Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine: Analysis of the EVOLVE Studies

Holland C. Detke, Brian A. Millen, Qi Zhang, Karen Samaan, Jessica Ailani, David W. Dodick, Sheena K. Aurora

Research output: Contribution to journalArticle

Abstract

Objective: To evaluate onset of effect of galcanezumab in patients with episodic migraine. Background: Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide and is indicated for preventive treatment of migraine. Design/Methods: Data on the primary outcome measure were analyzed from 2 previously published double-blind, Phase 3 studies (EVOLVE-1 [N = 858] and EVOLVE-2 [N = 915]) wherein adult patients with episodic migraine were randomized to receive monthly subcutaneous injections of galcanezumab 120 mg (with 240-mg loading dose) or 240 mg or placebo for up to 6 months. Monthly onset of effect was defined as the earliest month at which galcanezumab achieved and subsequently maintained statistical superiority to placebo on the mean change from baseline in the number of monthly migraine headache days (MHDs). If onset occurred in Month 1, weekly onset was evaluated and defined as the earliest week at which galcanezumab statistically separated from placebo and maintained statistical separation for remaining weeks in that month. Day of onset of effect was also analyzed, as were monthly and weekly onset, for occurrence of ≥50% reduction from baseline in number of MHDs. Results: For both studies, change from baseline in monthly MHDs showed a statistically significant separation of galcanezumab from placebo at Month 1 and each subsequent month (each P <.001). Analysis of the first month for both studies indicated onset of effect in the first week, with galcanezumab-treated patients having significantly higher odds of having fewer MHDs in the first week (odds ratio [95% confidence interval] for EVOLVE-1, 2.71 [2.00, 3.66], and for EVOLVE-2, 2.88 [2.16, 3.86]; both P <.001) and each subsequent week compared with placebo-treated patients (P ≤.004). Daily analysis showed onset of effect at Day 1 (first day after injection day). Galcanezumab also demonstrated superiority to placebo on occurrence of ≥50% reduction in MHDs starting at Week 1 (percentage of patients with 50% response in galcanezumab group vs placebo group for EVOLVE-1, 54.3% vs 32.4% [P <.001], and for EVOLVE-2, 59.4% vs 38.0% [P <.001]). Conclusion: Rapid onset of preventive effect on the first day after injection of galcanezumab was confirmed in both studies of episodic migraine.

Original languageEnglish (US)
JournalHeadache
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Migraine Disorders
Placebos
Injections
Calcitonin Gene-Related Peptide
Subcutaneous Injections
Odds Ratio
Monoclonal Antibodies
Outcome Assessment (Health Care)
Confidence Intervals

Keywords

  • calcitonin gene-related peptide
  • episodic migraine
  • galcanezumab
  • onset of effect

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine : Analysis of the EVOLVE Studies. / Detke, Holland C.; Millen, Brian A.; Zhang, Qi; Samaan, Karen; Ailani, Jessica; Dodick, David W.; Aurora, Sheena K.

In: Headache, 01.01.2019.

Research output: Contribution to journalArticle

Detke, Holland C. ; Millen, Brian A. ; Zhang, Qi ; Samaan, Karen ; Ailani, Jessica ; Dodick, David W. ; Aurora, Sheena K. / Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine : Analysis of the EVOLVE Studies. In: Headache. 2019.
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title = "Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine: Analysis of the EVOLVE Studies",
abstract = "Objective: To evaluate onset of effect of galcanezumab in patients with episodic migraine. Background: Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide and is indicated for preventive treatment of migraine. Design/Methods: Data on the primary outcome measure were analyzed from 2 previously published double-blind, Phase 3 studies (EVOLVE-1 [N = 858] and EVOLVE-2 [N = 915]) wherein adult patients with episodic migraine were randomized to receive monthly subcutaneous injections of galcanezumab 120 mg (with 240-mg loading dose) or 240 mg or placebo for up to 6 months. Monthly onset of effect was defined as the earliest month at which galcanezumab achieved and subsequently maintained statistical superiority to placebo on the mean change from baseline in the number of monthly migraine headache days (MHDs). If onset occurred in Month 1, weekly onset was evaluated and defined as the earliest week at which galcanezumab statistically separated from placebo and maintained statistical separation for remaining weeks in that month. Day of onset of effect was also analyzed, as were monthly and weekly onset, for occurrence of ≥50{\%} reduction from baseline in number of MHDs. Results: For both studies, change from baseline in monthly MHDs showed a statistically significant separation of galcanezumab from placebo at Month 1 and each subsequent month (each P <.001). Analysis of the first month for both studies indicated onset of effect in the first week, with galcanezumab-treated patients having significantly higher odds of having fewer MHDs in the first week (odds ratio [95{\%} confidence interval] for EVOLVE-1, 2.71 [2.00, 3.66], and for EVOLVE-2, 2.88 [2.16, 3.86]; both P <.001) and each subsequent week compared with placebo-treated patients (P ≤.004). Daily analysis showed onset of effect at Day 1 (first day after injection day). Galcanezumab also demonstrated superiority to placebo on occurrence of ≥50{\%} reduction in MHDs starting at Week 1 (percentage of patients with 50{\%} response in galcanezumab group vs placebo group for EVOLVE-1, 54.3{\%} vs 32.4{\%} [P <.001], and for EVOLVE-2, 59.4{\%} vs 38.0{\%} [P <.001]). Conclusion: Rapid onset of preventive effect on the first day after injection of galcanezumab was confirmed in both studies of episodic migraine.",
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T1 - Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine

T2 - Analysis of the EVOLVE Studies

AU - Detke, Holland C.

AU - Millen, Brian A.

AU - Zhang, Qi

AU - Samaan, Karen

AU - Ailani, Jessica

AU - Dodick, David W.

AU - Aurora, Sheena K.

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N2 - Objective: To evaluate onset of effect of galcanezumab in patients with episodic migraine. Background: Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide and is indicated for preventive treatment of migraine. Design/Methods: Data on the primary outcome measure were analyzed from 2 previously published double-blind, Phase 3 studies (EVOLVE-1 [N = 858] and EVOLVE-2 [N = 915]) wherein adult patients with episodic migraine were randomized to receive monthly subcutaneous injections of galcanezumab 120 mg (with 240-mg loading dose) or 240 mg or placebo for up to 6 months. Monthly onset of effect was defined as the earliest month at which galcanezumab achieved and subsequently maintained statistical superiority to placebo on the mean change from baseline in the number of monthly migraine headache days (MHDs). If onset occurred in Month 1, weekly onset was evaluated and defined as the earliest week at which galcanezumab statistically separated from placebo and maintained statistical separation for remaining weeks in that month. Day of onset of effect was also analyzed, as were monthly and weekly onset, for occurrence of ≥50% reduction from baseline in number of MHDs. Results: For both studies, change from baseline in monthly MHDs showed a statistically significant separation of galcanezumab from placebo at Month 1 and each subsequent month (each P <.001). Analysis of the first month for both studies indicated onset of effect in the first week, with galcanezumab-treated patients having significantly higher odds of having fewer MHDs in the first week (odds ratio [95% confidence interval] for EVOLVE-1, 2.71 [2.00, 3.66], and for EVOLVE-2, 2.88 [2.16, 3.86]; both P <.001) and each subsequent week compared with placebo-treated patients (P ≤.004). Daily analysis showed onset of effect at Day 1 (first day after injection day). Galcanezumab also demonstrated superiority to placebo on occurrence of ≥50% reduction in MHDs starting at Week 1 (percentage of patients with 50% response in galcanezumab group vs placebo group for EVOLVE-1, 54.3% vs 32.4% [P <.001], and for EVOLVE-2, 59.4% vs 38.0% [P <.001]). Conclusion: Rapid onset of preventive effect on the first day after injection of galcanezumab was confirmed in both studies of episodic migraine.

AB - Objective: To evaluate onset of effect of galcanezumab in patients with episodic migraine. Background: Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide and is indicated for preventive treatment of migraine. Design/Methods: Data on the primary outcome measure were analyzed from 2 previously published double-blind, Phase 3 studies (EVOLVE-1 [N = 858] and EVOLVE-2 [N = 915]) wherein adult patients with episodic migraine were randomized to receive monthly subcutaneous injections of galcanezumab 120 mg (with 240-mg loading dose) or 240 mg or placebo for up to 6 months. Monthly onset of effect was defined as the earliest month at which galcanezumab achieved and subsequently maintained statistical superiority to placebo on the mean change from baseline in the number of monthly migraine headache days (MHDs). If onset occurred in Month 1, weekly onset was evaluated and defined as the earliest week at which galcanezumab statistically separated from placebo and maintained statistical separation for remaining weeks in that month. Day of onset of effect was also analyzed, as were monthly and weekly onset, for occurrence of ≥50% reduction from baseline in number of MHDs. Results: For both studies, change from baseline in monthly MHDs showed a statistically significant separation of galcanezumab from placebo at Month 1 and each subsequent month (each P <.001). Analysis of the first month for both studies indicated onset of effect in the first week, with galcanezumab-treated patients having significantly higher odds of having fewer MHDs in the first week (odds ratio [95% confidence interval] for EVOLVE-1, 2.71 [2.00, 3.66], and for EVOLVE-2, 2.88 [2.16, 3.86]; both P <.001) and each subsequent week compared with placebo-treated patients (P ≤.004). Daily analysis showed onset of effect at Day 1 (first day after injection day). Galcanezumab also demonstrated superiority to placebo on occurrence of ≥50% reduction in MHDs starting at Week 1 (percentage of patients with 50% response in galcanezumab group vs placebo group for EVOLVE-1, 54.3% vs 32.4% [P <.001], and for EVOLVE-2, 59.4% vs 38.0% [P <.001]). Conclusion: Rapid onset of preventive effect on the first day after injection of galcanezumab was confirmed in both studies of episodic migraine.

KW - calcitonin gene-related peptide

KW - episodic migraine

KW - galcanezumab

KW - onset of effect

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