Real-World Analysis of Clinical Characteristics, Treatment Patterns, and Patient-Reported Outcomes of Insufficient Responders and Responders to Prescribed Acute Migraine Treatment in China

Zhang, Lei; Novick, Diego; Zhong, Shiying; Li, Jinnan; Walker, Chloe J.; Harrison, Lewis; Jackson, James; Barlow, Sophie; Cotton, S

doi:10.1007/s40122-023-00494-1

Cited by 3 publications

(2 citation statements)

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“…In a retrospective study of 1453 adults with migraine at a headache treatment center in China, 6.5% (n = 240) met diagnostic criteria for MOH [29]. Finally, many patients respond poorly to these acute therapies; studies in China estimate that more than 40% of patients have insufficient response to acute treatment [8,30]. Insufficient response can lead to dissatisfaction with treatment and is a risk factor for transformation of episodic migraine to chronic migraine [31].…”

Section: Introductionmentioning

confidence: 99%

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Rimegepant orally disintegrating tablet 75 mg for acute treatment of migraine in adults from China: a subgroup analysis of a double-blind, randomized, placebo-controlled, phase 3 clinical trial

Yu,

Guo,

Wang

et al. 2024

J Headache Pain

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Background Rimegepant orally disintegrating tablet (ODT), an oral small-molecule calcitonin gene-related peptide receptor antagonist, is indicated for acute and preventive treatment of migraine in the United States and other countries. Previously, a large clinical trial assessed the efficacy and safety of rimegepant ODT 75 mg for the acute treatment of migraine in adults living in China or South Korea. A post hoc subgroup analysis of this trial was performed to evaluate the efficacy and safety of rimegepant for acute treatment of migraine in adults living in China. Methods Eligible participants were ≥ 18 years of age and had a ≥ 1-year history of migraine, with 2 to 8 attacks of moderate or severe pain intensity per month and < 15 headache days per month during the 3 months before screening. Participants self-administered rimegepant ODT 75 mg or matching placebo to treat a single migraine attack of moderate or severe pain intensity. The co-primary endpoints were pain freedom and freedom from the most bothersome symptom (MBS) at 2 h post-dose. Key secondary endpoints included pain relief at 2 h post-dose, ability to function normally at 2 h post-dose, use of rescue medication within 24 h post-dose, and sustained pain freedom from 2 to 24 h and 2 to 48 h post-dose. All p values were nominal. Safety was assessed via treatment-emergent adverse events (TEAEs), electrocardiograms, vital signs, and routine laboratory tests. Results Overall, 1075 participants (rimegepant, n = 538; placebo, n = 537) were included in the subgroup analysis. Rimegepant was more effective than placebo for the co-primary endpoints of pain freedom (18.2% vs. 10.6%, p = 0.0004) and freedom from the MBS (48.0% vs. 31.8%, p < 0.0001), as well as all key secondary endpoints. The incidence of TEAEs was comparable between the rimegepant (15.2%) and placebo (16.4%) groups. No signal of drug-induced liver injury was observed, and no study drug-related serious TEAEs were reported in the rimegepant group. Conclusions A single dose of rimegepant 75 mg rimegepant was effective for the acute treatment of migraine in adults living in China, with safety and tolerability similar to placebo. Trial registration Clinicaltrials.gov NCT04574362 Date registered: 2020-10-05. Graphical Abstract

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Section: Introductionmentioning

confidence: 99%

“…Insufficient response can lead to dissatisfaction with treatment and is a risk factor for transformation of episodic migraine to chronic migraine [31]. Thus, there is a clear unmet need in China for safe and effective acute treatments for migraine [8,30,32].…”

Section: Introductionmentioning

confidence: 99%

Rimegepant orally disintegrating tablet 75 mg for acute treatment of migraine in adults from China: a subgroup analysis of a double-blind, randomized, placebo-controlled, phase 3 clinical trial

Yu,

Guo,

Wang

et al. 2024

J Headache Pain

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First real-world study on the effectiveness and tolerability of rimegepant for acute migraine therapy in Chinese patients

Yang,

Wang,

Niu

et al. 2024

J Headache Pain

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Background Rimegepant, a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist, is indicated for acute and preventive migraine treatment in the United States and other countries. However, there is a lack of prospective real-world evidence for the use of rimegepant in Chinese migraine patients. Methods This was a single-arm, prospective, real-world study. While taking rimegepant to treat migraine attacks as needed, eligible participants were asked to record their pain intensity, functional ability, and accompanying symptoms for a single attack at predose and 0.5, 1, 2, 24, and 48 h postdose via a digital platform. Adverse events (AEs) during the rimegepant treatment period were recorded and analysed. The percentages of participants who experienced moderate to severe pain at predose and 0.5, 1, 2, 24, and 48 h postdose were assessed. Additionally, the percentages of participants who reported better/good outcomes in terms of pain intensity, functional ability, and accompanying symptoms at 0.5, 1, 2, 24, and 48 h postdose were analysed. In addition, the total cohort (full population, FP) was stratified into a prior nonresponder (PNR) group to observe the effectiveness and safety of rimegepant for relatively refractory migraine and a rimegepant and eptinezumab (RE) group to observe the effectiveness and safety of the combination of these drugs. Results By November 24th, 2023, 133 participants (FP, n = 133; PNR group, n = 40; RE group, n = 28) were enrolled, and 99 participants (FP, n = 99; PNR group, n = 30; RE group, n = 23) were included in the analysis. Rimegepant was effective in treating migraine in the FP and both subgroups, with a significant decreasing trend in the percentages of participants experiencing moderate to severe pain postdose (p < 0.05) and a marked increase in the percentages of participants who reported better/good outcomes in terms of pain intensity, functional ability, and accompanying symptoms at 0.5, 1, 2, 24, and 48 h postdose compared with predose. AEs were reported by 6% of participants in the FP, and all AEs were mild. Conclusions In the real world, rimegepant is effective in the acute treatment of migraine patients in China. The low incidence rate of AEs highlighted the favourable tolerability profile of rimegepant. Trial registration Clinicaltrials.gov NCT05709106. Retrospectively registered on 2023-02-01. Graphical Abstract

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Modulating oxidative stress and neurogenic inflammation: the role of topiramate in migraine treatment

Chen,

Meng,

2024

Front. Aging Neurosci.

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Migraine is a chronic, recurrent neurovascular disorder characterized by episodes closely associated with neurovascular hypersensitivity. Oxidative stress can worsen the hypersensitive state of the central nervous system, which in turn can trigger pro-inflammatory factors that result in neurogenic inflammation. Topiramate is frequently used as a preventative measure for migraines, but there is currently little empirical data to support its efficacy through pathways related to neurogenic inflammation and oxidative stress. This review provides an overview of current knowledge regarding the etiology, inducements, pathophysiology, and available treatments for migraine, with a focus on the clinical and experimental evidence of neurogenic inflammation and oxidative stress in migraine. It also delves into the antioxidant and anti-inflammatory qualities of topiramate, clarifying the possible ways in which topiramate affects these pathways to lessen migraine symptoms.

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Real-World Analysis of Clinical Characteristics, Treatment Patterns, and Patient-Reported Outcomes of Insufficient Responders and Responders to Prescribed Acute Migraine Treatment in China

Cited by 3 publications

References 39 publications

Rimegepant orally disintegrating tablet 75 mg for acute treatment of migraine in adults from China: a subgroup analysis of a double-blind, randomized, placebo-controlled, phase 3 clinical trial

Rimegepant orally disintegrating tablet 75 mg for acute treatment of migraine in adults from China: a subgroup analysis of a double-blind, randomized, placebo-controlled, phase 3 clinical trial

First real-world study on the effectiveness and tolerability of rimegepant for acute migraine therapy in Chinese patients

Modulating oxidative stress and neurogenic inflammation: the role of topiramate in migraine treatment

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