A Randomized Phase 2 Study of Erenumab for the Prevention of Episodic Migraine in Japanese Adults

Sakai, Fumihiko; Takeshima, Takao; Tatsuoka, Yoshihisa; Hirata, Koichi; Lenz, Robert; Wang, Yi; Cheng, Sunfa; Hirama, Toshiyasu; Mikol, Daniel D.

doi:10.1111/head.13652

Cited by 61 publications

(99 citation statements)

References 22 publications

(47 reference statements)

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“…The exploratory and post hoc analyses of the STRIVE pivotal clinical trial data presented here corroborate previous analyses on the efficacy of erenumab as a preventive treatment in EM 9‐14,23 and provide context for understanding the spectrum of response to erenumab. Erenumab has shown efficacy across a variety of response thresholds, from the standard ≥50% threshold 10 to the stricter ≥75% and 100% thresholds also presented here.…”

Section: Discussionsupporting

confidence: 76%

The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving ≥50%, ≥75%, and 100% Response

et al. 2020

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Objective.-To assess the efficacy of erenumab at the ≥50%, ≥75%, and 100% reduction in monthly migraine days (MMD) response thresholds, using data from the 6-month double-blind treatment phase (DBTP) of the Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention (STRIVE) pivotal clinical trial. Methods.-Enrolled patients with episodic migraine (EM; ≥4 MMD and <15 monthly headache days) were randomized (1:1:1) to erenumab 70 mg (n = 312), erenumab 140 mg (n = 318), or placebo (n = 316) once monthly. We determined the proportions of patients with ≥50%, ≥75% and 100% reduction in MMD over the last 3 months of the STRIVE DBTP (months 4 through 6) and conducted post hoc analyses to contextualize the treatment benefit in patient subgroups achieving, and not achieving, these response thresholds. Outcome measures included changes in MMD, acute migraine-specific medication days (MSMD), and patient-reported outcomes. Results.-The proportions of patients with a reduction in MMD from baseline were greater for erenumab than for placebo at all response thresholds. As previously reported for the ≥50% response threshold, 135/312 (43.3%) of patients on erenumab 70 mg and 159/318 (50.0%) on erenumab 140 mg responded, vs 84/316 (26.6%) for placebo. At months 4 through 6, 65/312 (20.8%) and 70/318 (22.0%) of those on erenumab 70 mg and erenumab 140 mg, respectively, achieved ≥75% reductions vs 25/316 (7.9%) on placebo. A reduction of 100% response, which required no migraine days over 3 consecutive months based on observed data, was achieved by 10/312 (3.2%) of patients treated with erenumab 70 mg and 16/318 (5.0%) for erenumab 140 mg, vs 9/316 (2.8%) for placebo. At all response thresholds, responders achieved numerically greater reductions in mean MMD and MSMD, and greater improvements in disability than did the overall population; importantly, these remarkable responses were noted early. Meanwhile, 60/312 (19.2%) and 53/318 (16.7%) patients on erenumab 70 and 140 mg, respectively, had no reduction in MMD from baseline in months 4 through 6, compared with 104/316 (32.9%) patients on placebo. Conclusions.-The responses at the ≥50%, ≥75%, and 100% thresholds provide context for establishing realistic patient and physician expectations regarding the magnitude of treatment benefit that may be achieved by patients with EM responding to erenumab (STRIVE, NCT02456740).

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Section: Discussionsupporting

confidence: 76%

The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving ≥50%, ≥75%, and 100% Response

et al. 2020

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“…1 trial included participants with both EM and CM 19 . Our included studies (Table 1) had 14 completed clinical trials in EM, 20–33 6 completed clinical trials studying CM, 34–39 and 1 trial which reported separate outcomes in patients with EM and CM 19 . Of the 21 trials included, data from 1 are unpublished (NCT02959177 Galcanezumab in EM) 32 .…”

Section: Resultsmentioning

confidence: 99%

Efficacy and Contextual (Placebo) Effects of CGRP Antibodies for Migraine: Systematic Review and Meta‐analysis

2020

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Background CGRP Antibodies are high‐cost newly licensed migraine preventatives. Objective To calculate the overall reduction in monthly migraine days and the proportion contextual effect (PCE) using meta‐analysis. The PCE is the ratio between the reduction in Monthly Migraine Days in the placebo group and the reduction in Monthly Migraine Days in the CGRP‐Ab group after 3 months of treatment. Methods Meta‐analysis of randomized double‐blind placebo‐controlled trials of anti‐CGRP antibodies in people with episodic migraine (EM) or chronic migraine (CM) in persons aged 18 or over. Non‐randomized trials and trials in persons under 18 years excluded. Search of National Clinical Trials Register 2000‐2019, MEDLINE to September 2019, Hand search of major headache conference abstract books 2012‐2019. Two investigators used standard proforma to reach consensus. Trial quality assessed using Cochrane Collaboration risk of bias tool. PRISMA guidelines followed. Results 21 completed trials with 13367 participants (8075 EM, 5292 CM). Compared to placebo, pooled reduction in MMD was 1.50 days in 15 EM trials (95%CI 1.16, 1.84; I2 = 69%, Phetereogeneity < .001) and 2.24 days in 7 CM trials (95%CI 1.82, 2.65, I2 = 15%, Phetereogeneity = .320). In EM trials, pooled PCE was 0.66 (95%CI 0.59,0.75; I2 = 64%, Phetereogeneity = .001). In CM trials the PCE was .68 (95%CI 0.61, 0.75; I2 = 20%, Phetereogeneity = .280). Industry funded every study, but risk of bias was low. Conclusions CGRPAbs are effective but sixty‐six percent of the benefit is from contextual effects, including placebo effect. Contextual effects merit further scrutiny as a means of improving migraine headache.

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“…ICHD-3 like criteria and the diagnostic criteria from ICHD-3 are summarized in Supplementary Table 1 . Respondents having migraine without aura (including probable migraine without aura) or migraine with aura (including probable migraine with aura), according to ICHD-3 like criteria and having at least 4 MHDs (at least 4 headache days in the past 30 days) [ 19 – 21 ], were classified as migraine patients in this study. Respondents who reported no experience with migraine were classified as non-migraine respondents.…”

Section: Methodsmentioning

confidence: 99%

Burden of migraine among Japanese patients: a cross-sectional National Health and Wellness Survey

Kohno

Chen²,

Taniguchi³

et al. 2020

J Headache Pain

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Background Limited studies have measured the burden of migraine in Japan. This study aimed at estimating the disease burden of migraine in Japan and identifying factors associated with the burden using the 2017 National Health and Wellness Survey. Methods Migraine patients were defined by ICHD-3 like criteria with ≥4 monthly headache days (MHDs), and non-migraine respondents were selected using 1:4 propensity score matching. Multivariate analyses were conducted to compare Health-related Quality of Life (HRQoL), work productivity and activity impairment (WPAI), healthcare resource utilization (HRU) and costs between the two groups, and to identify factors associated with these outcomes in migraine patients. Results In 30,001 respondents, 378 migraine patients were identified. Compared to matched controls (N = 1512), migraine patients had lower physical (45.17 vs. 49.89), mental (42.28 vs. 47.71) and role/social (37.91 vs. 44.19) component summary scores (p < 0.001). Migraine patients had higher absenteeism (6.4% vs. 2.2%), presenteeism (40.2% vs. 22.5%), total work productivity impairment (44.3% vs. 24.5%), total activity impairment (45.0% vs. 23.9%), indirect costs (1,492,520 JPY vs. 808,320 JPY) and more visits to healthcare providers in the past 6 months (7.23 vs. 3.96) (p < 0.001). More MHDs was associated with worse HRQoL, and higher HRU and indirect costs. Conclusions Japanese migraine patients experience an incremental burden. This demonstrates the unmet needs among Japanese migraine patients.

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A Randomized Phase 2 Study of Erenumab for the Prevention of Episodic Migraine in Japanese Adults

Cited by 61 publications

References 22 publications

The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving ≥50%, ≥75%, and 100% Response

The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving ≥50%, ≥75%, and 100% Response

Efficacy and Contextual (Placebo) Effects of CGRP Antibodies for Migraine: Systematic Review and Meta‐analysis

Burden of migraine among Japanese patients: a cross-sectional National Health and Wellness Survey

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