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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 Who Is Considering Starting a Family

Meet Monica, a 28-year-old patient with severe active progressive RA,1 who recently found out that many RA treatments could interfere with family planning.2

     

‘This diagnosis couldn't have happened at a worse time – we both really want to start having children soon’.

    

‘I want to feel better, and don’t want this to get worse, but I’ve heard that some treatments for RA can be risky if taken while pregnant.2

    

The decision on drug therapy during pregnancy and lactation should be based on agreement between the internist/rheumatologist, gynaecologist/obstetrician and the patient.2 The half-life needs to be taken into account when selecting a TNFi for women of fertile age. Published EULAR guidance2,*

   

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

     

Patients such as Monica, who may need to interrupt treatment, benefit from the flexibility of Enbrel® monotherapy1,2,†

  • Half-life of Enbrel® is <3 days1,‡
     
    • Short half-life can result in rapid elimination from the body1,3-6
       
  • Required period of contraception after Enbrel® treatment discontinuation is 3 weeks1
     
  • Enbrel® is well tolerated across all its indications1,7-30
     
    • RA: Low rates of discontinuation due to AEs for up to 12 years7-11

TNFi therapies indicated for RA1,3-6

     

     

Adapted from Enbrel® LPD. Version LPDENB062021; Götestam Skorpen C, et al. 2016; Remicade SmPC; Simponi SmPC; Humira SmPC; Cimzia SmPC.

     

     

Enbrel® should only be used during pregnancy if clearly needed. Women with childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Enbrel® therapy and for 3 weeks after discontinuation of therapy. Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breastfeeding or to discontinue Enbrel® therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.1

     

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.

    

*EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation.
Enbrel can be used in MTX-intolerant patients, in patients not responsive to MTX as well as in MTX-naïve patients with severe, active and progressive disease.1
Mean half-life. Range: 7 to 300 hours.1 
§Median half-life. Range: 8 to 9.5 days.
||±3 days.4 
Mean half-life.5

    

AE, adverse event; AS, ankylosing spondylitis; EULAR, European Alliance of Associations for Rheumatology; LPD, local product document; JIA, juvenile idiopathic arthritis; MTX, methotrexate; PsA, psoriatic arthritis; PsO, psoriasis; RA, rheumatoid arthritis; SmPC, summary of product characteristics; TNFi, tumour necrosis factor inhibitor.

    

References:

Enbrel. Local product document. Version LPDENB062021.Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75(5):795-810.Remicade. Summary of product characteristics. Accessed July 18, 2022. https://www.ema.europa.eu/en/documents/product-information/remicade-epar-product-information_en.pdfSimponi. Summary of product characteristics. Accessed July 18, 2022. https://www.ema.europa.eu/en/documents/product-information/simponi-epar-product-information_en.pdfHumira. Summary of product characteristics. Accessed July 18, 2022. https://www.ema.europa.eu/en/documents/product-information/humira-epar-product-information_en.pdfCimzia. Summary of product characteristics. Accessed July 18, 2022. https://www.ema.europa.eu/en/documents/product-information/cimzia-epar-product-information_en.pdfHetland 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. 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-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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