An open-label, prospective cohort pilot study to evaluate the efficacy and safety of etanercept in the treatment of moderate to severe plaque psoriasis in patients who have not had an adequate response to adalimumab.
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BACKGROUND: The past several years have seen the approval of five different biologic agents for the treatment of moderate to severe plaque psoriasis in the United States and Canada. Psoriasis has proven to be a difficult disease to treat and treatment failures, even with newer biologic therapies, are not uncommon. The vast majority of clinical data for these medications is derived from treatment of biologic-naive patients, or patients who have not responded to, or lost response to, or not tolerated systemic therapy for psoriasis. There is currently little data available on therapeutic response of a second biologic therapy after loss of response, or no response, to the first biologic therapy initiated. It has become common clinical practice to switch medications that are structurally distinct but therapeutically similar in order to achieve an improved clinical outcome. Therapeutic interchange now is being applied to the biologic agents used to treat psoriasis. OBJECTIVES: Using a proof of concept study, describe the response of etanercept after adalimumab has failed to produce a satisfactory response in moderate to severe plaque psoriasis. METHODS: A total of 10 biologically naive patients with moderate to severe psoriasis who were initiated on adalimumab for at least 12 weeks but had a Physician's Global Assessment (PGA) of mild or worse were transitioned to commercial etanercept 50 mg twice weekly (BIW) for 12 weeks followed by a dose reduction to 50 mg once weekly (OW) for an additional 12 weeks. Ethics approval was obtained and the study registered with ClinicalTrials.gov (NCT00833729). The primary outcome measured was the mean change in Physician?s Global Assessment (PGA) score (range 0-5) from baseline (when the first etanercept injection is given) to 12 weeks of etanercept therapy. The secondary outcomes measures included the mean change in Dermatology Quality of Life Index (DLQI), mean change in body surface area (BSA) covered in psoriasis, Subject's Global Assessment of disease (SGA), proportion of patients achieving an improvement in PGA score from baseline to 12 weeks and again at 24 weeks and safety. RESULTS: Overall, there were significant favorable changes in all outcomes measured (PGA, SGA, BSA and DLQI) with respect to etanercept's efficacy after an inadequate response to at least 12 weeks of adalimumab therapy. There were no significant safety issues noted especially during the transition period from adalimumab to etanercept. ClinicalTrials.gov identifier: NCT00833729.
