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Innovative drugs have been approved for new dosage forms to help the clinical treatment of RA!
Tocilizumab opened the era of "double dosage form" and helped the long-term standardized management of RA
Recently, the subcutaneous injection form of the humanized monoclonal antibody tocilizumab (trade name: Yameiro) of the interleukin-6 receptor (IL-6R) has been used in Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine, the First Affiliated Hospital of Harbin Medical University, the Pearl River Hospital of Southern Medical University, Peking University People's Hospital, the Second Affiliated Hospital of Fujian Medical University, Daping Hospital affiliated to Chongqing Army Medical University, Jiangxi Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Shaanxi Provincial People's Hospital and other hospitals in all regions of the country were officially opened
.
Previously, the national marketing meeting of tocilizumab subcutaneous dosage form was held on October 22, and the city listing meeting
was also held in Beijing, Shanghai, Guangzhou, Hangzhou, Nanjing, Jinan, Chengdu, Wuhan, Xi'an and Zhengzhou.
This marks that tocilizumab has officially entered the era of "double dosage form" of intravenous injection and subcutaneous injection in China, bringing more convenient treatment options
for patients with rheumatoid arthritis (RA).
Swipe left to see more
Figure 1.
The First Affiliated Hospital of Harbin Medical University - Professor Zhang Zhiyi
Pearl River Hospital of Southern Medical University - Professor Yu Qinghong Figure 3.
Peking University People's Hospital - Professor Liu Tian Figure 4.
The Second Affiliated Hospital of Fujian Medical University - Professor Chen Xiaoqing Figure 5.
Shaanxi Provincial People's Hospital - Professor Li Xiaoyan Figure 6.
Patients in Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine completed the injection under the guidance of a doctor
RA is a chronic, highly disabling autoimmune disease with erosive joint inflammation as the main clinical manifestation, the most common clinical manifestation of patients is joint swelling and pain, the condition is repeated and gradually aggravated, eventually leading to joint structure destruction, resulting in disability
.
RA is the most common systemic rheumatism in China, there are about 5 million RA patients in China, RA not only causes the decline of patients' physical function, quality of life and social participation, but also brings huge economic burden to patients' families and society [1-2].
Due to the unclear pathogenesis, RA is still a disease that cannot be completely cured, but with the improvement of early diagnosis and treatment of RA in recent years, and the approval of a variety of innovative therapeutic drugs, the disease control status of RA patients has been significantly improved, among which the targeted tocilizumab is the representative, biologics have shown their skills in the treatment of RA in the 21st century, showing good disease control effects
。
Tocilizumab previously approved for the treatment of RA in China is intravenous injection, patients need to be hospitalized, and each intravenous drip is more than one hour, so in order to make patients receive more convenient treatment and save treatment time, tocilizumab has developed a new subcutaneous injection dosage form, which has been officially approved by the National Medical Products Administration (NMPA) on April 13, 2022.
For adult patients with moderate to severe active RA who do not respond adequately to the treatment of antirheumatic drugs (DMARDs) that improve their condition, the issuance of the first batch of prescriptions also marks the official "online" clinical trial of the new dosage form of tocilizumab, providing patients with more convenient choices
.
To maintain long-term treatment of patients, the subcutaneous dosage form of tocilizumab has clear clinical significance
At present, the overall goal of RA treatment is: to improve the symptoms of joint swelling and pain in patients, control the progression of the disease, reduce the disability rate, in order to improve the quality of life of patients [2], but the premise of achieving these goals is that patients need to adhere to long-term medication to achieve better results, this aspect requires that the treatment drugs have good efficacy, to establish confidence for long-term treatment of patients, on the one hand, it is also necessary to use therapeutic drugs enough to be convenient and fast enough to reduce the burden caused by long-term medication.
Both doctors and patients will prefer convenient and efficient medicines
.
As a classic biologic drug in the treatment of RA, tocilizumab is currently the only approved biological agent in China that acts on the IL-6 receptor pathway, and it is also a first-line biological agent for RA treatment consistently recommended by domestic and foreign guidelines, which has a clear effect
on improving RA inflammation and joint destruction.
Since its approval in 2013, tocilizumab has accumulated nearly 10 years of clinical use experience in China, and its efficacy and safety have been supported and recognized
by China's regulatory authorities and many clinical experts.
Compared with the intravenous injection method that requires hospitalization and each intravenous drip is more than one hour, subcutaneous injection of tocilizumab can obviously save patients the time of going back and forth to the hospital, hospitalization and other links, greatly improve the convenience and accessibility of treatment, and in the long-term chronic disease management of RA, this is also very important
to improve patients' treatment compliance and prolong the duration of treatment.
At the same time, the results of a large number of clinical studies also show that there is no obvious difference in efficacy, safety, patient compliance and maintenance of utilization rate between subcutaneous tocilizumab and intravenous injection, such as the results of the international clinical study SUMMACTA show that the efficacy and safety of using tocilizumab subcutaneous injection combined with traditional DMARDs in the treatment of RA are consistent with intravenous tocilizumab combined with traditional DMARDs; In the RoSwitch study conducted in France, patients with RA who switched sequentially from intravenous tocilizumab to subcutaneous therapy maintained their effectiveness at both six and 12 months [3-4].
It is worth noting that when using the subcutaneous injection form of tocilizumab, in addition to the first subcutaneous injection under the supervision of a qualified medical professional, after that, with the consent of both the doctor and the patient and the patient and the patient receiving appropriate injection technique, the patient can inject himself subcutaneously at home and quickly complete each bolus, which will make the treatment more convenient
.
In addition, under the background of the normalization of the prevention and control of the new crown pneumonia epidemic, the epidemic and prevention and control often affect the medical treatment of RA patients, affect the use of the intravenous dosage form of tocilizumab that requires hospitalization, and the subcutaneous injection dosage form of tocilizumab can be used by patients at home, which will help maintain the patient's condition control during the epidemic, reduce the potential negative impact, and improve the level of
patient self-management.
New dosage form, new expectations: tocilizumab expands clinical application scenarios
Tocilizumab has been used in the treatment of clinical RA for 9 years, many rheumatology experts are no strangers to the "old friend" of tocilizumab, and now the approval of the new dosage form of tocilizumab is a new therapeutic "sharp weapon" for doctors and patients, and it is even more expected for the future application of the new dosage form in clinical practice:
Tocilizumab has been on the market in China for nine years to help many rheumatic patients, and the launch of subcutaneous dosage forms has increased the convenience of the drug and brought good news
to more patients with rheumatic diseases.
——Professor Zhang Zhiyi of the First Affiliated Hospital of Harbin Medical University "Tocilizumab is a sharp weapon for clinical IL-6-centered hyperinflammatory related diseases.
"
——Professor Ye Shuang, Renji Hospital, Shanghai Jiao Tong University School of Medicine, "Tocilizumab, as the world's first IL-6 receptor inhibitor, has changed the pattern of biologics application targets, and I believe that subcutaneous dosage forms can better serve patients.
"
——Professor Yu Qinghong, Pearl River Hospital of Southern Medical University, "Tocilizumab has opened the era of dual dosage forms in China, and will help more patients in different scenarios!"
——Professor Liu Tian of Peking University People's Hospital "hopes that tocilizumab will benefit more patients and eliminate pain for more patients.
"
We are willing to work together to contribute to a healthy China!
—Professor Li Xiaoyan, Shaanxi Provincial People's Hospital
All in all, as the world's first humanized monoclonal antibody against IL-6 receptors, the new subcutaneous injection dosage form of tocilizumab has been officially put into clinical use, which will provide Chinese RA patients with more efficient, safe and convenient individualized treatment options, improve patients' treatment experience and compliance, and effectively help the "long-term stability" of RA, and also look forward to more innovative therapeutic drugs in the future, which can develop "more friendly" dosage forms for RA patients and work together with patients to fight RA!
References:
[1] TIAN Xinping,LI Mengtao,ZENG Xiaofeng.
Current situation and challenges of diagnosis and treatment of rheumatoid arthritis in China:2019 annual report of rheumatoid arthritis in China[J].
Chinese Journal of Internal Medicine,2021,60(07):593-598.
)
[2] Geng Yan, Xie Xi, Wang Yu, et al.
Diagnosis and treatment norms for rheumatoid arthritis[J].
Chinese Journal of Internal Medicine,2022,61(01):51-59.
)
[3] Burmester G R,Rubbert-Roth A,Cantagrel A,et al.
Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97(SUMMACTA)[J].
Annals of The Rheumatic Diseases,2016,75(1):68-74.
[4] Darloy J,Segaud N,Salmon J H,et al.
Tocilizumab effectiveness after switching from intravenous to subcutaneous route in patients with rheumatoid arthritis:the RoSwitch study[J].
Rheumatology and Therapy,2019,6(1):61-75.
This article is intended solely to provide scientific information to healthcare professionals and does not represent the position of
the Platform.
