TY - JOUR
T1 - Effect of erenumab on the reversion from chronic migraine to episodic migraine in an Asian population
T2 - A post hoc analysis of the DRAGON study
AU - Wang, Shuu Jiun
AU - Kim, Byung Kun
AU - Wang, Hebo
AU - Zhou, Jiying
AU - Wan, Qi
AU - Yu, Tingmin
AU - Lian, Yajun
AU - Arkuszewski, Michal
AU - Ecochard, Laurent
AU - Snellman, Josefin
AU - Wen, Shihua
AU - Yin, Fangfang
AU - Li, Zheng
AU - Su, Wendy
AU - Yu, Shengyuan
N1 - Publisher Copyright:
© 2024 American Headache Society.
PY - 2024
Y1 - 2024
N2 - Background: Erenumab is a fully human monoclonal antibody that selectively targets the calcitonin gene–related peptide receptor. It has been proven to be safe and efficacious in patients with episodic migraine (EM) and chronic migraine (CM) as demonstrated in phase 2 and 3 clinical trials including patients from Europe, Japan, and the United States. Reversion from CM to EM, as indicated by a reduction in the frequency of headache days, is an important indicator for efficacy outcome, though it has not been analyzed widely in patients with CM to date. Objective: Primary results of the DRAGON study demonstrated the efficacy and safety of erenumab in patients with CM from China and other Asian countries. This post hoc analysis evaluated the rate of reversion from CM to EM in the overall population and in subgroups of patients defined by baseline demographic and clinical characteristics (age, body mass index, gender, prior preventive treatment failure, medication overuse status, and disease duration). Methods: Reversion from CM to EM was defined as a reduction in headache frequency to < 45 headache days over the 12 weeks of the double-blind treatment period. In addition, migraine-related disability and disease impact on functional impairment were assessed within each treatment group in reverters and non-reverters using the Headache Impact Test-6 (HIT-6), Migraine Physical Function Impact Diary (MPFID), and modified Migraine Disability Assessment (mMIDAS). Results: Overall, 557 patients with CM were randomized to monthly erenumab 70 mg (n = 279) or placebo (n = 278), of whom 52.3% (146 of 279) treated with erenumab reverted from CM to EM compared to 41.0% (114 of 278) in the placebo group (odds ratio [OR] 1.59, 95% confidence interval: 1.1–2.2; p = 0.007). Treatment with erenumab resulted in a greater mean change (standard error) from baseline in the HIT-6 total score for reverters versus non-reverters compared to placebo (erenumab: −9.5 [0.6] vs. −5.1 [0.5]; placebo: −8.9 [0.7] vs. −4.9 [0.5]). A similar pattern was observed for mMIDAS score in erenumab treatment groups versus placebo (erenumab: −22.1 [1.2] vs. −6.3 [1.8]; placebo: −19.9 [1.3] vs. −7.9 [1.6]). Substantial improvements were reported in MPFID-Physical Impairment (PI) and Everyday Activities (EA) scores in reverters versus non-reverters in erenumab treatment groups (MPFID-PI: −5.9 [0.3] vs. −1.9 [0.6]; MPFID-EA: −7.9 [0.4] vs. −3.4 [0.6]) and in placebo (MPFID-PI: −5.4 [0.4] vs. −1.0 [0.5]; MPFID-EA: −7.1 [0.5] vs. −3.2 [0.5]). Conclusions: This analysis demonstrated that a greater proportion of patients treated with erenumab reverted from CM to EM compared to patients treated with placebo. The reversion from CM to EM was reflected by the greater improvements in patient-reported outcomes in the erenumab group.
AB - Background: Erenumab is a fully human monoclonal antibody that selectively targets the calcitonin gene–related peptide receptor. It has been proven to be safe and efficacious in patients with episodic migraine (EM) and chronic migraine (CM) as demonstrated in phase 2 and 3 clinical trials including patients from Europe, Japan, and the United States. Reversion from CM to EM, as indicated by a reduction in the frequency of headache days, is an important indicator for efficacy outcome, though it has not been analyzed widely in patients with CM to date. Objective: Primary results of the DRAGON study demonstrated the efficacy and safety of erenumab in patients with CM from China and other Asian countries. This post hoc analysis evaluated the rate of reversion from CM to EM in the overall population and in subgroups of patients defined by baseline demographic and clinical characteristics (age, body mass index, gender, prior preventive treatment failure, medication overuse status, and disease duration). Methods: Reversion from CM to EM was defined as a reduction in headache frequency to < 45 headache days over the 12 weeks of the double-blind treatment period. In addition, migraine-related disability and disease impact on functional impairment were assessed within each treatment group in reverters and non-reverters using the Headache Impact Test-6 (HIT-6), Migraine Physical Function Impact Diary (MPFID), and modified Migraine Disability Assessment (mMIDAS). Results: Overall, 557 patients with CM were randomized to monthly erenumab 70 mg (n = 279) or placebo (n = 278), of whom 52.3% (146 of 279) treated with erenumab reverted from CM to EM compared to 41.0% (114 of 278) in the placebo group (odds ratio [OR] 1.59, 95% confidence interval: 1.1–2.2; p = 0.007). Treatment with erenumab resulted in a greater mean change (standard error) from baseline in the HIT-6 total score for reverters versus non-reverters compared to placebo (erenumab: −9.5 [0.6] vs. −5.1 [0.5]; placebo: −8.9 [0.7] vs. −4.9 [0.5]). A similar pattern was observed for mMIDAS score in erenumab treatment groups versus placebo (erenumab: −22.1 [1.2] vs. −6.3 [1.8]; placebo: −19.9 [1.3] vs. −7.9 [1.6]). Substantial improvements were reported in MPFID-Physical Impairment (PI) and Everyday Activities (EA) scores in reverters versus non-reverters in erenumab treatment groups (MPFID-PI: −5.9 [0.3] vs. −1.9 [0.6]; MPFID-EA: −7.9 [0.4] vs. −3.4 [0.6]) and in placebo (MPFID-PI: −5.4 [0.4] vs. −1.0 [0.5]; MPFID-EA: −7.1 [0.5] vs. −3.2 [0.5]). Conclusions: This analysis demonstrated that a greater proportion of patients treated with erenumab reverted from CM to EM compared to patients treated with placebo. The reversion from CM to EM was reflected by the greater improvements in patient-reported outcomes in the erenumab group.
KW - Asia
KW - calcitonin gene–related peptide
KW - erenumab
KW - migraine
KW - patient-reported outcomes
KW - reversion rate
UR - http://www.scopus.com/inward/record.url?scp=85194356599&partnerID=8YFLogxK
U2 - 10.1111/head.14733
DO - 10.1111/head.14733
M3 - Article
C2 - 38785393
AN - SCOPUS:85194356599
SN - 0017-8748
JO - Headache
JF - Headache
ER -