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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

AS Patients With Functional Limitations

Meet Shiva, a 44-year-old patient dealing with the functional challenges of AS.1,2

  

Example

‘Every single day is a struggle and I feel so useless. I’m not even able to do basic household tasks or show my son how to tie his shoe laces’.2

   

‘I can’t afford to take any more time off work, and I’m worried all the NSAIDs I’m being prescribed are going to have a negative impact on me in the future’.3

   

The rate of severe functional disability was 32% higher in men with AS versus men with RA.2,*

   

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

   

AS patients with functional limitations such as Shiva benefit from treatment with Enbrel®3-5

  • Improvements in function and mobility sustained over 5 years4,†
  • Increased QoL for all Enbrel®-treated patients5,‡
    • Significant improvements in work productivity5
  • Clinically relevant NSAID-sparing effects, coinciding with significant improvements in conventional clinical outcomes3,§
  • Enbrel® is well tolerated across all its indications1,6-29

From an open-label, multicentre, Phase 4 study in 59 patients with AS treated with Enbrel® 25 mg BIW.4,†

   

Reduction in Functional Impairment Over 5 Years4

   

   

Adapted from Martín-Mola E, et al. 2010.

   

Improvement in Spinal Mobility Over 5 Years4

   

   

Adapted from Martín-Mola E, et al. 2010.

   

Adapted from Martín-Mola E, et al. 2010.

   

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.

  

*Data were analysed from the German rheumatological database of 52,444 patients with RA and 8776 patients with AS. Age- and sex-matched groups of patients were compared for functional disability, pain, global assessment of health status, education level and employment status. Across all evaluated age groups, men with AS were rated more disabled than men with RA (e.g. 41-50 years: 38.5% vs. 29.1%, respectively [P<0.0025]).2

  

From an open-label, multicentre, Phase 4, 3-year extension study in 59 patients with AS who completed a 3-month RCT followed by a 2-year open-label study. Improvements in physical function (mean BASFI score) and spinal mobility (mean modified Schober’s test score) were sustained from Week 108 through Week 264.4

  

Study design: Martin-Mola E, et al. 2010.

  

A 12-week randomised, placebo-controlled study (N=84) of Enbrel® was followed by a 96-week open-label study (n=81); 59 subjects subsequently enrolled in a second open-label trial and continued Enbrel® 25 mg BIW for an additional 156 weeks (total duration: 264 weeks, original Enbrel® group; 252 weeks, original placebo group). The objective of the trial was to assess the long-term safety and clinical efficacy of Enbrel® for up to 5 years in patients with AS.4

   

Efficacy assessments included improvements in AS (as defined by the ASAS) and the individual core components of the ASAS criteria, including BASFI, subject global assessment of disease activity, back pain (total and nocturnal) and morning stiffness. Other variables assessed were BASDAI, PGAs of disease, spinal mobility as measured by the modified Schober’s test, chest expansion scores, occiput-to-wall distance, number of painful and swollen joints, CRP levels and percentage of subjects  achieving partial remission.4

      

From a Phase 4, open-label, multicentre (UK, Scandinavia) extension study in 84 patients with AS who completed ASCEND, a 16-week,randomised, controlled, active-comparator study. QoL increased for all subjects, with a mean of 0.3 as measured by EQ-5D. Mean number of sick days significantly decreased from 37.4 to 15.1 (P = 0.008). Mean number of work days significantly increased from 226 to 241 (P = 0.144).5

  

§From SPARSE, an 8-week, double-blind, placebo-controlled study in 90 patients with active axSpA (57% of whom had radiographic sacroiliitis) despite optimal NSAID intake. Mean change (SE) from baseline to Week 8 in ASAS-NSAID score: 63.9 (6.1) with Enbrel® versus 36.6 (5.9) with placebo (P = 0.002). ASAS-NSAID score of <10: 46.2% with Enbrel® versus 16.7% with placebo (P = 0.008). ASAS-NSAID score of 0: 41.0% with Enbrel® versus 14.3% with placebo (P = 0.013).3

ASCEND, Ankylosing Spondylitis Study Comparing ENbrel and Sulfasalazine Dosed Weekly; AS, ankylosing spondylitis; ASAS, Assessment of SpondyloArthritis international Society; ASAS-NSAID, Assessment of SpondyloArthritis international Society - nonsteroidal anti-inflammatory drug use; axSpA, axial spondyloarthritis; BASFI, Bath Ankylosing Spondylitis Functional Index; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BIW, twice a week; CRP, C-reactive protein; EQ-5D, EuroQoL Group Score; LOCF, last observation carried forward; NSAID, non-steroidal anti-inflammatory drug; PASS, patient acceptable symptom state; PGA, physician global assessment; QoL, quality of life; RA, rheumatoid arthritis; RCT, randomised controlled trial; SE, standard error; SmPC, summary of product characteristics; SPARSE, A Study to Evaluate the NSAIDS Sparing Effect of Etanercept in Subjects With Axial Spondyloarthritis; UK, United Kingdom.

  

References:

Enbrel. Local product document. Version LPDENB062021.Zink A, Braun J, Listing J, Wollenhaupt J. Disability and handicap in rheumatoid arthritis and ankylosing spondylitis – results from the German rheumatological database. German Collaborative Arthritis Centers. J Rheumatol. 2000;27(3):613-622.Dougados M, Wood E, Combe B, et al. Evaluation of the nonsteroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study. Arthritis Res Ther. 2014;16(6):481.Martín-Mola E, Sieper J, Leirisalo-Repo M, et al. Sustained efficacy and safety, including patient-reported outcomes, with etanercept treatment over 5 years in patients with ankylosing spondylitis. Clin Exp Rheumatol. 2010;28(2):238-245.Moots RJ, Ostor AJ, Loft AG, et al. Reduction of direct and indirect costs in patients with AS receiving etanercept: results from an open-label 36-week extension of the ASCEND study in four European countries. Rheumatology (Oxford). 2012;51(2):393-396.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):289-300.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. 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.pdfConstantin 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.de 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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