Article

Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population.

Probity Medical Research, Waterloo, Ontario, Canada.
Journal of the American Academy of Dermatology (impact factor: 3.99). 02/2012; 66(2):e33-45. DOI:10.1016/j.jaad.2010.07.026
Source: PubMed

ABSTRACT Etanercept is well tolerated and effective in moderate to severe plaque psoriasis. However, effectiveness and safety data beyond 2.5 years have not been reported.
We sought to assess the effectiveness and safety profile of up to 4 years of etanercept therapy in psoriasis.
We analyzed prospective data from previous trials and open-label extensions, including 506 patients who initiated etanercept therapy in either of two phase III trials. Patients received etanercept, 25 mg twice weekly, 50 mg weekly, or 50 mg twice weekly, depending on which trial therapy was started. Dosage adjustments were allowed in open-label extensions, but no patients exceeded 50 mg twice weekly. Outcomes included change from baseline for the static Physician Global Assessment and Dermatology Life Quality Index scores. Exposure-adjusted adverse event (AE) rates were calculated.
In all, 75.9% (95% confidence interval 67.9-84.0) and 27.8% (95% confidence interval 19.3-36.2) maintained Dermatology Life Quality Index response (≥ 5-point improvement from baseline) and static Physician Global Assessment response (clear or almost clear) at 48 months, respectively. AE and serious AE rates were 243.5 and 7.8 events per 100 patient-years, respectively. No serious AE rates exceeded 1.0 event per 100 patient-years. Overall infection and serious infection rates were 96.9 and 0.9 events per 100 patient-years, respectively. No cases of tuberculosis or lymphoma were reported.
Effectiveness data were limited to static Physician Global Assessment and Dermatology Life Quality Index scores. Analysis of AE rates was limited to available comparator databases.
Etanercept demonstrated sustained effectiveness and a favorable safety profile with no cumulative toxicity for up to 4 years, representing, to our knowledge, the longest published study on etanercept use in psoriasis to date.

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    Article: Heterogeneity of inflammatory and cytokine networks in chronic plaque psoriasis.
    William R Swindell, Xianying Xing, Philip E Stuart, Cynthia S Chen, Abhishek Aphale, Rajan P Nair, John J Voorhees, James T Elder, Andrew Johnston, Johann E Gudjonsson
    [show abstract] [hide abstract]
    ABSTRACT: The clinical features of psoriasis, characterized by sharply demarcated scaly erythematous plaques, are typically so distinctive that a diagnosis can easily be made on these grounds alone. However, there is great variability in treatment response between individual patients, and this may reflect heterogeneity of inflammatory networks driving the disease. In this study, whole-genome transcriptional profiling was used to characterize inflammatory and cytokine networks in 62 lesional skin samples obtained from patients with stable chronic plaque psoriasis. We were able to stratify lesions according to their inflammatory gene expression signatures, identifying those associated with strong (37% of patients), moderate (39%) and weak inflammatory infiltrates (24%). Additionally, we identified differences in cytokine signatures with heightened cytokine-response patterns in one sub-group of lesions (IL-13-strong; 50%) and attenuation of these patterns in a second sub-group (IL-13-weak; 50%). These sub-groups correlated with the composition of the inflammatory infiltrate, but were only weakly associated with increased risk allele frequency at some psoriasis susceptibility loci (e.g., REL, TRAF3IP2 and NOS2). Our findings highlight variable points in the inflammatory and cytokine networks known to drive chronic plaque psoriasis. Such heterogeneous aspects may shape clinical course and treatment responses, and can provide avenues for development of personalized treatments.
    PLoS ONE 01/2012; 7(3):e34594. · 4.09 Impact Factor
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.

Keywords

100 patient-years
 
50 mg weekly
 
AE rates
 
available comparator databases
 
Dermatology Life Quality Index response
 
Dermatology Life Quality Index scores
 
Dosage adjustments
 
Effectiveness data
 
etanercept therapy
 
Exposure-adjusted adverse event
 
favorable safety profile
 
phase III trials
 
previous trials
 
safety profile
 
serious AE rates
 
serious infection rates
 
severe plaque psoriasis
 
static Physician Global Assessment response
 
trial therapy
 
≥ 5-point improvement