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

David William Dodick, Messoud Ashina, Jan Lewis Brandes, David Kudrow, Michel Lanteri-Minet, Vera Osipova, Kerry Palmer, Hernan Picard, Daniel D. Mikol, Robert A. Lenz

Research output: Contribution to journalArticle

89 Citations (Scopus)

Abstract

Background: Calcitonin gene-related peptide plays an important role in migraine pathophysiology. Erenumab, a human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, is being evaluated for migraine prevention. Methods: In this randomized, double-blind, placebo-controlled, phase 3 study, 577 adults with episodic migraine were randomized to placebo or 70 mg erenumab; 570 patients were included in efficacy analyses. Primary endpoint was change in monthly migraine days. Secondary endpoints were ≥50% reduction in monthly migraine days, change in acute migraine-specific medication treatment days, and ≥5-point reduction in Physical Impairment and Impact on Everyday Activities domain scores measured by the Migraine Physical Function Impact Diary. All endpoints assessed change from baseline at month 3. Results: Patients receiving erenumab experienced −2.9 days change in monthly migraine days, compared with −1.8 days for placebo, least-squares mean (95% CI) treatment difference of −1.0 (−1.6, −0.5) (p < 0.001). A ≥ 50% reduction in monthly migraine days was achieved by 39.7% (erenumab) and 29.5% (placebo) of patients (OR:1.59 (95% CI: 1.12, 2.27) (p = 0.010). Migraine-specific medication treatment days were reduced by −1.2 (erenumab) and −0.6 (placebo) days, a treatment difference of −0.6 (−1.0, −0.2) (p = 0.002). The ≥5-point reduction rates in Migraine Physical Function Impact Diary – Physical Impairment were 33.0% and 27.1% (OR:1.33 (0.92, 1.90) (p = 0.13) and in Migraine Physical Function Impact Diary – Everyday Activities were 40.4% and 35.8% (OR:1.22 (0.87, 1.71) (p = 0.26). Safety and adverse event profiles of erenumab were similar to placebo. Most frequent adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis. Conclusions: As a preventive treatment of episodic migraine, erenumab at a dosage of 70 mg monthly significantly reduced migraine frequency and acute migraine-specific medication use. (Funded by Amgen). Trial registration: ClinicalTrials.gov, NCT02483585.

Original languageEnglish (US)
JournalCephalalgia
DOIs
StateAccepted/In press - Jan 1 2018

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Migraine Disorders
Placebos
Nasopharyngitis
Calcitonin Gene-Related Peptide Receptors
Therapeutics
Calcitonin Gene-Related Peptide
Least-Squares Analysis
Respiratory Tract Infections

Keywords

  • calcitonin gene-related peptide
  • efficacy
  • Erenumab
  • migraine
  • safety

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Dodick, D. W., Ashina, M., Brandes, J. L., Kudrow, D., Lanteri-Minet, M., Osipova, V., ... Lenz, R. A. (Accepted/In press). ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. https://doi.org/10.1177/0333102418759786

ARISE : A Phase 3 randomized trial of erenumab for episodic migraine. / Dodick, David William; Ashina, Messoud; Brandes, Jan Lewis; Kudrow, David; Lanteri-Minet, Michel; Osipova, Vera; Palmer, Kerry; Picard, Hernan; Mikol, Daniel D.; Lenz, Robert A.

In: Cephalalgia, 01.01.2018.

Research output: Contribution to journalArticle

Dodick, DW, Ashina, M, Brandes, JL, Kudrow, D, Lanteri-Minet, M, Osipova, V, Palmer, K, Picard, H, Mikol, DD & Lenz, RA 2018, 'ARISE: A Phase 3 randomized trial of erenumab for episodic migraine', Cephalalgia. https://doi.org/10.1177/0333102418759786
Dodick, David William ; Ashina, Messoud ; Brandes, Jan Lewis ; Kudrow, David ; Lanteri-Minet, Michel ; Osipova, Vera ; Palmer, Kerry ; Picard, Hernan ; Mikol, Daniel D. ; Lenz, Robert A. / ARISE : A Phase 3 randomized trial of erenumab for episodic migraine. In: Cephalalgia. 2018.
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abstract = "Background: Calcitonin gene-related peptide plays an important role in migraine pathophysiology. Erenumab, a human monoclonal antibody that inhibits the calcitonin gene-related peptide receptor, is being evaluated for migraine prevention. Methods: In this randomized, double-blind, placebo-controlled, phase 3 study, 577 adults with episodic migraine were randomized to placebo or 70 mg erenumab; 570 patients were included in efficacy analyses. Primary endpoint was change in monthly migraine days. Secondary endpoints were ≥50{\%} reduction in monthly migraine days, change in acute migraine-specific medication treatment days, and ≥5-point reduction in Physical Impairment and Impact on Everyday Activities domain scores measured by the Migraine Physical Function Impact Diary. All endpoints assessed change from baseline at month 3. Results: Patients receiving erenumab experienced −2.9 days change in monthly migraine days, compared with −1.8 days for placebo, least-squares mean (95{\%} CI) treatment difference of −1.0 (−1.6, −0.5) (p < 0.001). A ≥ 50{\%} reduction in monthly migraine days was achieved by 39.7{\%} (erenumab) and 29.5{\%} (placebo) of patients (OR:1.59 (95{\%} CI: 1.12, 2.27) (p = 0.010). Migraine-specific medication treatment days were reduced by −1.2 (erenumab) and −0.6 (placebo) days, a treatment difference of −0.6 (−1.0, −0.2) (p = 0.002). The ≥5-point reduction rates in Migraine Physical Function Impact Diary – Physical Impairment were 33.0{\%} and 27.1{\%} (OR:1.33 (0.92, 1.90) (p = 0.13) and in Migraine Physical Function Impact Diary – Everyday Activities were 40.4{\%} and 35.8{\%} (OR:1.22 (0.87, 1.71) (p = 0.26). Safety and adverse event profiles of erenumab were similar to placebo. Most frequent adverse events were upper respiratory tract infection, injection site pain, and nasopharyngitis. Conclusions: As a preventive treatment of episodic migraine, erenumab at a dosage of 70 mg monthly significantly reduced migraine frequency and acute migraine-specific medication use. (Funded by Amgen). Trial registration: ClinicalTrials.gov, NCT02483585.",
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AU - Ashina, Messoud

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AU - Kudrow, David

AU - Lanteri-Minet, Michel

AU - Osipova, Vera

AU - Palmer, Kerry

AU - Picard, Hernan

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