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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

Advanced AS Patients

Meet Naidu, a 38-year-old patient living with the symptoms of advanced AS.1

   

'I’ve had back pain2,3 for over 10 years4, but it was only when I started having difficulty breathing that I was diagnosed with advanced AS’.

  

‘Despite taking NSAIDs for the last 6 years, my symptoms are worsening.1 Also, with AS I could develop uveitis5 that might lead to vision loss, which is terrifying’.

  

I live by myself and don’t know how I’d be able to function without help if my health deteriorates’.

  

Average diagnosis delay in AS is approximately 6 years (±5 years).3,* Among rheumatological diseases, the longest diagnosis delay is in AS.4

  

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

  

Patients with advanced AS such as Naidu benefit from treatment with Enbrel®1-3,5

  • Onset of action was rapid (as early as Week 2), with a significant effect from Week 8 and sustained until Week 123,†

    - Significant improvements at Week 12 observed for AS symptoms (pain), markers of inflammation (CRP), spinal mobility and pulmonary function
     
  • Clinically-relevant improvements sustained through week 242,‡
     
  • Established safety profile in patients with (or at risk of) uveitis5,§

         - No increased rates of uveitis observed with Enbrel®5

  • Enbrel® is well tolerated across all its indications1,5-29

From SPINE, the first placebo-controlled trial to evaluate a TNFi – and the first to evaluate pulmonary function – in advanced AS.3,‡

   

Improvement in BASDAI for up to 24 Weeks2

   

   

P = 0.008. Enbrel® versus placebo at Week 12.3
No statistical analysis reported for the OLE period.
Adapted from Dougados M, et al. 2012.

   

   

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 cross-sectional study that included 111 patients with AS who were interviewed/evaluated to determine the diagnosis delays experienced (defined as the gap between first spondiloarthropathic symptoms and correct diagnosis) as well as the possible reasons for the delays.4
In patients with advanced AS from SPINE, a 12-week, randomised, double-blind, placebo-controlled study.3
In patients who completed the 12-week OLE of the SPINE study.2

   

Study design: Dougados M, et al. 2011; 2012.

   

SPINE was a European, multicentre, randomised, double-blind, placebo-controlled trial of 12 weeks duration,3 followed by a 12-week OLE study.Patients included in the double-blind study had a diagnosis of AS (modified NY criteria) and met at least 1 criterion that defined advanced/severe spinal ankylosis: (1) 2 intervertebral adjacent bridges and/or fusion at the lumbar spine; (2) 3 intervertebral adjacent bridges and/or fusion at the thoracic spine; (3) 2 intervertebral adjacent bridges and/or fusion at the cervical spine.2 Patients (n=82) were randomly assigned to receive either Enbrel® 50 mg QW or placebo.A total of 77 patients completed the 12 weeks of treatment (38 who received Enbrel® and 39 who received placebo) and entered the OLE study.2

   

The primary endpoint of the double-blind study was improvement in the BASDAI (normalised net incremental AUC) between baseline and Week 12.3 Other outcome measures included PGA, BASFI, BASMI and CRP level. Patient-evaluated endpoints included MCII and PASS from Weeks 2 to 12.At Weeks 0 and 12, pulmonary function tests were locally performed in accordance with the standards of the American Thoracic Society.2
Safety assessments included AEs, premature discontinuations and laboratory tests.2

§Clinical trials of Enbrel® in AS (4 placebo-controlled; 1 active-controlled; 3 open-label) were examined for reports of uveitis. Rates of uveitis with Enbrel® were lower than those with the placebo (in placebo-controlled trials) and similar to sulfasalazine in an active comparator trial.5

   

AE, adverse event; AS, ankylosing spondylitis; AUC, area under the curve; axSpA, axial spondyloarthritis; BASDAI, Bath AS Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath AS Metrology Index; CRP, C-reactive protein; MCII, minimum clinically important improvement; NSAID, non-steroidal anti-inflammatory drug; OLE, open-label extension; PGA, patient global assessment; QW, once a week; RCT, randomised control trial; SEM, standard error of the mean; SmPC, summary of product characteristics; TNFi, tumour necrosis factor inhibitor.

   

References:

Enbrel. Local product document. Version LPDENB062021.Dougados M, Braun J, Szanto S, et al. Continuous efficacy of etanercept in severe and advanced ankylosing spondylitis: results from a 12-week open-label extension of the SPINE study. Rheumatology (Oxford). 2012;51(9):1687-1696.Dougados M, Braun J, Szanto S, et al. Efficacy of etanercept on rheumatic signs and pulmonary function tests in advanced ankylosing spondylitis: results of a randomised double-blind placebo-controlled study (SPINE) [published correction appears in Ann Rheum Dis. 2011;70(7):1349]. Ann Rheum Dis. 2011;70(5):799-804.Dincer U, Cakar E, Kiralp MZ, Dursun H. Diagnosis delay in patients with ankylosing spondylitis: possible reasons and proposals for new diagnostic criteria. Clin Rheumatol. 2008;27(4):457-462.Sieper J, Koenig A, Baumgartner S, et al. Analysis of uveitis rates across all etanercept ankylosing spondylitis clinical trials. Ann Rheum Dis. 2010;69(1):226-229.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. Procedure No. EMEA/H/C/000262/A46/145. European Medicines Agency. January 11, 2013. Accessed May 5, 2022.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 rthritis, 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®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.

    

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