The Usage and Precautions of Adalimumab

Adalimumab (Humira) is a self-injectable biotherapeutic drug. It has been approved by the China Food and Drug Administration (CFDA) for 2 indications, namely rheumatoid arthritis and ankylosing spine inflammation.

In 2013, through the study of adverse events in clinical trials of adalimumab for various indications in the past 12 years, no new safety signals for adverse reactions that exceeded previous experience were found. Among patients treated with adalimumab, the overall incidence of malignant tumors was the same as expected by the general population. The drug is generally used alone or in combination with methotrexate.

Pharmacological action

TNF is a cytokine that occurs naturally in inflammation and immune responses. Studies have found that in the synovial fluid of RA patients, TNF levels are elevated and play an important role in pathological inflammation and joint destruction. This product can specifically bind to TNF-α (and block its interaction with p55 and p75 cell surface TNF receptors. In the presence of complement in vitro, this product can also dissolve surface TNF-expressing cells. This product It does not bind to or inactivate lymphotoxin (TNF-β). This product also regulates the biological response induced or regulated by TNF, and changes the level of adhesion molecules that cause leukocyte displacement.

Clinical evaluation

Four randomized double-blind studies evaluated the effectiveness and safety of this product. The patients participating in the study were 18 years or older and were diagnosed with active RA according to the American College of Rheumatology (ACR) criteria. The patient has at least 6 swollen and 9 tender joints. Treatment options include subcutaneous administration of this product in combination with methotrexate (12.5-25 mg, Study I and Research...), or administration of this product alone (Study 11), or combined use of this product with other DMARDs (Study IV). Study I included 271 patients who failed at least 1 but not more than 4 times while using other DMARD treatments and had an inadequate response to methotrexate. The selected patients were randomly given this product (20, 40 or 80 mg) or placebo every 1 week for 24 consecutive weeks.

Precautions

Patients must be closely monitored for infection, including tuberculosis, and treatment with this product cannot be started until the infection is controlled. When the patient has a new serious infection or hepatitis B is reactivated, the treatment with this product should be interrupted until the infection is controlled. Patients with a history of recurrence of infection or prone to infection, central nervous system demyelination disorders, malignant diseases, and mild heart failure should be used with caution. During treatment, patients with abnormal blood system, symptoms of lupus syndrome and positive double-stranded DNA antibody should be stopped immediately. This product has a slight effect on driving and operating machinery. It is not recommended for use in children, pregnancy or breastfeeding. Women of childbearing age should use contraception during the medication period to at least 5 months after the end of the treatment, and breastfeeding women cannot breastfeed.