 2= 022;42(7):1227-34.=C2=A0 13. Calvo Gutierrez J, Ortega Castro R, =C3=81balos-Aguilera MC, et al. Imp= act of baseline rheumatoid factor titers and anti-TNF molecular structure o= n the retention rate in patients with rheumatoid arthritis. Ann Rheum Dis. = 2023;82:1400-1.=C2=A0 14. Senolt L. Emerging therapies in rheumatoid arthritis: focus on monoclon= al antibodies. F1000Res. 2019;8:F1000 Faculty Rev-1549. 15. CIMZIA^=C2=AE (certolizumab pegol) EU SmPC. April 2022. Available at: h= ttps://www.ema.europa.eu/en/documents/product-information/cimzia-epar-produ= ct-information_en.pdf. Last accessed: November 2023. ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x148352x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium