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AboutIntroducing Enbrel®Heritage of Enbrel®IndicationsTherapeutic IndicationsRheumatoid ArthritisJuvenile Idiopathic ArthritisPsoriatic ArthritisAxial SpondyloarthritisPsoriasis & Paediatric PsoriasisMechanism of actionMode of ActionHalf-lifeDosingDosingRheumatoid Arthritis, Psoriatic Arthritis & Axial SpondyloarthritisJuvenile Idiopathic ArthritisPsoriasisPaediatric PsoriasisAdministration & StorageAdministrationMYCLIC®StorageEfficacy & SafetyEfficacyRapid EffectivenessSustained EffectivenessEffectiveness With Monotherapy or Combination TherapySafetyTolerability Across IndicationsSummary of Prescribing InformationImmunogenicityImmunogenicity & Clinical ResponseImmunogenicity & Enbrel®Experience & InsightsExperience & InsightManufacturingPatient StoriesRheumatoid ArthritisPatient With an Increased Risk of Serious InfectionsMTX-IR PatientPatient Who Is Considering Starting a FamilyElderly-onset RA PatientYoung Patient Worried About the Lifelong Impact of RAYoung Patient Worried About Treatments That Lose Effectiveness Over TimeJuvenile Idiopathic ArthritisJuvenile PatientPatient Moving From Childhood to AdolescenceAxial SpondyloarthritisAS Patients With Heel EnthesitisAS Patients With Functional LimitationsAdvanced AS PatientsPsoriatic Arthritis & PsoriasisPsO Patient With Severe SymptomsPsO Patients With Cyclical SymptomsPsA Patient With Metabolic SyndromePsA Patient With Multiple Skin & Joint SymptomsSupport & ServicesSupport & ServicesUsing Enbrel®Summary of Prescribing InformationPatient ResourcesEventsMaterialsVideos

MTX-IR Patient

Meet Anjali, a 55-year-old patient whose active lifestyle is limited by her MTX-IR RA.1-3


‘After 6 years of living with active RA1, I’m tired of struggling to do the things that were second nature to me’.


‘When I’m in remission, I feel alive again, but then it all falls apart’.


How can I stay positive when treatments like steroids or MTX ultimately don’t work?1-3
The MTX even made me sick2,3 – I’ve lost all hope of ever feeling like I used to’.


Although its benefits are proven in RA, MTX is not effective or induces significant AEs in a considerable number of patients.2,3


Note: This is a hypothetical case for representation purpose only.


MTX-IR RA patients such as Anjali benefit from the flexibility of Enbrel® + MTX treatment1,4-7

  • Clinical and radiographic benefits achieved with Enbrel® alone or in combination with MTX4-6
    • Similar substantial improvements in disease activity and symptoms4,5,*
    • Numerically similar inhibition of radiographic progression up to 24 months6,†
  • Clinical, functional and QoL benefits achieved with Enbrel® + MTX appear independent of MTX dosage7,‡
  • Enbrel® is well tolerated across all its indications1,8-31
    • RA: Low rates of discontinuation due to AEs for up to 12 years8-12
  • From CAMEO, an open-label, non-inferiority trial of 258 MTX-IR patients over 24 months.6,†

Radiographic Progression Over 24 Months6


Adapted from Keystone EC, et al. 2016.



Please consult the LPD for contraindications, warnings, precautions and other important safety information.



Please note: The examples described here are not of actual patients, but fictitious representations of scenarios for which Enbrel® (etanercept) could be considered.


*From ADORE, a 16-week, randomised, open-label study that evaluated 315 patients with MTX-IR RA treated with Enbrel® monotherapy or Enbrel® plus MTX.4 Substantial improvements in disease activity were achieved in both treatment arms.4 Similar improvements were also observed across a range of PROs including disability, pain, general health and morning stiffness.5
From CAMEO, an open-label, non-inferiority trial of 258 patients with MTX-IR RA.6


Study design: Keystone EC, et al. 2016.


The CAMEO study was a Phase 4, multicentre, open-label, randomised, non-inferiority trial conducted at 27 sites in Canada. A total of 258 active RA patients with an inadequate response to MTX with or without other DMARDs who had access to Enbrel® under usual care were initially treated with Enbrel® 50 mg weekly plus steady-state MTX (minimum dose 15 mg/week) for 6 months. Patients who continued in the study were then randomised to continue Enbrel® 50 mg weekly plus MTX (dose adjustments were allowed for MTX post randomisation per the clinician’s standard of care) (n=107) or discontinue MTX and receive Enbrel® monotherapy (n=98) for an additional 18 months.6
The primary endpoint was the difference between the treatment groups in the change in DAS28-ESR from 6-month randomisation to 12 months. Radiographic outcomes (X-rays of the hands and feet) were assessed at baseline and at 12 and 24 months or at the time of discontinuation. mTSS, JSN and erosion scores were determined. Rates of radiographic progression (mTSS, JSN and erosion scores) were calculated using each patient’s duration from baseline to last X-ray.6
At Month 12, the non-inferiority of Enbrel® monotherapy to combination therapy was not demonstrated. However, most patients in both treatment arms (60.6% on Enbrel®, 64.4% on Enbrel® + MTX) had no change in mTSS from baseline to Month 24.6


From a post hoc analysis of 2 randomised clinical trials (TEMPO and COMET). Patients in the Enbrel® plus MTX combination treatment arms of both trials were pooled and stratified at 24 months by weekly MTX dosage (low [<10.0 mg], medium [10.0-17.5 mg], high [>17.5 mg]). Treatment
responses were consistently high across the MTX dosage groups, with very similar rates of DAS28 LDA/remission and ACR20/50/70. Improvements in DAS28, HAQ-DI and EQ-5D VAS were also not dependent on the MTX dosage.7


ACR, American College of Rheumatology; ADORE, Add Enbrel or Replace Methotrexate; AE, adverse event; AS, ankylosing spondylitis; CAMEO, Canadian Methotrexate and Etanercept Outcome; COMET, COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis; DAS28, Disease Activity Score-28 joint count; DAS28-ESR, Disease Activity Score-28 joint count-erythrocyte sedimentation rate; DMARD, disease-modifying antirheumatic drug; EQ-5D VAS, EuroQol 5-dimensions visual analogue scale; HAQ-DI, Health Assessment Questionnaire Disability Index; JIA, juvenile idiopathic arthritis; JSN, joint space narrowing; LDA, low disease activity; mTSS, modified total Sharp score; MTX, methotrexate; MTX-IR, methotrexate-inadequate responder; PRO, patient-reported outcome; PsA, psoriatic arthritis; PsO, psoriasis; QoL, quality of life; RA, rheumatoid arthritis; SD, standard deviation;  TEMPO, Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes.



Enbrel. Local product document. Version LPDENB062021.Romão VC, Canhão H, Fonseca JE. Old drugs, old problems: where do we stand in prediction of rheumatoid arthritis responsiveness to methotrexate and other synthetic DMARDs? BMC Med. 2013;11:17.Weinblatt ME, Kaplan H, Germain BF, et al. Methotrexate in rheumatoid arthritis. A five-year prospective multicenter study. Arthritis Rheum. 1994;37(10):1492-1498.van Riel PL, Taggart AJ, Sany J, et al. Efficacy and safety of combination etanercept and methotrexate versus etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: the ADORE study. Ann Rheum Dis. 2006;65(11):1478-1483.Van Riel PL, Freundlich B, MacPeek D, et al. Patient-reported health outcomes in a trial of etanercept monotherapy versus combination therapy with etanercept and methotrexate for rheumatoid arthritis: the ADORE trial. Ann Rheum Dis. 2008;67(8):1104-1110.Keystone EC, Pope JE, Thorne JC, et al. Two-year radiographic and clinical outcomes from the Canadian Methotrexate and Etanercept Outcome study in patients with rheumatoid arthritis. Rheumatology (Oxford). 2016;55(2):327-334.Gallo G, Brock F, Kerkmann U, Kola B, Huizinga TW. Efficacy of etanercept in combination with methotrexate in moderate-to-severe rheumatoid arthritis is not dependent on methotrexate dosage. RMD Open. 2016;2(1):e000186.Hetland ML, Christensen IJ, Tarp U, et al. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum. 2010;62(1):22-32.Aaltonen KJ, Virkki LM, Malmivaara A, Konttinen YT, Nordström DC, Blom M. Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis. PLoS One. 2012;7(1):e30275.Gómez-Reino JJ, Rodríguez-Lozano C, Campos-Fernández C, et al. Change in the discontinuation pattern of tumour necrosis factor antagonists in rheumatoid arthritis over 10 years: data from the Spanish registry BIOBADASER 2.0. Ann Rheum Dis. 2012;71(3):382-385.Marchesoni A, Zaccara E, Gorla R, et al. TNF-alpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice. Ann N Y Acad Sci. 2009;1173:837-846.Favalli EG, Pregnolato F, Biggioggero M, et al. Twelve-year retention rate of first-line tumor necrosis factor inhibitors in rheumatoid arthritis: real-life data from a local registry. Arthritis Care Res (Hoboken). 2016;68(4):432-439.Lovell DJ, Reiff A, Ilowite NT, et al. Safety and efficacy of up to eight years of continuous etanercept therapy in patients with juvenile rheumatoid arthritis. Arthritis Rheum. 2008;58(5):1496-1504.Assessment Report for Enbrel. Procedure No. EMEA/H/C/000262/A46/145. January 11, 2013. European Medicines Agency.Constantin T, Foeldvari I, Vojinovic J, et al. Two-year efficacy and safety of etanercept in pediatric patients with extended oligoarthritis, enthesitis-related arthritis, or psoriatic arthritis. J Rheumatol. 2016;43(4):816-824.Foeldvari I, Constantin T, Vojinović J, et al. Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019;21(1):125.Horneff G, Burgos-Vargas R, Constantin T, et al. Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis related arthritis and psoriatic arthritis: part 1 (week 12) of the CLIPPER study. Ann Rheum Dis. 2014;73(6):1114-1122.Lovell DJ, Reiff A, Jones OY, et al. Long-term safety and efficacy of etanercept in children with polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2006;54(6):1987-1994.Minden K, Niewerth M, Zink A, et al. Long-term outcome of patients with JIA treated with etanercept, results of the biologic register JuMBO. Rheumatology (Oxford). 2012;51(8):1407-1415.Minden K, Klotsche J, Niewerth M, Horneff G, Zink A. Biologikaregister JuMBO. Langzeitsicherheit von biologikatherapie bei juveniler idiopathischer arthritis [Biologics register JuMBO. Long-term safety of biologic therapy of juvenile idiopathic arthritis]. Z Rheumatol. 2013;72(4):339-346.Southwood TR, Foster HE, Davidson JE, et al. Duration of etanercept treatment and reasons for discontinuation in a cohort of juvenile idiopathic arthritis patients. Rheumatology (Oxford). 2011;50(1):189-195.Windschall D, Müller T, Becker I, Horneff G. Safety and efficacy of etanercept in children with the JIA categories extended oligoarthritis, enthesitis-related arthritis and psoriasis arthritis. Clin Rheumatol. 2015;34(1):61-69.Carmona L, Gómez-Reino JJ; BIOBADASER Group. Survival of TNF antagonists in spondylarthritis is better than in rheumatoid arthritis. Data from the Spanish registry BIOBADASER. Arthritis Res Ther. 2006;8(3):R72.Gottlieb AB, Gordon K, Giannini EH, et al. Clinical trial safety and mortality analyses in patients receiving etanercept across approved indications. J Drugs Dermatol. 2011;10(3) Vlam K, Boone C; The Prove Study Group A. Treatment adherence, efficacy, and safety of etanercept in patients with active psoriatic arthritis and peripheral involvement in Belgium for 66 months (PROVE study). Clin Exp Rheumatol. 2015;33(5):624-631.Girolomoni G, Altomare G, Ayala F, et al. Safety of anti-TNFα agents in the treatment of psoriasis and psoriatic arthritis. Immunopharmacol Immunotoxicol. 2012;34(4):548-560.Cantini F, Niccoli L, Nannini C, et al. Tailored first-line biologic therapy in patients with rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis. Semin Arthritis Rheum. 2016;45(5):519-532.Puig L, López-Ferrer A, Laiz A. Etanercept in the treatment of psoriatic arthritis. Actas Dermosifiliogr. 2015;106(4):252-259.Mease PJ, Kivitz AJ, Burch FX, et al. Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept. J Rheumatol. 2006;33(4):712-721.Kimball AB, Pariser D, Yamauchi PS, et al. OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis. J Am Acad Dermatol. 2013;68(5):756-764.Papp KA, Poulin Y, Bissonnette R, et al. Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population. J Am Acad Dermatol. 2012;66(2):e33-e45.


Please click the Prescribing Information link to view the safety and adverse events information of Enbrel®.
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