@Tonic patient, the first domestic oral JAK inhibitor approved for indications!

*For medical professionals to read and reference the first oral small molecule targeted drug in the field of rheumatism and immunity, bringing new treatment options for AS patients Pfizer announced on April 15 that China's National Medical Products Administration (NMPA) has approved citric acid Tofacitinib (trade name: Shangjie) is indicated for adult patients with active ankylosing spondylitis (AS) for whom one or more TNF blockers are insufficiently effective or intolerable
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This is the second indication approved in China after tofacitinib was approved for the treatment of moderate to severe rheumatoid arthritis in March 2017
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As the first and only oral small molecule targeted drug approved for the treatment of AS in China, tofacitinib will bring breakthroughs in the field of AS treatment
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After approval, Changzheng Hospital Affiliated to Naval Military Medical University and Peking University First Hospital issued the first prescription for patients, benefiting AS patients at the first time, opening a new pattern of oral targeted therapy for AS in China, and bringing new opportunities to AS patients.
treatment options and hope
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AS is more common in young men, and can be severely disabling and teratogenic.
AS is a chronic autoinflammatory disease.
Currently, there are more than 5 million AS patients in China [1]
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Most of the AS patients are young men.
As the most important labor force and family support in the society, AS patients will bring a heavy burden to the family and society
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AS is a progressive systemic disease, with the accumulation of damage over time, often causing irreversible structural damage, which can seriously lead to disability and teratogenicity
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Because AS cannot be completely cured, most patients are not only suffering from the pain, but also the pain, fatigue, functional limitation, and often accompanied by negative emotions such as insomnia, depression, anxiety, etc.
, which seriously affect their daily study, work and life
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The early symptoms of AS are not obvious, and it is very easy to be misdiagnosed and missed.
The average delay in diagnosis is about 2-6 years [2]
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Therefore, early diagnosis and standardized treatment are particularly important for AS patients, which can effectively alleviate and control the progression of the disease and help patients return to normal life
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If the patient has symptoms such as lower back pain, they should be vigilant and go to the rheumatology and immunology department of the hospital as soon as possible to do relevant examinations, follow the doctor's advice, and grasp the best time for treatment
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For the treatment of AS, the 2019 American College of Rheumatology (ACR) guidelines recommend physical therapy and non-steroidal anti-inflammatory drugs (NSAIDs) as first-line therapy.
NSAIDs treatment has problems such as low clinical remission rate and large side effects
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Existing intensive treatment regimens using biological agents (including TNF-α inhibitors and IL-17A inhibitors) are effective, but some biological agents cannot effectively control the extra-articular damage caused by AS, and even aggravate inflammatory bowel disease; The incidence of hepatitis B and tuberculosis infection of the preparations is high; some biological preparations have secondary failure problems due to the production of neutralizing antibodies
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Under the normalization of the epidemic, the way of injecting and administering biological agents faces the challenge of low compliance and is not easy to manage the long-term disease of patients
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Under the current treatment plan, there are still many unmet treatment needs of patients
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As the first and only oral small molecule targeted drug approved for the treatment of AS in China, tofacitinib is approved for the treatment of AS indications, and will To provide new treatment options for clinical experts, it is expected to meet the needs of oral treatment of AS patients, improve compliance and achieve "targeted treatment"
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Tofacitinib is a JAK inhibitor.
Compared with existing drugs in the field of AS treatment, it is a brand-new mechanism of action.
By blocking the JAK-STAT pathway in immune cells, it can directly or indirectly block a variety of AS-related Cytokine signal transduction to achieve the purpose of inhibiting inflammation and relieving disease
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Professor Xu Huji, the lead expert of the China Phase III clinical research project for the AS indication of tofacitinib and director of the Department of Rheumatology and Immunology, Changzheng Hospital Affiliated to Naval Medical University, said: "AS patients are mostly young and middle-aged men, and the damage continues to accumulate over time.
It often causes irreversible structural damage.
If it is not treated in time or improperly treated, it will affect the ability to work and bring a burden to the family and society
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The phase III clinical study of tofacitinib AS is in 75 centers in 14 countries.
The randomized, double-blind, placebo-controlled study carried out, in which the number of patients enrolled in China is about 18%, which has contributed 'China's strength' to this approval
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It is expected that the approval of tofacitinib AS indication will give more Multiple AS patients will bring benefits
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” Professor Zhang Zhuoli, director of the Department of Rheumatology and Immunology, Peking University First Hospital, said: “Tofacitinib is the first JAK inhibitor to enter China, and together with Chinese experts, we have developed a small molecule for rheumatoid arthritis.
The era of targeted therapy
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I am glad to see the approval of the second indication of tofacitinib in China for AS, bringing a new treatment option with a new mechanism of action for Chinese AS patients
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Tofacitinib blocks JAK-STAT signaling by blocking It can comprehensively inhibit the production of various cytokines related to AS disease, thereby controlling the symptoms of AS
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Under the normalization of the epidemic, it is inconvenient for patients to seek medical treatment and injections.
The oral administration of tofacitinib can help patients improve compliance and continuous medication Tofacitinib
’s
AS indications have been approved in 9 countries and regions including China, the United States, and the European Union
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References[1]Zhao J , Huang C , Huang H , et al.
Prevalence of ankylosingspondylitis in a Chinese population: a systematic review and meta-analysis[J].
Rheumatology International.
2020.
40:859-872.
[2] HayCA,Packham J,Ryan S,et al.
Diagnostic delay in axialspondyloarthritis: a systematic review[J].
Clinical Rheumatology.
2022:1-12.
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