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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

Juvenile Patient

Meet Vishala, a 3-year-old diagnosed with RF+ pJIA,1 and her mother.

   

Example

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'Sometimes I wonder whether we did something wrong2 when she was born. I question everything I did while pregnant – I know it’s ridiculous’.

‘At least we know what it is now,2,3 but we were shocked when we found out Vishala has JIA; we just don’t know how to manage it’.

‘I worry so much that the drugs won't work and about the effect they could have on her.2,3

Worries about future consequences of the therapy is the most commonly reported barrier to adherence in JIA.4,*

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

   JIA patients such as Vishala benefit from the rapid and predictable response of early treatment with Enbrel®1,5-15   Enbrel® was the first biologic approved for patients with JIA16-20  and the first TNFi approved for patients with JIA aged as young as 2 years11,21
  • An important predictor to response in Enbrel® in JIA is younger age and early treatment5-9
  • Long-term safety profile in JIA has been established up to 10 years1,10-13
    • No increase in the frequency of SAEs and a consistently low rate of MIIs through 8 years in pJIA10,†
    • Very infrequent SAEs in juvenile patients (2-4 years) through 2 years in pJIA11‡
  • Long-term efficacy in JIA has been established up to 10 years1,10-13
    • Marked improvement in juvenile patients (2-4 years) through 2 years in pJIA11,†
Long-term use of Enbrel® in JIA helps to reduce the dose of, or completely discontinue, most concomitant drugs,14,15 thereby reducing the risk of NSAID- or GC-associated AEs.14

From a long-term OLE trial that evaluated 69 patients with pJIA.10,‡

   

Exposure-adjusted Rates of SAEs and MIIs in Patients Receiving Enbrel® Over 8 Years10

   

SAEs were those occurring during the study period or within 30 days of the last Enbrel® dose. MIIs were defined as infections resulting in the need for intravenous antibiotic therapy or hospitalisation.
Adapted from Lovell D, et al. 2008.

  

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.

*A barrier assessment tool was used to identify patient and parent-reported adherence barriers across several JIA treatments in 7 rheumatology clinics across the United States. Data were collected from 578 parents and 99 patients (a total of 677 barrier assessments) over the study period.4

From an OLE study (N=58) that followed an RCT (N=69) in patients with active pJIA who received up to 8 years of continuous treatment with Enbrel®. SAEs were those occurring during the study period or within 30 days of the last Enbrel® dose. MIIs were defined as infections resulting in the need for intravenous antibiotic therapy or hospitalisation.10

From an analysis of all pJIA patients aged 2 to 4 years in the German BIKER registry who initiated TNFi treatment with Enbrel® or adalimumab between January 2001 and March 2015. Given the observational design of the registry, no efficacy comparison between the 2 agents was intended.11

Study design: Lovell DJ, et al. 2008.

This long-term OLE observational trial, which followed an RCT, was conducted to evaluate the safety and efficacy of Enbrel® in JIA patients for up to 8 years of therapy.10 Patients with active pJIA were eligible to enrol in the original RCT.10 The primary efficacy endpoint, which was evaluated in the double-blind study, was the number of patients with disease flares.22

MTX and other DMARDs were discontinued 4 and 2 weeks, respectively, before enrollment on the RCT. After 1 year in the OLE, patients were allowed to receive MTX at a maximum dose of 10-20 mg/m2.

  

Efficacy was assessed using the ACR Pedi 30/50/70/90/100 criteria for improvement. Other parameters included patient- and physician-reported assessments and laboratory analyses. Safety endpoints included the incidence of SAEs, MIIs and death.12

ACR Pedi, American College of Rheumatology Pediatric; AE, adverse event; DMARD, disease-modifying antirheumatic drug; GC, glucocorticoid; JIA, juvenile idiopathic arthritis; MII, medically important infection; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; OLE, open-label extension; pJIA, polyarticular juvenile idiopathic arthritis; RCT, randomised controlled trial; RF+, rheumatoid factor positive; RF−, rheumatoid factor negative; SAE, serious adverse event; SmPC, summary of product characteristics; TNFi, tumour necrosis factor inhibitor.

References:

Enbrel. Local product document. Version LPDENB062021.Chausset A, Gominon AL, Montmaneix N, et al. Why we need a process on breaking news of Juvenile Idiopathic Arthritis: a mixed methods study. Pediatr Rheumatol Online J. 2016;14(1):31. Published 2016 May 21.Heath-Watson S, Sule S. Living with Juvenile Idiopathic Arthritis: Parent and Physician Perspectives. Rheumatol Ther. 2018;5(1):1-4.Favier LA, Taylor J, Loiselle Rich K, et al. Barriers to adherence in juvenile idiopathic arthritis: a multicenter collaborative experience and preliminary results. J Rheumatol. 2018;45(5):690-696.Wallace CA, Giannini EH, Spalding SJ, et al. Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis. Arthritis Rheum. 2012;64(6):2012-2021.Otten MH, Prince FH, Armbrust W, et al. Factors associated with treatment response to etanercept in juvenile idiopathic arthritis. JAMA. 2011;306(21):2340-2347.Solari N, Palmisani E, Consolaro A, et al. Factors associated with achievement of inactive disease in children with juvenile idiopathic arthritis treated with etanercept. J Rheumatol. 2013;40(2):192-200.Geikowski T, Becker I, Horneff G; German BIKER Registry Collaborative Study Group. Predictors of response to etanercept in polyarticular-course juvenile idiopathic arthritis. Rheumatology (Oxford). 2014;53(7):1245-1249.Kearsley-Fleet L, Davies R, Lunt M, Southwood TR, Hyrich KL. Factors associated with improvement in disease activity following initiation of etanercept in children and young people with Juvenile idiopathic arthritis: results from the British Society for Paediatric and Adolescent Rheumatology Etanercept Cohort Study. Rheumatology (Oxford). 2016;55(5):840-847.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.Windschall D, Horneff G. Safety and efficacy of etanercept and adalimumab in children aged 2 to 4 years with juvenile idiopathic arthritis. Clin Rheumatol. 2016;35(12):2925-2931.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.Assessment Report for Enbrel. European Medicines Agency. Procedure No. EMEA/H/C/000262/A46/145. January 11, 2013. Accessed May 5, 2022. https://www.ema.europa.eu/en/documents/variation-report/enbrel-h-c-262-p46-145-epar-assessment-report_en.pdfAlexeeva E, Dvoryakovskaya T, Denisova R, et al. Dynamics of concomitant therapy in children with juvenile idiopathic arthritis treated with etanercept and methotrexate. Pediatr Neonatol. 2019;60(5):549-555.Khraishi M, Millson B, Woolcott J, et al. Reduction in the utilisation of prednisone and/or methotrexate following the initiation of etanercept in paediatric patients. THU0588 Poster presented at: Annual European Congress of Rheumatology (EULAR 2018); June 14, 2018; Amsterdam, The Netherlands.EMA. CHMP assessment report for pediatric use study [Enbrel]. 11 January 2013. Available at: https://www.ema.europa.eu/en/documents/variation-report/enbrel-h-c-262-p46-1341-epar-assessment-report_en.pdf Accessed July 18, 2022.PharmaNews.eu. Abbott’s HUMIRA (adalimumab) approved in European Union. September 2008. Available at: https://www.pharmanews.eu/abbott/6%5Eqabbottsqhumirarqadalimumabqapprovedqinqtheqeuropeanqunion Accessed July 18, 2022.Business Wire. European Commission approves Orencia (Abatacept) in combination with methotrexate fir children with moderate to severe polyarticular juvenile idiopathic arthritis. January 2010. Available at: https://www.biospace.com/article/releases/european-commission-approves-bristol-myers-squibb-company-s-orencia-r-abatacept-in-combination-with-methotrexate-for-children-with-moderate-to-seve/ Accessed July 18, 2022.PR Newswire. Simponi receives CHMP positive opinion for treatment for polyarticular juvenile idiopathic arthritis. May 2016. Available at:  https://www.prnewswire.co.uk/news-releases/simponi-receives-chmp-positive-opinion-for-treatment-of-polyarticular-juvenile-idiopathic-arthritis-581086211.html Accessed July 18, 2022.Juvenile Arthritis news. Kineret, new therapy for systemic JIA, receives positive opinion from EU’s CHMP, February 2018. Available at: https://juvenilearthritisnews.com/2018/02/26/kineret-therapy-systemic-jia-stills-disease-receives-positive-opinion-chmp/ Accessed July 18, 2022.EMA. Enbrel procedural steps taken and scientific information after the authorization. Last updated November 2020. Available at: https://www.ema.europa.eu/en/documents/procedural-steps-after/enbrel-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf Accessed July 18, 2022.Lovell DJ, Giannini EH, Reiff A, et al. Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric rheumatology collaborative study group. N Engl J Med. 2000;342(11):763-769.

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