Etanercept (Enbrel) - An Update

B. Goffe, MD

Disclosures

Skin Therapy Letter. 2004;9(10) 

In This Article

Abstract and Introduction

Etanercept is a tumor necrosis factor antagonist with anti-inflammatory effects. It is currently approved in the US for psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis and juvenile rheumatoid arthritis. Clinical trials have shown this agent to have an excellent safety profile and to be well tolerated by both adult and pediatric patients.

Etanercept (Enbrel® Amgen) is a recombinant human protein with anti-inflammatory properties that was the first approved treatment for psoriatic arthritis by the US FDA in January 2002. It was approved by TPP Canada in January 2004 for the same indication.[1,2,3] In May 2004, the US FDA approved this drug for the treatment of adult patients with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In September 2004, the European Union approved it for the treatment of adult patients with moderate-to-severe plaque psoriasis who failed to respond to, or have a contraindication to, or are intolerant of other systemic therapies. Also in September 2004, the US FDA approved a new dosing form: a 50mg/ml prefilled syringe, which will allow most patients to take only one injection per week instead of two. Additional indications for etanercept include the treatment of rheumatoid and polyarticular-course juvenile rheumatoid arthritis (RA and JA respectively), and ankylosing spondylities. In RA the clinical responses to etanercept have been maintained for up to 7 years in clinical trials.[4] Tumor necrosis factor (TNF) is a proinflammatory cytokine that has been strongly implicated in the pathogenesis of psoriasis and psoriatic arthritis, and plays a key role in the activation of innate and acquired immune responses. An inappropriate production of this cytokine is seen in psoriasis and psoriatic arthritis, which can lead to chronic inflammation, tissue damage and excessive keratinocyte proliferation. The downstream effects of excessive TNF production on various cell types and the clinical manifestations relevant to psoriasis and psoriatic arthritis are summarized in Table 1 . Currently there are three TNF-alpha inhibitors available in the US – one receptor fusion protein (etanercept), and two monoclonal antibodies (infliximab and adalimumab).

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