A new treatment option under the normalization of the epidemic--Ozamod treated patients can generate an effective immune response after being vaccinated against the new crown

Introduction Novel coronavirus pneumonia (COVID-19) is an infectious disease caused by a new type of coronavirus (SARS-CoV-2), which has been raging around the world since its first outbreak at the end of 2019
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According to the latest data from the World Health Organization, as of 2:36 on April 15, Beijing time, the cumulative number of confirmed cases of new coronary pneumonia in the world exceeded 500 million, and the cumulative number of deaths exceeded 6.
19 million1
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In the context of the normalization of the epidemic, how to standardize the management of MS patients, ensure their own safety and effectively control the disease has become a global issue
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The spread of the new coronavirus has been mutated many times.
At present, the Omicron strain has replaced the Delta strain as the main epidemic strain.
The existing evidence shows that the Omicron strain is more transmissible than the Delta strain, resulting in The severity of the disease has attenuated 2
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Since the introduction of the Omicron strain into China, China's epidemic prevention and control work has once again faced enormous pressure
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The "New Coronary Virus Pneumonia Diagnosis and Treatment Program (Trial Ninth Edition)" pointed out that the vaccination of the new coronavirus can reduce the infection and incidence of the new coronavirus, and it is an effective means to reduce the incidence of severe disease and death.
Those who meet the requirements for vaccination should be vaccinated
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Vaccination objects who meet the conditions for booster immunization should receive booster immunization in time 2
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Based on the above advantages, vaccination is being actively promoted at home and abroad to establish a herd immunity barrier as soon as possible 3
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The vaccination rate of the new crown continues to rise in China.
At the same time, for MS patients, can the new crown vaccine be vaccinated? Questions such as how the impact is still urgently needed to be interpreted 3
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Therefore, the Neuroimmunology Group of the Neurology Branch of the Chinese Medical Association released the "Chinese Expert Consensus on Novel Coronavirus Vaccination in Patients with Multiple Sclerosis and Neuromyelitis Optic Spectrum Diseases" to guide MS patients to vaccinate against the new crown virus in an orderly manner
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 The main content of the "Chinese Expert Consensus on Novel Coronavirus Vaccination in Patients with Multiple Sclerosis and Neuromyelitis Optic Spectrum Disease" points out that MS disease itself does not increase the risk of new coronavirus infection.
It can cause MS recurrence or affect the efficacy of DMT drugs.
Therefore, under the principle of informed consent, MS patients with stable disease should be advised to receive the new crown vaccine
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The vaccination plan for MS should be individually formulated considering patient factors, vaccine factors and DMT treatment factors
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3 There are differences in the effects of different DMT drugs on the antibody response and protective efficacy after Covid-19 vaccination.
The consensus outlines whether DMT drugs affect the effectiveness of Covid-19 vaccines
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Based on the drug mechanism and clinical studies with small sample size, the consensus pointed out that beta-interferon, teriflunomide, and dimethyl fumarate will not affect the effectiveness of the new crown vaccine, while receiving sphingosine-1-phosphate (S1P) Efficacy of vaccination in MS patients treated with body modulators (including fingolimod, siponimod) and anti-CD20 monoclonal antibodies (rituximab and its biosimilars, ofatumumab) may have declined
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3 Ozamod is a new selective S1P receptor modulator.
When the consensus was written, it was not included in the consensus due to insufficient research evidence
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Since 2022, a number of studies involving the impact of Ozamod on new crown vaccination have been released, providing strong evidence support for the use of Ozamod during the epidemic
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 ACTRIMS2022: Humoral immune responses, antibody dynamics and seroprotection levels to COVID-19 vaccine in MS patients receiving different DMTs, three-month results of a prospective observational study to investigate the effects of different DMT drugs on COVID-19 vaccination in MS patients Effects of post-sera immune responses, a prospective observational study at ACTRIMS 2022 in 273 MS patients over 18 years of age and 273 similar healthy controls, prior to vaccination (t1) and first dose of vaccination Receptor binding domain (RBD) antibodies (anti-SARS-CoV-2-S) were quantitatively measured after weeks 4 (t2), 6 (t3), 8 (t4), and 16 (t5) to assess humoral immune responses
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Of the 273 MS patients, 35 received fingolimod and 7 received selective S1P receptor modulators (including siponimod, ozamod, and Ponesimod)
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The results showed that MS patients treated with selective S1P receptor modulators developed higher antibody titers after vaccination with COVID-19 compared with the fingolimod group (Figures 1 and 2)
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4 Figure 1.
Anti-RBD titers (t5) in healthy controls and MS patients receiving different DMT treatments Figure 2.
Distribution of protective extent in healthy controls and MS patients receiving different DMT treatments according to anti-RBD titers after vaccination (t5) AAN2022: Responses to COVID-19 Vaccines in RMS Patients Treated with Ozamod and Other DMTs To assess antibody responses to COVID-19 vaccines in RMS patients treated with Ozamod or other DMTs, 2022 A prospective observational study presented at the AAN meeting included 60 patients with RMS (30 on ozamod and 30 on other DMTs) who responded to antibody responses before and 28 days after the subjects were fully vaccinated.
Responses were descriptive statistics
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The primary endpoint was the proportion of SARS-CoV-2 anti-spike IgG positivity among subjects treated with Ozamod 4 weeks after full vaccination compared to pre-vaccination levels
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The results showed that RMS patients receiving Ozamod, 4 weeks after the second dose of vaccine, the proportion of patients with positive anti-spike protein IgG was 100%, while the proportion of patients receiving other DMT treatment was 87%, and other end points such as shown in Table 1
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The study showed that RMS patients treated with Ozamod developed effective antibodies to the COVID-19 mRNA vaccine
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5 Table 1.
Effects of Ozamod and other DMTs on the effectiveness of vaccination 4 weeks after the second dose of the vaccine Under the normalization of the epidemic, patients treated with Ozamod can generate an effective immune response after receiving the new crown vaccine , so it can be used as a new choice for the treatment of multiple DMT drugs in MS, especially high-efficiency DMT drugs
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 Expert Profile Professor Quan Chao Chief Physician of the Department of Neurology, Huashan Hospital Affiliated to Fudan University, Master Supervisor Youth Member of Neurology Branch Member of Neuroimmunology Genetics and Biochemistry Group of Neurology Branch of Shanghai Medical Association Member of ICC-Member of International Clinical Consortium for NMOMember of NMO Treatment Choice Consensus Board Neuroimmunology Reports Editorial Board Chair of National Natural Science Foundation of China Clinical and scientific work on myelin diseases, including "neuromyelitis optica" and "multiple sclerosis"
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Participated in the compilation of "Practical Internal Medicine", "Treatable Rare Diseases" and "Practical Neurology"
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Experts commented that under the background of the normalization of the epidemic, MS patients need to consider a variety of factors when starting or changing the existing DMT treatment.
Since the new crown vaccination is the most effective method to prevent the spread of the new crown virus, the impact of DMT drugs on the effectiveness of the new crown vaccine is the choice.
One of the important considerations when taking medicines
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As mentioned in the consensus, this guidance is clearly valid and needs to be updated based on new research data
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Ozamod is a brand-new selective S1P receptor modulator, which is about to be approved in China for the treatment of MS and other diseases
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Previous data on the effect of this drug on vaccine effectiveness were limited and were therefore not mentioned in the consensus
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The latest data from AAN2022 shows that the proportion of patients with anti-spike protein IgG positive after full vaccination with Ozamod is 100% (other DMT is 87%), this evidence supports Ozamod in the epidemic normality provides a basis for its use in the context of chemistry
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In clinical application, the effectiveness, safety and individual needs of patients should be comprehensively considered, so as to use the right medicine and the right medicine to the greatest extent
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Patients treated with Ozamod can not only produce an effective immune response after being vaccinated against the new crown, but also have a comprehensive control of the disease
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Compared with interferon beta-1a, Ozamod significantly reduced ARR and MRI activity, significantly delayed the volume loss of the whole brain, cortical gray matter and thalamus, and also had a good performance in improving cognitive performance, and the efficacy was maintained for a long time
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It is hoped that Ozamod will be launched as soon as possible to provide more treatment options for MS patients in China
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References: 1.
https://covid19.
who.
int/2.
Novel coronavirus pneumonia diagnosis and treatment plan (trial ninth edition) 3.
Neuroimmunology group of neurology branch of Chinese Medical Association.
Multiple sclerosis and neuromyelitis optica spectrum Chinese Expert Consensus on Novel Coronavirus Vaccination in Patients with Disease [J].
Chinese Journal of Neurology, 2022, 55(04): 289-299.
4.
CoV-2vaccineresponseinRMSpatientstreatedwithozanimodandotherDMTs.
AAN2022.