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UCB Media Room: Cimzia EU label update

INFORMATION REGLEMENTEE


[05/08/2020 | 07:02]
https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513= 9PTmAm2ORJ-2Fb7C-2B6emQ7BIFt9Y1shr1srjzWddwBY9yQuU0NBOpzMRiiKPYBDWZJnMwh8R-= 2BGEmqbubm5YWtvkBWBBXxyje6jqtfky467Emv_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7= KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1= wbsFH46yK0J-2Bw2HMht4ki0AawPJQH24ycsyaZKFxcDdUDP0ZL7SvibQHaP-2FABFnm82m7RD3= 3HqGVn3XVC95VQED84MzDN8BHIzA7Aw9NUTZVBndUOmnIWa3OPPBF7rgF2901GIJ30WJ3XXJ1sd= WVSjcnTpuHmVqlDBzJ3RZq9AJ7a-2FGtxwIYKV1E243zaUSiSXN36Gd-2FgQ9awX-2BykqVmH12= MnPBFaOb1QoEEJW-2BTjzumEvcyvbZteUdx-2FineLPcYcE-3D ** CIMZIA^=C2=AE is the First and Only Biologic Approved in Europe with the= Option for a Reduced Maintenance Dose for Patients Across the Full Axial S= pondyloarthritis Spectrum ------------------------------------------------------------ =C2=B7 European label extended to include a dose reduction option for the t= reatment of adult patients with axial spondyloarthritis (axSpA), including = non-radiographic and radiographic axSpA, who are in sustained remission aft= er one year of CIMZIA^=C2=AE (certolizumab pegol) treatment,^1=C2=A0underpi= nned by results of the Phase 3b C-OPTIMISE study=C2=A0 =C2=B7 C-OPTIMISE showed that, once axSpA patients are in sustained remissi= on, it is possible to benefit from a reduced CIMZIA dosing regimen without = compromising clinical efficacy^2=C2=A0 Brussels, Belgium =E2=80=93 5 August 2020 =E2=80=93 UCB today announced tha= t the European Medicines Agency (EMA) has approved a label extension for CI= MZIA^=C2=AE (certolizumab pegol) for use in adult patients with axial spond= yloarthritis (axSpA) at a reduced maintenance dose of 200 mg every four wee= ks (Q4W), once sustained remission is achieved after one year of CIMZIA 200= mg every two weeks (Q2W) or 400 mg Q4W.^1 The approval makes CIMZIA the on= ly biologic in Europe with a dose reduction option in its label for patient= s in the broad axSpA population.^1=C2=A0 Clinical remission is recommended as a major treatment target in the Assess= ment of SpondyloArthritis international Society (ASAS)/European League Agai= nst Rheumatism (EULAR) recommendations for axSpA and treat-to-target recomm= endations for spondyloarthritis.^3,4=C2=A0Additionally, strategies for the = maintenance of remission are necessary to prevent future deterioration in d= isease status.^5 Maintenance dose reduction supports the long-term management of patients wi= th axSpA, when sustained disease remission has been achieved.^2 This approa= ch offers an additional option that preserves the clinical benefits to pati= ents of remaining on treatment, while responding to specific patient needs,= and can optimise the cost of their therapy.^2 The extension of CIMZIA=E2= =80=99s label in Europe^1 addresses an under-recognised unmet need^6,7=C2= =A0by providing the first validated dose reduction strategy for patients ac= ross the broad axSpA spectrum who have achieved sustained remission. =E2=80=9CAxSpA patients typically experience symptom onset in their mid-twe= nties and may therefore be concerned about lifelong continuation of therapy= . The CIMZIA label extension now offers healthcare providers a validated do= se reduction strategy that can meet the needs of patients. Furthermore, the= option to reduce the maintenance dose may provide cost reductions, benefit= ing the wider healthcare system,=E2=80=9D said Robert Landew=C3=A9, MD, PhD= , Amsterdam Rheumatology & Clinical Immunology Center, and lead author of t= he C-OPTIMISE study. =E2=80=9CC-OPTIMISE is the first and only randomised controlled trial to co= mpare both maintenance dose continuation and dose reduction versus placebo = in a broad axSpA population. Taken with previous clinical evidence showing = that early treatment of axSpA with CIMZIA provides improved clinical outcom= es, axSpA patients have a treatment option that can help address their symp= toms at every stage of their disease: from initiation of biologic therapy, = to remission and maintenance. Our clinical study package in axSpA showed th= at r-axSpA and nr-axSpA are part of the same disease entity. If treated ear= ly, remission is a realistic target and patients can have the flexibility t= o reduce their dose once they have achieved sustained remission,=E2=80=9D s= aid Emmanuel Caeymaex, Executive Vice President Immunology Solutions and He= ad of US, UCB. The EMA label extension is based on data from the Phase 3b C-OPTIMISE trial= in adults with early active axSpA.^2 =C2=A0At week 48 of the induction per= iod, 43.9 percent (323/736) of patients achieved sustained remission (Ankyl= osing Spondylitis Disease Activity Score (ASDAS) <1.3 at weeks 32 or 36 and= 48). Of those patients, 313 were randomised to full maintenance dose (CIMZ= IA 200 mg Q2W), reduced maintenance dose (CIMZIA 200 mg Q4W), or placebo.^2= At week 96, 84 percent, 79 percent and 20 percent of patients receiving th= e full maintenance dose, reduced maintenance dose, or placebo, respectively= , remained flare-free.^2 =C2=A0Of patients who flared in the reduced mainte= nance dose arm, 60 percent regained remission after 12 weeks of treatment w= ith the full maintenance dose of CIMZIA.^2 =C2=A0 There were no differences in responses between radiographic axSpA (r-axSpA)= and non-radiographic axSpA (nr-axSpA) patients in both the induction and m= aintenance periods.^2 No new safety signals with CIMZIA were observed over = the course of the study compared to previous studies.^1,2 In patients who a= chieve sustained remission, dose reduction is an option, but treatment shou= ld not be withdrawn, because of the high risk of flare.^2 About Non-Radiographic Axial Spondyloarthritis (nr-axSpA) and Radiographic = Axial Spondyloarthritis (r-axSpA) Non-radiographic axSpA (nr-axSpA) and radiographic axSpA (r-axSpA, also kno= wn as ankylosing spondylitis or AS) comprise the axial spondyloarthritis, o= r axSpA, spectrum of disease, which typically starts in patients in their m= id-twenties. Nr-axSpA and r-axSpA share similar symptomology and disease bu= rden. In r-axSpA, there is a definitive structural damage in the sacroiliac= joints detectable by x-ray. In nr-axSpA, there is no definitive radiograph= ic sacroiliitis, though magnetic resonance imaging (MRI) testing often show= s evidence of active sacroiliitis, visible as inflammation in the sacroilia= c joints. Historically, nr-axSpA has not been well-recognised due to a lack= of understanding of the disease history, progression, and prognosis, resul= ting in substantial diagnostic delay. As a result, nr-axSpA is often misdia= gnosed and undertreated. Axial spondyloarthritis is estimated to affect up to 1.4 percent of adults.= ^8,9=C2=A0Roughly two thirds of nr-axSpA patients are women.^10=C2=A0Yet, a= xSpA is often overlooked in women, with 89 percent being initially misdiagn= osed, leading to a significantly longer time to diagnosis in women compared= to men, on average more than two years. Underdiagnosis or misdiagnosis can= have long-term consequences for patients with axSpA.^11 About the C-OPTIMISE Study^2 C-OPTIMISE was a two-part, multicentre Phase 3b trial in adults with early = active axSpA (radiographic and non-radiographic). During the 48-week open-l= abel induction period, patients received CIMZIA 200 mg every 2 weeks (Q2W) = with loading dose of CIMZIA 400 mg at weeks 0, 2 and 4. At week 48, patient= s in sustained remission (Ankylosing Spondylitis Disease Activity Score (AS= DAS) <1.3 at weeks 32 or 36 and 48) were randomised to CIMZIA 200 mg Q2W (f= ull maintenance dose), CIMZIA 200 mg every 4 weeks (Q4W; reduced maintenanc= e dose) or placebo (withdrawal) for an additional 48 weeks. The primary end= point was the proportion of patients remaining flare-free (flare: ASDAS =E2= =89=A52.1 at two consecutive visits or ASDAS >3.5 at any time point) during= the maintenance period. C-OPTIMISE is the first and only randomised, interventional, placebo-contro= lled study in the full axSpA spectrum with three arms (full dose, reduced d= ose and placebo) that provides strong evidence on the dosing options for he= althcare professionals to manage axSpA patients that have achieved sustaine= d remission with CIMZIA treatment.=C2=A0 About CIMZIA^=C2=AE in the EU/EEA In the EU, CIMZIA^=C2=AE in combination with methotrexate (MTX) is indicate= d for the treatment of moderate to severe active RA in adult patients inade= quately responsive to disease-modifying anti-rheumatic drugs (DMARDs) inclu= ding MTX.=C2=A0 CIMZIA can be given as monotherapy in case of intolerance to MTX or when co= ntinued treatment with MTX is inappropriate. CIMZIA in combination with MTX= is also indicated for the treatment of severe, active and progressive RA i= n adults not previously treated with MTX or other DMARDs. CIMZIA has been shown to reduce the rate of progression of joint damage as = measured by X-ray and to improve physical function, when given in combinati= on with MTX. CIMZIA, in combination with MTX, is also indicated for the treatment of act= ive psoriatic arthritis in adults when the response to previous DMARD thera= py has been inadequate. CIMZIA can be given as monotherapy in case of intol= erance to MTX or when continued treatment with MTX is inappropriate. CIMZIA is also indicated in the EU for the treatment of adult patients with= severe active axial spondyloarthritis (axSpA), comprising:=C2=A0 =C2=B7 Ankylosing spondylitis (AS) =E2=80=93 adults with severe active AS w= ho have had an inadequate response to, or are intolerant to non-steroidal a= nti-inflammatory drugs (NSAIDs).=C2=A0 =C2=B7 Axial spondyloarthritis (axSpA) without radiographic evidence of AS = =E2=80=93 adults with severe active axSpA without radiographic evidence of = AS but with objective signs of inflammation by elevated C-reactive protein = (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate re= sponse to, or are intolerant to NSAIDs. CIMZIA is also indicated for the treatment of moderate to severe plaque pso= riasis in adults who are candidates for systemic therapy.=C2=A0 Cimzia^=C2=AE (certolizumab pegol) EU/EEA* Important Safety Information=C2= =A0 Cimzia^=C2=AE was studied in 4,049 patients with rheumatoid arthritis (RA) = in controlled and open label trials for up to 92 months. The commonly repor= ted adverse reactions (1-10 percent) in clinical trials with Cimzia=C2=AE a= nd post-marketing were viral infections (includes herpes zoster, papillomav= irus, influenza), bacterial infections (including abscess), rash, headache = (including migraine), asthenia, leukopenia (including lymphopenia, neutrope= nia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormaliti= es, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme= increase), injection site reactions, and nausea. Serious adverse reactions= include sepsis, opportunistic infections, tuberculosis (including miliary,= disseminated and extrapulmonary), herpes zoster, lymphoma, leukaemia, soli= d organ tumours, angioneurotic oedema, cardiomyopathies (includes heart fai= lure), ischemic coronary artery disorders, pancytopenia, hypercoagulation (= including thrombophlebitis, pulmonary embolism), cerebrovascular accident, = vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairmen= t/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4 p= ercent 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 =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 an= d Cimzia^=C2=AE 200 mg every 2 weeks was generally similar and consistent w= ith 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 GL-P-CZ-axSpA-1900034 Important Safety Information Cimzi= a Revised April 2020 * EU/EEA means European Union/European Economic Area c= linical symptoms and/or radiographic evidence of demyelinating disease incl= uding multiple sclerosis; of formation of autoantibodies and uncommonly of = the development of a lupuslike syndrome; of severe hypersensitivity reactio= ns. If a patient develops any of these adverse reactions, Cimzia^=C2=AE sho= uld 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=AE should be taken int= o consideration if a surgical procedure is planned. A patient who requires = surgery 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= N1-2FyZYmHi9NLhb7vDDKsRPZltwUi15bM0x45OibpF0iFs0if5dFw-3D-3DkntJ_xDPID0vOuy= lFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf= -2FOeoCOG9ekocVj-2F2X9c9g1wbsFH46yK0J-2Bw2HMht4ki0AawPJQH24ycsyaZKFxcDdUDP0= ZL7SvibQHaP-2FABFnm82m7RD33HqGVn3XVC95VQED84MzDN8BHIzA7Aw9NUTZVG5YiLzCR-2B0= 2ihMdpkO-2BSCPyuJyjqh8D4XQI6D3t37xbVUg-2F9PioEhHuFEhA6-2B-2BdgoDCzENld-2Bpx= MIbRPXi2uSSCDoaATO3ZQ-2BS-2ByHu-2FhwAnNHtVeRk0dGTiUF8wIDbSh49YcUvHKDCmN8cjm= eTXAEo-3D =C2=A0 CIMZIA^=C2=AE is a registered trademark of the UCB Group of Companies. 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 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.=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 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.=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. Corporate Communications Laurent Schots=C2=A0 Media Relations, UCB =C2=A0 T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0 Investor Relations Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 Investor Relations, UCB T +32.2.559.94.14 antje.witte@ucb.com Isabelle Ghellynck, =C2=A0Investor Relations, UCB T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0 Brand Communications Andrea Levin Christopher, Immunology Communications, UCB T +1.404.483.7329, andrea.christopher@ucb.com=C2=A0 1. =C2=A0 European Medicines Agency (EMA). Certolizumab pegol summary of pr= oduct characteristics, July 2020: https://u7061146.ct.sendgrid.net/ls/click= ?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3EU-2FWvZebf3RrOmE3Tk7MlrShjDNSVHpnfL6TfOxZ= owbuWXJCI8bbCZVOamVwH9nu7OTyWvLsHdN1-2FyZYmHi9NLhb7vDDKsRPZltwUi15uS1-2FlNN= EJGWLObTwwGSlAw-3D-3DV1tl_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN4= 6DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wbsFH46yK0J-2= Bw2HMht4ki0AawPJQH24ycsyaZKFxcDdUDP0ZL7SvibQHaP-2FABFnm82m7RD33HqGVn3XVC95V= QED84MzDN8BHIzA7Aw9NUTZVJYb9AQJB1PwoAN4nhMrHp1HxmxLupoQwE9-2BU-2Byk4SJpIGXt= 1lZkU3DypIK0MCbcOS0GJ4nuX7FGTAssQpsgAyDlMP2FNsYCDd6UVFzvZggOT1v2LqZSWqTFGFf= D-2B1zm4kdbtWnSY-2Fv-2Fg1TOawzPRtU-3D Last accessed: August 2020. 2. Landew=C3=A9 R, Van der Heijde D, Dougados M, et al. Maintenance of Clin= ical Remission in Early Axial Spondyloarthritis Following Certolizumab Pego= l Dose Reduction. Ann Rheum Dis. 2020;79:920-928. 3. Van der Heijde D, Ramiro S, Landew=C3=A9 R, et al. 2016 update of the AS= AS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum = Dis. 2017;76(6):978=E2=80=93991. 4. Smolen JS, Sch=C3=B6ls M, Braun J, et al. Treating axial spondyloarthrit= is and peripheral spondyloarthritis, especially psoriatic arthritis, to tar= get: 2017 update of recommendations by an international task force. Ann Rhe= um Dis. 2018;77(1):3=E2=80=9317. 5. Landew=C3=A9 R, Van der Heijde D, Dougados M, et al. Induction of Sustai= ned Clinical Remission in Early Axial Spondyloarthritis Following Certolizu= mab Pegol Treatment: 48-Week Outcomes from C-OPTIMISE. 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