China News Service, Beijing, April 28 (Reporter Li Yanan) Novartis Pharmaceuticals (China) announced on the 28th that Ke Shan Ting (Skuchiyu monoclonal antibody) has been approved by the China State Drug Administration for rigid treatment with ineffective rigidity Adult patient with spondylitis. This is Ke Shanting's second indication approved in China after being previously approved for the treatment of moderate to severe plaque psoriasis. It is also the first and only domestic interleukin class approved for the treatment of ankylosing spondylitis Inhibitor.
According to reports, ankylosing spondylitis is a chronic inflammatory disease that belongs to rheumatic immune disease. In China, the prevalence of ankylosing spondylitis is about 0.3%, the age of onset is usually 13-31 years old, and it is more common in men. Data show that about 80% of ankylosing spondylitis patients have spinal pain and fatigue symptoms, and the proportion of morning stiffness reaches 90%. In addition, it may also cause bone structural damage.
Under normal circumstances, the human spine and vertebrae are connected by flexible ligaments, so the waist and back can move flexibly. The connection point of the ligament and the bones of the upper and lower vertebral bodies is called the attachment point, and the inflammation at the attachment point of patients with ankylosing spondylitis will repeatedly produce pathological new bone. Healthy ligaments gradually begin to ossify, resulting in osteophytes and connecting bone bridges, eventually leading to spinal fusion and rigidity and varying degrees of disability.
Professor Huang Feng, Chief Physician of the Department of Rheumatology, 301 Hospital, said: "Ankylosing spondylitis is an inflammatory disease. It is very important to suppress the level of inflammation, and it is also the focus of current clinical drug treatment. However, studies in recent years have found that even if the inflammation level is obtained Control, there will still be further deterioration of bone structure damage. How to adopt a two-pronged approach, especially "inhibiting the progress of bone structure" has become an urgent need for treatment. "
Ankylosing spondylitis will go through several stages from the onset to the final bone fusion: ostitis-fat deposition-osteophyte-bone bridge-bone fusion. "New bone formation" is the pathological basis for the progress of the entire disease course, and interleukin-17A (IL-17A) is an important "booster". On the one hand, it is a key cytokine and inflammatory mediator in the pathogenesis of attachment site inflammation, which can further promote the inflammatory cascade reaction; on the other hand, it is a key mediator of bone remodeling and participates in new bone formation. Therefore, inhibition of IL-17A can block inflammatory pathways and relieve pain, while inhibiting the formation of new bone to prevent further damage to the bone structure.
According to reports, as the world's first and only fully human-derived IL-17A inhibitor, multiple clinical studies have confirmed the multiple benefits that can be supported:
Results of the MEASURE2 study showed that patients received 150mg for 4 weeks and improved back pain by 39% from baseline (placebo group: 15%), morning stiffness from baseline by 34.4% (placebo group: 14.8%), and fatigue from baseline 28% improvement (placebo group: 8%). Continue to receive good treatment, 97% of patients without osteophytes at baseline and 73% of patients with osteophytes at baseline had no new osteophytes within 2 years, and nearly 80% of patients had no deterioration of spinal injuries within 4 years. IL-17A is downstream of the entire inflammatory pathway, and the fully human preparation process reduces the risk of adverse reactions. Studies have shown that there are no reports of increased susceptibility to tuberculosis in patients treated with Keshan, and there have been no reports of hepatitis B reactivation after Keshan treatment. The incidence of anti-drug antibodies in 5 years is <1%.
As the head of the phase III clinical study of Succhiumumab in China, Professor Huang Feng said: "The emergence of Succhiumab has undoubtedly provided patients with a new treatment option and hope, and it has also allowed us to The clinical performance and potential of the target in the field of ankylosing spondylitis are full of expectations. I hope to see more Chinese patients benefit from the new generation of innovative drugs. "
It is reported that Keshanting has been listed in many countries and regions including the EU countries and the United States, and is approved for the treatment of psoriasis, psoriatic arthritis and ankylosing spondylitis. (Finish)