A Controlled Trial of Erenumab for Episodic Migraine

Goadsby, PJ; Reuter, Uwe; Hallström, Yngve; Broessner, Gregor; Bonner, Jo; Zhang, Feng; Sapra, Sandhya; Picard, Hernàn; Mikol, Daniel D.; Lenz, Robert

doi:10.1056/nejmoa1705848

Cited by 762 publications

(1,036 citation statements)

References 27 publications

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“…In previous global studies in episodic migraine, 7,9,10 erenumab 70 mg led to statistically significant improvements in multiple outcome measures, whereas improvements with 21 and 7 mg monthly doses were not statistically significant. In previous global studies in episodic migraine, 7,9,10 erenumab 70 mg led to statistically significant improvements in multiple outcome measures, whereas improvements with 21 and 7 mg monthly doses were not statistically significant.…”

Section: Methodsmentioning

confidence: 67%

“…9 Because the Japanese population had a lower body mass index than the global study population (22.0 vs 27.2 kg/m 2 ), this finding is likely attributable to differences in erenumab exposure between the 2 populations. In the global STRIVE study, however, maximal efficacy was observed with the 140-mg dose.…”

Section: Discussionmentioning

confidence: 97%

“…[7][8][9][10] Erenumab has also demonstrated efficacy in the prevention of chronic migraine, 11 including patients who had failed previous preventive migraine treatments. To date, 3 global, randomized, double-blind, placebo-controlled, clinical studies have demonstrated the efficacy of erenumab in the prevention of episodic migraine, including patients who had failed previous preventive migraine treatments.…”

Section: Introductionmentioning

confidence: 99%

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

Sakai

Takeshima

Tatsuoka³

et al. 2019

Headache

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Objective.-A phase 2, double-blind, placebo-controlled study to evaluate the efficacy and safety of erenumab for the prevention of episodic migraine in Japanese patients was conducted.Background.-Previous global clinical studies have demonstrated the efficacy of erenumab in the prevention of migraine.Methods.-Patients were randomized to placebo or erenumab 28, 70, or 140 mg administered subcutaneously once per month for 6 months. The primary endpoint was change from baseline in mean monthly migraine days over months 4-6 of the double-blind treatment phase. Secondary endpoints included the proportion of patients achieving ≥50% reduction from baseline in mean monthly migraine days (≥50% response) and change from baseline in mean monthly acute migraine-specific medication treatment days (MSMD) and mean Headache Impact Test (HIT-6™) scores. Efficacy outcomes were also determined at months 1, 2, and 3.Results.-Four hundred and seventy five patients were randomized 2:1:2:2 to placebo and erenumab 28, 70, and 140 mg, respectively. Greater reductions in monthly migraine days were observed for erenumab vs placebo with differences of -1.25 (95% CI: -2.10 to -0.41; P = .004), -2.31 (95% CI: -3.00 to -1.62; P < .001), and -1.89 (95% CI: -2.58 to -1.20; P < .001) days for erenumab 28, 70, and 140 mg. The odds of having a ≥50% response were 3.2, 5.6, and 4.7 times greater for erenumab 28 mg (95% CI: 1.30-7.88; P = .009), 70 mg (95% CI: 2.60-12.06; P < .001), and 140 mg (95% CI: 2.24-9.99; P < .001) than for placebo. Greater reductions from baseline in mean acute monthly MSMD were observed for erenumab vs placebo with differences of -1.07 (95% CI: -1.80 to -0.35; P = .004), -2.07 (95% CI: -2.66 to -1.49; P < .001), and -2.04 (95% CI: -2.63 to -1.45; P < .001) days for erenumab 28, 70, and 140 mg. Erenumab 70 and 140 mg also resulted in greater improvements in HIT-6™ scores. The safety profile was similar across treatment groups. The most common adverse event was nasopharyngitis, which occurred in 29.4% of patients in the placebo group and 28.9%-33.3% of patients in the erenumab groups.Conclusion.-Monthly subcutaneous injections of erenumab 70 mg demonstrated statistically significant and numerically maximal efficacy with a favorable safety profile, suggesting that erenumab is a potential new therapy for migraine prevention in Japan.This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Section: Methodsmentioning

confidence: 67%

Section: Discussionmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 99%

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

Sakai

Takeshima

Tatsuoka³

et al. 2019

Headache

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“…shown placebo-like tolerability and good efficacy to date. [7][8][9] There is reason to expect that these safe, effective and tolerable migrainespecific investigational drugs may be a viable new option for migraine patients in the near future.…”

Section: Q: What Is the Discontinuation Rate For Preventative Treatment?mentioning

confidence: 99%

Preventative Therapies for Migraine

Reuter¹

2017

European Neurological Review

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“…Existing preventive treatments are not effective for everyone, and some are poorly tolerated. Although trials of CGRP mAbs reported a modest reduction in days with migraine per month compared with placebo, the treatments had few adverse effects 2345…”

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confidence: 99%