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Novartis recently announced that the Phase 3 study of Aimovig® (Erenumab) DRAGON has achieved positive results and reached its primary endpoint
.
The DRAGON study aims to evaluate the effectiveness and safety of Erenumab in the preventive treatment of chronic migraine in adults.
The study population is mainly Chinese
.
The results of the DRAGON study are highly consistent with previous key studies and the results of the Asian-centered EMPOWER study
.
The DRAGON study is an Asia-centered, multi-center, prospective, randomized, double-blind, placebo-controlled Phase 3 study
.
A total of 557 chronic migraine patients aged 18 to 65 were enrolled in this study, mainly Chinese
.
In this study, adult subjects with chronic migraine received subcutaneous injection of Erenumab 70 mg or placebo once a month to evaluate the effectiveness and safety of Erenumab in the preventive treatment of adult chronic migraine
.
Research data showed that in the last 4 weeks of the 12-week double-blind treatment period, the Erenumab 70mg group was significantly better than the placebo group in reducing the number of migraine days per month (MMD) efficacy endpoint (primary endpoint) compared to baseline
.
In addition, the number of migraine days per month in the Erenumab 70mg group was reduced by more than 50% compared with baseline, and the response rate was significantly higher than that in the placebo group
.
The DRAGON study also showed that Erenumab was safe and well tolerated, similar to the placebo group, and no new safety issues were found
.
The results of the DRAGON study are highly consistent with previous key studies and the results of the Asian-centered EMPOWER study
.
Expert comment: Professor Yu Shengyuan, DRAGON China Project Group, Principal Investigator (PI), Director, Professor, Department of Neurology, Chinese People's Liberation Army General Hospital, Ph.
D.
Supervisor, Chairman, Chinese Medical Doctor Association, Neurologist Branch, Chinese Medical Association Pain Branch, Former Chairman, International Headache Society (IHS) Director, International Headache Society China Branch Chairman Migraine is a primary headache disease characterized by moderate to severe headache attacks, reversible neurological symptoms and systemic symptoms
.
Migraine causes great troubles to the normal life and work of patients, and it also causes great economic burden to the society
.
At present, there is still a lack of specific therapeutic drugs for migraine prevention in China, and a large number of patients have to suffer from migraine all year round
.
As the world's first approved calcitonin gene-related peptide (CGRP) pathway monoclonal antibody drug, Erenumab has a new mechanism of action.
The DRAGON study has confirmed that Erenumab can significantly reduce the number of migraine days per month for the main chronic migraine population in China (MMD), the safety tolerance is similar to placebo
.
I hope that it can be introduced into China as soon as possible in the future to provide new solutions for Chinese migraine patients
.
About Erenumab Erenumab is the world's first approved drug for the preventive treatment of migraine that blocks CGRP receptors that play a key role in migraine
.
1
Erenumab is a fully human monoclonal antibody drug that can bind to the CGRP receptor and antagonize the function of the CGRP receptor related to the key pathological mechanism of migraine to achieve the curative effect of preventing migraine
.
Erenumab is self-administered by the patient using an auto-injector once a month without a loading dose1
.
As the only CGRP receptor monoclonal antibody, Erenumab has been confirmed in a number of large, global, randomized, double-blind, and controlled studies for its safety and effectiveness in preventing migraine 2
.
About migraine migraine is a common chronic neurovascular disease.
Its condition is characterized by recurrent, pulsating severe headache on one or both sides, and it mostly occurs on the side of the head, and is accompanied by nausea, vomiting and light exposure.
, Sound and odor sensitivity 3
.
Migraine attacks mostly occur in children and adolescence.
The incidence peaks in young and middle-aged.
Women are significantly higher than men.
It is the second leading cause of disability and loss of healthy life years worldwide4
.
According to a large-scale national epidemiological survey, there are approximately 130 million migraine sufferers in China, causing a huge disease burden of 5.
5 million disabled years of healthy life (YLD) in China5.
China is a global migraine sufferer.
The country with the largest number of people
.
This epidemiological survey showed that 86.
3% of migraine patients reported moderate to severe headaches; 9.
5% of patients had headaches ≥15 days per month; 54.
7% of patients had migraines at least one day a month; 38% of patients Reported a moderate to severe HALT classification (headache-attribute lost time, that is, loss of work, life, and study time within 3 months due to headache)6
.
At the same time, migraine brings a huge economic burden to society, causing annual economic losses of 33.
17 million yuan, accounting for 1.
1% of the country's total GDP that year, of which the economic loss caused by migraine-induced productivity loss is 27.
37 million yuan7
.
Therefore, there is a huge demand for drugs in the field of migraine treatment in China under the currently available therapeutic drug options8
.
Standard preventive treatment can effectively improve the treatment effect in the acute phase, reduce the frequency and extent of attacks, and reduce the social damage of patients
.
References: 1.
Aimovig | European Medicines Agency (europa.
eu) 2.
Sacco Simona, Bendtsen Lars, Ashia Messoud, et al.
The Journal of Headache and Pain, 2019, 20(1) 3.
Guidelines for the prevention and treatment of migraine in China , Chinese Journal of Pain Medicine 2016,22(10).
4.
Steiner TJ, Stovner LJ, Vos T, et al.
J Headache Pain.
2018;19(1):17.
5.
Chengye Yao, Yu Wang, Lijun Wang, et al.
The Journal of Headache and Pain (2019) 20:102.
6.
Ruozhuo Liu, Shengyuan Yu, Mianwang He, et al.
The Journal of Headache and Pain 2013, 14:47.
7.
Shengyuan Yu, Ruozhuo Liu,Gang Zhao, et al.
Headache 2012;52:582-591.
8.
Shengyuan Yu, Yanlei Zhang, Yuan Yao and Haijun Cao.
The Journal of Headache and Pain (2020) 21:53.
.
The DRAGON study aims to evaluate the effectiveness and safety of Erenumab in the preventive treatment of chronic migraine in adults.
The study population is mainly Chinese
.
The results of the DRAGON study are highly consistent with previous key studies and the results of the Asian-centered EMPOWER study
.
The DRAGON study is an Asia-centered, multi-center, prospective, randomized, double-blind, placebo-controlled Phase 3 study
.
A total of 557 chronic migraine patients aged 18 to 65 were enrolled in this study, mainly Chinese
.
In this study, adult subjects with chronic migraine received subcutaneous injection of Erenumab 70 mg or placebo once a month to evaluate the effectiveness and safety of Erenumab in the preventive treatment of adult chronic migraine
.
Research data showed that in the last 4 weeks of the 12-week double-blind treatment period, the Erenumab 70mg group was significantly better than the placebo group in reducing the number of migraine days per month (MMD) efficacy endpoint (primary endpoint) compared to baseline
.
In addition, the number of migraine days per month in the Erenumab 70mg group was reduced by more than 50% compared with baseline, and the response rate was significantly higher than that in the placebo group
.
The DRAGON study also showed that Erenumab was safe and well tolerated, similar to the placebo group, and no new safety issues were found
.
The results of the DRAGON study are highly consistent with previous key studies and the results of the Asian-centered EMPOWER study
.
Expert comment: Professor Yu Shengyuan, DRAGON China Project Group, Principal Investigator (PI), Director, Professor, Department of Neurology, Chinese People's Liberation Army General Hospital, Ph.
D.
Supervisor, Chairman, Chinese Medical Doctor Association, Neurologist Branch, Chinese Medical Association Pain Branch, Former Chairman, International Headache Society (IHS) Director, International Headache Society China Branch Chairman Migraine is a primary headache disease characterized by moderate to severe headache attacks, reversible neurological symptoms and systemic symptoms
.
Migraine causes great troubles to the normal life and work of patients, and it also causes great economic burden to the society
.
At present, there is still a lack of specific therapeutic drugs for migraine prevention in China, and a large number of patients have to suffer from migraine all year round
.
As the world's first approved calcitonin gene-related peptide (CGRP) pathway monoclonal antibody drug, Erenumab has a new mechanism of action.
The DRAGON study has confirmed that Erenumab can significantly reduce the number of migraine days per month for the main chronic migraine population in China (MMD), the safety tolerance is similar to placebo
.
I hope that it can be introduced into China as soon as possible in the future to provide new solutions for Chinese migraine patients
.
About Erenumab Erenumab is the world's first approved drug for the preventive treatment of migraine that blocks CGRP receptors that play a key role in migraine
.
1
Erenumab is a fully human monoclonal antibody drug that can bind to the CGRP receptor and antagonize the function of the CGRP receptor related to the key pathological mechanism of migraine to achieve the curative effect of preventing migraine
.
Erenumab is self-administered by the patient using an auto-injector once a month without a loading dose1
.
As the only CGRP receptor monoclonal antibody, Erenumab has been confirmed in a number of large, global, randomized, double-blind, and controlled studies for its safety and effectiveness in preventing migraine 2
.
About migraine migraine is a common chronic neurovascular disease.
Its condition is characterized by recurrent, pulsating severe headache on one or both sides, and it mostly occurs on the side of the head, and is accompanied by nausea, vomiting and light exposure.
, Sound and odor sensitivity 3
.
Migraine attacks mostly occur in children and adolescence.
The incidence peaks in young and middle-aged.
Women are significantly higher than men.
It is the second leading cause of disability and loss of healthy life years worldwide4
.
According to a large-scale national epidemiological survey, there are approximately 130 million migraine sufferers in China, causing a huge disease burden of 5.
5 million disabled years of healthy life (YLD) in China5.
China is a global migraine sufferer.
The country with the largest number of people
.
This epidemiological survey showed that 86.
3% of migraine patients reported moderate to severe headaches; 9.
5% of patients had headaches ≥15 days per month; 54.
7% of patients had migraines at least one day a month; 38% of patients Reported a moderate to severe HALT classification (headache-attribute lost time, that is, loss of work, life, and study time within 3 months due to headache)6
.
At the same time, migraine brings a huge economic burden to society, causing annual economic losses of 33.
17 million yuan, accounting for 1.
1% of the country's total GDP that year, of which the economic loss caused by migraine-induced productivity loss is 27.
37 million yuan7
.
Therefore, there is a huge demand for drugs in the field of migraine treatment in China under the currently available therapeutic drug options8
.
Standard preventive treatment can effectively improve the treatment effect in the acute phase, reduce the frequency and extent of attacks, and reduce the social damage of patients
.
References: 1.
Aimovig | European Medicines Agency (europa.
eu) 2.
Sacco Simona, Bendtsen Lars, Ashia Messoud, et al.
The Journal of Headache and Pain, 2019, 20(1) 3.
Guidelines for the prevention and treatment of migraine in China , Chinese Journal of Pain Medicine 2016,22(10).
4.
Steiner TJ, Stovner LJ, Vos T, et al.
J Headache Pain.
2018;19(1):17.
5.
Chengye Yao, Yu Wang, Lijun Wang, et al.
The Journal of Headache and Pain (2019) 20:102.
6.
Ruozhuo Liu, Shengyuan Yu, Mianwang He, et al.
The Journal of Headache and Pain 2013, 14:47.
7.
Shengyuan Yu, Ruozhuo Liu,Gang Zhao, et al.
Headache 2012;52:582-591.
8.
Shengyuan Yu, Yanlei Zhang, Yuan Yao and Haijun Cao.
The Journal of Headache and Pain (2020) 21:53.
