Enbrel® is the commercial brand name of Etanercept Solution for Injection, a recombinant human tumor necrosis factor receptor fusion protein developed by Pfizer. It competitively binds to TNF-α and blocks its pro-inflammatory biological activity, thereby alleviating autoimmune inflammatory lesions.
Main Indications
Treatment of moderately to severely active rheumatoid arthritis;
Treatment of active ankylosing spondylitis and psoriatic arthritis;
Treatment of adult moderate to severe plaque psoriasis;
Treatment of polyarticular juvenile idiopathic arthritis.
Clinical Research
Global multicenter phase III trials demonstrated that etanercept effectively relieves joint pain and swelling, delays progressive joint damage and improves quality of life in patients with rheumatic diseases;
Registration clinical trials conducted in Chinese patients achieved consistent therapeutic efficacy and safety outcomes compared with global study populations;
Long-term extension studies confirmed sustained disease control with repeated subcutaneous administration and a manageable safety profile.
Common Side Effects
Severe but important risks: Serious infections including tuberculosis, invasive fungal infections, malignant tumors, demyelinating disorders and severe hypersensitivity;
Common mild adverse reactions: Injection site erythema and pruritus, upper respiratory tract infection, headache, rash and mild gastrointestinal discomfort.
Approval Status in China
Original drug Enbrel® (Etanercept Solution for Injection) was officially approved for marketing in China in 2005, with the specification of 50mg/0.94ml. It is currently a prescription biologic agent included in China’s Category B medical insurance catalogue.
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