Biological agents for ankylosing spondylitis

  A variety of biologic agents, such as tumor necrosis factor-a antagonists and adalimumab, are available for the treatment of ankylosing spondylitis in China.  The most commonly used is etanercept, a soluble TNF-a receptor fusion protein that binds with high affinity to the body’s TNF-a (which is increased when developing ankylosing spondylitis), causing the loss of TNF-a’s biological activity for therapeutic purposes. However, since TNF-a is an important component of the body’s natural immune response, excessive inhibition can lead to immune deficiency and adverse reactions such as infusion reactions, heart failure, lupus-like syndrome, and increased prevalence of infections (including tuberculosis, etc.) and tumors.  The second is infliximab (trade name: Classic), an anti-TNF-a monoclonal antibody that binds specifically to human TNF-a. Serious adverse reactions can also occur, such as an increased chance of infection, mainly in the form of respiratory infections such as pneumonia, sepsis and tuberculosis. It also includes infusion reactions, lupus-like syndrome, and malignancies of the lymphatic system and/or bone marrow.  Clinically, it has been observed that both Ixepro and analogues provide good control of the symptoms of ankylosing spondylitis, with long-term remission achieved with maintenance therapy. However, the most important barrier to the use of these products is their high price. The monthly cost of Iceptap is approximately RMB 8,000 per month at the adult dose, and the average monthly cost of Classic is no less than this.  Although biologics are effective in rapidly eliminating symptoms and patients gain a greater sense of disease control than ordinary drugs, they do not cure ankylosing spondylitis or stop the progression of ligamentous calcification and spinal ankylosis, and most patients will still relapse within 3-6 months after stopping the drug. To date, such drugs are not covered by medical insurance. Therefore, patients who are financially well off are free to choose them under the guidance of their physicians; patients with more severe clinical symptoms who do not respond to common treatment options can also try them; most patients have good control of their disease with common options and do not need such expensive treatment.  All patients with ankylosing spondylitis should use biologics under medical supervision. For pregnant or nursing women, active infections (patients at high risk of infection include: chronic lower extremity ulcers, history of tuberculosis, infectious arthritis occurring within 1 year, history of joint prosthesis infection within 1 year, persistent or recurrent chest pain, indwelling catheters), those with a history of lupus or multiple sclerosis, malignant or precancerous lesions (excluding basal cell carcinoma, and diagnosed and treated for more than 10 years malignant tumors) are contraindicated.  For patients who plan to use biologics, a chest X-ray, tuberculin test and three tests for tuberculosis are generally required, in addition to four tests for serum (including hepatitis virus and HIV).