Multiple sclerosis is different in different groups, this drug is more "friendly" to Chinese patients

*For medical professionals' reference only, Teriflunomide provides Chinese patients with multiple sclerosis with a combination of curative effects and high satisfaction
.

Multiple sclerosis (MS) is a chronic inflammatory autoimmune disease of the central nervous system (CNS).
There are currently more than 2.
5 million MS patients worldwide.
The disease is a common cause of disability in young people, especially women Health
.

MS can also cause severe neurological dysfunction, such as sensory problems, movement disorders, visual impairment, pain, etc.
[1]
.

(Big coffee talks about MS) Disease Modification Therapy (DMT) has now become the main long-term comprehensive management strategy for MS treatment, which can reduce the frequency of MS recurrence, reduce the degree of deterioration, delay the natural progression of the disease, alleviate the clinical symptoms of patients, and improve the prognosis of patients[2]
.

Because patients need long-term medication, the efficacy, long-term safety, and convenience of DMT drugs need to be considered
.

Teriflunomide is a DMT oral drug, which is more convenient than injection.
What about its efficacy and satisfaction among MS patients in my country? There are ethnic differences in Part 1MS, and there are many differences in clinical manifestations between Chinese patients and foreign patients.
Since the 1970s, it has been recognized that MS patients in Asia have different clinical characteristics from patients in North America and Europe
.

The main differences are lower prevalence, rare familial disease, higher proportion of women relative to men, more severe optic nerve and spinal cord injuries, less brain and cerebellar lesions, lower rate of disease progression, and lower incidence of positive oligoclonal bands Etc.
[3]
.

Studies have shown [4] that the prevalence of MS in China was 5.
2 cases per 100,000 people in 2013
.

The prevalence rate in predominantly white countries is much higher, and it has been increasing over time, with the prevalence rate reaching 115 cases per 100,000 in 2015
.

Although the risk of Asian populations is lower than that of other populations, the prevalence of MS in Asian countries (including China) has increased in recent years
.

However, the low incidence of MS in China may be partly related to the difficulty of diagnosis, and may also be related to differences in social culture and environment
.

In terms of the ratio of males to females, a joint Asian study showed that the ratio of females to males in Asian groups is 3.
8:1, which is higher than that of Western countries
.

Optic neuritis is a common symptom of MS.
In this study, it was found that at least 48% of MS patients in the Asian population suffer from optic neuritis.
In Western countries, the incidence of optic neuritis in MS patients is about 15%-35% [5]
.

Although the magnetic resonance imaging (MRI) performance of Asian MS patients is basically similar to that of Western patients in terms of lesion distribution and appearance, there are some differences
.

For example, Asian patients have fewer brain lesions, and spinal cord lesions are longer and more severe, but less involve the cerebellum [6]
.

Therefore, considering that the disease characteristics of MS patients in different populations are different, in the management of Chinese MS patients, the individual characteristics of Chinese patients should be combined and the treatment path of "Chinese characteristics" should be taken
.

It is gratifying that teriflunomide has shown satisfactory efficacy in the Chinese MS patient population
.

Part 2 The first oral DMT drug approved in my country, the annual recurrence rate of the Chinese subgroup has improved far better than the overall population! Teriflunomide was approved by the U.
S.
Food and Drug Administration (FDA) for marketing in the United States as early as September 2012.
It has abundant clinical trial data and real-world research data.
As the first oral DMT drug approved in China, The efficacy and safety of MS patients in China have also been verified
.

The TOWER study China subgroup [7] is part of the TOWER global study.
A total of 148 Chinese patients with relapsing MS (RMS) participated in the TOWER study, accounting for 12.
7% of the total study population
.

Patients were randomized to receive teriflunomide 7mg, 14mg or placebo for ≥48 weeks.
The primary and secondary study endpoints were the annual recurrence rate (ARR) and the 12-week risk of disability progression, respectively
.

The results showed that in the Chinese population, compared with placebo, 14mg teriflunomide significantly reduced the ARR of patients (a decrease of 71.
2%, P=0.
0012) and the risk of disability progression at 12 weeks (a decrease of 68.
1%, P=0.
1194), and the reduction in ARR was far Better than TOWER global population (ARR reduction rate of the overall population is 36.
3%) [7,8]
.

The incidence of adverse events is similar to that of the global population
.

Figure 1: The degree of ARR improvement between the Chinese subgroup and the overall population (RRR: relative risk reduction) The reason for the large difference in the ARR improvement of the TOWER China subgroup from the overall population may come from the following aspects [7]: Chinese subgroup population The enrollment time is shorter: the average time from first symptom onset to enrollment in the Chinese subgroup of MS patients is 5.
0 years, and the average enrollment time for the overall population is 8.
0 years; the steady-state AUCtau and Cmax of the Chinese subgroup are higher: Terri There may be ethnic differences in the pharmacokinetic characteristics of fluamine.
The results of population pharmacokinetic studies show that after the administration of 14 mg of teriflunomide, the steady-state AUCtau and Cmax of Chinese subjects are higher than those of non-Asian subjects.
Increases by 51% and 55%, respectively; the proportion of Asian patients carrying the allele ABCG2 is higher: breast cancer resistance protein (BCRP/ABCG2) has genetic polymorphisms, and the proportion of Asian patients carrying the allele ABCG2 is higher.
This leads to a decrease in BCRP activity, thereby reducing the efflux of teriflunomide, and increasing the exposure level of Chinese patients; the proportion of Chinese subgroups who have received other DMT drugs is small: the proportion of patients in the Chinese subgroup who have received other DMT drugs within 2 years The average is 2.
0%, and the overall population average is 32.
8%
.

In addition to the above-mentioned TOWER research data, there are currently a number of real-world data analyzing the efficacy and safety of teriflunomide in the Chinese population
.

A retrospective analysis of the efficacy of teriflunomide in MS patients in Wuhan from 2018 to 2020[9] included 38 MS patients.
55% of the patients had previously been treated with other DMT drugs and the patients received teriflunomide.
The median duration of treatment was 13 months
.

The results showed that teriflunomide can significantly reduce the ARR of Chinese MS patients (0.
27 after treatment vs.
1.
14 before treatment) by 76.
3% (P＜0.
01), and the patients’ Extended Disability Status Scale (EDSS) score during treatment No significant increase was seen
.

In terms of safety, teriflunomide has a low incidence of adverse reactions and is generally well tolerated
.

Another single-center, retrospective, observational, real-world study on teriflunomide [10] included 74 patients with MS, and the median time that patients received teriflunomide (14 mg/d) treatment was 9 Month
.

The primary endpoint of the study is ARR
.

The results of the study showed that teriflunomide treatment can significantly reduce the ARR of MS patients (0.
20±0.
47 at the last follow-up vs.
1.
02±0.
81 before treatment) by 78% (P=0.
005)
.

Among patients treated with teriflunomide, up to 75% did not relapse during the study period; up to 82% did not develop disability progression
.

In terms of safety, up to 66.
4% of patients did not experience any adverse events, and no serious adverse events were reported
.

Part 3 High patient satisfaction with treatment is the most direct recognition of drugs.
In the treatment of MS, patient satisfaction is also a very important consideration
.

High treatment satisfaction can improve the compliance of MS patients, and can also increase the treatment retention rate of drugs, thereby comprehensively improving the treatment effect and improving the overall prognosis
.

The Teri-Pro study [11] is a real-world phase IV study (n=1000) that mainly explores the outcome of patient reports including treatment satisfaction.
This study uses the Drug Treatment Satisfaction Questionnaire (TSQM, including effectiveness, adverse reactions) , Convenience, and overall satisfaction).
When MS patients received teriflunomide treatment for 48 weeks, the average TSQM overall satisfaction score was at a relatively high level (68.
2 points), and other treatment satisfaction scores such as effectiveness were also relatively high.
High (66.
3~90.
4 points)
.

Figure 2: The average TQM score of MS patients after receiving teriflunomide treatment.
The subgroup analysis showed that patients who switched to teriflunomide after taking other DMT drugs in the past had better treatment satisfaction than baseline at the 48th week of treatment.
Improve
.

For example, among 74 patients who had previously received dimethyl fumarate therapy, after switching to teriflunomide therapy, their satisfaction with drug effectiveness, adverse reactions, and convenience was significantly improved compared with baseline; Among the 29 patients who had previously received fingolimod therapy, after switching to teriflunomide therapy, the patients' satisfaction with the convenience of taking the drug increased significantly
.

Figure 3: From Fingolimod to teriflunomide before and after switching to teriflunomide, patients’ satisfaction scores for treatment convenience are summarized: Early DMT treatment to control MS disease activity can reduce clinical and subclinical recurrence, delay disease progression, and prevent patients Exacerbation of disability and maintenance of quality of life play a key role
.

Teriflunomide has a convenient way of taking, consistent and significant effectiveness and good safety, high user satisfaction, and clinical studies have shown that the Chinese population has a higher ARR improvement rate
.

Overall, these evidences indicate that teriflunomide can provide long-term effective, safe and stable treatment options for Chinese MS patients
.

 Expert Profile: Professor Geng Jia, Affiliated Hospital of Chengdu University; Doctor of Neurology, Affiliated Hospital of Chengdu University; Associate Professor, Master's Tutor; Youth Committee, Neuromodulation Committee, Chinese Medical Doctor Association; Member, Cognitive Disorder Branch, Chinese Geriatrics Association; Member, Yunnan Provincial Hospital, China Association for Prevention and Treatment of Alzheimer's Disease Member and Secretary of the Professional Committee of Neurology Management of the Association Member and Secretary of the Stroke Prevention and Control Committee of the Yunnan Preventive Medicine Association Member and Secretary of the Hyperbaric Oxygen Branch of the Yunnan Medical Association Member of the Duke University Medical Center Visiting scholar presided over 1 National Natural Science Foundation project and participated in 2 projects Presided over and participated in a number of applied basic research in Yunnan Province, published 10 SCI papers as the first or corresponding author, and trained the subject (neurology direction) of Yunnan Province Medical Discipline Leaders.
Third Prize of Yunnan Province Science and Technology Progress Reference Materials: [1]Jelcic I, Al Nimer F,Wang J,et al.
Memory B cells activate brain-homing,autoreactive CD4+T cells in multiple sclerosis[J].
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e23.
[2], Guo Li.
Clinical research progress of teriflunomide in the treatment of multiple sclerosis[J].
Chinese Journal of Nervous and Mental Diseases,2018,44(08):504-508.
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[J].
The Medical journal of Malaysia,2008,63(5).
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[J].
Neurologia(Barcelona,Spain),2020.
[ 5]Chong HT,Li PC,Ong B,et al.
Severe spinal cord involvement is a universal featureof Asians with multiple sclerosis:A joint Asian study[J].
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[6]Chong HT,Ramli N,Lee KH,et al.
Magnetic resonance imaging of Asians with multiple sclerosis was similar to that of the West[J].
Canadian journal of neurological sciences,2006,33(1):95-100 .
[7]Qiu W,Huang DH,Hou SF,et al.
Efficacy and Safety of Teriflunomide in Chinese Patients with Relapsing Forms of Multiple Sclerosis:A Subgroup Analysis of the Phase 3 TOWER Study[J].
Chin Med J(Engl) .
2018 Dec 5;131(23):2776-2784.
[8]Confavreux C,O'Connor P,Comi G,et al.
Oral teriflunomide for patients with relapsing multiple sclerosis(TOWER):a randomised,double-blind, placebo-controlled,phase 3 trial[J].
The Lancet Neurology,2014,13(3):247-256.
[9],.
Clinical characteristics and teriflunomide in patients with multiple sclerosis viewed from statistics The efficacy analysis of the Chinese Medical Association.
The 23rd National Neurology Branch of the Chinese Medical Association.
[10] Effectiveness and safety of teriflunomide in patients with multiple sclerosis: a real-world study from West China hospital, China.
ISPOR 2021.
[11 ]Coyle PK,Khatri B,Edwards KR,et al.
Patient-reported outcomes in relapsing forms of MS:Real-world,global treatment experience with teriflunomide from the Teri-PRO study[J].
Mult Scler Relat Disord.
2017 Oct;17:107- 115.
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Sanofi does not recommend using this product in any way that is inconsistent with the prescription information approved by your country.