Humira® is the commercial brand name of Adalimumab Solution for Injection, a fully human recombinant anti-TNF-α monoclonal antibody developed by AbbVie. It specifically binds and neutralizes tumor necrosis factor-alpha (TNF-α), blocks inflammatory signal transduction, and suppresses abnormal autoimmune inflammatory responses in multiple tissues.
Main Indications
Moderately to severely active rheumatoid arthritis combined with methotrexate;
Active psoriatic arthritis and severe ankylosing spondylitis;
Moderate to severe chronic plaque psoriasis suitable for systematic therapy;
Moderately to severely active Crohn’s disease and ulcerative colitis;
Polyarticular juvenile idiopathic arthritis and non-infectious uveitis.
Clinical Research
Global multicenter phase III pivotal trials confirmed that adalimumab effectively alleviates inflammatory symptoms, delays joint structural damage and maintains long-term clinical remission in patients with rheumatic and gastrointestinal autoimmune diseases;
Phase III registration trials conducted in Chinese patients demonstrated consistent efficacy, skin lesion clearance and joint improvement compared with global study cohorts;
Long-term open-label extension studies verified sustained therapeutic effects and a predictable, manageable safety profile after repeated subcutaneous injection every two weeks.
Common Side Effects
Severe but important risks: Severe opportunistic infections including tuberculosis, invasive fungal infections, lymphoma and other malignancies, severe hypersensitivity reactions, hematologic disorders;
Common mild adverse reactions: Injection site erythema, pruritus and swelling, upper respiratory tract infection, headache, rash and mild nausea.
Approval Status in China
Original drug Humira® (Adalimumab Solution for Injection) obtained marketing approval in China in 2010, with the standard specification of 40mg/0.8mL pre-filled pen/syringe. It is a prescription biologic agent included in China’s Category B medical insurance catalogue.
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