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
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.
Please click the Prescribing Information link to view the safety and adverse events information of Enbrel®.
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PP-ENB-IND-0814 August 2022
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For more details on, Who is a Registered medical practitioner*, please visit https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf , Page No. 39, Rule 2 part (ee), last accessed on 26th April 2021.
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