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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

Patient Moving From Childhood to Adolescence

Meet Dhruv, a 16-year-old patient diagnosed with JIA (extended oligoarthritis).1

  

'I was only 12 when they first told me that I had JIA.1'

‘My parents have tried to stay positive over the years, but I can tell they find it difficult2,3 – I’m really dependent on them’.

‘I just want to do what everyone else is doing – go out with my friends, hang out at the park – without feeling awful,4 without people feeling sorry for me’.

‘The NSAIDs and MTX just make me feel rubbish all the time.1,4 How am I going to be able to go to university or get a good job if I can’t even do basic things’?

Despite advances in JIA treatment, many children may never attain long-term remission in their adolescence.2,5,6 Only 33% of patients with JIA obtain complete remission in early adolescence.6,*

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

   

Patients with JIA such as Dhruv moving from childhood to adolescence benefit from the long-term efficacy and safety profile of Enbrel®1,7-16

   

Enbrel® was the first biologic approved for more than 1 subtype of JIA.17

  • Long-term efficacy and tolerability maintained in clinical trials for up to 10 years1,7-11
    • Measures of disease activity and PROs were relatively stable in eoJIA, ERA and PsA7,†
    • Number and frequency of TEAEs, excluding infections and ISRs, decreased over time7,†
  • Long-term efficacy and tolerability maintained in real-life clinical practice for up to 10 years12-16
    • ​​​​​​​Therapeutic benefits were sustained in sJIA, poJIA, eoJIA, pJIA (RF+ and RF−) PsA and ERA12,‡
    • No functional limitations reported by almost half of the patients who were followed into adulthood12,‡
    • No new safety risks identified during 5+ years of exposure13,14,§

From the 6-year interim findings of the 2-year open-label CLIPPER study of JIA patients (eoJIA, ERA and PsA) (N=127) and its ongoing long-term extension, CLIPPER 2 (N=109).7,†

   

ACR and JADAS Inactive Disease Response Rates Over 72 Months7

   

   

   

Total population, n=127
Adapted from Foeldvari I, et al. 2019.

   

   

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 a prospective cohort study of 434 patients diagnosed with JIA between 1997 and 2000 in Denmark, Norway, Sweden and Finland. Results are based on outcomes of 329 patients who attended a clinical follow-up visit approximately 18 years after disease onset. Complete remission was defined as remission for at least 12 months off medication.4

   

From the 6-year interim findings of the 2-year open-label CLIPPER study of patients with JIA (eoJIA, ERA, PsA) (N=127) and its ongoing long-term extension, CLIPPER2 (N=109).7

   

Study design: Foeldvari I, et al. 2019.

   

CLIPPER was a 2-year open-label study that assessed the efficacy and safety of Enbrel® in paediatric patients with eoJIA, ERA and PsA. Patients who received at least 1 dose of Enbrel® and who completed approximately 2 years of CLIPPER were eligible to enter CLIPPER 2, which is an ongoing, 8-year, long-term extension study.7

The primary endpoint of CLIPPER was the percentage of patients achieving ACR30 response at Week 12.8 Efficacy endpoints assessed to date (24 months of CLIPPER and 48 months of CLIPPER 2) included the JIA core set of measures, the JIA ACR response criteria and the JADAS.8 Safety assessments included TEAEs.7

   

From the JuMBO registry, which followed 346 patients with JIA formerly included in the BiKeR registry into adolescence. Both physician- (clinical status, AEs) and patient- (functional capacity, HRQoL) reported outcomes were recorded.12

   

§From observation of Enbrel® safety in JIA patients enrolled in BiKeR and JuMBO, most of whom were prospectively followed for more than 5 years.13,14

   

ACR, American College of Rheumatology; AE, adverse event; BiKeR, German Biologics JIA Registry; CLIPPER, CLinical Study In Pediatric Patients of Etanercept for Treatment of ERA; eoJIA, extended oligoarticular juvenile idiopathic arthritis; ERA, enthesitis-related arthritis; HRQoL, health-related quality of life; ISR, injection site reaction; JADAS, Juvenile Arthritis Disease Activity Score; JIA, juvenile idiopathic arthritis; JuMBO, Juvenile arthritis MTX/Biologics long-term Observation; MTX, methotrexate; NSAID, non-steroidal anti-inflammatory drug; pJIA, polyarticular juvenile idiopathic arthritis; poJIA, persistent oligoarticular juvenile idiopathic arthritis; PRO, patient-reported outcome; PsA, psoriatic arthritis; RF+, rheumatoid factor positive; RF−, rheumatoid factor negative; sJIA, systemic juvenile idiopathic arthritis; SmPC, summary of product characteristics; TEAE, treatment-emergent adverse event.

   

References:

Enbrel. Local product document. Version LPDENB062021.Rasu RS, Cline SK, Shaw JW, Hayes O, Agbor Bawa W, Cifaldi MA. Impact of JIA on parents’ work absences. Rheumatology (Oxford). 2015;54(7):1177-1185.Bruns A, Hilário MO, Jennings F, Silva CA, Natour J. Quality of life and impact of the disease on primary caregivers of juvenile idiopathic arthritis patients. Joint Bone Spine. 2008;75(2):149-154.Barut K, Adrovic A, Şahin S, Kasapçopur Ö. Juvenile Idiopathic Arthritis. Balkan Med J. 2017;34(2):90-101.Foster HE, Minden K, Clemente D, et al. EULAR/PReS standards and recommendations for the transitional care of young people with juvenile-onset rheumatic diseases [published correction appears in Ann Rheum Dis. 2018 Jun;77(6):960]. Ann Rheum Dis. 2017;76(4):639-646.Glerup M, Rypdal V, Arnstad ED, et al. Long-Term Outcomes in Juvenile Idiopathic Arthritis: Eighteen Years of Follow-Up in the Population-Based Nordic Juvenile Idiopathic Arthritis Cohort. Arthritis Care Res (Hoboken). 2020;72(4):507-516.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):125.8.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 rheumatoidarthritis. Arthritis Rheum. 2006;54(6):1987-1994.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. 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.pdfMinden 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, et al. 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.Klotsche J, Klein A, Niewerth M et al. Safety profile of etanercept in long-term use in patients with juvenile idiopathic arthritis (JIA). Oral presentation OP0060 at: EULAR Annual Meeting; June 12-15, 2019; Madrid, Spain.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.PharmaTimes online. EU regulators expand license of Pfizer’s Enbrel. August 2012. Available at: http://www.pharmatimes.com/news/eu_regulators_expand_license_of_pfizers_enbrel_976816. Accessed June 2022.

   

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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