Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial

Tepper, Stewart J.; Ashina, Messoud; Reuter, Uwe; Brandes, Jan Lewis; Doležil, David; Silberstein, Stephen D.; Winner, Paul; Leonardi, Dean; Mikol, Daniel D.; Lenz, Robert

doi:10.1016/s1474-4422(17)30083-2

Cited by 661 publications

(900 citation statements)

References 35 publications

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“…found that 34/755 patients in mAbs suffered from upper respiratory tract infection and nasopharyngitis, 14/755 patients experienced sinusitis, but there is no significant difference between CGRP mAbs and placebo (Silberstein et al, ). Tepper et al () found that 11/378 patients suffered from upper respiratory tract infection, as compared to 4/282 patients in placebo. And there is no difference in incidence of urinary tract infection.…”

Section: Discussionmentioning

confidence: 99%

“…Approximately 2% of the population occurs chronic migraine, which leads to lower health‐related quality of life and functional impairment as compared with episodic migraine (Bigal et al, ; Silberstein et al, ; Tepper et al, ). Patients with chronic migraine are more likely suffering from be divorced, be unemployed psychological comorbidity, and high risk with acute medication overuse for headache treatment (Bigal et al, ; Silberstein et al, ; Tepper et al, ). The expert opinion suggests that patients with chronic migraine should receive abortive and preventive treatments (Giacomozzi et al, ; Irimia, Carmona‐Abellan, & Martinez‐Vila, ; Lionetto et al, ; Pringsheim et al, ; Puledda, Messina, & Goadsby, ).…”

Section: Introductionmentioning

confidence: 99%

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CGRP monoclonal antibody for preventive treatment of chronic migraine: An update of meta‐analysis

Han

Liu²,

Xiong

et al. 2019

Brain and Behavior

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Background CGRP monoclonal antibody (mAb) is a promising preventive treatment for episodic migraine and has been approved by US FDA recently. But the treatments for chronic migraine are rare. Therefore, we performed meta‐analysis to assess the efficacy and safety of CGRP mAbs in preventing chronic migraine. Methods Database including Cochrane Library and PubMed were systematically searched for randomized controlled trials (RCTs) which are about CGRP mAb in preventing treatment of chronic migraine. Evaluating the bias and quality of RCTs was carried out according to the Cochrane collaboration's tool for assessing risk of bias. The data analysis was carried out by reviewer manager 5.2. Results Totally, 6 articles enrolled in the present meta‐analysis, including 4 independent clinical trials and 3,166 patients. After pooled analysis, it indicated that CGRP mAb improved 50% responder rate (OR = 2.42, 95% CI = [2.04, 2.87], I 2 = 0%, p < 0.00001) and 75% responder rate (OR = 1.95, 95% CI = [1.30, 2.91], I 2 = 0%, p = 0.001), as compared with placebo. And there was no difference in incidence of adverse events between CGRP mAb group and placebo group except incidence of injection site discomfort. Conclusions CGRP mAb is an effective and safety preventive treatment for chronic migraine.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

CGRP monoclonal antibody for preventive treatment of chronic migraine: An update of meta‐analysis

Han

Liu²,

Xiong

et al. 2019

Brain and Behavior

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“…[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%

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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“…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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Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial

Cited by 661 publications

References 35 publications

CGRP monoclonal antibody for preventive treatment of chronic migraine: An update of meta‐analysis

CGRP monoclonal antibody for preventive treatment of chronic migraine: An update of meta‐analysis

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

Preventative Therapies for Migraine

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