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Migraine is a common chronic neurovascular disease.
According to previous research data from the Global Burden of Disease Survey, migraine is the sixth most common disease in humans.
Based on years of life loss (YLDs) caused by disability, migraine is the first Two disabling diseases [1]
.
Migraine not only causes mental distress and economic pressure to the patients themselves, but also creates a great burden on society and medical care
.
Preventive treatment is an important measure to reduce the frequency of migraine attacks and the risk of chronic migraine.
The calcitonin gene-related peptide (CGRP) pathway is a new target for migraine-specific drug treatment that has made important progress in the world in recent years
.
This year’s 20th International Headache Conference (IHC) announced the latest efficacy data of the CGRP receptor monoclonal antibody Erenumab.
Studies have shown that it has significant advantages over the existing traditional preventive treatment drug topiramate in terms of efficacy and tolerability.
The published East Asian population data also showed efficacy and safety consistent with the global population
.
The post-analysis results of the HER-MES study are announced.
Compared with the existing preventive drug topiramate, Erenumab has significant advantages in the efficacy and tolerability of migraine prevention.
As the world's first approved migraine-specific preventive drug acting on the CGRP pathway , Erenumab is a fully human monoclonal antibody, which can specifically bind to the CGRP receptor related to the key pathological mechanism of migraine, thereby exerting the efficacy of preventing migraine
.
The HER-MES study is the only head-to-head randomized controlled study that compares CGRP pathway therapy (Erenumab) with existing therapy (topiramate) to prevent migraine
.
The study showed that compared with topiramate, Erenumab has better tolerance and efficacy in preventing migraine.
.
In order to avoid the impact of compliance issues on the efficacy results, and to further confirm the efficacy of the drugs in patients who adhered to the treatment, the researchers conducted a post-sensitivity analysis of the HER-MES study
.
1.
Research introduction The HER-MES study included a total of 777 cases of episodic migraine or chronic migraine who had not previously received or received 3 or less preventive migraine therapies, and the number of migraine days per month (MMD) ≥ 4 days.
For adult patients with migraine, Erenumab (70mg and 140mg) was compared with the highest tolerated dose (50-100mg/day) of topiramate (Figure 1)
.
Figure 1 Study design II.
Main study results During the study process, 14.
1% and 40.
5% of the patients in the Erenumab group and the topiramate group stopped study drug treatment during the double-blind treatment phase (Table 1)
.
Table 1 Proportion of patients who discontinued study drug treatment during the 24-week double-blind treatment phase.
In the sensitivity analysis, the researchers assumed that all patients tolerate their randomized treatment (Erenumab/topiramate), using multiple imputation, based on observations in the study The curative effect value during the treatment period of the study complements the missing information on the curative effect of patients who discontinued treatment in the study
.
The intention-to-treat analysis was performed in the full analysis set population, preserving the randomness of the study
.
Sensitivity analysis showed that compared with topiramate group, the proportion of patients with MMD reduction ≥50% in Erenumab group was significantly higher (at the first month, 23.
9% vs 39.
3%, OR 2.
06, 95% CI: 1.
49-2.
84, P ＜0.
001; 43.
2% vs 60.
4% at 4-6 months, OR 2.
02, 95% CI: 1.
48-2.
76, P＜0.
001, Figure 2)
.
Figure 2 The proportion of patients whose MMD was reduced by at least 50%.
Compared with the topiramate group, patients in the Erenumab group had a more significant reduction in MMD (-4.
90 days vs -6.
13 days, OR -1.
24, 95% CI: -1.
87--0.
61, P< 0.
001, Figure 3)
.
Figure 3 Changes in MMD from baseline in the last three months (4th, 5th, and 6th months) 3.
Research conclusions The post-mortem analysis of the HER-MES study confirmed that both Erenumab and topiramate have the effect of preventing migraine
.
At the same time, whether it is from the proportion of patients whose MMD is reduced by ≥50%, the number of days of MMD reduction, or the speed of onset (significant advantages starting from the first month), it is proved that Erenumab is a more effective Migraine prevention therapy
.
The sensitivity analysis results further support the conclusions of the HER-MES study, confirming the advantages of Erenumab preventive treatment over topiramate in a wide range of migraine patients
.
EMPOwER study East Asian population subgroup data released-East Asian population efficacy and safety results are consistent with global population Erenumab's safety and effectiveness for episodic migraine and chronic migraine have been in a number of large-scale, global, randomized, and double-blind , It is confirmed in the controlled study
.
However, most of Erenumab's key studies are conducted in North America and Europe, and the data for Asian patients is scarce
.
The EMPOwER study confirmed the efficacy and safety of Erenumab (70mg and 140mg) in Asian, Middle Eastern, and Latin American populations (about 80% of Asian populations)
.
In order to further explore the efficacy and safety of Erenumab in patients with East Asian episodic migraine (EM), the EMPOwER researchers further conducted a subgroup analysis of the patients in Taiwan and South Korea in the study
.
1.
Study design The EMPOwER study is a 12-week, randomized, double-blind, placebo-controlled phase 3 study, which included 900 adult EM patients from 83 research centers in 11 countries in Asia, the Middle East and Latin America.
.
These patients were diagnosed with migraine (with/without aura) for at least 12 months and MMD for 4-15 days
.
In the 4th, 8th and 12th weeks of the double-blind treatment period (DBTP), patients meeting the enrollment criteria were randomized to receive a placebo, Erenumab 70 mg, and Erenumab 140 mg once a month at a ratio of 3:3:2, and received a period of 3.
Months of safety follow-up (Figure 4)
.
Figure 4 Study design II.
Main research results This analysis conducted a subgroup analysis of the subgroup of the Middle East Asian population (Taiwan, South Korea)
.
Among the 385 patients who entered the screening stage, 249 were randomly assigned to the placebo group (n=98), the Erenumab 70 mg group (n=90) or the Erenumab 140 mg group (n=61); the average age of the patients was 40.
4 (± 10.
3) ) Years old, females accounted for 79.
1%, and the average MMD was 7.
94 (2.
39) days
.
At the 3rd month, compared with the placebo group (decreased by 2.
37 days), the Erenumab 70mg group (decreased by 3.
68 days, P=0.
007) and the 140mg group (decreased by 4.
81 days, P<0.
001) reduced the average MMD compared with the baseline The number of days is significantly more, and the advantage is statistically significant (Figure 5)
.
Figure 5 The change in MMD of the three groups of subjects from baseline during 3 months of treatment compared with the placebo group (33.
7%), the Erenumab 70mg group (52.
8%, P=0.
011) and the 140mg group (67.
2%, P<0.
001) ) The proportion of patients with MMD reduction ≥50% is higher (Table 2)
.
Table 2 Changes in the secondary endpoints relative to the baseline at the third month of treatment.
Compared with the placebo group (reduced by 0.
54 days), the Erenumab 70 mg group (reduced by 1.
5 days, P=0.
007) and the 140 mg group (reduced by 2.
36 days, P < 0.
001) monthly migraine-specific acute medication days (MSMD) decreased more than baseline
.
Compared with the placebo group (decreased by 4.
77), the headache impact test questionnaire (HIT-6TM) scores of the Erenumab 70mg group (decreased by 7.
59, P=0.
007) and 140mg group (decreased by 7.
98, P=0.
006) also decreased more, suggesting Significantly improve patient-reported outcomes
.
Safety Overall, the safety of Erenumab in East Asian patients is consistent with that of the global population, and no new safety incidents have occurred
.
Thirty-nine (39.
8%) patients who received placebo, 30 (33.
7%) patients who received Erenumab 70 mg, and 25 (41.
0%) patients who received Erenumab 140 mg reported adverse events during treatment, and Erenumab treatment No serious adverse events or adverse events leading to discontinuation occurred in the group
.
Common adverse events include constipation, dizziness, nasopharyngitis and so on
.
3.
Research conclusions The study proved that the efficacy and safety of Erenumab (70mg and 140mg) in adult EM patients in East Asia (Taiwan, China and South Korea) are consistent with the results of the global population
.
References: 1.
Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016.
Lancet 2017; 390: 1211–1259.
2.
Marc Ehrlich, Monika Maier-Peuschel, et al, Erenumab versus topiramate for the prevention of migraine: Results of a post-hoc efficacy analysis, IHC 2021.
3.
Shuu-Jiun Wang, Byung-Kun Kim, Gabriel Paiva Da Silva Lima, et al, Efficacy and Safety of Erenumab in patients with Episodic Migraine in East Asia: Taiwan and Korea subpopulation analysis of the EMPOwER study, IHC 2021.
According to previous research data from the Global Burden of Disease Survey, migraine is the sixth most common disease in humans.
Based on years of life loss (YLDs) caused by disability, migraine is the first Two disabling diseases [1]
.
Migraine not only causes mental distress and economic pressure to the patients themselves, but also creates a great burden on society and medical care
.
Preventive treatment is an important measure to reduce the frequency of migraine attacks and the risk of chronic migraine.
The calcitonin gene-related peptide (CGRP) pathway is a new target for migraine-specific drug treatment that has made important progress in the world in recent years
.
This year’s 20th International Headache Conference (IHC) announced the latest efficacy data of the CGRP receptor monoclonal antibody Erenumab.
Studies have shown that it has significant advantages over the existing traditional preventive treatment drug topiramate in terms of efficacy and tolerability.
The published East Asian population data also showed efficacy and safety consistent with the global population
.
The post-analysis results of the HER-MES study are announced.
Compared with the existing preventive drug topiramate, Erenumab has significant advantages in the efficacy and tolerability of migraine prevention.
As the world's first approved migraine-specific preventive drug acting on the CGRP pathway , Erenumab is a fully human monoclonal antibody, which can specifically bind to the CGRP receptor related to the key pathological mechanism of migraine, thereby exerting the efficacy of preventing migraine
.
The HER-MES study is the only head-to-head randomized controlled study that compares CGRP pathway therapy (Erenumab) with existing therapy (topiramate) to prevent migraine
.
The study showed that compared with topiramate, Erenumab has better tolerance and efficacy in preventing migraine.
.
In order to avoid the impact of compliance issues on the efficacy results, and to further confirm the efficacy of the drugs in patients who adhered to the treatment, the researchers conducted a post-sensitivity analysis of the HER-MES study
.
1.
Research introduction The HER-MES study included a total of 777 cases of episodic migraine or chronic migraine who had not previously received or received 3 or less preventive migraine therapies, and the number of migraine days per month (MMD) ≥ 4 days.
For adult patients with migraine, Erenumab (70mg and 140mg) was compared with the highest tolerated dose (50-100mg/day) of topiramate (Figure 1)
.
Figure 1 Study design II.
Main study results During the study process, 14.
1% and 40.
5% of the patients in the Erenumab group and the topiramate group stopped study drug treatment during the double-blind treatment phase (Table 1)
.
Table 1 Proportion of patients who discontinued study drug treatment during the 24-week double-blind treatment phase.
In the sensitivity analysis, the researchers assumed that all patients tolerate their randomized treatment (Erenumab/topiramate), using multiple imputation, based on observations in the study The curative effect value during the treatment period of the study complements the missing information on the curative effect of patients who discontinued treatment in the study
.
The intention-to-treat analysis was performed in the full analysis set population, preserving the randomness of the study
.
Sensitivity analysis showed that compared with topiramate group, the proportion of patients with MMD reduction ≥50% in Erenumab group was significantly higher (at the first month, 23.
9% vs 39.
3%, OR 2.
06, 95% CI: 1.
49-2.
84, P ＜0.
001; 43.
2% vs 60.
4% at 4-6 months, OR 2.
02, 95% CI: 1.
48-2.
76, P＜0.
001, Figure 2)
.
Figure 2 The proportion of patients whose MMD was reduced by at least 50%.
Compared with the topiramate group, patients in the Erenumab group had a more significant reduction in MMD (-4.
90 days vs -6.
13 days, OR -1.
24, 95% CI: -1.
87--0.
61, P< 0.
001, Figure 3)
.
Figure 3 Changes in MMD from baseline in the last three months (4th, 5th, and 6th months) 3.
Research conclusions The post-mortem analysis of the HER-MES study confirmed that both Erenumab and topiramate have the effect of preventing migraine
.
At the same time, whether it is from the proportion of patients whose MMD is reduced by ≥50%, the number of days of MMD reduction, or the speed of onset (significant advantages starting from the first month), it is proved that Erenumab is a more effective Migraine prevention therapy
.
The sensitivity analysis results further support the conclusions of the HER-MES study, confirming the advantages of Erenumab preventive treatment over topiramate in a wide range of migraine patients
.
EMPOwER study East Asian population subgroup data released-East Asian population efficacy and safety results are consistent with global population Erenumab's safety and effectiveness for episodic migraine and chronic migraine have been in a number of large-scale, global, randomized, and double-blind , It is confirmed in the controlled study
.
However, most of Erenumab's key studies are conducted in North America and Europe, and the data for Asian patients is scarce
.
The EMPOwER study confirmed the efficacy and safety of Erenumab (70mg and 140mg) in Asian, Middle Eastern, and Latin American populations (about 80% of Asian populations)
.
In order to further explore the efficacy and safety of Erenumab in patients with East Asian episodic migraine (EM), the EMPOwER researchers further conducted a subgroup analysis of the patients in Taiwan and South Korea in the study
.
1.
Study design The EMPOwER study is a 12-week, randomized, double-blind, placebo-controlled phase 3 study, which included 900 adult EM patients from 83 research centers in 11 countries in Asia, the Middle East and Latin America.
.
These patients were diagnosed with migraine (with/without aura) for at least 12 months and MMD for 4-15 days
.
In the 4th, 8th and 12th weeks of the double-blind treatment period (DBTP), patients meeting the enrollment criteria were randomized to receive a placebo, Erenumab 70 mg, and Erenumab 140 mg once a month at a ratio of 3:3:2, and received a period of 3.
Months of safety follow-up (Figure 4)
.
Figure 4 Study design II.
Main research results This analysis conducted a subgroup analysis of the subgroup of the Middle East Asian population (Taiwan, South Korea)
.
Among the 385 patients who entered the screening stage, 249 were randomly assigned to the placebo group (n=98), the Erenumab 70 mg group (n=90) or the Erenumab 140 mg group (n=61); the average age of the patients was 40.
4 (± 10.
3) ) Years old, females accounted for 79.
1%, and the average MMD was 7.
94 (2.
39) days
.
At the 3rd month, compared with the placebo group (decreased by 2.
37 days), the Erenumab 70mg group (decreased by 3.
68 days, P=0.
007) and the 140mg group (decreased by 4.
81 days, P<0.
001) reduced the average MMD compared with the baseline The number of days is significantly more, and the advantage is statistically significant (Figure 5)
.
Figure 5 The change in MMD of the three groups of subjects from baseline during 3 months of treatment compared with the placebo group (33.
7%), the Erenumab 70mg group (52.
8%, P=0.
011) and the 140mg group (67.
2%, P<0.
001) ) The proportion of patients with MMD reduction ≥50% is higher (Table 2)
.
Table 2 Changes in the secondary endpoints relative to the baseline at the third month of treatment.
Compared with the placebo group (reduced by 0.
54 days), the Erenumab 70 mg group (reduced by 1.
5 days, P=0.
007) and the 140 mg group (reduced by 2.
36 days, P < 0.
001) monthly migraine-specific acute medication days (MSMD) decreased more than baseline
.
Compared with the placebo group (decreased by 4.
77), the headache impact test questionnaire (HIT-6TM) scores of the Erenumab 70mg group (decreased by 7.
59, P=0.
007) and 140mg group (decreased by 7.
98, P=0.
006) also decreased more, suggesting Significantly improve patient-reported outcomes
.
Safety Overall, the safety of Erenumab in East Asian patients is consistent with that of the global population, and no new safety incidents have occurred
.
Thirty-nine (39.
8%) patients who received placebo, 30 (33.
7%) patients who received Erenumab 70 mg, and 25 (41.
0%) patients who received Erenumab 140 mg reported adverse events during treatment, and Erenumab treatment No serious adverse events or adverse events leading to discontinuation occurred in the group
.
Common adverse events include constipation, dizziness, nasopharyngitis and so on
.
3.
Research conclusions The study proved that the efficacy and safety of Erenumab (70mg and 140mg) in adult EM patients in East Asia (Taiwan, China and South Korea) are consistent with the results of the global population
.
References: 1.
Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016.
Lancet 2017; 390: 1211–1259.
2.
Marc Ehrlich, Monika Maier-Peuschel, et al, Erenumab versus topiramate for the prevention of migraine: Results of a post-hoc efficacy analysis, IHC 2021.
3.
Shuu-Jiun Wang, Byung-Kun Kim, Gabriel Paiva Da Silva Lima, et al, Efficacy and Safety of Erenumab in patients with Episodic Migraine in East Asia: Taiwan and Korea subpopulation analysis of the EMPOwER study, IHC 2021.
