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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

Young Patient Worried About Treatments That Lose Effectiveness Over Time

Meet Vishal, a 30-year-old – recently diagnosed with severe RA1 – worried about the effectiveness of some treatments over time.2-10

   

‘I’m still shocked to be experiencing this at my age. If I hadn’t hurt my knee, would this be happening to me? Will I even be able to continue playing sports’?

    

‘I’ve been told I should try a new treatment – but what if it doesn’t work – just like all of the others I’ve been prescribed before’?

    

‘And if it does, I’ve heard some RA treatments lose effectiveness over time2-10 – what am I supposed to do if that happens’?

  

ADAbs can be associated with reduced clinical response.2-10,*,†

   

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

   

Patients such as Vishal benefit from the long-term efficacy1,11,12 of Enbrel® and lack of clinically relevant immunogenicity1,10,13,14

  • Although ADAbs to Enbrel® have been detected in some patients, they have all been non-neutralising and appear to have no correlation to clinical response or AEs1
     
  • Enbrel® is well tolerated across all its indications1,11,15-37
     
    • RA: Low rates of discontinuation due to AEs for up to 12 years11,15-18
       
  • ​​​​​​​From a meta-analysis of 68 studies (RA, SpA and IBD) which evaluated a total of 14,651 patients, 8766 of whom had RA.2,‡
Percentage of ADAbs2    

   

Adapted from Thomas SS, et al. 2015.

   

    

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.

    

*Many factors impact the efficacy and safety of biologics and how an individual patient responds to a biologic. The presence or absence of neutralising ADAbs is one of these factors and does not lead to any conclusions about the overall efficacy and safety of a drug. The occurrence of ADAbs is also influenced by several factors, including the co-treatment with immunosuppressive drugs such as MTX. As immunogenicity analyses are product-specific, comparison of antibody rates with those from other products is not appropriate. ADAbs can be neutralising or non-neutralising and both may impact the bioavailability and safety of the drug. Neutralising antibodies bind to the binding site of the therapeutic protein and neutralise it whereas non-neutralising antibodies bind to the therapeutic protein but do not neutralise it.38

    

Antibodies to Enbrel® have been detected in the sera of some subjects treated with it. These antibodies have all been non-neutralising and are generally transient. There appears to be no correlation between antibody development and clinical response or AEs.1

    

Study design: Thomas SS, et al. 2015.

   

The objective of this study was to examine the immunogenicity of TNFi (Enbrel®, adalimumab, infliximab, golimumab and certolizumab) in RA, SpA and IBD, and to examine the potential effect of ADAbs on the loss of clinical response through a systematic literature review and meta-analysis. A comprehensive literature search was conducted using 3 databases (PubMed, Web of Science and the Cochrane Library) to identify studies examining the immunogenicity of TNFi in autoimmune diseases between 1966 and 31 December 2013. Inclusion criteria required that the studies be written in English, and also that they be RCTs, observational studies or case reports involving more than 5 patients, and that the patients be aged 18 years or older.2

    

Studies were excluded if they were strictly genetic with no clinical correlation, if the patients had concomitant cancer within 5 years of the study or if the patients had a renal disease requiring dialysis. Double extraction was followed by a third extraction if needed.

    

Random-effect models were generated for the meta-analysis of 68 studies (N=14,651) to estimate the OR of the ADAb effects on TNFi response. Regression analysis was used to compare among the drugs and diseases.2

   

ADAb, anti-drug antibody; AE, adverse event; AS, ankylosing spondylitis; CI, confidence interval; IBD, inflammatory bowel disease; JIA, juvenile idiopathic arthritis; MTX, methotrexate; MTX-IR, methotrexate-inadequate responder; OR, odds ratio; PsA, psoriatic arthritis; PsO, plaque psoriasis;
RA, rheumatoid arthritis; RCT, randomised control trial; SmPC, summary of product characteristics; SpA, spondyloarthritis; TNFi, tumour necrosis factor inhibitor.

   

References:

Enbrel. Local product document. Version LPDENB062021.Thomas SS, Borazan N, Barroso N, et al. Comparative immunogenicity of TNF inhibitors: impact on clinical efficacy and tolerability in the management of autoimmune diseases. A systematic review and meta-analysis. BioDrugs. 2015;29(4):241-258.Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007;66(7):921-926.Bartelds GM, Krieckaert CL, Nurmohamed MT, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA. 2011;305(14):1460-1468.Finckh A, Dudler J, Wermelinger F, et al. Influence of anti-infliximab antibodies and residual infliximab concentrations on the occurrence of acquired drug resistance to infliximab in rheumatoid arthritis patients. Joint Bone Spine. 2010;77(4):313-318.Pascual-Salcedo D, Plasencia C, Ramiro S, et al. Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis. Rheumatology (Oxford). 2011;50(8):1445-1452.Radstake TR, Svenson M, Eijsbouts AM, et al. Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis. Ann Rheum Dis. 2009;68(11):1739-1745.van der Laken CJ, Voskuyl AE, Roos JC, et al. Imaging and serum analysis of immune complex formation of radiolabelled infliximab and anti-infliximab in responders and non-responders to therapy for rheumatoid arthritis. Ann Rheum Dis. 2007;66(2):253-256.Wolbink GJ, Vis M, Lems W, et al. Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum. 2006;54(3):711-715.Garcês S, Demengeot J, Benito-Garcia E. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann Rheum Dis. 2013;72(12):1947-1955.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.Weinblatt ME, Bathon JM, Kremer JM, et al. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken). 2011;63(3):373-382.Jani M, Chinoy H, Warren RB, et al. Clinical utility of random anti-tumor necrosis factor drug-level testing and measurement of antidrug antibodies on the long-term treatment response in rheumatoid arthritis [published correction appears in Arthritis Rheumatol. 2015;67(11):3096]. Arthritis Rheumatol. 2015;67(8):2011-2019.Vincent FB, Morand EF, Murphy K, Mackay F, Mariette X, Marcelli C. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective. Ann Rheum Dis. 2013;72(2):165-178.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.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):289-300.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-TNF 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.Atiqi S, Hooijberg F, Loeff FC, Rispens T, Wolbink GJ. Immunogenicity of TNF-inhibitors. Front Immunol. 2020;11:312.

   

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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