Open Label Study to Evaluate the Efficacy of Re-Treatment With Etanercept in Patients With Psoriasis
August 2012 | Volume 11 | Issue 8 | Original Article | 950 | Copyright © 2012
Background: Etanercept has been used to treat chronic plaque psoriasis. Previously reported data demonstrated that some patients experienced secondary failure and frequently rotational-switch therapy is used. The re-treatment with etanercept as part of the rotational therapy could be considered as another safe and efficient therapeutic approach.
Objective: To evaluate the efficacy of the re-treatment with etanercept in patients with a history of etanercept use with good response and secondary loss of efficacy.
Methods: This is an open label prospective study involving 20 patients with moderate to severe plaque psoriasis, who had been initially treated with etanercept and were re-treated after a variable interval with 50 mg BIW for 12 weeks.
Results: At week 12 of etanercept re-treatment, 13 of 20 patients (65%) achieved a PGA score of 2 or less and 40% (8 of 20), achieved a PGA score of 0 to 1. Etanercept was well tolerated and no serious adverse events were reported.
Limitations: Our study involved a small number of patients. Failure of etanercept was establish by patient's history. However we were able to correlate such failure from our medical records in 17 patients.
Conclusions: Re-treatment with etanercept, after secondary loss of efficacy should be considered in patients with psoriasis if satisfactory therapy cannot be achieved with other therapeutic regimens.
J Drugs Dermatol. 2012;11(8):950-954.
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Psoriasis is a chronic, genetically determined, immune-mediated inflammatory skin disease affecting approximately 2% to 3% of the Caucasian population. Plaque type is the most common form, even though other forms such as guttate, inverse or erythrodermic have also been described. In 42% of patients, psoriatic arthritis may occur.1 Psoriasis is characterized by infiltration of the skin with activated T-cells and by abnormal keratinocyte proliferation and differentiation. Dysregulation of T-cell antigen presenting cell interactions and over expression of pro-inflammatory cytokines play a central role in pathogenesis of psoriatic skin lesions.1,2
Tumor necrosis factor-α (TNF-α) levels are increased in psoriatic lesions as compared to levels in uninvolved skin or in the skin of normal of individuals. Serum and lesional TNF-α levels decrease after effective psoriasis therapy, correlating with clinical improvement of the disease. The benefit demonstrated by etanercept andother anti TNF-α agents in the treatment of psoriasis confirms the critical role of TNF-α in psoriasis pathophysiology.3 Etanercept, a fusion protein binding to soluble TNF-α, is nowadays one of the most widely used systemic treatments for moderate to severe psoriasis. There are numerous studies reporting its efficacy and safety.3
Over the years, it has been noted that some patients experience primary failure, defined as patients that never respond to etanercept. Others have experienced secondary failure,defined as patients who initially respond to etanercept and then loose efficacy over time. In the case of secondary failure, patients are frequently switched to alternative treatments and are not usually considered for re-treatment, based on the assumption that the patient has developed a long lasting resistance. In our experience, some patients are switched to other treatments prematurely. However, we have encountered patients who have previously been treated with etanercept and experienced well-documented secondary failure whereas re-treatment with etanercept provided excellent results.3,4
The objective of this study was to evaluate the efficacy of re-treatment with etanercept in patients with a history of etanercept use, whose response had decreased and were switched to another biologic or systemic therapy. In order to enter the study, patients had to have moderate to severe disease and therefore were failing the treatment following etanercept.
This study was approved by an institutional review board and informed consent was obtained from each patient.
This was an open label, single arm, prospective study with twenty subjects, older than 18 years with chronic plaque psoriasis. Subjects were screened and enrolled on a first come first