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
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.
Please click the Prescribing Information link to view the safety and adverse events information of Enbrel®.
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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 13th September 2019.
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