ARISE: A Phase 3 randomized trial of erenumab for episodic migraine

Dodick, David W.; Ashina, Messoud; Brandes, Jan Lewis; Kudrow, David; Lantéri-Minet, Michel; Осипова, В. В.; Palmer, Kerry; Picard, Hernàn; Mikol, Daniel D.; Lenz, Robert

doi:10.1177/0333102418759786

Cited by 478 publications

(583 citation statements)

References 34 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%

“…[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%

See 1 more Smart Citation

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: 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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“…65 Patients who received erenumab had a −2.9 days change in monthly migraine days (MMD), vs −1.8 days for placebo. 65 Patients who received erenumab had a −2.9 days change in monthly migraine days (MMD), vs −1.8 days for placebo.…”

Section: Cgrp Monoclonal Antibodiesmentioning

confidence: 99%

“…In the phase 3 STRIVE trial, patients with episodic migraine received monthly doses of either 70, 140 mg, or placebo for 6 months. 65,66 There is evidence supporting the use of erenumab as preventive treatment in patients with refractory migraine. There was 50% or greater reduction in mean number of migraine days per month in 43.3% of patients in the 70 mg group and in 50.0% of patients in the 140 mg group (26.6% for placebo).…”

Section: Cgrp Monoclonal Antibodiesmentioning

confidence: 99%

Novel Medications for the Treatment of Migraine

2019

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Objective To describe the new classes of medication for headache management and their roles in clinical practice. Background Calcitonin gene‐related peptide (CGRP) is a key component in the underlying pathophysiology of migraine. Research focused on targeting CGRP for headache treatment has led to the development of entirely new classes of medications – the gepants and the CGRP monoclonal antibodies (mAbs) – for both acute and preventive treatment. A third class, the ditans, is being developed to target the 5‐HT1F receptor to provide acute treatment without vasoconstrictive effects. Methods This article reviews the pathophysiology of migraine that has led to these new pharmacologic developments. Available information from randomized controlled trials, abstracts, press releases, and relevant preclinical studies is summarized for each class of medications. Results At the time of this writing, one ditan has been submitted to the U.S. Food and Drug Administration (FDA) for approval. One gepant is anticipated to be submitted within the first quarter of 2019, and others are in clinical trials. Three CGRP mAbs have been FDA approved and are now available in clinical practice, and a fourth was submitted in the first quarter of 2019. Conclusions The development of new migraine‐specific classes of medications provides more treatment options for both acute and preventive treatment of migraine.

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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…”

mentioning

confidence: 99%