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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

PsO Patient With Severe Symptoms

Meet Kalyani, a 35-year-old patient diagnosed with severe PsO1 <1 year ago.

   

‘I’m still trying to learn how to live with severe PsO.1 The itching makes me feel so uncomfortable,2 sometimes I call in sick’.3

‘It’s difficult because the topical steroids, PUVA and other drugs the doctor prescribed haven’t been effective.1

‘I try to cover up to hide the lesions, which means I can’t wear half of the things in my wardrobe anymore’.

‘I was affectionate, now I can’t bear to have anyone touch me.4

In spite of a range of available treatment options 20% of patients with severe PsO are treated with topical agents alone.5,*

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

   

Patients with severe PsO such as Kalyani benefit from flexible Enbrel® dosing6,7

  • Efficacy demonstrated with both QW and BIW reduced to QW dose regimens6,7,†
    • Improvements were greater with BIW treatment, a benefit that was sustained even after dose reduction to QW6,7
    • Rapid symptom relief, particularly with BIW treatment6,7
   
Significant itch alleviation observed in a randomised trial as early as Week 2.8,‡
  • Long-term safety and efficacy demonstrated for up to 4 years9,¶

  

From PRISTINE, a randomised, double-blind study that assessed the efficacy and safety of 2 Enbrel®  dose regimens in 273 patients with PsO.6,†

  

PASI Response Over 24 Weeks6

  

  

Adapted from Strohal R, et al. 2013.

  

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 biannual surveys conducted in the United States from 2003 to 2011 by the National Psoriasis Foundation, and completed by 5604 patients with PsO or PsA. Evaluated measures included non-treatment, undertreatment, treatment trends (determined by the use of prescription medication [topical, phototherapeutic, oral systemic and biologic]), treatment satisfaction and reasons for medication discontinuation.5

  

The PRISTINE trial included a randomised, double-blind, 12-week study period followed by a 12-week open-label treatment period. In total, 273 patients with PsO were randomly assigned (1:1) to 1 of 2 Enbrel® treatment groups: 50 mg QW for 24 weeks or 50 mg BIW for 12 weeks followed by 50 mg QW for 12 weeks.6

  

Study design: Strohal R, et al. 2013.

  

The PRISTINE trial was a randomised study that assessed the efficacy and safety of 2 dose regimens of Enbrel®: 50 mg QW for 24 weeks and 50 mg BIW for 12 weeks followed by 50 mg QW for 12 weeks. The study consisted of a 12-week double-blind treatment period, followed by a 12-week open-label treatment period and a 2-week post-treatment follow-up period.6
Patients had active, chronic, moderate to severe plaque PsO and were intolerant of (or contraindicated/not a candidate for) MTX or PUVA. Most topical agents were not permitted 2 weeks before the study’s baseline visit through Week 12. After Week 12 and through Week 24, unrestricted use of topical agents was allowed at the discretion of the investigator.6
The primary efficacy endpoint was the proportion of subjects achieving PASI75 at Week 24. Secondary endpoints included proportions of subjects achieving PASI50/75/90 throughout the study, mean improvements in PASI, PGA of ‘clear’ or ‘almost clear’, mean improvements in PGA, percentage of BSA involved and total score on DLQI. Safety assessments included physical examinations, laboratory analyses and monitoring of AEs.6

   

From a randomised, double-blind, Phase III trial in which patients with PsO received Enbrel® for 24 weeks or placebo for 12 weeks followed by Enbrel® for 12 weeks.8
§From a post hoc analysis of prospective data from previous trials and OLE, including 506 patients who initiated Enbrel® therapy in either of the 2 Phase III trials. Depending on the trial in which the therapy was initiated, patients received Enbrel® BIW or QW.9

  

AE, adverse event; BIW, twice a week; BSA, body surface area; DLQI, Dermatology Life Quality Index; MTX, methotrexate; OLE, open-label extension; PASI, Psoriasis Activity and Severity Index; PGA, physician global assessment; PRISTINE, Personalised Approach to Improve aSThma prescrIbing iN children; PsA, psoriatic arthritis; PsO, psoriasis; PUVA, psoralen plus ultraviolet A radiation; QW, once a week; SmPC, summary of product characteristics.

  

References:

Enbrel. Local product document. Version LPDENB062021.Rentz AM, Skalicky AM, Burslem K, et al. The content validity of the PSS in patients with plaque psoriasis. J Patient Rep Outcomes. 2017;1(1):4.Mustonen A, Mattila K, Leino M, Koulu L, Tuominen R. How much of the productivity losses among psoriasis patients are due to psoriasis. BMC Health Serv Res. 2015;15:87.Sampogna F, Tabolli S, Abeni D; IDI Multipurpose Psoriasis Research on Vital Experiences (IMPROVE) investigators. Living with psoriasis: prevalence of shame, anger, worry, and problems in daily activities and social life. Acta Derm Venereol. 2012;92(3):299-303.Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011 [published correction appears in JAMA Dermatol. 2014;150(1):103] [published correction appears in JAMA Dermatol. 2014;150(3):337]. JAMA Dermatol. 2013;149(10):1180-1185.Strohal R, Puig L, Chouela E, et al. The efficacy and safety of etanercept when used with as-needed adjunctive topical therapy in a randomised, double-blind study in subjects with moderate-to-severe psoriasis (the PRISTINE trial). J Dermatolog Treat. 2013;24(3):169-178.Kemeny L, Amaya M, Cetkovska P, et al. Effect of etanercept therapy on psoriasis symptoms in patients from Latin America, Central Europe, and Asia: a subset analysis of the PRISTINE trial. BMC Dermatol. 2015;15:9.Feldman SR, Kimball AB, Krueger GG, Woolley JM, Lalla D, Jahreis A. Etanercept improves the health-related quality of life of patients with psoriasis: results of a phase III randomized clinical trial. J Am Acad Dermatol. 2005;53(5):887-889.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.

    

PP-ENB-IND-0814 August 2022

    

Psoriatic Arthritis & Psoriasis
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