Exquisite jade pen, flowers all the way - Quanxinda​® (ofatumumab) brings new hope to "beauty disease"

On December 21, 2021, the National Medical Products Administration approved the fully human anti-CD20 monoclonal antibody Quasinda® (ofatumumab) developed by Novartis as a subcutaneously administered dosage form for the treatment of relapse in adults multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis
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[1] Only 65 days after being approved for marketing, the first batch of drugs arrived at Shanghai Customs on February 24, 2022, passed the drug test on March 18, and the team of Professor Chen Xiangjun, Department of Neurology, Huashan Hospital, Fudan University, on March 31.
Prescribe a prescription for a multiple sclerosis (MS) patient, and benefit Chinese MS patients with the fastest speed under the severe epidemic situation in Shanghai! MS is an immune-mediated disease characterized by inflammatory demyelinating lesions of the central nervous system
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The early symptoms are not obvious, and there are repeated episodes of diverse clinical symptoms, including limb weakness, paresthesia, vision problems, ataxia, or cognitive impairment
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The disease progresses slowly and is easily misdiagnosed and missed.
It is the most common non-traumatic disabling disease in young people
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When the neurological damage of MS accumulates to a certain level, the clinical symptoms will no longer be relieved, and the disease will slowly and continuously progress and deteriorate over time, which may eventually lead to serious consequences of blindness, disability, and loss of self-care ability
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Disease-modifying therapy (DMT) is the standard treatment for MS patients during the remission period.
Since May 2018, the state has successively issued policies for the diagnosis and treatment of rare diseases, and various drugs such as sinimod and fingolimod have been included in the medical insurance list, which has greatly improved MS.
Domestic availability of innovative drugs
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The launch of Novartis' Quanxinda® (ofatumumab) has created a new disease management method for Chinese MS patients.
While efficiently controlling disease activity, taking into account safety, subcutaneously once a month Drug administration provides great convenience for patient treatment
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Quanxinda® (ofatumumab) is a fully human monoclonal antibody targeting CD20 that acts by binding to two unique epitopes on CD20-expressing B cells, inducing pathogenic B cell lysis and Elimination, while achieving precise and efficient treatment, retains the immune reconstitution function of B cells and the immune surveillance function of plasma cells [2], and the risk of infection is low
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The approval of ofatumumab is based on the results of the Phase III clinical trial ASCLEPIOS (Ask) [3]
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A total of 1,882 patients with relapsing multiple sclerosis were included in the study.
The results showed that compared with the active control group, ofatumumab significantly reduced new gadolinium-enhanced T1 lesions by 98%, and reduced new or enlarged T2 lesions.
85%, reducing the annual recurrence rate by 59% (the annual recurrence rate in the ofatumumab group reached 0.
1, which is equivalent to only one recurrence in ten years), and reducing the risk of disability progression by 34%, all of which were statistically significant
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In the second year of ofatumumab treatment, nearly 90% of patients achieved the composite index of no recurrence, no new or enlarged lesions, and no disability progression-NEDA-3 (no evidence of disease activity) [4]
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             Figure 1 A summary of images from the ASCLEPIOS study shows almost complete clearance of gadolinium-enhanced (Gd+) T1 lesions after 12 months of ofatumumab treatment
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Oxford BDI Images pooled images from ASCLEPIOS stage III, gadolinium-enhanced (Gd+) T1 magnetic resonance imaging (MRI) of 314 newly diagnosed untreated patients at baseline and after 1 year of Quanxinda (images from 314 patients were pooled).
Superimpose) In the treatment of MS, time is myelin, time is brain and spinal cord! For patients diagnosed with MS, high-efficiency disease-modifying therapy should be initiated as soon as possible to suppress lesion activity as much as possible, reduce recurrence, and avoid long-term disability progression
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Especially for young patients, this has a big impact on their work and quality of life for decades to come
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An MS patient who visited the Department of Neurology, Huashan Hospital Affiliated to Fudan University, took this highly effective biological agent ofatumumab on March 31
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Fig.
2 Professor Chen Xiangjun of the Department of Neurology of Huashan Hospital and his team, the chief physician Yu Hai, repeatedly communicated the treatment plan with the patientFig.
3 Professor Chen Xiangjun, the chief physician of the Department of Neurology of Huashan Hospital, demonstrated Quanxinda® (ofatumumab) injection therapy for MS patientsFig.
4 Yu Hai, the attending physician of the Department of Neurology of Huashan Hospital, introduced Quanxinda® (ofatumumab) injection therapy for MS patients.
Prof.
Xiangjun Chen is a professor, chief physician, and doctoral supervisor in the Department of Neurology, Huashan Hospital, Fudan University
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Research direction: clinical and mechanism research of autoimmune diseases of nervous system, peripheral neuropathy and motor neuron disease
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He has long been engaged in clinical research in the fields of autoimmune diseases of the nervous system, especially demyelinating diseases of the central nervous system (NMO and MS), autoimmune encephalitis, peripheral neuropathy and myasthenia gravis, with solid theoretical knowledge and rich practice He has done a series of fruitful work in pioneering the early diagnosis of autoimmune diseases of the nervous system
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Outpatient information: Tuesday afternoon (special needs): Clinic No.
15 on the 7th floor of the outpatient department of the General Hospital Wednesday morning (specialist): Clinic No.
7 of the Western Hospital Outpatient Department Thursday morning (special needs): Clinic No.
1 on the 7th floor of the General Hospital Outpatient Clinic Thursday afternoon (MDT): "Neuroimmunity and Inflammation MDT Clinic" on the 7th floor of the outpatient department of the General Hospital, Yu Hai, the Department of Neurology, Huashan Hospital Affiliated to Fudan University, attending physician
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He specializes in immune-related demyelinating diseases of the nervous system, and has rich experience in the treatment of vascular, infectious and severe diseases of the nervous system
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Engaged in clinical work for many years, has rich clinical experience
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He has successively participated in clinical work in the cerebrovascular group, immune group, degenerative disease group, myopathy group and other professional groups, and has participated in the seventh batch of cadres in Shanghai to aid Xinjiang (the Second People's Hospital of Kashgar)
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Outpatient information: Wednesday afternoon (special disease): Clinic No.
35 on the fifth floor of the outpatient department of the general hospital Thursday afternoon (MDT): "neuroimmunity and inflammation MDT outpatient clinic" on the seventh floor of the outpatient department of the general hospital Reference: [1] For the treatment of rare diseases Ofatumumab injection launched https:// P, HuckC, Wegert V, et al.
Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity.
Poster presentation at: ECTRIMS; September 2016; London, UK.
[3]Hauser SL etal.
N Engl J Med.
2020;383(6):546-557.
[4]Hauser S, Bar-Or A, Cohen J, et al.
Ofatumumab versus teriflunomide in relapsing multiplesclerosis: Analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOSI and II trials.
Eur J Neurol.
2020;27(1):261 –263.