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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

PsA Patient With Multiple Skin & Joint Symptoms

Meet Divya, a 36-year-old struggling to deal with her PsA.1

   

‘PsA impacts every aspect of my life2: At home, I cannot run around with the children, in the office I cannot concentrate on my work. Plus, it has been progressively getting worse since I was diagnosed 3 years ago’.

   

‘I have been prescribed MTX,1 but my fingers and toes still get swollen and my joints are always stiff.3 The lesions on my scalp4 mean I avoid washing my hair and my nails are thick and discoloured.5'

   

‘With PsA, I am not myself – instead, I look and feel exhausted’.

   

Up to 40% of patients with PsO will develop PsA, usually within 5 to 10 years of cutaneous disease onset.3

   

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

   

   

Patients with PsA having multiple skin and joint symptoms such as Divya benefit from treatment with Enbrel®4-8

  • Significant and consistent improvements in:
    • Psoriatic scalp symptoms4,*
    • Nail PsO5,†
    • Enthesitis and dactylitis6,‡
  • Significant and clinically meaningful improvements in QoL of patients with:
    • Skin symptoms7,†
    • Scalp symptoms8,*
    • Nail symptoms5,†
    • Joint pain5,†
  • Enbrel® is well tolerated across all its indications1,9-32
    • PsA: Established safety profile for up to 5.5 years9-13

From a randomised, double-blind, placebo-controlled study of 124 patients with PsO having significant scalp symptoms.4,*

   

PSSI Improvement Over 24 Weeks4

   

  

P<0.01 for both groups versus baseline from Week 3 onwards.
Adapted from Bagel J. 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 24-week, randomised, placebo-controlled study of patients with PsO having significant scalp symptoms treated with either Enbrel® 50 mg BIW/ Enbrel® 50 mg QW (N=62) or placebo/ Enbrel® 50 mg BIW (n=62)4

  

Study design: Bagel J, et al. 2012.

  

This was a 24-week, double-blind, placebo-controlled, multicentre North American study. Adult patients with stable plaque PsO and significant scalp symptoms were randomised to receive either Enbrel® 50 mg BIW for 12 weeks followed by Enbrel® 50 mg QW for 12 weeks (Group A, n=62) or placebo for 12 weeks followed by Enbrel® 50 mg BIW for 12 weeks (Group B, n=62). The study’s primary endpoint was percentage change in PSSI score at Week 12. Secondary endpoints included percentage change in the PSSI score at Week 24 for Group B patients, PSSI 75 improvement at Week 12, patient satisfaction with treatment at Week 12 and Enbrel® safety (AEs).4
At Week 12, patients treated with Enbrel® experienced a significantly greater mean PSSI score improvement versus placebo patients: Mean (SD) improvement, 86.8% (18.0%) versus 20.4% (39.3%), P<0.0001. During Weeks 13 to 24, when dosage of Enbrel® was reduced and placebo patients initiated Enbrel® therapy, all patients experienced notable mean improvements from baseline.4 
DLQI and PROMIS emotional distress/depression scores were significantly better for Enbrel® at Week 12, and patients who switched from placebo to Enbrel® during the second 12 weeks experienced similar significant improvements.8

  

CRYSTEL was a 54-week, randomised, open-label, multicentre study in 720 patients with PsO treated with either continuous Enbrel® 25 mg BIW (n=357) or paused (intermittent) Enbrel® 50 mg/25 mg BIW (n=363).5

  

In a post hoc subanalysis of patients from CRYSTEL who reported nail symptoms at baseline (79% of the entire population) (pooling patients receiving continuous and paused therapy together), Enbrel® significantly improved nail symptom severity: NAPSI scores decreased from 4.64 at baseline to 3.30 at Week 12 (28.9% improvement) (P<0.001) and to 2.38 at Week 54 (51% improvement), with 30% of patients reporting no nail psoriasis at the end of treatment.5
Both continuous and paused Enbrel® treatment regimens showed significant improvements at Week 54 in DLQI, EQ-5D, HADS-D, HADS-A and SF-36 vitality.7
In patients with baseline nail PsO, treatment with Enbrel® significantly improved DLQI and EQ-5D VAS.5
In patients with baseline joint pain, treatment with Enbrel® significantly improved DLQI, EQ-5D VAS, SF-36 Vitality, HADS-D and HADS-A.5

  

From PRESTA, a double-blind, multicentre, outpatient study of patients with both PsO and PsA randomised to receive Enbrel® 50 mg BIW (n=379) or 50 mg QW (n=373) for 12 weeks. All patients then received open-label Enbrel® 50 mg QW for 12 additional weeks, while remaining blinded to the regimen. Enthesitis and dactylitis improved equally well on both Enbrel® regimens.6

  

AE, adverse event; BIW, twice a week; CRYSTAL, Cetuximab combined with iRinotecan in first-line therapY for metaSTatic colorectAL
cancer; DLQI, Dermatology Life Quality Index; EQ-5D, EuroQoL-5D; HADS-A, Hospital Anxiety and Depression Scale-Anxiety; HADS-D, Hospital Anxiety and Depression Scale-Depression; MTX, methotrexate; NAPSI, nail psoriasis severity index; PRESTA, Psoriasis Randomized Etanercept STudy in Subjects with Psoriatic Arthritis; PROMIS, Prostate MRI Imaging Study; PsA, psoriatic arthritis; PsO, psoriasis; PSSI, Psoriasis Scalp and Severity Index; QoL, quality of life; QW, once a week; SD, standard deviation; SF-36, 36-item Short-Form; SmPC, summary of product characteristics; VAS, visual analogue scale.

  

References:

Enbrel. Local product document. Version LPDENB062021.Merola JF, Shrom D, Eaton J, et al. Patient perspective on the burden of skin and joint symptoms of psoriatic arthritis: results of a multi-national patient survey. Rheumatol Ther. 2019;6(1):33-45.Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs. 2014;74(4):423-441.Bagel J, Lynde C, Tyring S, Kricorian G, Shi Y, Klekotka P. Moderate to severe plaque psoriasis with scalp involvement: a randomized, double-blind, placebo-controlled study of etanercept. J Am Acad Dermatol. 2012;67(1):86-92.Luger TA, Barker J, Lambert J, et al. Sustained improvement in joint pain and nail symptoms with etanercept therapy in patients with moderate-to-severe psoriasis. J Eur Acad Dermatol Venereol. 2009;23(8):896-904.Sterry W, Ortonne JP, Kirkham B, et al. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010;340:c147.Daudén E, Griffiths CE, Ortonne JP, et al. Improvements in patient-reported outcomes in moderate-to-severe psoriasis patients receiving continuous or paused etanercept treatment over 54 weeks: the CRYSTEL study. J Eur Acad Dermatol Venereol. 2009;23(12):1374-1382.Torchia D. New clues on the path of understanding unilateral naevoid telangiectasia. J Eur Acad Dermatol Venereol. 2013;27(1):129-130.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.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.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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